top ten priorities for fda in 2017 - american bar ... ten priorities for fda in 2017 aba ad law...

TOP TEN PRIORITIES FOR FDAIN 2017

ABA AD LAW COMMITTEE ON FOOD & DRUG LAW

PROF. JAMES T. O’REILLY

PROF. KATHARINE VAN TASSEL

EDGAR J. ASEBEY, ESQ.

FDA’S SAFETY IMPORTANCE TO CONSUMERSIS A MISSION THAT DETERS POLITICAL FORCES• ADMINISTRATION POSITIONS TOWARD FDA REFLECT A WARINESS OF

APPEARING TO THE PUBLIC AS INCREASING SAFETY RISKS

• THIS INDUSTRY DOES NOT WANT “WILD WEST” REGULATORY VIEW

• TARIFF POLICY WILL CHANGE TO DISCOURAGE LOW-COST IMPORTS

• CHINA’S KEY SOURCE FOR DRUGS MAY FACTOR INTO TRUMP TRADE

• CONCERN ABOUT LESSENING HEALTHY FOOD & LESS SAFE DRUGS

• FDA COMMISSIONER JOB IS SENATE-CONFIRMED

• WATCH LOBBYISTS ASSIGNED TO HHS TRANSITION – NO POLICY PAPERS ON FDA ISSUES WERE AVAILABLE DURING CAMPAIGN

REAL “TOP TEN” DECIDED BELOW LEVEL OF TRUMP BY SELECTED HHS TEAM• LINGERING WOUND: REJECTION OF TRUMP DURING CAMPAIGN BY

OLD-LINE REPUBLICANS LEADING “ESTABLISHMENT”

• WILL THERE BE PAYBACK FOR KOCH FOODS’ INVESTMENTS?

• PHARMA ASSN & DEVICE MAKERS WILL HAVE WAY MORE POWER

• ACA REPEAL WILL KILL DEVICE TAX; UNCLEAR HOW SUBSIDIES FOR LOW-INCOME INSURC. NEEDS WILL BE FUNDED, OR JUST ELIMINATED

• WATCH THE HHS TRANSITION TO SEE WHO DISPLACES COM. CALIFF

• WATCH 115TH CONGRESS COMMITTEE CHAIR SELECTION BY RYAN AS INDICATORS OF WHICH REPEALS WILL MOVE FIRST

DON’T JUST WATCH FDA

• GIULIANI’S JUSTICE DEPT WILL SHIFT STAFF AWAY FROM REGULATORY ENFORCEMENT TEAMS TO “HARD NOSED” CRIME SUPPRESSION

• HENCE FEWER DoJ ENFORCEMENT CASES ACCEPTED FROM FDA

• OMB/OIRA WILL SHIFT INTO REVERSE, EXTINGUISHING PENDING SET OF OBAMA “MIDNIGHT RULES’

• HHS GRANT MAKING VIA NIH LIKELY TO BE CUT SHARPLY

• DEA: MORE RESOURCES SPENT ON BORDER, LESS LIKELY TO ACT ON REGULATORY DOCUMENTATION ISSUES

• CUSTOMS: MUCH MORE ACTIVITY IN SCREENING CHINA CARGOES

1. IMPORT SAFETY ISSUES

• EDGAR J. ASEBEY, ESQ., REGULATORY & BUSINESS LAW (POMPANO BEACH, FL)

• TRADE & JOBS FOCUS OF CAMPAIGN: TRANSLATE INTO NEW TARIFF LAW & REDUCTION IN REGULATORY OVERSIGHT OF FDA-REGULATED INDUSTRIES

• “JOB CREATION” PLEDGE IN FOOD: WHO WANTS TO BE PICKERS & CLEANERS?

• FOREIGN TRADE CONCERNS FACTORED INTO ELECTION CAMPAIGN (I.E. NAFTA REPEAL?)

• FSMA LAW PROTECTIONS OF SAFETY OF FOOD IMPORTS

• ANTI-IMPORT MOOD: FOODS FROM TROPICAL AREAS, UNLIKE SOME INDUSTRIAL PLANTS, CAN’T BE MOVED BACK TO USA; IMMIGRATION WALL THREATENS US FARMERS’ ACCESS TO FIELD LABORERS

• WTO CHALLENGE ALLEGING UNFAIR TRADE PRACTICES?

• PREFERENCE FOR IMPORTATION OF CHEAPER RX DRUGS VS. REPUBLICAN PHARMA LOBBY

• API & DRUGS GENERIC PRODUCTION 80% EX-USA, CLOSER TO RAW MATERIALS & TECHNOLOGIES FOR MANUFACTURING, LESS LIKELY TO BE RETURNED TO USA

• DEVICES INCREASINGLY TESTED & SOURCED OUTSIDE USA

Does Mandatory Listing of Novel Ingredients Violate the First

Amendment's Protection Against Forced Speech?

Katharine Van TasselRetired Professor of Law, Creighton University Law School

Adjunct Professor, Georgetown UniversityRegulatory Counsel, FDA Imports, Inc.

GM Salmon

Lab Grown Meat

Lab Grown Meat or “Shmeat”

Nanoparticles

Mandatory Listing of Novel Ingredients and the First Amendment

For ideological, spiritual, or aesthetic reasons, consumers care about

– who produced

– how produced

– where produced

– what produced with

Is there a consumer “right to know” these facts about consumer products?

Mandatory Listing of Novel Ingredients and the First

Amendment

These preferences are real

– but, as we will see, they are unlikely to rise to a sufficiently substantial interest to justify compelling speech

As a public health agency, what position can the FDA take to support a listing requirement when it comes to novel ingredients that won’t run afoul of the Frist Amendment ?


The Supreme Court in Zauderer held that

compelled commercial speech, and the compelled disclosure of factualinformation in particular, should be subject to less demanding scrutiny.

Further, the Court stated that

the constitutionally protected interest in not providing any particular factualinformation in advertising is minimal.


The Zuaderer Court found that only reasonable basis review should apply, explaining that:

a requirement that a seller disclose factual information will be upheld so long as the requirement is not unduly burdensome and the requirement is “reasonably related” to a substantial governmental interest.

What could be a sufficiently substantial interest?

The novel nature of ingredients created using novel technologies suggests a need

To animate the public health product safety net

Post market tracking to protect public health

Public Health Product Safety Net

Ingredient Labeling= Post Market Surveillance

Report Injury to Physician for Proper

Treatment

Report to the FDA

Report to the CDC




Treatment

Report to the FDA

Report to the CDC Data Gathering

Public Health Safety Net



Treatment

Report to the FDA

Report to the CDC

Product Recall or Warnings or Reformulation

Data Gathering




Treatment

Report to the FDA

Report to the CDC


Enables Tort

System to Assess

Liability

Data Gathering




Treatment

Report to the FDA

Report to the CDC


Enables Tort

System to Assess

Liability

Data Gathering

Encourage Proper Investment in

Safety, Best Cost Avoider and

Spreader Cost, Production

3. MARIJUANA LEGALIZATION, WHAT NEXT?

• PROF. JIM O’REILLY, UNIV. CINCINNATI

• DEA REGTY. PRIMACY SHAKEN BY MULTIPLE STATE LEGALIZATIONS

• WILL THIS NEW CONGRESS ALLOW “LIBERALIZATION” OF MARIJUANA?

• HEALTH EFFECTS RESEARCH VERY CONSTRAINED BY SCHED 1 STATUS

• IF DEA REDUCE SCHEDULE 1 STATUS: FDA & RESEARCH SAFETY ISSUES

• STATES NOW HAVE DOMINANT ROLE, BUT VERY FRACTURED

• WILL FDA WORK WITH STATES TO DEVELOP CLIN. TESTING OPTIONS?

• BETWEEN FDA’S DRUG ROLE AND FDA TOBACCO ROLE, SHOULD FDA WILLINGLY ACCEPT NEW REGULATORY POWERS TO CONTROL SAFETY OF FORMS OF MARKETED MARIJUANA

4. IMPLEMENTING FSMA

• EDGAR J. ASEBEY, ESQ., REGULATORY & BUSINESS LAW (POMPANO BEACH, FL)

• ROLL OUT OF LEGISLATION INTO RULES IS NOT LIKELY TO BE HALTED

• WILL NEW ADMINISTRATION LIMIT THE EFFECTIVENESS OF FSMA REGULATIONS BY LIMITING FUNDING FOR ENFORCEMENT?

• PRIORITIES FOR FDA ARE TOP 5 FSMA RULES:• PREVENTIVE CONTROLS FOR HUMAN FOOD• PREVENTIVE CONTROLS FOR ANIMAL FOOD• PRODUCE SAFETY• FOREIGN SUPPLIER VERIFICATION PROGRAM• ACCREDITATION OF 3RD PARTY AUDITORS

• HOW WILL THE NEW TRUMP BIAS AGAINST IMPORTS FACTOR INTO FINAL RULES?

• DOES NEW POLITICAL CLOUT OF FOOD CORP’S MEAN FDA RULES ON FSMA RETREAT FROM TOUGH OVERSIGHT OF FOOD PLANTS?

5. REORGANIZATION OF FDA’S FIELD FORCE

• PROF. JIM O’REILLY

• PRODUCTIVITY CHALLENGES AS FDA FIELD STAFF SHRINKS

• CHANGES IN “WHO IN FDA DOES WHAT, WHERE” ARE PROGRESSING

• OLD FDA GEOGRAPHICAL DISTRICTS GOING AWAY

• NEW PRODUCT-CENTERED FIELD FOCUS REPLACING IT

• MORE TRAVEL BY MORE FDA FIELD STAFFERS

• SIGNIFICANT ISSUE RE COST OF INTERNATIONAL INSPECTIONS FORCE

• WHAT ARE MAJOR EFFECTS ON MORALE? FEAR FACTOR? TRAVELS?

• HOW HAVE “REGRETTED DEPARTURES” OF FDA VETS INCREASED?



When Is the Use of the Term “Healthy” on Foods

Deceptive and Misleading?

“Healthy” Claims on Foods

Obesity Crisis

• More than one-third (36.5%) of U.S. adults have obesity

• Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death.

• The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars; the medical costs for people who are obese were $1,429 higher than those of normal weight.

FDA Guidance - focuses on “healthy” as implied nutrient content claim

• Healthy means

– foods that have a fat profile of predominantly mono and polyunsaturated fats

– but do not meet the regulatory definition of “low fat”

– or that contain at least 10 percent of the Daily Value per reference amount customarily consumed of potassium or vitamin D

FDA Solicits Comments

• For example, what current dietary recommendations should be reflected in the definition of “healthy”?

• What are the public health benefits of defining the term “healthy”?

• What do consumers expect of foods that carry a “healthy” claim?

• What factors and criteria should be used for the new definition of “healthy”?


• Down the rabbit hole… again

• public comments on ‘natural’ claims

• heavily they rely on words such as ‘chemicals,’ 'natural, ‘artificial’ and ‘processed,’ which themselves are not clearly defined in law.


• Healthy: Not just about nutrition?

• comments reflect a shift in the way consumers think about ‘healthy’

– from being narrowly focused on fat, sugar, calories or other nutrients

• to more wide ranging definitions – ‘artificial ingredients’

– GMOs

– Equating healthy means 'organic


• Kelie Cichoski:

Healthy should mean no chemicals, no preservatives that are not naturally occurring, no hormones, and no antibiotics.


• George Inashvili:

–By far and away the most important definition of healthy is that it's true organic. Healthy is nonGMO… Healthy is elimination of sugar… Healthy is a mostly vegan, organic diet full of dark leafy greens, green teas, and plant protein.

Exhibit 6-17 MISBRANDING CASE - DESCRIPTION OF CHARGE FROM A COMPLAINT - FDA Manual

• Labeling that is alleged to be false or misleading under 21 U.S.C. 352(a) (or 343(a))

– A misleading statement need not be false to violate the Act; it is enough that a statement has the capacity or tendency to deceive, by indirection, ambiguity, or by partial or half-truths.

– A statement can even be technically true in its entirety and still violate the Act.

Standard for “Deceptive and Misleading” Claims?

What standard that should be used when

determining whether a claim is deceptive and

misleading?

Should the relative vulnerability of the health

status of the targeted population be considered?


On one end of the spectrum, courts state that the purpose of the FDCA is

"to protect the public, the vast multitude which includes the ignorant, the unthinking and the credulous who, when making a purchase, do not stop to analyze."

“The test is not the effect of the label on a 'reasonable consumer,' but upon 'the ignorant, the unthinking and the credulous' consumer.“


On the other end of the spectrum, some courts have held that the test is that of "purchasers who are of normal capacity and use that capacity in a common sense way."


2002 Guidance: FDA adopted

reasonable consumer standard


The "reasonable person" standard

used to assign fault, and thereby liability, through tort law that governs conduct between manufacturers and consumers

Is imported into the public health context


Reasonable person approach

ignores the role of the FDA to protect the health of all of the population

7. NOVEL: SENSORS, GENES & TELEMEDICINE

• PROF. JIM O’REILLY, UNIV. CINCINNATI

• FDA OFFICE OF COMBINATION PRODUCTS SEEKS TO RECONCILE INTERESTS

• INDUSTRY LIKELY TO CONTINUE WORK ON SENSORS FOR “PERSONALIZED MEDICINE” DIAGNOSTIC ABILITIES

• MUCH PROGRESS ON TELEMEDICINE WITH SENSORS

• TELEMED BATTLES ARE WITH STATE MEDICAL LICENSING BOARDS, UNCLEAR WHERE GIULIANI’S DoJ ANTITRUST DIVISION WILL ACT (OR NOT)

• PROGRESSIVE INTERACTIONS BY RX & DEVICE FIRMS NEEDED

• QUESTION OF IMPACTS OF LIKELY CUTS TO NIH AND HHS FUNDING

• WILL PVT SECTOR FUND ENOUGH GENE RESEARCH IF NIH GRANTS SHRINK

Vaccine Compensation Fund

And

Vaccine Court



Importance of Vaccines

The current routine childhood immunization schedule is estimated to:

–Prevent 42,000 deaths

–Prevent 20 million cases of disease

– Save $14 billion in direct medical costs

Per US birth cohort

The success of vaccines in reducing disease-associated mortality is second only to the introduction of safe drinking water

The National Vaccine Injury Compensation Program (VICP)

• To ensure individuals thought injured by routine childhood vaccines are provided with fair and efficient compensation

• To ensure a stable vaccine supply by limiting liability for manufacturers and administrators

Vaccine Injury Compensation Trust Fund

• Derives from excise tax of $.75 on each dose of covered vaccine purchased

• Examples:

• DTaP Vaccine -- $2.25

• IPV -- $.75

• Provides payment of awards

• Current balance is $1.3 billion

8 special masters.

Only 8 Special Masters

8 special masters.

Vaccine Compensation Fund

And

Vaccine Court



9. BACKLOGS OF GENERIC RX’S: HOW TO FIX?

• PROF. JIM O’REILLY, UNIV. OF CINCINNATI

• NOT LIKELY TRUMP COULD SIMPLY MASS-APPROVE OLDEST ANDA’S

• GDUFA MONEY VERY MUCH NEEDED TO STAFF UP, MOVE BACKLOGS

• VIEWS OF TRUMP RE “RED TAPE” IN DRUG APPROVALS ARE HOSTILE

• ANTI-IMPORT, ANTI-CHINA VIEWS MAY TIGHTEN SAMPLING AT PORT

• INSIDER LOBBYIST EFFORTS TO BLOCK MORE GENERICS WILL RISE

• INSIDER REPUBLICAN WASHINGTON PHARMA LOBBY MAY CLASH WITH “CUT COST” INCENTIVES FOR REDUCTION OF WAIT TIME FOR MARKETING OF NEW GENERICS

10. WHITHER RESEARCH ON DEMENTIA?

• PROF. JIM O’REILLY, UNIV. OF CINCINNATI

• SEE MORE EXTERNAL STRESSES TO “FAST TRACK” NEW BRAIN DRUGS

• DON’T FORGET FINDING CURE FOR ALZHEIMER’S…IF YOU STILL CAN

• MANY RX TRIALS UNDERWAY, NO SILVER BULLET DRUGS YET

• STATISTICS SHOW BIG INCREASE AMONG BOOMERS & POST-70’S

• FAST TRACKED DRUGS MAY REDUCE ASSURANCE OF SAFETY

• TRUMP: LOSS OF NIH FUNDING LIKELY, FEWER GRANTS AVAILABLE

• UNCERTAINTY HOLDS BACK INVESTOR FUNDS TO LONG-SHOT R&D

TOUGH TIME TO BE INSIDE FDA STAFF

• REDUCTIONS IN “RED TAPE” ARE NOW POLICY

• ELIMINATION OF RULES, STOPPING NEW RULES AT OMB/OIRA

• DECISIONS MORE LIKELY TO RUN AGAINST FDA INITIATIVES

• INDUSTRY’S ALUMNI LIKELY TO BE IN KEY POLICY SETTING ROLES

• RETURN TO POWER OF FORMER ADVOCATES FOR INDUSTRY

• CAREER REGULATORS: “LAST ONE OUT, TURN OUT THE LIGHTS”

FSMA RULEMAKING – on line at

http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

Implementation Activity Mitigation Strategies to Protect Food Against Intentional

Adulteration Final Rule Sanitary Transportation of Human and Animal Food Final

Rule Produce Safety Final Rule and Environmental Impact

Statement Foreign Supplier Verification Programs (FSVP) Final Rule Accredited Third-Party Certification Final Rule Preventive Controls for Human Food Final Rule Preventive Controls for Food for Animals Final Rule

FSMA Guidance Documents – on line at

http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

Guidance for Industry: FDA's Voluntary Qualified Importer Program

November 10, 2016

Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)

November 7, 2016

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide

October 31, 2016

PLEASE NOTE: PANEL WILL ALSO ADDRESS NEW FDA LEGISLATION IF ADOPTED BEFORE CONFERENCE

“21st Century Cures Act” – FDA Most Relevant Segments as of Nov. 25, 2016 – Final Text of Bill as Passed is on congress.gov

==============================================

HOUSE RULES COMMITTEE PRINT 114-67

TITLE III—DEVELOPMENT

Subtitle A—Patient-Focused Drug Development

Sec. 3001. Patient experience data.

Sec. 3002. Patient-focused drug development guidance.

Sec. 3003. Streamlining patient input.

Sec. 3004. Report on patient experience drug development.

Subtitle B—Advancing New Drug Therapies

Sec. 3011. Qualification of drug development tools.

Sec. 3012. Targeted drugs for rare diseases.

Sec. 3013. Reauthorization of program to encourage treatments for rare pediatric diseases.

Sec. 3014. GAO study of priority review voucher programs.

Sec. 3015. Amendments to the Orphan Drug grants.

Sec. 3016. Grants for studying continuous drug manufacturing.

Subtitle C—Modern Trial Design and Evidence Development

Sec. 3021. Novel clinical trial designs.

Sec. 3022. Real world evidence.

Sec. 3023. Protection of human research subjects.

Sec. 3024. Informed consent waiver or alteration for clinical investigations.

Subtitle D—Patient Access to Therapies and Information

Sec. 3031. Summary level review.

Sec. 3032. Expanded access policy.

Sec. 3033. Accelerated approval for regenerative advanced therapies.

Sec. 3034. Guidance regarding devices used in the recovery, isolation, or delivery of regenerative advanced therapies.

Sec. 3035. Report on regenerative advanced therapies.

Sec. 3036. Standards for regenerative medicine and regenerative advanced therapies.

Sec. 3037. Health care economic information.

Sec. 3038. Combination product innovation. ======================================

Subtitle E—Antimicrobial Innovation and Stewardship

Sec. 3041. Antimicrobial resistance monitoring.

Sec. 3042. Limited population pathway.

Sec. 3043. Prescribing authority.

Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices.

Subtitle F—Medical Device Innovations

Sec. 3051. Breakthrough devices.

Sec. 3052. Humanitarian device exemption.

Sec. 3053. Recognition of standards.

Sec. 3054. Certain class I and class II devices.

Sec. 3055. Classification panels.

Sec. 3056. Institutional review board flexibility.

Sec. 3057. CLIA waiver improvements.

Sec. 3058. Least burdensome device review.

Sec. 3059. Cleaning instructions and validation data requirement.

Sec. 3060. Clarifying medical software regulation. ===============================

Subtitle G—Improving Scientific Expertise and Outreach at FDA

Sec. 3071. Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service.

Sec. 3072. Hiring authority for scientific, technical, and professional personnel.

Sec. 3073. Establishment of Food and Drug Administration Intercenter Institutes.

Sec. 3074. Scientific engagement.

Sec. 3075. Drug surveillance.

Sec. 3076. Reagan-Udall Foundation for the Food and Drug Administration.

Electronic copy available at: http://ssrn.com/abstract=2240034

VAN TASSEL PROOF F (DO NOT DELETE) 10/23/2013 1:13 AM

433

Regulating in Uncertainty: Animating the

Public Health Product Safety Net to Capture

Consumer Products Regulated by the FDA

that Use Innovative Technologies, Including

Nanotechnologies, Genetic Modification,

Cloning, and Lab Grown Meat

Katharine Van Tassel†

I. INTRODUCTION

“For want of a nail, the war was lost.”1

The past several decades have seen the creation of

transformative new technologies that are being used to design

† Professor of Law, University of Akron School of Law, BSN, Case Western Reserve

University; JD, Case Western Reserve University School of Law; MPH, Harvard School

of Public Health.

1 Part of a proverbial rhyme showing that small actions can result in large

consequences:

For want of a nail the shoe was lost.

For want of a shoe the horse was lost.

For want of a horse the rider was lost.

For want of a rider the message was lost.

For want of a message the battle was lost.

For want of a battle the kingdom was lost.

And all for the want of a horseshoe nail.

Benjamin Franklin, Poor Richard’s Almanack 69 (1758). This Article will explain how

the powerful public health product safety net is activated when innovative ingredients

are identified on product labels. For example, nanotech ingredients can be identified

with just four simple letters, “nano,” in front of each ingredient that is nano-sized, or just

two letters, “GM,” can be placed in front of ingredients that are genetically modified.

With just the simple step of placing a couple of letters on the ingredient lists on product

labels, the public health product safety net will be activated, potentially averting a

public health crisis from exposures to novel, innovative ingredients. Thus, this small

action could avert a large consequence.



434 THE UNIVERSITY OF CHICAGO LEGAL FORUM [2013

innovative consumer product ingredients never before seen in

nature. Examples include the use of nanotechnology and genetic

modification, and, right around the corner, cloned animals used

for food, as well as lab-grown meat.2 These innovative, novel3

technologies are harbingers of more pioneering consumer

product ingredients to come. This remarkable pace in the

development of groundbreaking new technologies means that

the population is being steadily exposed to novel ingredients

with unknown health risks.

Optimally, the Food and Drug Administration (FDA) should

be regulating these innovative, novel ingredients in consumer

products to meet the twin goals of fostering innovation while

protecting public health. However, the current litmus test that

the FDA is using to trigger regulation to protect public health is

focused on hazard.4 Linking public health protections to the

degree of hazard when operating in scientific uncertainty is

outcome determinative—it means no regulation to protect public

health at all. This is because it is common for the development

of innovative, novel technologies to far outpace the development

of the science necessary to test for the health risks associated

with these technologies.5 This scientific lag time creates an

information void with regard to risks to human health that can

2 See generally Henry Fountain, Building a $350,000 Burger, NY Times (May 12,

2013), online at http: //www.nytimes.com/2013/05/14/science/engineering-the-325000-in-

vitro-burger.html?pagewanted=all&_r=0 (visited Sept 15, 2013) (describing a five ounce

hamburger being assembled from tiny bits of lab grown beef muscle tissue in a lab that

will be eaten at an event at London to show the world that lab grown meat is possible);

Zachary Schneider, Comment, In Vitro Meat: Space Travel, Cannibalism, and Federal

Regulation, 50 Houston L Rev 991 (2013) (describing why lab grown meat could ease

many of the environmental burdens of worldwide meat production).

3 These products are described as both innovative and novel. In technology, an

innovation “may be an improvement to something already existing.” Merriam-Webster,

“Innovation” (Merriam-Webster 2013), online at http: //www.merriam-webster.

com/dictionary/innovation (visited Sept 15, 2013). On the other hand, to be “novel”

means “new and not resembling something formerly known or used.” Merriam-Webster,

(Merriam-Webster 2013), online at http: //www.merriam-webster.com/dictionary/novel

(visited Sept 15, 2013). Thus, the descriptive “novel innovation” as used in this Article

means an improvement to an already existing product that involves the use of

ingredients that are new and that do not resemble anything formerly used or known.

Examples include nanotech particles, GM food, cloned animals used as food, or lab-grown

meat.

4 See notes 95–109 and accompanying text.

5 For a series of examples dealing with tributylin (“TBT”), polychlorinated

biphenyls (“PCBs”), diethylstilbestrol (“DES”), the Great Lakes pollution, thalidomide,

medical x-rays, benzene, asbestos, chlorofluorocarbons (“CFCs”), and DES, see Part

II.E.1.



433] ANIMATING THE PUBLIC HEALTH PRODUCT SAFETY NET 435

last for decades.6 This health risk information void cripples the

FDA’s ability to regulate to protect public health during this

often decades-long period of scientific uncertainty.7

Many propose that the proper way to deal with the

problems caused by this health risk information void is to adopt

some form of the Precautionary Principle. According to Professor

Cass Sunstein, “[s]imply put, the principle counsels that we

should avoid steps that will create a risk of harm; until safety is

established through clear evidence, we should be cautious. In a

catch-phrase: Better safe than sorry.”8 However, there are

downsides to this approach. Professor Sunstein points out that

the bar to the use of innovative technologies for the time period

it takes to prove them to be safe comes with its own harm—

keeping the potentially life-saving benefits of these innovative

technologies from reaching people in need.9 Professor Sunstein

gives the example of genetically modified food (“GM food”),

which may allow the production of food that is healthier,

cheaper, and easier to grow under difficult environmental

conditions.10 This GM food may provide great benefits to the

populations of developing countries, including the prevention of

many deaths.11 Following the Precautionary Principle means

refusing to allow the use of GM food until it is proven to be safe.



8 Cass R. Sunstein, The Paralyzing Principle, 25 Reg 32, 32 (2003). Professor

Sunstein explains that the Precautionary Principle has a wide range of definitions, from

weak to strong. An example of what he refers to as a weak version is that which was

adopted by the 1992 Rio Declaration that states “[w]here there are threats of serious or

irreversible damage, lack of full scientific certainty shall not be used as a reason for

postponing cost-effective measures to prevent environmental degradation.” Id at 33. An

example of a strong version of the Precautionary Principle that Professor Sunstein uses

is drawn from the

widely publicized Wingspread Declaration, from a meeting of

environmentalists in 1998 . . . “When an activity raises threats of harm to

human health or the environment, precautionary measures should be taken

even if some cause and effect relationships are not established scientifically. In

this context, the proponent of the activity, rather than the public, should bear

the burden of proof.”

Id.

9 Id.

10

Id.

11

Professor Sunstein clarifies that “the point is not that genetic modification will

definitely have those benefits, or that the benefits of genetic modification outweigh the

risks. The point is only that if the Precautionary Principle is taken literally, it is

offended by regulation and by non-regulation.” Id.



This means that the potential benefits of GM food will be

withheld during the health risk information void. Thus, this

choice brings its own risks of harm.

How should the FDA regulate consumer products to protect

public health when operating in scientific uncertainty? This

Article suggests that, when it comes individual risk,12 such as

those risks faced by individual consumers when choosing and

using a particular product—in contrast to collective risks such as

those environmental risks faced by all individuals as a

collective13—neither of these “all or nothing” approaches fits the

bill.

This Article is the first to propose a unique, yet entirely

feasible, middle ground that uses what this Article calls the

public health product safety net. Instead of a focus on the

unknown, which is the degree of hazard associated with a new

and innovative technology, the lodestar of the FDA for

regulation in the context of consumer products should be on

novelty.14 Keying regulation to novelty allows for “strings” to be

attached to consumer products using novel technologies. These

strings take the form of a requirement that all ingredients

created through the use of novel technologies be listed in the

ingredient section of product labels. This requirement allows for

data collection and tracking to ensure that, if an innovative

technology is, in fact, harmful, public health officials can

identify this fact relatively quickly, pull the attached “strings” to

rapidly recall the consumer product, and avert, or at least

mitigate, a possible public health disaster. This Article describes

how a focus on novelty, coupled with an already-existing

provision in the Food, Drug, and Cosmetic Act (FDCA, or “the

Act”) requiring that all material information be provided on

product labels, triggers an ingredient-listing requirement.

Importantly, ingredient listing is the key to the public

health product safety net.15 In a nutshell, novel ingredient

12

For a discussion of the difference between individual risk and collective risk and

what this difference means to appropriate regulatory choices, see notes 189–193 and

accompanying text.

13

Id. Of note is that these approaches are also problematic when dealing with

collective risk. This topic is beyond the scope of this Article as the issues relating to

collective risk are, in many ways, very different from those arising in the context of

individual risks, including the appropriate role of government.

14

See notes 189–195 and accompanying text.

15

This term is different from what the popular literature refers to as the health



listing protects consumer safety through consumer self-

protection. If a consumer knows that she is being exposed to a

novel ingredient, she can use heightened vigilance for symptoms

of harm. It also allows for the appropriate treatment of injured

consumers by medical professionals who will, for the first time,

be able to identify novel ingredients as potential causative

agents through accurate exposure reporting by consumers.

Ingredient listing also allows for the proper reporting of injury-

causing agents to state and federal public health protection

agencies in charge of the early warning and product recall

systems. Finally, the data collected by these public health

protection agencies provides the evidence needed to actuate the

instrumental use of the tort system to encourage the proper

investment in product safety and to insulate against the overuse

and overconsumption of relatively risky products. Together,

these public and private actors join to form the public health

product safety net.16

While this system is far from perfect, it is likely to improve

exponentially as this country moves into the era of big data.17

The public health product safety net will use big data strategies

to take more traditionally created data generated by the state

and federal consumer product reporting systems and link it to

the information that is only recently being gathered from a

massive collection of electronic health records.18 Adding to this

care safety net that refers to health care providers who provide care to low-income

people. See, for example, Coalition of Community Health Clinics, What is the Health

Care Safety Net, online at http: //www.coalitionclinics.org /safety-net.html (visited Sept

15, 2013) (“Health care safety net clinics are community-based providers who offer

health services to low-income people, including those without insurance.”).

16


17

See Data, data everywhere, The Economist (Feb 25, 2010), online at

http: //www.economist.com/node/15557443 (visited Sept 15, 2013) (“[T]he world contains

an unimaginably vast amount of digital information which is getting ever vaster ever

more rapidly. This makes it possible to do many things that previously could not be done:

spot business trends, prevent diseases, combat crime and so on. Managed well, the data

can be used to unlock new sources of economic value, provide fresh insights into science

and hold governments to account.”); Dan Kusnetzky, What is “Big Data”?, Virtually

Speaking (ZDNet Feb 26, 2010), online at http: //www.zdnet.com/blog /virtualization/

what-is-big-data/1708 (visited Sept 15, 2013) (“In simplest terms, the phrase refers to the

tools, processes and procedures allowing an organization to create, manipulate, and

manage very large data sets and storage facilities.”).

18

Thomas L. Friedman, Obamacare’s Other Surprise, NY Times (May 25, 2013),

online at http: //www.nytimes.com/2013/05/26/opinion/sunday/friedman-obamacares-

other-surprise.html?emc=tnt&tntemail0=y (visited Sept 15, 2013) (detailing the

remarkable growth in conversion to electronic medical records and the use of data

mining to access information contained therein).



data stream is an enormous amount of new information that is

being culled through the 2013 phenomenon of data mining,

consumer use of social media, such as tweets and on-line

discussion forums, as well as search engines such as those

created by Google, Microsoft, and Yahoo, in order to identify

defective products that cause physical harm. Just this year,

scientists announced that they were able to use the data from

these unique sources to identify harmful product defects

significantly before the FDA,19 and several apps have been

developed to track food-borne illnesses using data collected from

Twitter.20 All told, these integrated data streams will ultimately

create a highly sensitive, state-of-the-art, consumer product

safety surveillance system.21 This system will identify early

warnings of product safety problems associated with ingredients

created by innovative technologies to proactively mitigate their

effects through national product warning notifications and

recalls.

Adding to this picture, a focus on novelty fits well with the

overarching theme of the FDCA that titers the degree and kind

of regulation it uses to protect consumers from harm from third

parties to the level and type of vulnerability of those consumers.

It also tracks how the Act has historically dealt with regulating

novel ingredients when the health risks associated with these

ingredients are unknown.22

Finally, the result of this focus on novelty reflects the

appropriate role of the government when protecting its citizens

against the risks of harm by third parties. In the context of

consumer products and individual risk, the proper role of the

government is to protect individual choice with regard to the

amount and nature of the risk the consumer is willing to

encounter. This contrasts with the appropriate role of

government in the context of collective risk created by third

19


20

Beth Krietsch, Social Media Apps Use Twitter to Track Illness Outbreaks, Food

Safety News (Aug 19, 2013), online at http: //www.foodsafetynews.com/2013/08/social-

media-moves-to-help-detect-outbreaks/ (visited Sept 15, 2013); Tracking Twitter May

Enhance Monitoring of Food Safety at Restaurants, ScienceDaily (Aug 7, 2013), online at

http: //www.sciencedaily.com/releases/2013/08/130807134510.htm (visited Sept 15, 2013).

21

See note 20.

22




parties when the individual has no ability to avoid the risk

through their own means.23

This Article will use nanotechnology as an example that

highlights how regulation based on novelty rather than hazard

achieves the proper balance between protecting public health

while encouraging innovation through the animation of the

public health product safety net. In Part II, this Article starts by

explaining what nanotechnology is and the remarkable growth

of its use in everyday consumer products. It then summarizes

the steadily increasing number of studies that suggest that

there are likely to be serious health risks associated with the

use of nanotech consumer products. Next, it explains how the

FDA is currently regulating these products by focusing on the

degree of hazard and the serious problems that arise from this

misguided focus. In Part III, the history of the FDCA is

summarized in order to explain how, and why, the FDCA came

to titer the degree and kind of regulation it uses to protect

consumers from harm from third parties to the level and type of

vulnerability of targeted consumers. Next, this Article builds on

this history to describe how the Act has historically dealt

specifically with regulating novel ingredients with unknown

health risks in order to deal with consumer vulnerabilities. This

history is then used to illuminate the reasons why a switch from

a focus on hazard to a focus on novelty is supported by precedent

and better fits the policies and goals of the FDCA while, at the

same time, achieving the proper balance between protecting

public health and encouraging innovation. This Article shows

how a simple provision that is already a part of the FDCA can be

relied upon to require ingredient listing based on novelty so that

additional legislation is not required. In Part IV, this Article

illustrates how this focus will operate to achieve the balance

between safety and innovation with other innovative, novel

technologies used as ingredients in consumer products such as

cloned animals, genetically modified plants and animals used for

food, as well as with lab-grown meat. Finally, in Part V, this

Article describes why the use of cost-benefit analysis by the

Office of Management and Budget to evaluate the change

23

Daniel Wickler, Persuasion and Coercion for Health: Ethical Issues in

Government Efforts to Change Life-Styles, 56 Health & Society 303–38 (1978), reprinted

in Rolf Sartorius, Paternalism (Minnesota 1984).



suggested by this Article is inappropriate when dealing with

novel ingredients in the context of individual risk.

II. NANOTECHNOLOGY USED IN CONSUMER PRODUCTS

The benefits of nanotechnologies are varied. On one hand,

some claim that nanotechnology could provide the solution to

global challenges such as providing a cure for cancer, a source

for renewable energy, and the solution to the provision of clean

water.24 Others assert that nanotechnology could provide new

medical treatments, reduced use of limited resources, and

economic benefits.25 On the other hand, nanoparticles used in

consumer products offer far less important benefits. Nanotech

cosmetics may improve appearance,26 and nanotech sunscreens

are transparent instead of white and pasty.27 Some nanotech

dietary supplement manufacturers claim that their products are

better absorbed by the body.28 Nanotechnology used in foods

could provide more vivid colors and more potent flavors,

24

Fabio Salamanca-Buentello, et al, Nanotechnology and the Developing World, 2

PLOS Med 0383, 0385 (2005). According to a study by the Canadian Program on

Genomics and Global Health at the University of Toronto Joint Centre for Bioethics, the

top ten applications of nanotechnology most likely to benefit developing countries, and

which may contribute to the attainment of the United Nations Millennium Development

Goals (MDGs), are as follows: energy storage; production and conversion; agricultural

productivity enhancement; water treatment and remediation; disease diagnosis and

screening; drug delivery systems; food processing and storage; air pollution and

remediation; construction; health monitoring; vector and pest detection; and control. Id.

25

The Royal Society and The Royal Academy of Engineering, Nanoscience and

Nanotechnologies: Opportunities and Uncertainties *vii (July 2004), online at

http: //www.nanotec.org.uk/report /Nano%20report%202004%20fin.pdf (visited Sept 15,

2013).

26

Cristina Buzea, Ivan I. Pacheco Blandino, and Kevin Robbie, Nanomaterials and

Nanoparticles: Sources and Toxicity, 2 Biointerphases MR17, MR36 (2007) (discussing

how engineered nanomaterials in cosmetic products regenerate skin cells, help maintain

a youthful appearance of the skin, and hide wrinkles and creases).

27

Natasha Singer, New Products Bring Side Effect: Nanophobia, NY Times E1 (Dec

3, 2008).

28

William B. Schultz and Lisa Barclay, A Hard Pill to Swallow: Barriers to

Effective FDA Regulation of Nanotechnology-Based Dietary Supplements *9 (Woodrow

Wilson International Center for Scholars 2009), online at http: //www.nanotechproject.

org /process/assets/files/7056/pen17_final.pdf (visited Sept 15, 2013) (“Examples of

product claims that tout special properties due to the use of nanotechnology include:

increased effectiveness in a calcium/magnesium product; more rapid, uniform and

complete absorption of nutrients in a spray form; increased absorption of a B12 vitamin

spray; supplements that pass through membranes directly into human cells; and

increased absorption of gel supplements by transforming fat-soluble nutrients into

water-soluble ones.”).



nutritional additives, and antibacterial ingredients for food

packaging.29

To take advantage of some of these less socially beneficial

improvements, engineered nanoparticles are pouring into

everyday consumer products in steadily increasing amounts,

resulting in a concomitant increase in consumer exposure to

these novel ingredients. These nanoparticles are engineered to

be only one to 100 nanometers in size.30 To give an idea of just

how small these nanoparticles are, a human hair is about 80,000

nanometers wide.31

Consumer products that use nanoscale materials can be

found almost everywhere. Nanotech ingredients are in

cosmetics, electronics, catalytics, magnetic and materials

applications, as well as in drug delivery and medical imaging

products.32 Just a small sampling of the specific products that

contain nanotech ingredients includes cell phones, stain-

29

Toxic Nanoparticles Might Be Entering Human Food Supply, ScienceDaily (Aug

22, 2013), online at http: //www.sciencedaily.com/releases/2013/08/130822194530.htm?

utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+sciencedaily%

2Ftop_news%2Ftop_health+%28ScienceDaily%3A+Top+News+—+Top+Health%29

(visited Sept 15, 2013).

30

“Nanotechnology is the art and science of manipulating matter at the nanoscale

to create new and unique materials and products.” Schultz and Barclay, A Hard Pill to

Swallow at 20–23 (cited in note 28). The National Nanotechnology Initiative (“NNI”) is a

federal research and development initiative that manages and coordinates the nanoscale

research and technology endeavors of twenty-five different government agencies,

including the FDA. The NNI considers nanotechnology to include activities that involve

the following characteristics:

(1) research and technology development at the atomic, molecular or

macromolecular level, in the length scale of 1–100 nanometers; (2) creating and

using structures, devices and systems that have novel properties and functions

because of their small or intermediate size; and (3) ability to control or

manipulate on the atomic scale.

Id.

31


Nanotechnologies at viii–x (cited in note 25) (noting that a nanometer is one billionth of a

meter.); National Nanotechnology Initiative, What is Nanotechnology? (nano.gov), online

at http: //www.nano.gov/nanotech-101/what /definition (visited Sept 15, 2013). To attempt

to intellectualize just how small a nanoparticle is, compare nanoparticles to the

thickness of a sheet of paper, which is roughly 100,000 nanometers wide, or to the size of

a human hair, which is approximately 80,000 nanometers wide. National

Nanotechnology Initiative, Size of the Nanoscale (nano.gov), online at http: //www.

nano.gov/nanotech-101/what /nano-size (visited Sept 15, 2013).

32

See, for example, Centers For Disease Control and Prevention, Nanotechnology:

Frequently Asked Questions, online at http: //www.cdc.gov/niosh/topics/nanotech/faq.html

(visited Sept 15, 2013) (acknowledging the broad array of different categories of products

that contain nanoparticles).



resistant clothing, sporting goods, digital cameras, eyeglasses,

paints, and computers.33

Importantly, some of these types of products use nanotech

ingredients that are “fixed” inside a solid matrix: for example,

cell phones, computers, and sporting goods, such as tennis

racquets and golf clubs. This makes these types of nanotech

ingredients less likely to move into the human body or the

environment.34 While nanotech ingredients that are

manufactured and then “fixed” in consumer products are of less

concern to consumers, they are of great concern to the workers

who make the products as they are exposed to large amounts of

these nanotech ingredients during the manufacturing process.35

33

See Hope Shand and Kathy Jo Wetter, Shrinking Science: An Introduction to

Nanotechnology, in Linda Starke, ed, State of the World 2006 78, 80–82 (2006) (providing

a list of various consumer products that containing nanotech ingredients); Project On

Emerging Nanotech, Nanotechnology Consumer Products Inventory, online at

http: //www.nanotechproject.org /inventories/consumer/browse/categories/ (visited

Apr 3, 2013) (acknowledging the broad array of different categories of products that

contain nanoparticles).

34

The industry opines that fixed nanoparticles are unlikely to be absorbed by the

human body or migrate into the environment. However, whether this is true is still being

studied. See, for example, Singer, New Products Bring Side Effect: Nanophobia, NY

Times at E1 (cited in note 27) (noting representatives of the cosmetic industry have

stated that there was no evidence that nanotech personal care products are a health

hazard). Dr. Andrew Maynard, the former chief science advisor to the Project on

Emerging Nanotechnologies, states that: “I would be very surprised if [fixed carbon

nanotubes are] dangerous to use, let us say, [in] a tennis racket or baseball bat[,] . . .

[b]ut I do not think it is OK to tell people that we think it is safe—we’ve got to have

evidence.” Ann Fernholm, Carbon Nanotubes May Be as Harmful as Asbestos, SF

Chronicle C-1 (May 21, 2008). The unresolved problem is what happens when fixed

nanoparticles are released as the result of natural wear and tear. For example, when a

product breaks or the surface of one of these products is rubbed against the ground. Id.

Dr. Maynard points out that the level of human exposure to asbestos as car brake pads

containing asbestos wore down and roads paved with asbestos-containing materials

deteriorated was high. See generally Agency for Toxic Substances and Disease Registry,

United States Department of Health and Human Services, Asbestos Toxicity, online at

http: //www.atsdr.cdc.gov/csem/asbestos/

docs/asbestos.pdf (visited Sept 15, 2013).

35

See generally Department of Health and Human Services, Current Intelligence

Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers *1–2 (National

Institute for Occupational Safety and Health Apr 2013), online at

http: //www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf (visited Sept 15, 2013)

(“NIOSH Bulletin”) (discussing the risks associated with exposure of workers to

nanoparticles during the manufacturing process); Arthur Miller, et al, Characterizing

Exposures to Airborne Metals and Nanoparticle Emissions in a Refinery, 54 Annals of

Occup Hygiene 504, 511–12 (2010); R.J. Aitken, K.S. Creely, and C.L. Tran,

Nanoparticles: An Occupational Hygiene Review 2–3 (Health and Safety Executive 2004),

online at http: //www.hse.gov.uk/research/rrpdf/rr274.pdf (visited Sept 15, 2013).

Importantly, higher exposure levels may occur during cleaning and maintenance of

production, research, and handling facilities. See NIOSH Bulletin at 1–2; Georgia Miller,



Products that contain predominantly “free” nanotech

particles, such as liquid products, should be of more concern to

consumers. Nanotech particles that are “free” are extremely

mobile,36 and the human body can absorb them through several

different routes of exposure.37 Nanoparticles can enter the blood

stream through the skin,38 the gastrointestinal tract,39 or the

lungs.40 When inhaled, nanoparticles can invade all areas of the

lungs.41 They can pass into the brain via the olfactory nerves42

et al, Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big risks *10

(Friends of the Earth Report 2006), online at http: //libcloud.s3.amazonaws.com/93/

ce/0/633/Nanomaterials_sunscreens_and_cosmetics.pdf (visited Sept 15, 2013). As the

science on safe exposure levels and protective equipment in the work place is still

changing, little is known about the levels at which workers can safely be exposed to

nanoparticles while on the job. NIOSH Bulletin at 1–2. This is a pressing issue as it is

estimated that, by 2015, over two million workers worldwide will be directly employed by

industries using nanoparticles. Mihail C. Roco, Converging Science and Technology at

the Nanoscale: Opportunities for Education and Training, 21 Nature Biotech 1247, 1248

(2003). It is likely that the numbers of workers employed indirectly in the supply chain

will be significantly higher. Id (explaining that nanotechnology has the potential to

create five million related jobs by 2015).

36

David Rotman, Measuring the Risks of Nanotechnology, Tech Rev 71–73 (Apr

2003) (interviewing Dr. Vicki Colvin, Director of the Center for Biological and

Environmental Nanotechnology at Rice University, about possibly unique health and

environmental risks associated with nanotechnology); Buzea, Pacheco Blandino, and

Robbie, 2 Biointerphases at MR44–48, MR50–57 (cited in note 26).

37

Günter Oberdörster, et al, Principles for Characterizing the Potential Human

Health Effects from Exposure to Nanomaterials: Elements of a Screening Strategy, 2

Particle and Fibre Toxicology 1, 2, 4 (2005).

38

Cosmetics that use nanotech ingredients that are rubbed onto the skin contain

nano-size particles 1000 nm in size. At this size, they can be absorbed through intact

skin. Jillian Rouse and Jianzhong Yang, Repetitive Motion Speeds Nanoparticle Uptake:

‘Bucky Amino Acid’ Penetrates Faster, Deeper When Skin Is Flexed, Sciencedaily (Jan 9,

2007), online at http: //www.sciencedaily.com/releases/2007/01/070104144839.htm

(visited Sept 15, 2013) (noting that chemists and toxicologists find that uptake of

nanoparticles through the skin is sped up through repetitive movement); Sally S. Tinkle,

et al, Skin as a Route of Exposure and Sensitization in Chronic Beryllium Disease, 111

Envir Health Persp 1202, 1204–05 (2003) (presenting a study of the degree of

penetration of nano-size particles into human skin). Damage to the skin can occur

through sunburn, blemishes, shaving cuts, eczema, or other trauma. When skin is

traumatized, nano-sized particles up to 7000 nm are absorbed by the skin. Günter

Oberdörster, Eva Oberdörster, and Jan Oberdörster, Nanotoxicology: An Emerging

Discipline Evolving from Studies of Ultrafine Particles, 113 Envir Health Persp 823, 834

(2005). Importantly, many cosmetics and sunscreens containing nanotech ingredients

are especially formulated to be used on damaged skin.

39

Oberdörster, Oberdörster, and Oberdörster, 113 Envir Health Perspectives at

833–37 (cited in note 38); Peter H.M. Hoet, Irene Bruske-Hohlfeld, and Oleg V. Salata,

Nanoparticles: Known and Unknown Health Risks, 2 J Nanobiotech 1, 1, 2–10 (Dec

2004).

40

NIOSH Bulletin at 1–2 (cited in note 35).

41

Oberdörster, Oberdörster, and Oberdörster, 113 Envir Health Persp at 837 (cited

in note 38); Hoet, Bruske-Hohlfeld, and Salata, 2 J Nanobiotech at 1–4 (cited in note 39).



and can also cross the formidable blood-brain barrier.43 In

contrast to macro-particles that are trapped and eradicated by

the body’s immune systems,44 once nanoparticles are absorbed

into the blood stream, they can travel unhindered into the

muscles, liver, bone marrow, and spleen, and can actually move

into cells.45 Amazingly, nanoparticles can move through the

cytoplasm and bind to cellular structures.46 This includes the

ability to get wedged in the mitochondria.47 Finally, if absorbed

by a pregnant woman, nanoparticles can cross the placenta,

enter the fetus, and invade all of the areas listed above.48

This use of free nanoparticles in food,49 drugs,50 cosmetics,51

dietary supplements,52 and sunscreens53 creates a large and

42

Buzea, Pacheco Blandino, and Robbie, 2 Biointerphases at MR50–51 (cited in

note 26); Alex Kirby, Tiny Particles ‘Threaten Brain’ (BBC News Jan 8, 2004), online at

http: //news.bbc.co.uk/2/hi/science/nature/3379759.stm (visited Sept 15, 2013); Annabelle

Hett, Nanotechnology: Small Matter, Many Unknowns *17 (Swiss Reins Co 2004), online

at http: //media.swissre.com/documents/nanotechnology_small_matter_many_unknowns_

en.pdf (visited Sept 15, 2013).

43

Rotman, Tech Rev at 73 (cited in note 36); Buzea, Pacheco Blandino, and Robbie,

2 Biointerphases at MR51 (cited in note 26); Kirby, Tiny Particles at 17 (cited in note 42).

44

Hett, Nanotechnology at 21 (cited in note 42).

45

Id at 22–23.

46

Karen Florini, et al, Nanotechnology: Getting It Right the First Time, 3 Nanotech

L and Bus 39, 42 (2006).

47

Dusica Maysinger, et al, Nanoparticles in Medicine, in 3 Oxford Handbook of

Nanoscience and Technology: Applications 503, 519 (A.V. Narlikar, et al, eds, 2010);

Buzea, Pacheco Blandino, and Robbie, 2 Biointerphases at MR48 (cited in note 26).

48

Karin S. Hougaard, et al, Effects of Prenatal Exposure to Surface-Coated

Nanosized Titanium Dioxide (UV-Titan): A Study in Mice, 7 Particle & Fibre Toxicology

16, 22 (2010).

49

See, for example, Georgia Miller and Rye Senjen, Out of the Laboratory and on to

our Plates: Nanotechnology in Food and Agriculture *9 (Friends of the Earth 2008),

online at http: //www.foeeurope.org /activities/nanotechnology/Documents/Nano_food_

report.pdf (visited Sept 15, 2013) (stating nano-size additives can be found in some soft

drinks, dairy products, sausages, beer, and other processed foods).

50

See, for example, Christopher Weldon, Bozhi Tian, and Daniel S. Kohane,

Nanotechnology for Surgeons, 3 Wiley Interdisciplinary Rev: Nanomed & Nanobiotech

223, 226 (2011) (discussing how the science of nanotechnology could create powerful new

tools greatly enhancing surgeons’ access to therapeutic and diagnostic measures); Kevin

O’Donnell and Robert O. Williams, Nanoparticulate Systems for Oral Drug Delivery to

the Colon, 8 Intl J Nanotech 4, 4–15 (2011) (arguing that by encapsulating a drug

molecule within a nano-size module, a highly effective tool for controlling drug delivery

to a specific target could be created, for example for the treatment of a cancerous tumor);

Dorothy Farrell, et al, Recent Advances from the National Cancer Institute Alliance for

Nanotechnology in Cancer, 4 ACS Nano 589 (2010) (noting nanotechnology holds great

promise for the treatment of cancer).

51

See, for example, Miller and Senjen, Out of the Laboratory at 4 (cited in note 49).

52

See, for example, Schultz and Barclay, A Hard Pill to Swallow at 8 (cited in note

28). Dietary supplements with nanotech ingredients have jumped in number from eleven



growing level of consumer exposure to novel ingredients never

before seen in nature. Nanotech ingredients are being used in

rapidly increasing amounts to create “more potent food

colourings, flavourings and nutritional additives, antibacterial

ingredients for food packaging, and more potent agrochemicals

and fertilisers.”54 Food analysts estimate that nanotech food

additives are being used in more than six hundred different food

products.55 Food packagers are also steadily increasing their use

of nanotech particles in food packaging. This creates the

opportunity for these particles to migrate into the food.56

The National Institute of Occupational Safety and Health

(“NIOSH”) reports that consumer products containing nanotech

ingredients are being introduced into the market at a frequency

of three to four per week.57 Consumer products that contain

nanotech ingredients number in the thousands,58 while

thousands of tons of nanoparticles are produced each year.59

Nanotech research and development is predicted to reach $3.1

trillion globally by 2015.60 In 2007, $147 billion in manufactured

in 2007 to forty-four in 2009. Id at 9.

53

Id.

54

Miller and Senjen, Out of the Laboratory at 4 (cited in note 49). Nanotech particle

additives can be found in sodas, margarine, dairy products, and sausages. Id at 9.

Another growing area is the use of nanotech content in food and beverage packaging, for

example “nanoclay composites—plastics to which nanoscale clay platelets have been

added.” Id at 4. These nanoclay materials are also used “in agriculture pipes and plastics

to allow controlled release of herbicides.” Id.

55

Stephen Daniells, Think Big, Think Nano (Foodnavigator.com Dec 19, 2007),

online at http: //www.foodnavigator.com/Science-Nutrition/Think-big-think-nano (visited

Sept 15, 2013).

56

Miller and Senjen, Out of the Laboratory at 4 (cited in note 49) (stating that

between four hundred and five hundred foods have nanotech packaging).

57

See, for example, Center For Disease Control and Prevention, Nanotechnology:

Frequently Asked Questions (Sept 22, 2010), online at http: //www.cdc.gov/niosh/topics/

nanotech/faq.html (visited Sept 15, 2013) (acknowledging the broad array of different

categories of products that contain nanoparticles).

58

See Schultz and Barclay, A Hard Pill to Swallow at 20–23 (cited in note 28)

(explaining that the increasing amounts of products integrating nanotechnology go

unregulated, due to the dated FDA regulatory scheme).

59


Nanotechnologies at 26–27 (cited in note 25).

60

Schultz and Barclay, A Hard Pill to Swallow at 8 (cited in note 28). See also

Buyer Beware: Product List Highlights Both Nanotech and Nano-marketing (Electro IQ

Mar 16, 2006), online at http: //www.electroiq.com/articles/stm/2006/03/buyer-beware-

product-list-highlights-both-nanotech-and-nano-marketing.html (visited Sept 15, 2013)

(detailing the growing number of products containing nanoparticles); Center for Disease

Control and Prevention, Nanotechnology: Frequently Asked Questions (cited in note 32).



goods using nanotech ingredients were produced.61

Unfortunately, the financial resources invested into the

development, application, and production of nanoparticle

technology is far more than the amount of money invested in the

exploration of health and safety issues.62

A. Why Are Nanotech Ingredients Novel?

Nanotech particles are unique. Nanoparticles and normal

size particles have a whole range of fundamentally different

properties. There are remarkable differences between the two in

toxicity, bioaccumulation, persistence, chemical, magnetic,

electrical, explosiveness, and optical characteristics.63

Engineered nanoparticles differ significantly from their

normal size counterparts64 for two main reasons. First, the laws

61

Schultz and Barclay, A Hard Pill to Swallow at 8 (cited in note 28). See also

Buyer Beware: Product List Highlights Both Nanotech and Nano-marketing, Electro IQ

(Mar 16, 2006), http: //www.electroiq.com/articles/stm/2006/03/buyer-beware-product-list-

highlights-both-nanotech-and-nano-marketing.html (detailing the growing number of

products containing nanoparticles); Center for Disease Control and Prevention,

Nanotechnology: Frequently Asked Questions (cited in note 32).

62

Compared to the amount of funding for nanotech commercial applications, the

amount of money spent on health and environmental risks associated with nanotech

products is very small. For example, as of 2010, only approximately 5 percent of the

NNI’s budget is dedicated to the health and environmental implications of this new

technology. John F. Sargent Jr, Nanotechnology and Environmental, Health, and Safety:

Issues for Consideration *11 (Congressional Research Service Jan 20, 2011), online at

http: //www.fas.org /sgp/crs/misc /RL34614.pdf (visited Sept 15, 2013).

63

Buzea, Pacheco Blandino, and Robbie, 2 Biointerphases at MR17, MR23–25,

MR47, MR59 (cited in note 26). See also Ernie Hood, Nanotechnology: Looking as We

Leap, 112 Envir Health Persp A740, A741 (2004); The Royal Society and The Royal

Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and

Uncertainties at 5 (cited in note 25).

64

In order to conform to the nomenclature adopted by the literature, this Article

refers to particles that manifest these different properties as “nanoparticles” or

“nanoscale” or “nano-sized” materials or versions and will refer to larger scale particles

of the same chemical that do not have these unique properties as normal size materials

or bulk materials. Buzea, Pacheco Blandino, and Robbie, 2 Biointerphases at MR23–25

(cited in note 26); The Royal Society and The Royal Academy of Engineering,

Nanoscience and Nanotechnologies: Opportunities and Uncertainties at 7 (cited in note

25). For example, the list of FDA-approved active ingredients for use in sunscreens

includes titanium dioxide for use up to a 25 percent concentration. Food and Drug

Administration, Sunscreen Drug Products for Over-The-Counter Human Use: Final

Monograph, 64 Fed Reg 27666, 27672 (May 21, 1999), to be codified at 21 CFR § 352

(“Final Monograph”). The safety and effectiveness of titanium dioxide in sunscreens was

reviewed by the FDA prior to industry use of the engineered nanoparticle form of

titanium dioxide pursuant to the normal process for over-the-counter (“OTC”) approval.

Food and Drug Administration, Small Business Assistance: Frequently Asked Questions

on the Regulatory Process of Over-the-Counter (OTC) Drugs, online at

http: //www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm0



of classical physics apply to normal size particles.65

Comparatively, the laws of quantum mechanics apply to

nanoparticles.66 Second, nanoparticles enjoy an enormous

surface-to-volume ratio, which translates into a greater

proportion of atoms existing on the particle’s surface.67 As

chemical reactions occur on the surface of particles, a

nanoparticle has a greater potential for biological interaction.

This means that nanoparticles are far more bioreactive than

their normal size counterparts.68 It is critical to note, as a public

health matter, that this means that the inherent toxicity of any

given quantity of nano-sized particles is much greater than the

same quantity of their normal-sized counter parts.69

69917.htm (visited Sept 15, 2013) (describing the process for OTC approval). The FDA

stated that it is aware that sunscreen products use engineered nanoparticles but that it

“does not consider micronized titanium dioxide to be a new ingredient but it considers it

a specific grade of titanium dioxide originally reviewed by the Panel.” 64 Fed Reg at

27671–72.

65

Buzea, Pacheco Blandino, and Robbie, 2 Biointerphases at MR23 (cited in note

26) (stating the laws of classical physics don’t apply to particles that are smaller than

approximately 100 nanometers (nm)); The Royal Society and The Royal Academy of

Engineering, Nanoscience and Nanotechnologies: Opportunities and Uncertainties at 7

(cited in note 25).

66

Buzea, Pacheco Blandino, and Robbie, 2 Biointerphases at MR24–25 (cited in

note 26) (noting the laws of quantum mechanics apply to nanoparticles affecting the

magnetic, optical, and electric behavior of materials); The Royal Society and The Royal

Academy of Engineering, Nanoscience and Nanotechnologies: Opportunities and

Uncertainties at 7 (cited in note 25).

67

Andre Nel, et al, Toxic Potential of Materials at the Nanolevel, 311 Sci 622, 622

(2006). Compared to macro-particles,

[T]his provides a greater surface area per unit mass. In the size range of < 100

nm, the number of surface molecules (expressed as a % of the molecules in the

particle) is inversely related to particle size. For instance, in a particle of 30 nm

size, about 10% of its molecules are expressed on the surface, whereas at 10

and 3 nm size the ratios increase to 20% and 50%, respectively. Because the

number of atoms or molecules on the surface of the particle may determine the

material reactivity, this is key to defining the chemical and biological

properties of nanoparticles.

Id at 623 fig 1.

68

Id at 622.

69

Id; Scientific Committee on Emerging and Newly Identified Health Risks

(“SCENIHR”), Modified Opinion on the Appropriateness of Existing Methodologies to

Assess the Potential Risks Associated with Engineered and Adventitious Products of

Nanotechnologies 13, 13 (European Commission 2005), online at http: //ec.

europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003b.pdf (visited Sept

15, 2013).



B. What Are the Health Risks Associated with Exposure to

Nanotech Ingredients?

Over the past several years, a number of scientific animal

studies have started to provide at least some ideas about the

type of negative health effects that can be expected to occur from

exposure to the unique properties of nanotech ingredients. Some

of the side effects could include a contribution to the

development of neurodegenerative processes, such as

Alzheimer’s disease70 or mesothelioma, the condition caused by

asbestos.71

Studies show that there are two main negative physical

effects that could cause these disorders.72 First, the increased

bioreactivity of nanoparticles discussed above can harm living

tissue.73 Once inside cells, this enhanced bioreactivity can

interfere with cell signaling, damaging the cell’s structure and

DNA.74 In the opposite effect of the saying “the poison is in the

dose,” the smaller the size of the particle, the more likely it is to

have a toxic effect because its bioreactivity increases.75 For

example, even if a material, like titanium dioxide, is harmless at

a normal size, when it shrinks to nano-size, pulmonary toxicity

increases.76 Second, the human body contains scavenger cells

70

Andre E. Nel, et al, Understanding Biophysicochemical Interactions at the Nano-

Bio Interface, 8 Nature Mat 543, 550 (2009).

71

Id at 546.

72

See Jelena Kolosnjaj, Henri Szwarc, and Fathi Moussa, Toxicity Studies of

Carbon Nanotubes, Bio-Apps of Nanoparticles 181 (Warren C.W. Chan ed 2007)

(containing an exceptional survey of toxicity studies). For a comprehensive summary of

the experimental mechanisms of nanotech toxicity, see Nel, et al, 8 Nature Mat at 551,

table 4 (cited in note 70).

73

Nel, et al, 8 Nature Mat at 543, table 4 (cited in note 70).

74

Jirasak Wong-Ekkabut, et al, Computer Simulation Study of Fullerene

Translocation Through Lipid Membranes, 3 Nature Nanotech 363, 363, 367 (2008); C.L.

Tran, et al, A Scoping Study to Identify Hazard Data Needs for Addressing the Risks

Presented by Nanoparticles and Nanotubes, Institution of Occupational Medicine 15, 25

(2005); Hisao Hidaka, et al, In Vitro Photochemical Damage to DNA, RNA and Their

Bases by an Inorganic Sunscreen Agent on Exposure to UVA and UVB Radiation, 111 J

Photochem & Photobio 205, 212 (1997); Rosemary Dunford, et al, Chemical Oxidation

and DNA Damage Catalysed by Inorganic Sunscreen Ingredients, 418 FEBS Letters 87,

87–90 (1997).

75

Qamar Rahman, et al, Evidence That Ultrafine Titanium Dioxide Induces

Micronuclei and Apoptosis in Syrian Hamster Embryo Fibroblasts, 110 Envir Health

Persp 797, 797, 799 (2002); T. Uchino, et al, Quantitative Determination of OH Radical

Generation and its Cytotoxicity Induced by TiO2-UVA Treatment, 16 Toxicology in Vitro

629, 634 (2002); Nel, et al, 311 Sci at 622 (cited in note 67).

76

Tran, et al, A Scoping Study, at 21–23 (cited in note 74); Nel, et al, 311 Sci at 622



called phagocytes that eliminate foreign substances. These

phagocytes can cease to function when they become clogged with

nanotech particles.77 This means that foreign particles,

including bacteria, can invade the body with impunity as the

phagocytes have been neutralized, causing an HIV-like effect.78

While unfortunate, it is no surprise that there are very few

animal studies of the health effects of exposure to nanoparticles

in light of the relative amounts of investment in product

development as compared to the investment in safety testing.79

One of the first well-known animal studies observes the impact

of exposures of nanoparticles called buckyballs80 on fish.81 The

result was that the brains of the fish, here largemouth bass,

developed a toxic side effect that manifested itself in significant

(cited in note 67).

77

Nel, et al, 8 Nature Mat at 550–52 (cited in note 70); Margot Lundborg, et al,

Human Alveolar Macrophage Phagocytic Function is Impaired by Aggregates of Ultrafine

Carbon Particles, 86 Envir Rsrch Sect A86 244, 252 (2001); Peter G. Barlow, et al,

Reduced Alveolar Macrophage Migration Induced by Acute Ambient Particle (PM10)

Exposure, 24 Cell Bio & Toxicology 243, 248–51 (2008); Buzea, Pacheco Blandino, and

Robbie, 2 Biointerphases at MR45–46 (cited in note 26).

78

Lundborg, et al, 86 Envir Rsrch Sect at 252 (cited in note 77); Barlow, et al, 24

Cell Bio & Toxicology at 251 (cited at 77); Buzea, Pacheco Blandino, and Robbie, 2

Biointerphases at MR45–46 (cited in note 26).

79

See Sargent, Nanotechnology and Environmental, Health, and Safety (cited in

note 62).

80

Buckminsterfullerene (C60), called “buckyballs,” was named for Richard

Buckminster Fuller, the famed engineer recognized for the creation of the geodesic dome.

Buckyballs Could Keep Water Systems Flowing, Sciencedaily (Mar 12, 2009), online at

http: //www.sciencedaily.com/releases/2009/03/090305080139.htm (visited Sept 15, 2013).

81

Eva Oberdörster, Manufactured Nanomaterials (Fullerenes, C60) Induce

Oxidative Stress in the Brain of Juvenile Largemouth Bass, 112 Envir Health Persp

1058, 1058 (2004). Buckyballs are soccer-ball-shaped, spherical molecules with sixty

carbon molecules. They are the smallest of the fullerene family. T. Csörgő, M. Gyulassi,

and D. Kharzeev, Letter to the Editor, Buckyballs and Gluon Junction Networks on the

Femtometre Scale, 30 J Physics G: Nuclear and Particle Physics L17, L17–18 (2004);

H.W. Kroto, et al, Letters to Nature, C60 Buckminsterfullerene, 318 NATURE 162, 162–

63 (1985). Fullerenes are molecules made entirely of carbon. Csörgő, Gyulassi, and

Kharzeev, 30 J Physics G: Nuclear and Particle Physics at L17.



lipid peroxidation.82 Buckyballs are commonly used in

cosmetics,83 food packaging, and dietary supplements.84

Another startling set of recent, significant studies85 suggests

that another form of nanoparticle, called multi-walled carbon

nanotubes,86 could turn out to be as harmful as asbestos.87 It

82

Oberdörster, 112 Envir Health Persp at 1060 (cited in note 81). See also Emil

Venere, ‘Buckyballs’ Have a High Potential to Accumulate in Living Tissue, Purdue News

(Sept 18, 2008), online at http: //news.uns.purdue.edu/x/2008b/080918JafvertBuckyballs.

html (visited Sept 15, 2013) (interviewing author Chad T. Jafvert who explains that his

research suggests that buckyballs have a greater probability of partitioning into fatty

tissue than the banned pesticide DDT), referring to Chad T. Jafvert and Pradnya P.

Kulkarni, Buckminsterfullerene’s (C60) Octanol—Water Partition Coefficient (Kow) and

Aqueous Solubility, 42 Envir Sci & Tech 5945, 5946–49 (2008).

83

Bethany Halford, Fullerene for the Face: Cosmetics Containing C60 Nanoparticles

are Entering the Market even if Their Safety is Unclear, 84 Chem & Engineering News

47, 47 (2006); Miller, et al, 54 Annals of Occup Hygiene at 7 (cited in note 35).

84

Leslie Pray and Ann Yaktine, Nanotechnology in Food Products: Workshop

Summary, Inst of Med 739, 741 (2009), online at http: //www.nap.edu/catalog.php?

record_id=12633 (visited Sept 15, 2013); Schultz and Barclay, A Hard Pill to Swallow at

*9 (cited in note 28); Walter Derzko, Novel, Safe Natural Food Supplement, Hydrated

Fullerenes (C60-HyFn) or Water-Soluble Buckyballs Could Make 50–60% of the Riskier

Synthetic Drugs and Pharmaceuticals Obsolete by 2025–30, Smart Economy (May 17,

2010), online at http: //smarteconomy.typepad.com/smart_economy/2010/05/novel-safe-

natural-food-supplement-hydrated-fullerenes-c60hyfn-or-watersoluble-buckyballs-could-

make.html (visited Sept 15, 2013); Questioning Safety Of Nanotechnology in Your

Vitamins, Sciencedaily (Jan 15, 2009), online at http: //www.sciencedaily.com/releases/

2009/01/090114114936.htm (visited Sept 15, 2013); Nanoparticles in Dietary

Supplements Cause Health Concerns, Regulatory Challenges, Sciencedaily (Feb 10,

2009), online at http: //www.sciencedaily.com/releases/2009/02/090209075633.htm

(visited Sept 15, 2013). The buckyballs negatively impacted the water habitat by killing

all the water fleas and bacteria. Oberdörster, 112 Envir Health Persp at 1059 (cited in

note 81). Another separate study showed that nanoparticles in small amounts are toxic

to soil bacteria. J.D. Fortner, et al, C60 in Water: Nanocrystal Formation and Microbial

Response, 39 Envir Sci and Tech 4307, 4307 (2005); Buckyballs Could Keep Water

Systems Flowing, Sciencedaily (cited in note 80).

85

Vincent Castranova, et al, Persistent Pulmonary Fibrosis, Migration to the

Pleura, and Other Preliminary New Findings After Subchronic Exposure to Multi-Walled

Carbon Nanotubes, NIOSH Sci Blog (Mar 19, 2009, 10:24 AM), online at

http: //blogs.cdc.gov/niosh-science-blog /2009/03/nano-2/ (visited Sept 15, 2013) (“NIOSH

Study”), reprinted as abstract in 108 Toxicologist 457 (2009); Craig A. Poland, et al,

Letters, Carbon Nanotubes Introduced into the Abdominal Cavity of Mice Show Asbestos-

Like Pathogenicity in a Pilot Study, 3 Nature Nanotech 423, 423–28 (2008); Carbon

Nanotubes that Look like Asbestos, Behave like Asbestos, Could Lead to Asbestos-Related

Disease, Sciencedaily (May 22, 2008), online at http: //www.sciencedaily.com/

releases/2008/05/080520144004.htm (visited Sept 15, 2013).

86

“Discovered nearly 20 years ago, carbon nanotubes have been described as the

wonder material of the 21st Century. Light as plastic and stronger that [sic] steel, they

are being developed for use in new drugs, energy-efficient batteries and futuristic

electronics.” Carbon Nanotubes that Look Like Asbestos, Sciencedaily (cited in note 85).

Carbon nanotubes are atom-thick sheets of graphite formed into cylinders.

They may be formed from a single layer of graphite or they may consist of

multiple concentric layers of graphite, resulting in multi-walled carbon



appears that these nanotubes have the potential to cause

mesothelioma,88 a cancer of the lung lining that appears

following exposure to asbestos.89 A pair of studies released in

nanotubes. While the diameter of a nanotube can vary from a few nanometers

up to tens of nanometers, they can be hundreds or even thousands of

nanometers long. Carbon nanotubes come in many forms, with different

shapes, different atomic arrangements, and varying amounts and types of

added chemicals—all of which affect their properties and might influence their

impact on human health and the environment.

Id.

87 Asbestos fibers are harmful because they are thin enough to penetrate deep

into the lungs, but sufficiently long to confound the lungs’ built-in clearance

mechanisms for getting rid of particles. Widespread exposure to asbestos has

been described as the worst occupational health disaster in U.S. history and

the cost of asbestos-related disease is expected to exceed $200 billion.

Id.

The toll of asbestos-related cancer, first noticed in the 1950s and 1960s, is

likely to continue for several more decades even though usage reduced rapidly

some 25 years ago. While there are reasons to suppose that nanotubes can be

used safely, this will depend on appropriate steps being taken to prevent them

from being inhaled in the places they are manufactured, used and ultimately

disposed of. Such steps should be based on research into exposure and risk

prevention, leading to regulation of their use.

Id (quoting Anthony Seaton, professor emeritus at the University of Aberdeen, UK).

Similar to buckyballs, nanotubes are part of the fullerene family. They consist entirely of

carbon molecules. Unlike buckyballs, nanotubes are made up of carbon atoms bonded

into a tube shape, sometimes with a single wall, called single-wall carbon nanotubes

(“SWCN”), or multiple walls, called multi-wall carbon nanotubes (“MWCN”). Marking on

this similarity, carbon nanotubes are called “buckytubes” by some as their ends, when

closed, take on the spherical shape of buckyballs. Nanotubes and Buckyballs,

nanotechnologynow.com, online at http: //www.nanotech-now.com/nanotube-buckyball-

sites.htm (visited Sept 15, 2013).

88

Nanotubes and Buckyballs, nanotechnologynow.com (cited in note 87).

89

Id. In a 2008 study, nanoparticles were injected into the abdominal cavity of mice

because this is a good predictor of how long fibers will affect the lung lining. Based on

the study findings, it appears that long, thin, multi-walled carbon nanotubes that look

like asbestos fibers, actually behave like asbestos fibers. This study suggests that people

who breathe in nanotubes may develop cancer at some point after exposure. Poland, et

al, 3 Nature Nanotech at 426–27 (cited in note 85). In 2009, only a year later, NIOSH

took the Poland study one step further by examining the impact on mice of inhaling a

small drop of liquid containing the multi-walled carbon nanotubes. See Castranova, et al,

Persistent Pulmonary Fibrosis (cited in note 85). This study was the first to demonstrate

that multi-walled carbon nanotubes aspirated by laboratory mice can actually migrate

throughout even the tiniest area of the lungs and can actually migrate into the pleura.

Id. See also LM Sargent, et al, Induction of Aneuploidy by Single-Walled Carbon

Nanotubes, 50 Envir Molecular Mutagenesis 708, 713–15 (2009) (showing that single-

walled carbon nanotubes can cause genotoxicity and abnormal chromosome number

caused by interference with cell division (mitosis)); Atsuya Takagi, et al, Induction of

Mesothelioma in p53+/- Mouse by Intraperitoneal Application of Multi-Walled Carbon

Nanotube, 33 J Toxicology Sci 105, 110–14 (2008) (describing intraperitoneal injection of

multi-walled carbon nanotubes causes mesothelial tumors in mice after). The mice had



May of 2013, completed by a consortium of seventy researchers

from seven universities and the National Institute of

Occupational Health and Safety, confirms that some types of

nanoparticles are likely to cause physical harm.90 This

consortium was able to measure similar adverse health effects

after exposure to nanoparticles by replicating their results in

separate studies across multiple independent labs.91 In one

study, laboratories measured pulmonary inflammation in

rodents exposed to carbon nanotubes and nanotech titanium

dioxide.92 In the second study, researchers demonstrated

adverse reactions in cell cultures exposed to carbon nanotubes,

nanotech titanium dioxide and nanotech zinc oxide.93 Based on

these collective studies, it appears that it is likely that carbon

persistent inflammation and fibrosis (scarring) in their lungs after inhaling the particles.

Castranova, et al, Persistent Pulmonary Fibrosis, NIOSH Sci Blog (cited in note 85).

These are important findings because multi-walled carbon nanotubes have properties

that are similar to asbestos and a form of cancer called mesothelioma takes form in the

pleura after exposure to asbestos. Id. The still unanswered question is whether MWCN

will cause mesothelioma. Id. Answering this question, according to the authors of the

study,

is of considerable importance, because research and business communities

continue to invest heavily in carbon nanotubes for a wide range of products

under the assumption that they are no more hazardous than graphite. Our

results suggest the need for further research and great caution before

introducing such products into the market if long-term harm is to be avoided.

Poland, et al, 3 Nature Nanotech at 423 (cited in note 85) (footnote omitted). Dr. Andrew

Maynard, the co-author of the NIOSH study, opines that “[t]his study is exactly the kind

of strategic, highly focused research needed to ensure the safe and responsible

development of nanotechnology. . . . It looks at a specific nanoscale material expected to

have widespread commercial applications and asks specific questions about a specific

health hazard. Even though scientists have been raising concerns about the safety of

long, thin carbon nanotubes for over a decade, none of the research needs in the current

U.S. federal nanotechnology environment, health and safety risk research strategy

address this question.” Carbon Nanotubes that Look like Asbestos, Sciencedaily (cited in

note 85) (internal quotation marks omitted).

90

See generally Robert Iafolla, Groundbreaking Nanotechnology Studies Replicate

Result Across Independent Labs, 28 BNA Toxics Law Reporter 533 (May 9, 2013).

91

Id.

92

Id; Interlaboratory Evaluation of Rodent Pulmonary Responses to Engineered

Nanomaterials: The NIEHS NanoGo Consortium, Environmental Health Perspectives,

(May 6, 2013), online at http: //ehp.niehs.nih.gov/wp-content /uploads/121/5/ehp.1205693.

pdf (visited Sept 15, 2013).

93

Iafolla, 28 BNA Toxics Law Reporter 533 (cited in note 90); Intralaboratory

Evaluation of In Vitro Cytotoxicity and Inflammatory Responses to Engineered

Nanomaterials: The NIEHS NanoGo Consortium (Environmental Health Perspectives

May 6, 2013), online at http: //ehp.niehs.nih.gov/wp-content /uploads/121/5/ehp.1306561.

pdf (visited Sept 15, 2013).



nanotubes, nanotech titanium dioxide, and nanotech zinc oxide

may pose a serious risk to human health.94

C. FDA Regulation of Nanotech Consumer Products or FDA

Regulations on Ingredient Labeling

Currently, the Food and Drug Administration (FDA) is

regulating nanotech ingredients the same way that it regulates

these ingredients’ bulk counterparts.95 If the macro-molecule

version of an ingredient has previously been found by the FDA

to be safe, for regulatory purposes, the FDA presumes that the

94

See, for example, Kolosnjaj, Toxicity Studies of Carbon Nanotubes, Bio-Apps Of

Nanoparticles at 181 (cited in 72) (opining that “available data clearly show that, under

some conditions, nanotubes can cross the membrane barriers and suggests that if raw

materials reach the organs they can induce harmful effects as inflammatory and fibrotic

reactions”); Alexandra E. Porter, et al, Direct Imaging of Single-Walled Carbon

Nanotubes in Cells, 2 Nature Nanotech 713, 713, 716 (2007) (showing that nanotubes

can penetrate into cell “cytoplasm and localize within the cell nucleus, causing cell

mortality in a dose-dependent manner”); Chiu-Wing Lam, et al, A Review of Carbon

Nanotube Toxicity and Assessment of Potential Occupational and Environmental Health

Risks, 36 Crit Rev in Toxicology 189, 207 (2006). See also A. Hubbs, et al, Persistent

Pulmonary Inflammation, Airway Mucous Metaplasia and Migration of Multi-Walled

Carbon Nanotubes from the Lung After Subchronic Exposure, 108 Toxicologist 457, 457

(2009) (describing how the fiber-like dimensions and durability of multi-walled carbon

nanotubes, as well as their ability to cause inflammation in the abdominal cavity, are

similar to asbestos); Elena Kisin, et al, Pulmonary Response, Oxidative Stress and

Genotoxicity Induced by Carbon Nanotubes, 114 Toxicologist A793, A793 (2010) (finding

acute inflammation and interstitial fibrosis in mice exposed to carbon nanofibers);

Robert R. Mercer, et al, Distribution and Persistence of Pleural Penetrations by Multi-

Walled Carbon Nanotubes, 7 Particle & Fibre Toxicology 1, 5–6 (2010) (demonstrating

the toxic effects of MWCNTs because they can invade both the alveollar epithelium and

visceral pleura); Jürgen Pauluhn, Subchronic 13-Week Inhalation Exposure of Rats to

Multi-Walled Carbon Nanotubes: Toxic Effects are Determined by Density of Agglomerate

Structures, not Fibrillan Structures, 113 Toxicology Sci 226, 226 (2010) (showing how

rats exposed to carbon nanotubes at low doses have lower lung clearance); Dale W.

Porter, et al, Mouse Pulmonary Dose—and Time Course—Responses Induced by

Exposure to Multi-Walled Carbon Nanotubes, 269 Toxicology 136, 136–47 (2010)

(observing the resemblance between asbestos fibers and the long and thin structures of

common carbon nanotubes and carbon nanofibres and how both can migrate from

pulmonary alveoli to pleural tissue, which is the same location where malignant

mesothelioma develops).

95

Katharine Van Tassel and Rose H. Goldman, The Growing Consumer Exposure to

Nanotechnology in Everyday Products: Regulating Innovative Technologies in Light of

Lessons from the Past, 44 U Conn 481, 503–13 (2010). Consistent with the nomenclature

adopted by the literature, this Article will refer to particles that manifest these different

properties as “nanoparticles” or “nanoscale” materials or versions and will refer to larger

scale particles of the same chemical that do not have these unique properties as normal

size materials or bulk materials. Buzea, Pacheco Blandino, and Robbie, 2 Biointerphases

at MR23-25 (cited in note 26); The Royal Society and The Royal Academy of Engineering,

Nanoscience and Nanotechnologies: Opportunities and Uncertainties at 7 (cited in note

25).



nanotech version is also safe.96 Thus, the FDA is treating

nanotech ingredients as bioequivalent to their normal size

counterparts.97

Regulating nanotech products exactly like their non-

nanotech counterparts has serious consequences.98 First, as

manufacturers of food, dietary supplements, and cosmetics are

not required to test their products for safety and are not

required to obtain premarket approval from the FDA, the

nanotech versions of these products are also not subject to these

premarket steps.99 With regard to sunscreens, nano-sized

ingredients are deemed to be just as safe as their previously

approved macro-sized ingredient counterparts, so no testing of

these nano-ingredients is required.100

Second, this regulatory stance of bioequivalence means that

the listing of nanotech ingredients on product packaging is not

required by the FDA. The FDA opines that product ingredient

lists that refer to nanomaterial content by the same name as the

normal size material counterpart are not false and misleading

based on its presumption of bioquivalence. The FDA grounds

this conclusion on its finding that there is no scientific basis

on which to conclude that nanoscale materials as a class are

inherently more hazardous than nonnanoscale materials.101

Thus, the FDA has taken the position that the fact that a

consumer product contains nanotech ingredients is not

“material” and need not be disclosed on labels.102

96

Van Tassel and Goldman, 44 U Conn at 503–15 (cited in note 95).

97

Id.

98

Id.

99

Id.

100

See note 64.

101

Food and Drug Administration, Nanotechnology Task Force Report 2007, online

at http: //www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/UCM2006659.htm


102

Under the FDCA, a drug, device, food, dietary supplement, cosmetic, or sunscreen

is deemed misbranded if its labeling is “false or misleading in any particular.” 21 USC

§ 362(a) (2006). See also 21 CFR § 701.1 (2011).

If an article is alleged to be misbranded because the labeling or advertising is

misleading, then in determining whether the labeling or advertising is

misleading . . . there shall be taken into account (among other things) not only

representations made or suggested by statement, word, design, device, or any

combination thereof, but also the extent to which the labeling or advertising

fails to reveal facts material in the light of such representations or material

with respect to consequences which may result from the use of the article to

which the labeling or advertising relates under the conditions of use prescribed



It is important to note that, while the FDA has recently

acknowledged on its website that nanoparticles “can have

chemical, physical, and biological properties that differ from

those of their larger counterparts,”103 the acknowledgment of the

possibility that “nano can mean different” has yet to be given

voice in any of the FDA’s regulatory positions on safety.

Third, conditioning the use of regulatory power to protect

public health with the establishment of scientific evidence that

will support a finding of hazard, will, as a general matter, be

outcome determinative. This is because, as explained in the next

section, the development of the scientific evidence needed to

show a product is hazardous to health significantly lags behind

the creation of the innovative technology itself. This regulatory

posture means that there will be no regulatory protection of

public health for perhaps decades.

Fourth, with regard to nanotech food, dietary supplements,

sunscreens, and cosmetics, if the FDA does have concerns about

their safety, it must use its seizure or injunctive powers to

remove the product from the market.104 In these court actions,

the FDA has the burden of proving that the product is

adulterated.105 A product is adulterated if it “presents a

in the labeling or advertising relates under the conditions of use prescribed in

the labeling or advertising thereof or under such conditions of use as are

customary or usual.

21 USC § 321(n) (emphasis added). See also 21 USC § 331(a) (prohibiting the

introduction into commerce of any food, device, or cosmetic that is misbranded); 21 USC

§ 343(a) (stating that foods are misbranded if their labeling is “false or misleading in any

particular”); 21 USC § 352(a) (stating that drugs and devices are misbranded if their

labeling is “false or misleading in any particular”); 21 USC § 362(a) (stating that

cosmetics are misbranded if their labeling is “false or misleading in any particular”).

103

Food and Drug Administration, Nanotechnology, online at http: //www.fda.gov/

ScienceResearch/SpecialTopics/Nanotechnology/default.htm (visited Sept 15, 2013) (“The

U.S. Food and Drug Administration (FDA) regulates a wide range of products, including

foods, cosmetics, drugs, devices, veterinary products, and tobacco products, some of

which may utilize nanotechnology or contain nanomaterials. Nanotechnology allows

scientists to create, explore, and manipulate materials measured in nanometers

(billionths of a meter). Such materials can have chemical, physical, and biological

properties that differ from those of their larger counterparts.”).

104

Richard A. Merrill, Regulating Carcinogens in Food: A Legislator’s Guide to the

Food Safety Provisions of the Federal Food, Drug, and Cosmetic Act, 77 Mich L Rev 171,

186–90 (1978).

105

21 USC § 342(a)(I); Merrill, 77 Mich L Rev at 186–90 (cited in note 104). For a

naturally occurring substance found in the food product, the food product is rendered

adulterated if the substance is ordinarily injurious to health. 21 USC § 342(a)(I).

However, if the substance in the food product is “added,” the food product is adulterated

if the substance “may render” the food injurious to health. 21 USC § 342(a)(I).



significant or unreasonable risk of illness or injury.”106 The FDA

interprets “the plain meaning of ‘unreasonable’ . . . [to] connote

[ ] comparison of the risks and benefit of the product.”107 Thus,

the FDA has the burden of “gathering data, soliciting comments

and conducting the risk-benefit analysis.”108

Once again, the FDA is likely to be unsuccessful using this

route for a long period of time, perhaps decades, unless a great

number of people have already been seriously injured. Even

then, as the case of Ephedra demonstrates, it is likely to take a

decade, or longer, for the FDA to be successful.109

106

21 USC § 342(f )(1).

107

Food and Drug Administration, Final Rule Declaring Dietary Supplements

Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable

Risk, 69 Fed Reg 6788, 6823 (Feb 11, 2004) (“Final Rule”).

108

Nutraceutical Corp v Andrew Von Eschenbach, 459 F3d 1033, 1040 (10th Cir

2006) (“The plain meaning of ‘significant risk’ is a great danger.”).

109

Id at 1036. Ephedra was an ingredient that was commonly used in dietary

supplements. Id. While ephedrine alkaloids occur naturally in some plants, ephedra falls

into the same chemical category as the street drug called “speed.” Barry A. Palevitz,

Harmless Energizers or Dangerous Drugs?, The Scientist (Dec 9, 2002), online at

http: //www.the-scientist.com/?articles.view/articleNo/14399/title/Harmless-Energizers-

or-Dangerous-Drugs-/ (visited Sept 15, 2013) (“Ephedrine is a close relative of

amphetamine, sometimes called benzedrene. A little chemical tinkering creates the

street drugs methamphetamine and Ecstasy.”). Products containing ephedrine alkaloids

were marketed as dietary supplements for weight loss and to enhance sports

performance. See Nutraceutical Corp, 459 F3d at 1036. Over time, the FDA began

receiving adverse event reports (“AERs”) from consumers, which included numerous

complaints of heart attacks, strokes, seizures, and deaths associated with the

consumption of products containing ephedrine alkaloids. See id. One of the most highly

publicized cases of a fatal consequence from the use of ephedrine alkaloids in a dietary

supplement was the death of Steve Belcher, a twenty-three-year-old baseball player with

the Baltimore Orioles. See Fran Hawthorne, Inside the FDA: The Business and Politics

Behind the Drugs We Take and the Food We Eat 57 (John Wiley and Sons 2005). In order

to meet its burden of proof necessary to remove this ingredient from the market, the

FDA took seven years to gather sufficient evidence on the safety of ephedrine alkaloids.

The FDA compiled an administrative record of 130,000 pages, 19,000 AERs, and engaged

in extensive notice and comment before it passed a regulation banning the sale of

products containing ephedrine alkaloids in 2004. See 69 Fed Reg at 6788 (cited in note

107); Nutraceutical Corp, 459 F3d at 1036. In this final rule, the FDA stated that “[t]he

best clinical evidence for a benefit . . . supports only a modest short-term weight loss,

insufficient to positively affect cardiovascular risk factors or health conditions associated

with being overweight or obese.” Nutraceutical Corp, 459 F3d at 1036–37. Then, the FDA

had to spend several additional years in litigation until Ephedra was finally taken off the

market. The manufacturer of Ephedra filed suit, arguing that the FDA had failed to

meet its burden of proof of showing that products containing ephedrine alkaloids were

unsafe. Id at 1043–44. The district court found for the manufacturer; however, in 2006,

the FDA prevailed on appeal. Id at 1038–39. The total time and expense involved in this

process, including the cost of the harm suffered by consumers, was tremendous. 69 Fed

Reg at 6788 (cited in note 107). Not only did this proceeding take almost a decade, the

amount of time and money that was spent by the FDA, which it could have used on other

matters, was enormous. It is worth pointing out that the taxpayers foot the bill for this



D. Impact of the FDA’s Focus on Hazard to Trigger Public

Health Safety Regulation

The FDA’s reliance on hazard to trigger the use of its

regulatory power to protect public health when innovative

ingredients are used in consumer products short-circuits its

ability to act for sometimes-lengthy periods of time. This is

because a substantial lag time, likely a decade or more,

invariably exists between the production and distribution of the

innovative technology to the public and the development of the

science necessary to identify the risks associated with that

technology. This lag time occurs when a manufacturer is not

required by the FDCA to prove safety before being allowed to

market a novel, innovative product as there is, otherwise, little

incentive to invest in the testing process to prove safety. The

cost of testing for safety is, instead, born by third parties—

almost entirely the government and, thus, the taxpayers110—and

is performed after the product has already been introduced into

effort, not the manufacturers who reaped tremendous profits over several decades from

marketing Ephedra.

110

Ian Urbina, Think Those Chemicals Have Been Tested?, NY Times (April 13,

2013), online at http: //www.nytimes.com/2013/04/14/sunday-review/think-those-

chemicals-have-been-tested.html (visited Sept 15, 2013). “Many Americans assume that

the chemicals in their shampoos, detergents and other consumer products have been

thoroughly tested and proved to be safe. This assumption is wrong. Unlike

pharmaceuticals or pesticides, industrial chemicals do not have to be tested before they

are put on the market.” Id.

Companies have to alert the Environmental Protection Agency before

manufacturing or importing new chemicals. But then it is the E.P.A.’s job to

review academic or industry data, or use computer modeling, to determine

whether a new chemical poses risks. Companies are not required to provide

any safety data when they notify the agency about a new chemical, and they

rarely do it voluntarily, although the E.P.A. can later request data if it can

show there is a potential risk. If the E.P.A. does not take steps to block the new

chemical within 90 days or suspend review until a company provides any

requested data, the chemical is by default given a green light. The law puts

federal authorities in a bind. ‘It’s the worst kind of Catch-22,’ said Dr. Richard

Denison, senior scientist at the Environmental Defense Fund. ‘Under this law,

the E.P.A. can’t even require testing to determine whether a risk exists

without first showing a risk is likely.’ As a result, the overwhelming majority of

chemicals in use today have never been independently tested for safety. In its

history, the E.P.A. has mandated safety testing for only a small percentage of

the 85,000 industrial chemicals available for use today. And once chemicals are

in use, the burden on the E.P.A. is so high that it has succeeded in banning or

restricting only five substances, and often only in specific applications:

polychlorinated biphenyls, dioxin, hexavalent chromium, asbestos and

chlorofluorocarbons.

Id.



the market. Thus, the focus on hazard means that the FDA

must wait to regulate to protect public health until the state of

the science on health risks catches up to the innovation itself.

During this scientific lag time, manufacturers are free to market

their products with no interference and no notice to

unsuspecting consumers.111 As explained in the next section,

this Article refers to this scientific lag time as the health risk

information void.

1. The health risk information void.

When a manufacturer is not required to prove safety before

being allowed to market a novel, innovative product, it is

common for the development of novel technologies to far outpace

the development of the science necessary to test for the health

risks associated with these technologies.112 This scientific lag

time creates a period during which there is an information void

with regard to risks to human health. As this information void is

slowly filled through scientific experimentation, the level of

uncertainty over health risks commonly progresses from

ignorance (where scientists don’t know what they don’t know) to

indeterminacy (where scientists know what they don’t know, but

can plan the scientific experiments necessary to find out) to,

finally, a tipping point in the state of knowledge when classic

probability analysis can be applied to predict, or quantify, risk

levels to human health.113 Thus, as health risks take time to

quantify, the result of the reliance on establishing hazard

through the use of risk/benefit analysis as a precondition to

regulation to protect public health is a foregone conclusion when

many new technologies first enter the market. The practical

result is that an unsafe product containing an innovative, novel

111

John M. Broder, New Alliance Emerges to Tighten Chemical Rules, NY Times

(May 24, 2013), online at http: //www.nytimes.com/2013/05/25/us/politics/lautenbergs-

chemical-safety-bill-gains-momentum.html?pagewanted=all (visited Sept 15, 2013) (“Of

roughly 85,000 chemicals registered for use in the United States, only 200 have been

tested by the Environmental Protection Agency and fewer than a dozen—including

polychlorinated biphenyls, dioxin and hexavalent chromium—have been restricted.”).

112

Nicholas A. Ashford, The Legacy of the Precautionary Principle in U.S. Law: The

Rise of Cost-Benefit Analysis and Risk Assessment as Undermining Factors in Health,

Safety and Environmental Protection, in Nicolas de Sadeleer, ed, Implementing The

Precautionary Principle: Approaches From The Nordic Countries, The EU and The

United States 356–61 (Routledge 2006).

113

Id.



ingredient is likely to remain on the market for a long period of

time before the FDA can take action.

a) Examples of lag times with serious health

consequences. There are numerous examples114 of the negative

impact on public health of this lag time between the

introduction of new chemical compounds and innovative

technologies into the market and the development of the science

necessary to identify the associated hazard to human health.115

For example, it took decades to develop the science necessary to

establish the endocrine disruption hazard caused by novel

product ingredients such as polychlorinated biphenyls (“PCBs”),

tributylin (“TBT”), diethylstilbestrol (“DES”), Thalidomide, and

the Great Lakes pollution.116 Illustratively, some evidence

existed in the 1930s that PCBs were a serious hazard to human

health.117 However, it took four decades before the state of the

science evolved to the point of identifying the extent of the

hazard to human health. Sweden was the first country to ban

PCBs in the 1970s, with the European Union following suit in

1996.118

Other examples include those of medical x-rays, benzene,

and asbestos. The first scientific warnings over medical x-rays

occurred in 1896, those relating to benzene occurred in 1897,

and those relating to asbestos occurred in 1898. Yet it took

between thirty (for PCBs)119 and one hundred years (for x-

114

For a comprehensive analysis of fourteen case studies of these types of scenarios,

see European Environmental Agency, Late Lessons From Early Warnings: The

Precautionary Principle 1896–2000, 22 Envir Issue Rpt, 66–69 (2001).

115

Urbina, Think Those Chemicals Have Been Tested?, NY Times (cited in note 110).

116

David Gee, Late Lessons from Early Warnings: Toward Realism and Precaution

with Endocrine-Disrupting Substances, 114 Envir Health Persp 152, 156 (2006). See also

Katharine A. Van Tassel, Slaying the Hydra: The History of Quack Medicine, the Obesity

Epidemic and the FDA’s Battle to Regulate Dietary Supplements Marketed as Weight

Loss Aids, 6 Ind Health L Rev 203, 228–29 (2009) (discussing the case of Thalidomide).

117

European Environmental Agency, 22 Envir Issue Rpt at 66–69 (cited in note 114).

118

Id at 126. In 1962, the book Silent Spring warned of the negative health effects

on humans and wildlife of this exposure. The marketing of these novel chemicals

continued unabated in spite of this warning. And the full extent of the devastating

consequences to the Great Lakes area of a five decades-long period of human and

environmental exposure to pesticides with the novel organochlorine compound

ingredients is still unknown. See generally Rachel Carson, Silent Spring (Houghton

Mifflin Harcourt 1962).

119

Gee, 114 Envir Health Persp at 155 (cited in note 116). Another example is the

introduction of CFCs. CFCs have created the ozone hole, resulting in thousands of

additional skin cancer cases that will only peak in number in the middle of this century.

Id at 155–56.



rays)120 for scientists to determine the extent of these hazards

and then for regulations to be promulgated to mitigate the

already extensive damage to public health caused by these

products.

b) Nanotech ingredients and the health risk information

void. While the use of nanoparticles in consumer products and

the resultant exposure of consumers are growing daily, the body

of science necessary to identify the health risks associated with

engineered nanoparticles is still in its infancy. When the FDA

first made its decisions on how to regulate nanotech products,

far less was known about the distinctive properties of

nanoparticles, their uniquely high level of bioreactivity, and the

resultant heightened potential for adverse health effects.

Scientists simply “did not know what they did not know” about

the health risks associated with nanotech particles. At that

point in time, the FDA made its regulatory choices in an

environment of ignorance, choosing to regulate based on what

scientists now know to be a false assumption of bioequivalence.

Over the past several years, a parade of major scientific

discoveries has shifted the nature of the uncertainty over the

public health risks of nanotech particles from ignorance to

indeterminacy.121 In other words, scientists have progressed

from not knowing what they do not know, to knowing what they

do not know. Scientists now understand that engineered

nanoparticles may create novel health risks caused by powerful

nano-bio interactions that have never before existed in nature.

In order to move from indeterminacy to classic risk analysis,

scientists must still determine the nature and extent of the

harm that occurs as a result of these nano-bio interactions.

Then, using classic risk analysis, scientists must quantify the

probability and degree of those harms. Thus, the new awareness

on the part of scientists that nanoparticles can cause serious

physical harm, and the identification of some of the potential

mechanisms for causation, opens the door to the ability to plan

out the systematic study of each new type of engineered

nanoparticle in order to eliminate or confirm the associated

health risks. In spite of the fact that the state of the science has

now moved into indeterminacy, the FDA’s reliance on

establishing hazard through the use of classic risk/benefit

120 European Environmental Agency, 22 Envir Issue Rpt at 66–69 (cited in note 114).

121 See Part II.B.



analysis in making decisions over whether to regulate for safety

means that, until the science on the health risks associated with

nanoparticles has matured to the point that the risks can be

quantified, the FDA will proceed as if this growing body of

science did not exist.

As explained in the next section, switching the FDA’s

regulatory focus onto novelty, rather than hazard, enables the

public health product safety net, which can act to safeguard the

public while this ponderous cycle of scientific inquiry runs its

course.

2. The FDA’s focus on hazard disables the public health

product safety net.

The public health safety net is a powerful, interactive

network that involves consumers as well as the healthcare

system, the state and federal public health protection agencies,

and the tort system. Importantly, ingredient listing is essential

to the creation of this safety net—without this listing, the safety

net unravels into nothing. To summarize, novel ingredient

listing protects consumer safety through consumer self-

protection. If a consumer knows that she is being exposed to a

novel ingredient, she can use heightened vigilance to watch for

symptoms of harm. It also allows for the appropriate treatment

of injured consumers by medical professionals who can identify

novel ingredients as potential causative agents through accurate

exposure reporting by consumers. Ingredient listing is also

necessary to the proper reporting of injury-causing agents to

state and federal public health protection agencies that manage

the early warning and product recall systems. Finally, the data

collected by these public health protection agencies makes up

the evidence required to enable the instrumental use of the tort

system, which encourages the proper investment by

manufactures in product safety and protects against the overuse

and overconsumption of harmful products by consumers.

Together, these public and private actors join to form the public

health product safety net.

a) Negative impact on consumer self-protection, medical

treatment, and the early warning and product recall systems.

The FDA’s current focus on hazard means that it can’t act to

regulate nanotech ingredients until each separate variety of

nanoparticle is proved to be hazardous to human health. Recall



that the number of different varieties of nanoparticles is only

limited by the creativity and ingenuity of engineers and

scientists so that this may number in the tens of thousands.

Until each variety of nanoparticle is proven to be hazardous to

human health, nanotech products will continue to be regulated

like their macro-sized counterparts. This means that

nanoparticles will not be listed on ingredient labels. Thus, the

FDA’s focus on hazard to trigger its authority to require

ingredient listing means that consumers are unaware of the

extent of their exposure to novel nanotech substances. This lack

of knowledge bars the ability of public health officials to monitor

whether the heavy exposure of US consumers to nanotech

products is causing acute or latent toxic reactions.

Consequently, it is currently highly unlikely that any potential

health risks to the population from this exposure can be

identified and eliminated.

For example, if a consumer uses a nanotech product and has

a toxic reaction, the consumer will assume that the reaction is to

the product itself, not an exposure to the nanoparticle ingredient

because the new nanotech ingredient is not listed on the product

label. The only result is that the consumer will avoid that

particular product in the future. A mild reaction will not merit a

visit to a physician and will go unreported.

If the reaction is moderate to severe, a physician may be

consulted. If the physician reports the adverse reaction, it will

be incorrectly reported as a reaction to the particular host

product based on the inaccurate information given by the

patient. It will not be correctly reported as a reaction to the host

product’s nanotech ingredients.

This misinformation has a broader impact in light of the

new way scientists are using big data collected through social

media to proactively identify product safety problems. “Using

data drawn from queries entered into Google, Microsoft, and

Yahoo search engines, scientists at Microsoft, Stanford, and

Columbia University have for the first time been able to detect

evidence of unreported prescription drug side effects before they

were found by the Food and Drug Administration’s warning

system.”122 Another group of scientists are using data analysis

122

John Markoff, Unreported Side Effects of Drugs are Found Using Internet Search

Data, Study Finds, NY Times (March 6, 2013), online at http: //www.nytimes.com/

2013/03/07/science/unreported-side-effects-of-drugs-found-using-internet-data-study-



tools to analyze social media, including tweets and on-line

discussion forums, to identify adverse drug reactions.123 These

scientists

retroactively analyzed four types of public on-line media

(websites, blogs, Web forums and social networking sites)

posted from 2000 to early 2012 and were able to identify

hundreds and thousands of documents containing

adverse drug reaction-related information. The

preliminary results suggest that these documents can

accurately provide warnings earlier—in some cases years

earlier—than existing channels.124

In the context of food safety, several apps have been developed

to help public health officials track food-borne illnesses using

data collected from Twitter.125 These big data strategies are just

the start of muscular new additions to product safety

surveillance systems representing a fundamental shift from a

reactive to proactive monitoring systems. However, if consumers

are not provided accurate information on the innovative new

ingredients in consumer products, this revolutionary data

collection system can’t be used by scientists or public health

officials to monitor the safety of novel, innovative ingredients,

such as those using nanotechnology.

The bottom line is that the FDA’s decision that

manufacturers need not list nanotech ingredients on package

labels means that the public health system in place for collecting

data on the harms from exposures to novel ingredients had been

disabled. This means that the key elements of the public health

product safety net have been deactivated: (1) a consumer cannot

engage in self-protection and avoid the novel ingredient if it is

causing injury; (2) a consumer’s ability to obtain appropriate

medical treatment if injured has been sabotaged as they can’t

correctly inform their physicians what new ingredients they

have been exposed to; (3) physicians and consumers can’t

finds.html?_r=0 (visited Sept 15, 2013).

123

H. Brevy Cannon, Research to Sift Social Media for Early Signs of Adverse Drug

Reactions, UVA Today (Sept 20, 2012), online at http: //news.virginia.edu/content /

research-sift-social-media-early-signs-adverse-drug-reactions (visited Sept 15, 2013).

124

Id.

125

Krietsch, Social Media Apps (cited in note 20); Tracking Twitter May Enhance

Monitoring of Food Safety at Restaurants, ScienceDaily (cited in note 20).



contribute to, or benefit from, the early warning system that

gives notice to consumers that a product is causing injuries to

some people so as to trigger heightened vigilance by all; and (4)

the product recall systems that all consumers rely upon to

protect against personal injury from unsafe products does not

work for novel ingredients.

b) Negative impact on the tort system. While the prime

objective of the tort system is to compensate innocent victims

harmed by defective products, shifting the cost of these injuries

onto the manufacturers is also instrumental to the proper

functioning of the public health product safety net. Forcing a

manufacturer to bear the costs of injuries incurred from its

products that are faulty in their manufacture or design may

deter future misconduct and may tacitly encourage more careful

behavior, such as increasingly diligent testing and product

design.

The cost of injuries from the use of a product may also then

be built into the price of the product and passed on to the

consumer. If these effects are realized, several additional goals

of the public health product safety net are furthered. First, the

cost of the risk will be borne by all of those using the product

generally through the increased price, instead of the innocent

victim alone. Second, the price of the product will reflect its true

social cost. This price will then mediate consumer choice, more

likely resulting in optimum levels of production and purchase.

As the price of the product increases as a result of

manufacturers’ internalizing the cost of injuries to product

users, the consumption of the product will likely decline as

consumers switch to less costly alternatives, resulting,

ultimately, in a decrease in injuries due to the fall in the use of

the product. Thus, the tort system is an important part of the

public health product safety net as it insulates against the

overuse and overconsumption of relatively risky products.

Moreover, as a part of the public health product safety net,

the tort system places the cost of injury avoidance on the least-

cost accident avoider. The manufacturer is often in the best

position to accurately access the various ways of avoiding costs

of injuries through redesign, quality control, and other safety

measures. As a result of its level of access, the manufacturer is

also often in the best position to insure against future injuries.

Internalizing all of these costs—as well as the costs associated

with injuries—into the price of the product may ultimately force



a manufacturer to consider the true cost of certain products

when making its choices of which products to produce. It is

hoped that the end result of this part of the public health

product safety net is a socially-efficient output.

However, this cascade of beneficial effects that can occur

from the proper use of the tort system is short-circuited when

the FDA focuses on hazard to regulate innovative products. The

principle reasons for this result are three-fold. First, as nanotech

ingredients are not required to be listed on product labels, the

consumer will not know that she was exposed to a nanotech

ingredient. Thus, the consumer is unlikely to suspect that her

injuries were caused by a novel substance.126 Second, if the

consumer learns that a nanotech ingredient was the cause of her

injury, she will be required to establish proximate cause under

tort law by showing that the manufacturer could have foreseen

the risk of harm.127 As with many new technologies, the rate of

the introduction of nanotech products into the market has far

outpaced the science needed to demonstrate its associated risks.

Under either the Daubert128 or Frye129 tests, this research lag

acts to insulate a manufacturer from liability based on a lack of

causation130 and foreseeability.131

The final hurdle arises in the context of both negligence and

strict liability claims. The lack of labeling means that the public

health protection agencies, such as the Center for Disease

Control (CDC) and the FDA, cannot collect the data that, over

time, could accumulate to the point of meeting the evidentiary

hurdles of causation and foreseeability. Over and above this

problem, unless the consumer can establish that she is a

126

Katharine Van Tassel, The Introduction of Biotech Foods to the Tort System:

Creating a New Duty to Identify, 72 U Cin L Rev 1645, 1681 (2004).

127

Id at 1683–84.

128

See Daubert v Merrell Dow Pharmceuticals, Inc, 509 US 579, 589 (1993).

129

See Frye v United States, 293 F 1013, 1014 (DC Cir 1923).

130

Under the Daubert and Frye standards, evidentiary principles are likely to bar

any introduction of scientific evidence to meet the burden of proof on causation as long as

there is scientific uncertainty. Daubert, 509 US at 589; Frye, 293 F at 1014. The Daubert

factors counsel judges to ask the following questions in making decisions on the

admissibility of scientific evidence: (1) Has the technique been tested in actual field

conditions (and not just in a laboratory)?; (2) Has the technique been subject to peer

review and publication?; (3) What is the known or potential rate of error? Is it zero, or

low enough to be close to zero?; (4) Do standards exist for the control of the technique’s

operation?; and, (5) Has the technique been generally accepted within the relevant

scientific community? Daubert, 509 US at 580.

131

Van Tassel, 72 U Cin L Rev at 1683–84 (cited in note 126).



member of a substantial class of people who are at risk for the

same type of adverse reaction, the case is likely to be dismissed

under what is commonly referred to as the “idiosyncratic

plaintiff defense.”132 This “de minimus harm” liability threshold

can range from tens of thousands to millions of people.133 As

with causation, because nanotech ingredients in consumer

products are unlabeled, injured consumers are unlikely to

recognize what actually caused their injuries. As a result, these

injuries will go unreported. Without this data, a consumer will

be unable to establish that she is a member of a substantial

class, creating an almost impassable barrier to recovery.134

The bottom line is that the FDA’s no-labeling decision

means that another key element of the public health product

safety net, the tort system, has also been disabled.

III. HISTORY OF FDCA REGULATION OF NOVEL INGREDIENTS

As explained in the prior section, the current focus by the

FDA on hazard to trigger regulation of novel, innovative

ingredients in the context of scientific uncertainty fosters

innovation but does nothing to protect public health. In the past,

the FDA has avoided this problem by focusing on novelty rather

than on hazard. As described in the next sections, this focus had

a domino effect that created the public health product safety net

that managed the scientific uncertainty over possible negative

health effects of these novel ingredients. This focus on novelty

also fits with the overall scheme of the FDCA, which titers the

degree and kind of regulation it uses to protect consumers from

harm from third parties to the level and type of vulnerability of

a product’s targeted consumers. The overall result was that an

appropriate balance between public health protection and

innovation was achieved. A look back at this history explains

why, and how, this balance was realized in the past and how it

can be reached in the modern day context of rapidly emerging

innovative technologies.

132

Id at 1680, 1683–84. This defense is basically a contention that a reasonable

consumer would not have had the reaction and that the defect is in the consumer, not

the product. Id.

133

Id.

134

Id.



A. The Pure Food Act of 1906

In the 1850s, a large majority of Americans lived and

worked on farms.135 Grain was milled at the local level by

thousands of mills and rural areas were peppered with hundreds

of small packing plants that packaged all of the locally produced

foods.136 By the turn of the century, the majority of the

population moved to the city, a far smaller number of mills did

the vast majority of the work, and packaging companies grew in

size, dwindled sharply in number, and moved to the cities.137

Food produced locally was shipped to these big city packing

companies, packaged in cans and jars and was then returned,

“watered down, preserved and cheap.”138 Soon, these products

were moving across great distances as horses were replaced with

cars, trucks, and trains. Food, clothing, and simple tools were no

longer made by people for their own use and the use of their

neighbors. “The modern estrangement between the people who

create goods and the people who consume them now emerged.”139

This “modern estrangement”

made adulteration and deception both easy and profitable

as manufacturers of food and medicines no longer had to

face their customers. Under laissez-faire regulation,

corruption and abuse were rampant. Food producers

scammed consumers by adding fillers to food to increase

weight (such as chalk, clay, or plaster of paris to flour

and ground up insect carcasses, commonly lice, to brown

sugar). Large amounts of untested chemicals (such as

formaldehyde, sulfites, borax, salicylic acid and benzoic

acid) were used liberally to preserve food for transport

and to disguise the taste and appearance of food that was

spoiled.140

135

Phillip J. Hilts, Protecting America’s Health: the FDA, Business, and One

Hundred Years of Regulation 11 (UNC 2004).

136

Id.

137

Id at 12.

138

Id.

139

Hilts, Protecting America’s Health at 12 (cited in note 135).

140

Van Tassel, 6 Ind Health L Rev at 230 (cited in note 116). See also Hilts,

Protecting America’s Health at 21–22 (cited in note 135) (“Copper sulfate can make faded

vegetables appear green again; sodium benzoate can prevent decayed tomatoes from

rotting altogether; stearins can stretch lard; borax can make odorous ham acceptable



Milk became one of the most adulterated products at the

turn of the century. It was frequently watered down or mixed

with formaldehyde, causing the deaths of numerous children.141

This was the state of affairs until Upton Sinclair’s book The

Jungle was published in 1905.142 The Jungle exposed the filthy

and appalling conditions for workers in meat packing

factories.143 An unintended consequence was to turn the

stomachs of the nation who read about men with tuberculosis

who spit globs of bloody mucous onto filthy, factory floors. The

workers then dragged dead, skinned carcasses along these same

filthy, contaminated floors to the cutting tables.144 In an attempt

to deal with these problems, Congress first passed the Pure Food

and Drug Act of 1906 (“1906 Act”), creating the first federal law

prohibiting the interstate transportation and sale of adulterated

food or drugs.145

B. The Food Drug and Cosmetic Act of 1938

Unfortunately, the 1906 Pure Food Act did not anticipate

two subsequent major developments: the processed food

revolution and a series of Supreme Court cases that eviscerated

the 1906 Act leaving unchecked the remarkable growth of quack

medicines.146

New food processing techniques triggered the processed food

revolution that swept across the country between the 1930s and

1950s. This new processed and packaged food created a black

box for consumers. For example, jelly had customarily been half

sugar and half fruit.147 But Strawberry BRED-SPRED did not

when canned.”); Food and Drug Administration, The Long Struggle for the 1906 Law

(June 1981), online at http: //www.fda.gov/AboutFDA/WhatWeDo/History/Centennial

ofFDA/TheLongStrugglefortheLaw/ (visited Sept 15, 2013).

141

Richard M. Cooper, The Struggle for the 1906 Act, in FDA: a Century of Consumer

Protection 28 (Wayne L. Pines, ed, 2006) (“Milk was one of the most adulterated products

in America at the turn of the century; it was frequently watered down and preserved

with formaldehyde.”).

142

Id.

143

Id.

144

Id.

145

Pure Food and Drug Act of 1906, Pub L No 59-384, 34 Stat 768 (1906).

146

Van Tassel, 6 Ind Health L Rev at 230 (cited in note 116).

147

Michelle Meadows, A Century of Ensuring Safe Foods and Cosmetics, FDA

Consumer Magazine, The Centennial Edition (Jan–Feb 2006), online at http: //www.fda.

gov/AboutFDA/WhatWeDo/History/FOrgsHistory/CFSAN/ucm083863.htm (visited Sept

15, 2013).



contain a single strawberry.148 It was made of highly

carcinogenic coal tar, artificial chemical pectin, artificial

chemical flavorings, grass seeds, and other chemical

preservatives.149 Consumers had no way to learn of this poor

quality, as ingredients were not listed on labels.150 This

information asymmetry meant that consumers were not able to

engage in self-protection.

This period of time also saw a remarkable growth in the

marketing of sham products to treat and cure disease.151

During this long period in U.S. history, the curative

claims of predatory sham medicine salesmen were

limited only by the gullibility of their targets. In many

cases, the degree of gullibility was proportional to the

level of desperation of the individual for a cure. The more

dire the condition, the more vulnerable an individual was

to the “flim flam” of the greedy snake oil salesman. And

the more dire the condition, the greater the degree of

harm when the sham medicine did not work, causing

injury over and above the original illness and/or causing

a delay in seeking effective medical treatment.152

To address both of these problems, Congress passed the

1938 Food, Drug, and Cosmetic Act (“1938 Act”), which is still in

force today. The 1938 Act answered the question of the proper

regulatory balance between the protection of individual choice in

matters involving self-regarding behavior, such as choosing a

consumer product or medicine, and the need to protect

vulnerable consumers from harm from third parties. The 1938

Act created this balance by linking the level of product

regulation with the level of vulnerability of the product’s

targeted population. This linkage translates into the provision of

the greatest amount of regulatory protection when products are

targeted at vulnerable populations. This linkage also established

the proper balance between regulating to protect public health

while allowing innovation to flourish.

148

Id.

149

Id.

150

Id.

151

Van Tassel, 6 Ind Health L Rev at 219–24 (cited in note 116).

152

Id at 216–17.



1. Regulating to protect vulnerability created by ill-health.

The FDCA of 1938 identifies two types of vulnerability. The

first is vulnerability that is created by ill health. Thus, products

claiming to aid in an individual’s struggle to return to normal

health fall into the categories of products that require the

greatest amount of regulation. Examples of products that fall

into this category include drugs and devices that require

premarket approval.153 This places the burden of proving both

safety and effectiveness on the manufacturer before these

products can be placed on the market.154 Thus, the 1938 FDCA

sharply curtailed the ability of the quack salesman to take

advantage of the desperation of those who suffer from ill health.

On the other hand, the FDCA requires far less regulatory

protection when products are targeted to healthy populations to

maintain or improve a normal state of health—for example,

dietary supplements or functional foods.155 Less regulation is

needed as this group of consumers is not blinded by desperate

desires to cure unbearable illnesses and return to good health.

Finally, the FDCA requires the least amount of regulation

to protect consumers in the context of traditional food. There is

little need to provide regulatory protection for consumers in this

context

as thousands of years of use of traditional food provides

consumers with the common knowledge, and thus the

ability, to protect themselves from the ordinary risks

associated with different traditional food products. . . .

This common knowledge and ability to self-protect

supports the presumption of safety that is granted to

traditional food under the FDCA.156

Therefore, traditional food products can be placed directly on the

market without undergoing any testing for safety.157

153

21 USC § 355(a) and 28 USC § 360e, respectively.

154

Van Tassel, 6 Ind Health L Rev at 236–41 (cited in note 116).

155

Id. The term “traditional food” is used to distinguish this category of product from

genetically modified food.

156

Id at 230.

157

Id at 230–31. Therefore, if a particular food poses a safety risk over and above

those which are normally associated with a food product, such as salmonella in peanut

butter, the FDA carries the burden of proving that the food is adulterated or misbranded

before it can be removed from the market. Id.



With these second two categories, the FDCA assumes that

consumers can engage in self-protection based on common,

customary knowledge regarding the risks associated with these

products. Of course, with regard to dietary supplements, this

assumption is suspect as many contain biologically active

ingredients that are being newly introduced into US markets.

2. Regulating to protect vulnerability created by

information asymmetry.

In addition to recognizing and protecting consumer

vulnerabilities relating to ill-health, the 1938 Act also

recognized a second kind of vulnerability that occurs when there

is an information asymmetry between the manufacturer of a

product and the consumers that the product targets. For

example, in order to cure the asymmetry created by the

processed food revolution, the FDCA required that the

ingredients of a food product be listed on the label. A good

example of information asymmetry in the processed food context

is the black box that was created by the advent of canned stews

with unknown contents. The FDCA’s listing cure worked for

traditional food product ingredients that were contained in these

canned stews, such as tomatoes and potatoes, as the health risks

associated with these ingredients were common knowledge.158

With this ingredient listing, consumers who had a history of an

allergic or toxic reaction to a particular traditional ingredient

could engage in self-protection by avoiding the product.

Enabling consumers to engage in self-protection created the first

line of defense that makes up the first part of the public health

product safety net.

158

See id, explaining that “The 1938 Act eliminated the ‘distinctive name proviso’

and required instead that the label of a food ‘bear its common or usual name.’ The food

would be illegal or misbranded if it represented itself as a standardized food unless it

conformed to that standard.” Meadows, A Century of Ensuring Safe Foods and Cosmetics

(cited in note 147). The FDCA authorized three kinds of food standards—identity,

quality, and fill of container. Id. In 1939, the first food standards were issued for canned

tomatoes, tomato purée, and tomato paste. Id. The standards looked like a recipe of

listed ingredients. Id. The next standards were for jams and jellies. “By 1957, standards

had been set for many varieties of foods such as chocolate, flour, cereals, bakery

products, milk, cheese, juices, and eggs.” Id.



C. Novel Ingredients and the Food Additives Amendments of

1958

Unfortunately, the 1938 Act did not anticipate the creation

of hundreds of novel chemicals for the use in processed foods

during the 1930s through the 1950s. Unlike the listing of

common traditional foods, such as tomatoes and potatoes, the

listing of these novel ingredients on food labels did nothing to

help consumers deal with these novel ingredients, as no common

knowledge existed regarding their health risks.159 By the 1950s,

the popular movement to regulate these chemical food additives

slowly gained traction and ultimately led to passage by Congress

of the Food Additives Amendment of 1958.160 The Food Additives

Amendment placed the burden on the chemical additive

industry to establish the safety of novel chemicals through

premarket testing for safety. Significantly, as the next two

subsections explain, this testing only decreased the uncertainty

over any possible health risks to a small degree for average

consumers and almost not at all for idiosyncratic consumers.161

The question then became how to deal with this excess

uncertainty. The answer, as explained in the next sections, was

the creation of what this Article calls the public health product

safety net.

159

In 1950, the Delaney Committee started a congressional investigation of the

safety of additives that laid the foundation for the Food Additives Amendment

and the Color Additive Amendments. Rep. James Delaney, D-NY, later

submitted a change to the bill proposing the Food Additives Amendment by

inserting the Delaney Clause, which prohibited the approval of any food

additive shown to induce cancer in humans or animals in studies with a

relevant route of exposure. Variations of the Delaney Clause were also

included in the Color Additive Amendments and animal drug provisions.

Id.

160

Id.

161

Id, explaining that

Enacted in 1958, the Food Additives Amendment required manufacturers of

new food additives to establish their safety to FDA’s satisfaction before

marketing. Food additives are substances that have no proven track record of

safety and that must be approved by the FDA before they can be used. A food

substance generally recognized by qualified experts as safe (GRAS) for its

intended use, based on publicly available information, is excluded from the

definition of food additive. Also in 1958, the FDA published the first list of

GRAS substances, which contained nearly 200 substances including ascorbic

acid, papain, and propylene glycol.



1. Excess uncertainty regarding health risks: premarket

testing and predictability of health risks for average

consumers.

As a general matter, premarket safety testing required by

the FDCA involves studies that use very small sample sizes.162

These small sample sizes mean that the uncertainty over the

possibility of health risks from exposure to novel ingredients is

decreased to only a certain degree by premarket testing, leaving

a significant excess amount of uncertainty.

For example, similarly small sample sizes with relatively

low statistical power are relied upon to test safety and

effectiveness for drugs today.163 The FDA recognizes that these

drug studies are too small to predict a large portion of the health

risks associated with novel substances. However, as larger, more

statistically powerful studies are deemed too expensive, the FDA

regularly approves novel drugs with the understanding that the

only way to seriously decrease the excess uncertainty over safety

is to expose the drug to the genetic diversity of the general

population.164 The FDA then uses the post-market surveillance

system specially created for drugs and medical devices to collect

heath data over time relating to the long-term exposures of the

population to these novel chemicals to fully identify the

statistical probability of adverse reactions.165 Under this

premarket testing regime, to date, serious adverse effects were

not detected for approximately one-half of the drugs on the

market until after the drugs received regulatory approval and

were made available to the general population.166 Discovering

these serious adverse side-effects has led to many drugs and

medical devices being pulled from the market as the information

162

Shelby D. Reed, et al, Use of Larger Versus Smaller Drug-Safety Databases Before

Regulatory Approval: The Trade-Offs, 27 Health Aff 360, 360–61 (2008).

163

Id.

164

Id. See also Marshall S. Shapo, Experimenting with the Consumer: The Mass

Testing of Risky Products on the American Public (Praeger 2008) (providing an excellent

discussion across a wide range of products of how manufacturers of new products fail to

disclose potential risks—or uncertainties about danger—to consumers who then become

unwitting experimental subjects when products are first introduced into the market).

165

Kevin Bullis, Screening for Toxic Nanoparticles: Researchers Suggest a Strategy

That Could Weed Out Dangerous Nanoparticles, Tech Rev (Feb 7, 2006), online at

http: //www.technologyreview.com/news/405268/screening-for-toxic-nanoparticles/


166

Reed, 27 Health Aff at 366–67 (cited in note 162).



gathered from post-market monitoring has demonstrated that

their actual risks outweigh their benefits. In the case of some

other drugs and medical devices, the discovery of serious side-

effects have led to the addition of safety measures, such as

warnings, when it is discovered over time that their actual risks,

though serious, are still outweighed by their potential benefits.

Thus, there is a regulatory recognition that premarket testing

will not detect many adverse reactions when novel substances

are distributed to the general population for use as drugs. The

bottom line is that post-market monitoring of novel substances

protects public health by managing the uncertainty over health

risks that premarket testing cannot significantly diminish.

For example, news of new and serious risks associated with

FDA-approved drugs is common.167 A readily recognized

example is the case of Vioxx.168 Subsequent to FDA approval,

distribution to over 2 million people in the United Sates, and

marketing to 80 different countries for total sales of 2.5 billion

dollars, it was discovered that Vioxx increased the risk of heart

attack and stroke by 50 percent.169 Another more recent case is

that of Omontys, a drug approved by the FDA in March of 2012

to treat adult patients on hemodialysis with anemia stemming

from chronic kidney disease.170 This approval was based upon a

relatively large premarket approval study, after which an FDA

advisory panel endorsed the drug by a vote of 15–1.171 The chair

of the panel remarked that the drug “doesn’t have any safety

signals.”172 Only one year later, in February of 2013, based on

data gathered from post-market surveillance, the FDA warned

of serious and fatal reactions to Omontys and counseled that

physicians should discontinue its use in all patients

immediately.173

167

Id.

168

Rita Rubin, How Did Vioxx Debacle Happen?, USA Today (Oct 12, 2004), online

at http: //usatoday30.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm# (visited

Sept 15, 2013).

169

Id.

170

John Gever, Fatal Reactions Prompt Omontys Recall, Medpage Today (Feb 24,

2012), online at http: //www.medpagetoday.com/HematologyOncology/Anemia/37509


171

Id.

172

Id.

173

Id.



Just as is the current situation with drugs, chemical

preservatives and flavorings were tested under the Food

Additive Amendments Act of 1958 using small sample sizes with

the understanding that these studies could only identify a

portion of these novel chemical’s adverse effects. Those that

were approved were added to food and distributed to the general

population. As with novel drugs and the current post-market

surveillance system set up by the FDA, the public heath product

safety net came into play when novel chemical food additives

were approved based on premarket testing which only partially

decreased the uncertainty over the associated health risks. This

safety net was activated by the simple, but essential, step—the

requirement that novel ingredients be listed on a product’s

packaging.

Activating the safety net started with the FDA’s recognition

of the fact that the novelty of these chemicals meant that their

addition to food was “material” because neither the

manufacturers nor the FDA knew what the actual risks of

exposure to these novel ingredients would turn out to be, in spite

of premarket safety testing. Under the 1938 Act, the material

nature of the new ingredients meant that consumers were

required to be given notice so that they would not assume that

the nature of the risk was the same as the traditional food

products without the novel chemical additives.174 In order to give

consumers notice, these novel chemical ingredients were

required to be listed on the product labels. Listing activated the

first line of safety by allowing the consumer to engage in self-

protection. Then, if the consumer experienced an injury through

exposure to a product, that consumer could search the label and

identify the novel ingredient and avoid it in the future. If the

injury was serious enough to warrant a trip to the doctor,

because the consumer could identify the causative agent, proper

treatment could be provided, minimizing the cost of treatment,

the extent of the injury, and the time for recovery. The physician

could then accurately report the injury and its cause to the

public health officials of the appropriate state or federal agency.

If the cumulative data suggested that the product was unsafe,

the early warning and recall mechanisms could be used by the

public health officials of the state or federal agency to avert a

174

See notes 101 and 102.



public health crisis. This data could also be used to meet the

evidentiary requirements of the tort system, allowing it to be

used instrumentally to increase product safety.

2. Excess uncertainly regarding health risks: premarket

testing and predictability of health risks for

idiosyncratic consumers.

More seriously, the initial studies performed during the

premarket approval process to decrease some uncertainty for the

average consumer, provide little to no assurance for those who

are referred to by the law as the “idiosyncratic consumers” or

non-average consumers.

The premarket studies required by the FDA are simply too

small to say much about safety for those who are not average.175

These consumers must rely 100 percent on self-protection by

watching ingredients listed on labels and stopping exposures to

novel ingredients as soon as they are symptomatic. Or, in

relation to long-term exposures, by hoping the public health

product safety net will be sensitive enough to pick up a surge in

injuries relating to novel products so that public health agencies

can issue a recall of that product. So, with novel ingredients, the

only way to significantly decrease uncertainty over health effects

for idiosyncratic consumers is to distribute the product to the

general population. Then, public health officials must “wait and

see,” while, at the same time, hoping to catch early warning

signs of a serious problem in time to minimize injuries through

early warnings and product recalls.

D. In the Past, a Focus on Novelty Created the Public Heath

Product Safety Net to Deal with Uncertainty Over Health

Risks

To recap, this history explains the overall FDCA regulatory

scheme that makes regulatory choices by balancing the

protection of individual choice in matters involving self-

regarding behavior, such as choosing a consumer product, with

the need to protect vulnerable consumers from harm from third

parties. This balance is created by linking the level of product

regulation with the nature and level of vulnerability of the

175

See Reed, 27 Health Aff at 366–67 (cited in note 162).



product’s targeted population. This linkage translates into the

provision of the greatest amount of regulatory protection when

products are targeted at the most vulnerable populations.

Vulnerability can arise in two basics ways. First,

vulnerability can arise in situations where products are targeted

to those with ill health. The FDA ensures that product

manufacturers cannot take advantage of this vulnerability, as

was the case with predatory snake oil salesman, by requiring

premarket testing to ensure that the product is actually as

effective as claimed. On the other hand, for products that are

targeted to the healthy population, vulnerability can arise

because of information asymmetries between the manufacturer

of a product and the consumers that the product targets. The

FDA cures this second type of asymmetry by requiring that all of

the information that is material to a reasonable consumer is

listed on the label. History shows that one type of information

asymmetry that creates a consumer vulnerability is when novel

ingredients are not listed on labels. Without this information,

consumers can’t engage in self-protection—just like when

canned stews with novel chemical preservatives and flavorings

were first introduced.

The FDCA dealt with novel chemical food additives and

consumer vulnerability arising out of their unknown health

risks by requiring premarket testing to decrease some of the

uncertainty over health risks. However, this testing still left a

great deal of remaining uncertainty. The FDCA dealt with this

remaining uncertainty by acknowledging that this uncertainty

was material and, therefore, requiring ingredient listing in order

to enable the public health product safety net. This safety net

was, and still is, used to capture signals that indicate that a

product may cause injury to health in order to avoid, or at least

mitigate, harm to all consumers through early warnings and

product recalls

The next section describes how this precedent should be

used to regulate the novel, innovative ingredients of today and

tomorrow.



IV. ANIMATING THE PUBLIC HEALTH PRODUCT SAFETY NET TO

CAPTURE CONSUMER PRODUCTS THAT USE INNOVATIVE

TECHNOLOGIES

As it did with novel chemicals in the 1950s, the focus on

novelty176 rather than hazard in the context of nanotech

ingredients takes the analysis out of the realm of scientific

uncertainty and empowers the FDA to regulate nanotech

consumer products to protect public health. A focus on novelty

acknowledges that the public health product safety net plays a

critical role in the identification of unsafe products in the

context of both products that have gone through premarket

testing and, importantly, those that have not.

A. Information Vulnerability and Novel Ingredients

The recognition that the vulnerability in the case of novel

ingredients, for example nanotech ingredients, is related to an

information asymmetry and that this asymmetry is material has

a domino effect that results in animating the powerful public

health product safety net. The only step the FDA needs to take

in order to engage the public health product safety net is to

recognize that the failure to list a novel ingredient, such as a

nanotech component, is a “material” omission under the FDCA.

In order for this omission to be “material,” it must be

“misleading.”177

176

One way to define novelty is to track the way this term is defined by the

European Union in the context of dietary supplements: “European Union novel foods

require any food or ingredient that can’t demonstrate a history of use prior to May 1997

to verify its safety and intended use.” Shane Sterling, Consultant: ‘No Need to Fear EU

Novel Food Laws’, NutraIngredients.com (William Reed Business Media Apr 29, 2013),

online at http: //www.nutraingredients.com/Regulation/Consultant-No-need-to-fear-EU-

novel-foods-laws (visited Sept 15, 2013). Another possibility is to link the definition to

the substances that are subject to a patent.

177

See text accompanying note 102 explaining that, under the FDCA, a drug, device,

food, dietary supplement, cosmetic, or sunscreen is deemed misbranded if its labeling is

“false or misleading in any particular.” 21 USC § 362(a) (2006). See also 21 CFR § 701.1

(2011).

[I]n determining whether the labeling or advertising is misleading . . . there

shall be taken into account (among other things) not only representations

made or suggested by statement, word, design, device, or any combination

thereof, but also the extent to which the labeling or advertising fails to reveal

facts material in the light of such representations or material with respect to

consequences which may result from the use of the article.

21 USC § 321(n) (2009).



As described in the next section, there are several

compelling arguments that this information asymmetry created

through intentionally omitting to list novel, innovative

ingredients is misleading. If the omission is misleading, this

creates an information defect that renders the product

misbranded. If the product is misbranded, it cannot be

distributed to consumers.

1. Intentionally failing to list novel, innovative ingredients

is materially misleading, rendering the product

misbranded.

To put the analysis of “materiality” into a real world

context, the ingredient lists on nanotech products currently refer

to the host product’s nanotech content by the same name as the

ingredient’s normal size counterpart. For example, the use of

nanotech titanium dioxide is so ubiquitous in sunscreens as to

be almost unavoidable. Instead of this nanotech titanium

dioxide content being listed as “nano titanium dioxide,” as is

required by law in the European Union,178 manufacturers in the

United States just list this ingredient as they always did before

they started using the nanotech version of this chemical—it is

listed as “titanium dioxide.” Thus, manufacturers in the United

States are allowed to hide their products’ nanotech ingredient

content from consumers.

This practice is misleading for numerous reasons. First,

when consumers choose to use a new product for the first time,

and they are aware that they are using a new product, they

engage in self-protection by being more vigilant in watching for

any untoward effects. This is particularly true for parents of

small children, those who suffer from ill health, and those who

deal with multiple allergies. When manufacturers

misrepresent179 to consumers that the ingredient is a normal

178

Iris Eisnenberger, et al, On Voluntary and Obligatory Nano-Labelling, 31 Nano

Trust Dossiers 1 (July 2012), online at http: //epub.oeaw.ac.at /0xc1aa500d_

0x002c9d9a.pdf (visited Sept 15, 2013) (providing publication of the Institute of

Technology Assessment of the Austrian Academy of Sciences explaining the European

Union requirements for labeling nanotech cosmetics and food and summarizing the

status of the labeling movement among EU countries).

179

One who fraudulently makes a misrepresentation of fact, opinion, intention or

law for the purpose of inducing another to act or to refrain from action in



size ingredient, the consumer will likely have been exposed to

this normal size ingredient in the past. If this past exposure has

not caused any harm, the consumer will assume that the need

for self-protection through heightened vigilance is unnecessary.

Thus, the consumer’s natural self-defense mechanism will have

been disarmed by the manufacture’s misrepresentation.

The second reason that this practice is misleading is that, if

a consumer has a negative physical reaction to the nanotech

ingredient (which the current state of the science suggests is

possible, even likely),180 the consumer will be unaware that the

adverse reaction is to the novel ingredient. Instead, the

consumer will assume that the injury was caused by the host

product and will avoid that product in the future. If, for

example, the product is a sunscreen containing unidentified

nanotech titanium dioxide and nanotech zinc oxide, this incident

may cause the consumer to incorrectly believe that they can no

longer use sunscreens at all. This results in an unnecessary

avoidance of a product that could protect the consumer from

other serious health consequences such as skin cancers, a

category of diseases that includes malignant melanomas, which

have a rapidly increasing incidence rate over the past several

years as a result of current problems with the ozone layer.181

The third reason that this deceptive practice is misleading

is that, if a consumer has a negative physical reaction to the

nanotech ingredient, the consumer will rely upon the proper

listing of ingredients on product labels in order to provide their

physicians with an accurate list of exposures so that they can be

correctly diagnosed and treated. A simple but very common

example occurs when a consumer develops a rash. In

determining the proper treatment, one of the first questions that

a physician is likely to ask is whether the consumer/patient has

purchased any new products for regular use. In other words,

reliance upon it, is subject to liability to the other in deceit for pecuniary loss

caused to him by his justifiable reliance upon the misrepresentation.

Restatement (Second) of Torts § 525 (1977). “A misrepresentation is material if it would

be likely to induce a reasonable person to manifest his assent, or if the maker knows that

it would be likely to induce the recipient to do so.” Restatement (Second) of Torts § 162

(1965).

180


181

Doris Day, As Cancer Deaths Fall, Malignant-Melanoma Rates Rise, LiveScience

(June 3, 2012), online at http: //www.livescience.com/37124-skin-cancer-deaths-grow.html




whether there are any new exposures that could be the cause for

the rash. A misleading label will thwart the physician’s ability

to determine the cause of the rash in order to properly treat the

condition.

The fourth reason this practice is misleading is that

individual consumers assume that the public health product

safety net is fully engaged and that, if the product is unsafe, the

early warning and product recall system will warn them to avoid

the product if it is causing harm. Parents with small children,

those who suffer from ill health, and those who deal with

multiple allergies are particularly reliant on these product

warning and recall systems. As both the consumer and the

physician have no idea that the consumer has been exposed to

the novel nanotech ingredient, neither can properly report the

injury to any to the state or federal agencies that collect and

analyze the data that is relied upon to alert the public of unsafe

products through early warning and product recall systems.

The fifth reason this practice is misleading is that

consumers purchase products with the customary

understanding that, if the product is unsafe and a consumer is

injured, the manufacturer will compensate them for these

injuries. As explained earlier, the failure to list nanotech

ingredients on product labels means that manufacturers of

nanotech ingredients are insulated from tort recovery.

Consumers have no notice of this special immunity and,

consequently, are not aware that the product carries a special

risk as the consumer won’t be compensated for any injuries the

product causes.

These arguments support a finding that novel, innovative

ingredient content in a consumer product is information that is

material to a consumer making a choice over whether to use a

consumer product. Failure to provide material information

renders a product misbranded, violating the FDCA.

B. Application to Future Technologies

This focus on novelty will engage the public health product

safety net to provide post-market surveillance for novel

ingredients created by the new technologies of the future. Thus,

as the food is created and placed on the market using meat from



cloned animals,182 or meat grown in the lab,183 or through the

genetic modification of animals,184 the FDA can regulate to

protect public health in a way that minimizes the roadblocks to

innovation. It is interesting to note that, if genetically modified

plants used for food had been identified as such pursuant to an

FDA focus on novelty, it is likely that much of the controversy

over its possible health effects would have abated as the public

health product safety net is likely to have picked up any short

term allergic or toxic reactions.185

182

Food and Drug Administration, Animal Cloning, online at http: //www.fda.gov/

animalveterinary/safetyhealth/animalcloning /default.htm (visited Sept 15, 2013).

183

People for the Ethical Treatment of Animals, PETA Offers $1 Million Reward to

First to Make In Vitro Meat, online at http: //www.peta.org /features/In-Vitro-Meat-

Contest.aspx (visited Sept 15, 2013); Julieanne Strachan, From a Petrie Dish to Your

Plate, ACT News (June 12, 2012), online at http: //www.canberratimes.com.au/act-

news/from-a-petrie-dish-to-your-plate-20120602-1zpau.html (visited Sept 15, 2013).

184

Food and Drug Administration, Genetically Engineered Animals, online at

http: //www.fda.gov/animalveterinary/developmentapprovalprocess/geneticengineering /ge

neticallyengineeredanimals/default.htm (visited Sept 15, 2013).

185

From the outset, food manufacturers using genetically modified (“GM”)

ingredients have declined to provide consumers notice of GM content. The FDA has not

mandated disclosure as it takes the position that the introduction of GMO ingredients

into food is not material. See generally Katharine Van Tassel, Genetically Modified Food,

Risk Assessment and Scientific Uncertainty Principles: Does the New Understanding of

the Networked Gene Trigger the Need for Post-Market Surveillance to Protect Public

Health?, 15 BU J Sci & Tech L 250 (2009); Stephanie Strom, Genetic Changes to Food

May Get Uniform Labeling, NY Times (Jan 31, 2013), online at http: //www.nytimes.com/

2013/02/01/business/food-companies-meet-to-weigh-federal-label-for-gene-engineered-

ingredients.html?pagewanted=all&_r=0 (visited Sept 15, 2013). This lack of

transparency resulted in consumer rights groups testing products for GMO use and

disclosing that use to consumers. Non GMO Project, GMO Facts: Frequently Asked

Questions (Non-GMO Project 2013), online at http: //www.nongmoproject.org /learn-more/

(visited Sept 15, 2013). As consumers have become aware of the extensive use of GMOs

in their food, a rising number have expressed the desire that these ingredients be

labeled. Rachel Hennessey, GMO Food Debate In The National Spotlight, Forbes, (Nov 3,

2012) online at http: //www.forbes.com/sites/rachelhennessey/2012/11/03/gmo-food-

debate-in-the-national-spotlight / (visited Sept 15, 2013) (“70% of items in America’s

grocery stores contain genetically modified organisms”). A recent ABC poll suggests that

93 percent of consumers now support mandatory disclosure of GMO content on labels.

Gary Langer, Poll: Skepticism of Genetically Modified Foods, ABC News (June 19, 2012),

online at http: //abcnews.go.com/Technology/story?id=97567&page=1 (visited Sept 15,

2013). When the industry ignored the consumer preference for listing of GM content, a

market was created for products that are “GMO-free.” Thus, the practice of “GMO-free”

labeling was born. The growing consumer labeling movement also triggered repeated

attempts to pass labeling laws. While these efforts have been unsuccessful to date, they

are gaining traction—for instance, it cost the industry 40 million dollars to block

California’s Proposition 37 calling for mandatory labeling last fall. Strom, Genetic

Changes to Food, NY Times (cited in note 185). With more legislative proposals cropping

up (a ballot initiative in Washington state and legislative proposals in Connecticut,

Vermont, New Mexico, and Missouri), a growing consumer boycott of some organic or

“natural” brands owned by major food companies and a recently introduced popular



V. DOES COST-BENEFIT ANALYSIS BAR THE LISTING OF NOVEL

INGREDIENTS ON PRODUCT LABELS?

Every president since Richard Nixon has established a

program to require review and clearance of agency regulatory

decisions before they are placed into effect.186 Usually, this

review is conducted by the Office of Information of Regulatory

Affairs (OIRA), which is part of the Office of Management &

Budget (OMB), using cost-benefit analysis.187 Cost-benefit

analysis

mobile app by Fooducate that allows consumers to check for GMO content in a growing

number of products, industry may be seeing the writing on the wall. Id; Hank Schultz,

Popular Mobile Food App Adds GMO Feature, FOODnavigator-usa.com (Oct 17, 2012),

online at http: //www.foodnavigator-usa.com/Business/Popular-mobile-food-app-adds-

GMO-feature (visited Sept 15, 2013). Just this year, Ben & Jerry’s Ice Cream has

decided to remove GMO ingredients from its supply chain. Hank Schultz, Research

Results Pointed Ben & Jerry’s Down Non-GMO Path, FOODnavigator-usa.com (Feb 1,

2013), online at http: //www.foodnavigator-usa.com/Business/Research-results-pointed-

Ben-Jerry-s-down-non-GMO-path (visited Sept 15, 2013). And the Meridian Institute,

which organizes discussion of major issues, convened a meeting in Washington just last

month that included executives from PepsiCo, ConAgra, and about 20 other major food

companies, as well as Wal-Mart and advocacy groups that favor labeling. Strom, Genetic

Changes to Food (cited in note 185). Just in March of 2013, three major grocery chains

announced that they will require food with genetically modified ingredients to list these

innovative ingredients on product labels. Stephanie Strom, Major Grocer to Label Foods

With Gene-Modified Content, NY Times (March 8, 2013), online at http: //www.

nytimes.com/2013/03/09/business/grocery-chain-to-require-labels-for-genetically-

modified-food.html?pagewanted=all (visited Sept 15, 2013). Many are predicting that

voluntary labeling may be right around the corner.

186

Dana D. Nelson, Bad for Democracy: How the Presidency Undermines the Power

of the People 152–53 (Minnesota 2008) (discussing the increasing presidential power

pursuant to the theory of the unitary executive that promises undivided presidential

control of the executive branch and its agencies as well as expanded unilateral powers).

187

See Office of Management and Budget, Circular A–4 (September 17, 2003), online

at http//:www.whitehouse.gov/omb/circulars_a004_a-4 (visited Sept 15, 2013):

In theory, cost-benefit analysis of a policy option enumerates all possible

consequences, both positive and negative; estimates the probability of each;

estimates the benefit or loss to society should each occur, expressed in

monetary terms; computes the expected social benefit or loss from each

consequence by multiplying the amount of the associated benefit or loss by its

probability of occurrence; and computes the net expected social benefit or loss

associated with the government policy by summing over the various possible

consequences. The reference point for these calculations is the state of the

economy in the absence of the government policy, termed the “baseline.”

Nicholas A. Ashford, The Legacy of the Precautionary Principle in US Law: The Rise of

Cost-Benefit Analysis and Risk Assessment as Undermining Factors in Health, Safety

and Environmental Protection, in Nicolas de Sadeleer, ed, Implementing the

Precautionary Principle: Approaches from the Nordic Countries, EU and USA 352, 366–

67 (Routledge 2007). Cost-benefit analysis attempts to describe the consequences of a

candidate regulation in monetary terms. This poses two problems. One is the difficulty,



is one of the primary tools used in regulatory analysis to

anticipate and evaluate the likely consequences of rules.

Although some regulatory benefits and costs are difficult

to quantify or monetize, those preparing those analyses

generally attempt to estimate the overall benefits that a

proposed or final rule would create as well as the

aggregate costs that it would impose on society, and then

determine whether the former justify the later.188

The first question becomes whether this cost-benefit tool should

be used to judge any FDA regulations requiring the listing of

novel ingredients on product labels? And, secondly, if this cost-

benefit tool is used, appropriately or not, will such a regulation

survive this process?

A. Is the Use of Cost-Benefit Analysis in the Context of

Consumer Products and Individual Risk Appropriate?

How people react to scientific evidence of risk is governed by

many factors, including how risk information is perceived and

communicated, how individuals react to social and cultural

influences, and how choices are structured.189 Examples abound

of situations where individuals’ risk perceptions lead them to act

in ways that appear contrary to their own interests, overreacting

even arbitrariness, of placing a monetary value on human life, health and safety, and a

healthy environment. Another is that by translating all of these consequences into

equivalent monetary units, discounting each to current value (since a US $/Euro

invested now is expected to earn interest over time), and aggregating them into a single

US$/Euro value intended to express the net social effect of the government policy, the

effects on the economy from investing now in future health, safety, and environmental

benefits are weighted far more heavily than those benefits that occur in the future,

including those to future generations.

188

Id. For an excellent critique of the role of OIRA, its use of cost-benefit analysis,

and suggestions for modification of OIRA’s role, see John S. Applegate, et al, Comments

Regarding Executive Order on OMB Regularity Review, Center for Progressive Reform

(Mar 16, 2009), online at http: //www.reginfo.gov/public /jsp/EO/fedRegReview/CPR_

Comments_New_EO_Reg_Rev_Final.pdf (visited Sept 15, 2013) (pointing out that the

use of cost-benefit analysis by OIRA is inconsistent with the law in most cases and

explaining how it is a failed tool of regulatory analysis).

189

See generally Cass R. Sunstein, Laws of Fear—Beyond the Precautionary

Principle (Cambridge 2005) (analyzing the relationship between “fear,” danger, and the

law); Richard A. Posner, Catastrophe—Risk and Response (Oxford 2004) (arguing that

“realism about science and scientists, innovative applications of cost-benefit analysis, a

scientifically literate legal profession, enhanced international cooperation, and a

pragmatic attitude toward civil liberties are among the keys to coping effectively with

catastrophic risks”).



to or neglecting risks.190 Regardless of whether these choices are

rational or not, when it comes to individual risk, as a general

matter our society respects the choice of the individual to

encounter or avoid a particular risk in accord with that

individual’s personal values.

In contrast, environmental risks are those faced by the

collective population. In the context of collective risk, the

question becomes how much risk the collective is willing to

encounter, for example, in the air, water, and soil.191 Under our

democratic system, one might suppose that the desired level of

risk would be assigned by the voting public. Instead, the current

use of cost-benefit analysis as a proxy for the collective will is an

attempt to impose rationality into the decision-making

process.192 Cost-benefit analysis disregards the will of the

collective that may be driven by what some label as “irrational”

perceptions of risk in light of the mathematical probability of

that risk actually occurring.193

Regardless of the merits of this sanitizing approach when it

comes to collective risk,194 it has no role in the area of consumer

products and individual risk. With collective risk, the

government is fulfilling its proper role in protecting individuals

from the risks that arise from the activities of third parties

190

Sunstein, Laws of Fear at 89–106 (cited in note 189).

191

Many strongly argue that this choice should be made in a democratic fashion.

Nelson, Bad for Democracy at 150, 152 (cited in note 186) (noting that the inception of

the series of presidential executive orders requiring review and clearance of agency

regulatory decisions before they are placed into effect conducted by the Office of

Management & Budget using cost-benefit analysis was a “significant turning point in the

accumulation of presidential power, in the executive’s receptiveness to business

concerns, and in the diminished responsiveness of federal government to citizen

interest”).

192

Sunstein, Laws of Fear at 89–106 (cited in note 189).

193

Id; Posner, Catastrophe at 9–12 (cited in note 189). The question becomes

whether collective choices that are driven by the values of individuals created by their

life experiences should be pejoratively labeled as “irrational fear,” a loaded term in

American society that values “courage” and disparages the fearful. See John M. Kang,

The Burdens of Manliness, Harv J L & Gender 477, 487, 490–507 (2010) (A stereotype

exists that men, to be considered men, must prove that they are courageous. So

embedded is the assumption that “[c]ourage and notions of manhood [are] inseparable,

the very word for courage in many languages deriv[es] from the word for man.”). Should

these individual values be discounted or not counted at all through the use of cost-benefit

analysis?

194

For a collection of critiques of cost-benefit analysis from a wide variety of stellar

academics, see Thomas O. McGarity, Sidney A. Shapiro, and David Bollier, Sophisticated

Sabotage: The Intellectual Games Used to Subvert Responsible Regulation

(Environmental Law Institute 2004).



when the individual has no ability to avoid the risk through

their own initiative.195 In contrast, in the context of consumer

products and individual risk, the proper role of the government

is to protect individual choice with regard to the amount and

nature of the risk the consumer is willing to encounter.

B. What Result If Cost-Benefit Is Applied?

Even if the OMB inappropriately applies a cost-benefit

analysis to a requirement that novel ingredients be listed on

product labels, the benefits to public health far outweigh the

costs. Thus, this FDA regulation is likely to survive this last

OMB hurdle.

The cost of such a regulation will be de minimus. For

example, the cost of placing two to four letters (“GM” or “nano”)

in front of all novel, innovative ingredients listed on product

labels is small. With regard to GM food, the old arguments that

the majority of the cost lies in trying to maintain separate food

collection and distribution systems so that GM versus GM-free

food can be identified have become moot. The organic and GM-

free movements have set up certification systems that require

food producers and packagers to meet a set of strict

requirements in order to be allowed to use the label denoting

that their products are organic and/or GM free. Thus, the cost of

keeping the GM-free food and GM food separated has been

placed on the GM-free, natural food and is, thus, no longer

relevant to the cost of the listing of GM ingredients in food.

The benefits of novel ingredient listing, as explained earlier,

are the ability of a consumer to self-protect, to receive proper

treatment if injured, and to allow for data collection and

surveillance so that any uptick in injuries can be quickly

detected and a crisis averted or mitigated. Finally, ingredient

listing also allows for the data collection necessary for the tort

system to work appropriately, which allows for compensation of

injured parties and for the instrumental benefits of the tort

system to accrue.

195

Wickler, 56 Health & Society at 303–38 (cited in note 23).



VI. CONCLUSION

Currently, the litmus test the FDA uses to trigger

regulation to protect public health when novel technologies are

used to create innovative ingredients in consumer products is

keyed to a finding of hazard. Linking public health protections

to the degree of hazard when operating in scientific uncertainty

is outcome determinative—it means no regulation at all. Thus, a

focus on hazard translates into the FDA ignoring its prime

mission, the protection of public health.

Instead, the FDA’s lodestar for triggering regulation should

be novelty. A focus on novelty results in the proper regulatory

balance between the twin goals of fostering innovation while

protecting public health. The results of this focus also fit well

with the overarching theme of the FDCA that titers the degree

and kind of regulation it uses to protect consumers from harm

from third parties to the level and type of vulnerability of those

consumers. It also tracks how the Act has historically dealt with

regulating novel ingredients with unknown health risks by

using what this Article calls the public health product safety

net.

This safety net is created when the healthcare system, the

state and federal public health protection agencies, and the tort

system are all networked together to protect public health. This

network is created through the simple expedient of novel

ingredient listing. This one small step empowers consumers’

abilities to self-protect, allows for appropriate medical treatment

by the correct identification of harmful causative ingredients,

and permits the proper reporting of products containing novel

ingredients to the state and federal public health protection

agencies in charge of the early warning and product recall

systems. This data can then be collected to allow for the

instrumental use of the tort system to encourage the proper

investment in product safety by manufacturers and insulate

against the overuse and overconsumption of relatively risky

products by consumers. While this network is far from perfect, it

is likely to improve exponentially as this country moves into the

era of big data and the collection of product safety information

reported directly by consumers in social media.

The proposed regulation of the use of nanotechnology in

consumer products set forth in this Article provides a good

example of how regulation based on novelty rather than hazard


488 THE UNIVERSITY OF CHICAGO LEGAL FORUM

achieves the proper balance between protecting public health

while encouraging innovation through the animation of the

public health product safety net. This same regulatory strategy

should be applied to other novel technologies used as ingredients

in consumer products such as cloned animals used for food,

genetically modified plants and animals used for food, and lab

grown meat.

VACCINE INJURY COMPENSATION

Most Claims Took Multiple Years and Many Were Settled through Negotiation

Report to the Chairman, Committee on Oversight and Government Reform, House of Representatives

November 2014

GAO-15-142

United States Government Accountability Office

United States Government Accountability Office

Highlights of GAO-15-142, a report to the Chairman, Committee on Oversight and Government Reform, House of Representatives

November 2014

VACCINE INJURY COMPENSATION Most Claims Took Multiple Years and Many Were Settled through Negotiation

Why GAO Did This Study Vaccines save lives by preventing disease in the people who receive them. In some instances, however, a vaccine can have severe side effects, including death or an injury requiring lifetime medical care. VICP provides compensation to people for injuries and deaths associated with certain vaccines for medical and other costs. The program includes an injury table that lists the injuries that are presumed to be caused by vaccines covered by the program. The program may also compensate individuals for injuries not on the table; however, in those cases causation is not presumed. In both cases, medical and other records are required. VICP pays claims from a trust fund. Since the program began in 1988, it has awarded more than $2.8 billion in compensation.

GAO was asked to review the program. GAO examined (1) how long it has taken to adjudicate claims and how claims have been adjudicated, (2) the changes to the vaccine injury table, and (3) how the balance of and spending from the Vaccine Injury Compensation Trust Fund have changed, among other objectives.

GAO examined data and interviewed officials from HHS, DOJ, and USCFC, including data on claims filed since fiscal year 1999 and their status as of March 31, 2014; reviewed laws and agency documents; and reviewed Treasury data and agency data on compensation and obligations for other VICP-related expenses for fiscal years 2009 through 2013.

HHS and USCFC agreed with GAO’s findings, and HHS, USCFC, DOJ, and Treasury provided technical comments that were incorporated as appropriate.

What GAO Found Most of more than 9,800 claims filed with the National Vaccine Injury Compensation Program (VICP) since fiscal year 1999 have taken multiple years to adjudicate (see fig.). More than 1,000 (11 percent) of claims filed since fiscal year 1999 were still in process (pending) as of March 31, 2014; most of these were pending for 2 years or less. A greater percentage of the claims filed since fiscal year 2009 were resolved within 1 or 2 years. In all but 1 year since fiscal year 2009, the program has met the target for the average time to adjudicate claims (about 3.5 years) tracked by the Department of Health and Human Services (HHS), which administers the program. Officials from the U.S. Court of Federal Claims (USCFC), where VICP claims are adjudicated, report that delays may occur while petitioners gather evidence for their claims. Since 2006, about 80 percent of compensated claims have been resolved through a negotiated settlement.

Time to Adjudicate National Vaccine Injury Compensation Program Claims Filed Fiscal Years 1999-2014, as of March 31, 2014

Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table, but it has not added covered injuries associated with these vaccines to the table. This means that while individuals may file VICP claims for these vaccines, each petitioner must demonstrate that the vaccine that was administered caused the alleged injury. HHS is considering adding covered injuries associated with these vaccines; but as of September 2014, it had not published any final rules to do so.

The balance of the Vaccine Injury Compensation Trust Fund, managed by the Department of the Treasury (Treasury) increased from $2.9 billion in fiscal year 2009 to nearly $3.3 billion at the end of fiscal year 2013 as the trust fund’s income (from net revenues from vaccine excise taxes and interest on investments) outpaced its disbursements to HHS, USCFC, and the Department of Justice (DOJ), which represents HHS in VICP proceedings. VICP compensation, funded by the trust fund, increased from less than $126 million in each of fiscal years 1999 to 2009 to over $254 million in fiscal year 2013.

View GAO-15-142. For more information, contact Marcia Crosse at (202) 512-7114 or [email protected].

http://www.gao.gov/products/GAO-15-142�

http://www.gao.gov/products/GAO-15-142�

Page i GAO-15-142 National Vaccine Injury Compensation Program

Letter 1

Background 4 Most Claims Took Multiple Years to Adjudicate and Many Were

Adjudicated by Settlement or Addressed by an Omnibus Proceeding 9

Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries, Resulting in More Off-Table Claims 16

Trust Fund Balance Has Increased since 2009, As Has Petitioner and Attorney Compensation and Other VICP-Related Spending 21

Information on VICP Petitioner Experience Is Limited; HHS Is Taking Steps to Address Criticism of Its Outreach Efforts 29

Concluding Observations 33 Agency Comments 34

Appendix I Vaccine Injury Table, September 2014 36

Appendix II Covered Vaccines and Injuries on the Vaccine Injury Table, Fiscal Years 1999-2014 38

Appendix III Compensation to Petitioners and Attorneys’ Fees and Costs, Fiscal Years 1999-2013 40

Appendix IV Comments from the Department of Health and Human Services 42

Appendix V Comments from the United States Court of Federal Claims 44

Appendix VI GAO Contact and Staff Acknowledgments 46

Contents

Page ii GAO-15-142 National Vaccine Injury Compensation Program

Tables

Table 1: Amounts Obligated by HRSA, DOJ, and USCFC for the National Vaccine Injury Compensation Program Administrative Expenses 28

Table 2: Compensation to Petitioners under the National Vaccine Injury Compensation Program, Fiscal Years 1999-2013 40

Table 3: Payments to Attorneys under the National Vaccine Injury Compensation Program, Fiscal Years 1999-2013 41

Figures

Figure 1: Time Taken to Adjudicate National Vaccine Injury Compensation Program Claims Filed Fiscal Years 1999-2014, as of March 31, 2014 10

Figure 2: Status of National Vaccine Injury Compensation Program Claims Filed Fiscal Years 2009-2014, as of March 31, 2014 11

Figure 3: Number of National Vaccine Injury Compensation Program Claims Filed Alleging Autism, Fiscal Years 1999-2014, as of March 31, 2014 16

Figure 4: Vaccine Injury Compensation Trust Fund Income, Disbursements, and Balance for Fiscal Years 2009–2013 23

Figure 5: Compensation to Petitioners under the National Vaccine Injury Compensation Program 25

Figure 6: Payments to Attorneys under the National Vaccine Injury Compensation Program 27

Page iii GAO-15-142 National Vaccine Injury Compensation Program

Abbreviations DOJ Department of Justice FTE full-time equivalent HHS Department of Health and Human Services HRSA Health Resources and Services Administration Treasury Department of the Treasury USCFC U.S. Court of Federal Claims VICP National Vaccine Injury Compensation Program

This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately.

GAO-15-142 National Vaccine Injury Compensation Program

441 G St. N.W. Washington, DC 20548

November 21, 2014

The Honorable Darrell E. Issa Chairman Committee on Oversight and Government Reform House of Representatives

Dear Mr. Chairman:

Vaccines save lives by preventing disease in the people who receive them. In some instances, however, a vaccine can have severe side effects, including death or an injury requiring lifetime medical care.1

To address this issue, Congress established the National Vaccine Injury Compensation Program (VICP), which is administered by the Department of Health and Human Services (HHS).

In the 1980s, lawsuits stemming from such incidents threatened to affect the availability and cost of vaccines as well as the development of new ones.

2 People who believe they or their child have been injured by vaccines covered by the program may file a petition making a claim with VICP for compensation for medical and other costs and for pain and suffering, as an alternative to civil court.3

1In this report, we use the term injury to refer to an illness, disability, or similar condition.

The program uses a vaccine injury table that lists the injuries and conditions that are presumed to be caused by vaccines covered by the program and thus may entitle a petitioner to compensation. The program may also compensate petitioners for injuries or conditions that are not on the vaccine injury table; however, in those cases causation is not presumed and the petitioner must demonstrate that the vaccine caused the injury or condition. The program pays claims from the Vaccine Injury Compensation Trust Fund, a trust fund supported by an excise tax on each dose of a vaccine covered by the program; since the program

2VICP was established by the National Childhood Vaccine Injury Act of 1986. Pub. L. No. 99-660, title III, §§ 301 et seq., 100 Stat. 3743, 3755 (amending the Public Health Service Act by inserting a new title XXI; codified, as amended, at 42 U.S.C. 300aa-1 et seq.). 3Petitions may also be filed for compensation for deaths from vaccines covered by the program.


began in 1988, more than 15,000 claims had been filed and more than $2.8 billion has been awarded to petitioners.

In 1999, we reported that while the program appears to provide an easier process for obtaining compensation than through the civil court system, the claims process was not as quick or easy as expected.4

To address these questions, we used data and information from the federal agencies involved in administering the program and managing the Vaccine Injury Compensation Trust Fund, and from stakeholders. Specifically, to examine how long it has taken to adjudicate VICP claims we examined VICP data and interviewed officials from HHS’s Health Resources and Services Administration (HRSA), which administers VICP; the Department of Justice (DOJ), which represents HHS in VICP proceedings; and the U.S. Court of Federal Claims (USCFC) and the Office of Special Masters within USCFC that adjudicates, or decides, VICP claims.

Recently, concerns have been raised about the timeliness for adjudicating VICP claims and making changes to the vaccine injury table, how the funds in the Vaccine Injury Compensation Trust Fund have been spent, and petitioner experiences and awareness of the program. You asked that we examine these issues. Specifically, this report examines (1) how long it has taken to adjudicate VICP claims and how claims have been adjudicated, (2) the changes to the vaccine injury table and in the types of claims filed, (3) how the balance of and spending from the trust fund have changed, and (4) available information on petitioner experience with VICP and how HHS has informed the public of the availability of VICP.

5 We analyzed USCFC data to examine time frames for the adjudication of claims filed in fiscal years 1999-2014.6

4GAO, Vaccine Injury Compensation Program Challenged to Settle Claims Quickly and Easily,

To examine changes to the vaccine injury table and in the types of claims filed, we reviewed relevant laws, and other documents, including Federal Register notices, studies conducted for HHS by the Institute of Medicine, and HRSA’s proposals for revising the vaccine injury table since fiscal year

GAO/HEHS-00-8 (Washington, D.C.: Dec. 22, 1999). 5For the purposes of this report, we use the term claim to refer to the petition and case filed under VICP. We refer to the individuals filing the claims as petitioners. HRSA administers the program in conjunction with DOJ and USCFC. 6We examined USCFC data showing when VICP petitions were filed and when each claim was adjudicated for petitions filed from fiscal year 1999 through March 31, 2014.

http://www.gao.gov/products/GAO/HEHS-00-8�


1999, and interviewed officials from HRSA and members of its Advisory Commission on Childhood Vaccines.7 We also examined HRSA data on the numbers of claims filed, by vaccine, and USCFC data on the number of claims alleging injuries on the vaccine injury table. To examine the balance of and spending from the Vaccine Injury Compensation Trust Fund, we reviewed reports from the Department of the Treasury (Treasury), which manages the trust fund, to determine the income into and disbursements from the trust fund for fiscal years 2009-2013. We also analyzed HRSA data on the amounts the agency reported for petitioner compensation and attorneys’ fees and costs, and data from HRSA, DOJ, and USCFC on the amounts they obligated for administrative and other expenses related to processing VICP claims for those fiscal years using appropriations from the trust fund.8 Finally, to examine available information on petitioner experience with VICP and how HHS has informed the public of the availability of VICP, we reviewed documents, including the Public Health Service Act, agencies’ congressional budget justifications, agency strategic plans, and studies prepared for HHS. We also reviewed statements and interviewed officials from HRSA, DOJ, and USCFC and stakeholders (from organizations representing providers, petitioners’ attorneys, and parents) regarding available information on petitioner experiences with VICP and steps HHS has taken to inform the public about the availability of the program.9

7The Advisory Commission on Childhood Vaccines (ACCV) consists of nine members appointed by the Secretary of Health and Human Services and advises the Secretary on certain issues relating to VICP. See 42 U.S.C. § 300aa-19. Some individual members of the ACCV provided GAO with their personal views that do not necessarily reflect the official position of the ACCV, which is reflected in consensus recommendations made by the ACCV to the Secretary of HHS.

We determined that the data we used from HRSA, DOJ, and USCFC and from Treasury reports on the trust fund were sufficiently reliable for our purposes by discussing data collection processes and limitations of the data with agency officials, conducting electronic data checks, and comparing the data against other published sources.

8The term obligation refers to a definite commitment by a federal agency that creates a legal liability to make payments immediately or in the future. We examined agency data on obligations for full-time equivalent (FTE) staff, and for other expenses. 9The stakeholders we contacted included the National Vaccine Information Center, Vaccine Injured Petitioners’ Bar Association, American Academy of Family Physicians, and American Academy of Pediatrics. In addition, other individuals and organizations contacted GAO and provided comments, which we considered as we conducted our review.


We conducted this performance audit from February 2014 to November 2014 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.

In general, individuals seeking compensation for a vaccine-related injury or death must first file a petition making a claim for compensation under VICP before suing in civil court.10

Several federal agencies—HHS, DOJ, and USCFC, are involved in administering VICP, and Treasury manages the trust fund which funds compensation for successful claims.

VICP includes a vaccine injury table that lists the vaccines covered by the program and the injuries associated with each those vaccines. (See app. I for the table.) Vaccines are added to the list covered by the program after the Centers for Disease Control and Prevention recommends them for routine administration to children and they are made subject to an excise tax that funds the Vaccine Injury Compensation Trust Fund.11 When individuals submit a claim for an injury listed on the table (called an on-table injury), they do not need to prove that the injury was caused by the vaccine. Instead, if they submit documentation showing that they received a particular vaccine and that they sustained the associated covered injury within the time interval specified on the table, they may receive compensation based on a presumption of causation (unless there is evidence that the injury is due to other factors).12

10Petitioners must first file a VICP claim before suing in civil court unless the civil suit is for $1,000 or less. 42 U.S.C. § 300aa-11(a)(2)(A).

Individuals seeking compensation may submit claims for injuries not listed on the table (called

11The program may provide compensation for individuals who were injured or died after receiving the covered vaccines regardless of their age at the time of vaccination—that is, even though the vaccines are recommended for routine administration for children, adults who are vaccinated with a covered vaccine are also eligible for the program. 1242 U.S.C §§ 300aa-11(c)(1), 300aa-13(a)(1). A petitioner’s claim of an on-table injury must also meet the Qualifications and Aids for Interpretation that define the injuries listed on the vaccine injury table.

Background

Vaccines Covered by the Program and on the Vaccine Injury Table


off-table injuries) but they need to demonstrate by the preponderance of the evidence that the vaccine caused the alleged injury.13

HHS has authority to promulgate rules to modify the vaccine injury table when certain criteria are met.

14 HHS is also required to amend the table to include a vaccine within 2 years of the Centers for Disease Control and Prevention’s recommending it for routine administration to children.15 The Advisory Commission on Childhood Vaccines, which was established by the act creating the program, is required to make recommendations concerning changes to the table.16 In 1999, GAO reported that HHS added seven injuries and removed three others from the table in 1995 and 1997, respectively, using findings from Institute of Medicine reviews conducted in 1991 and 1994—in conjunction with public policy considerations provided by the Advisory Commission on Childhood Vaccines, scientific issues raised by HHS’s National Vaccine Advisory Committee, and input from the public.17

Individuals who believe they or their child have been injured by or a death resulted from a vaccine covered by the program may file a petition

13The preponderance of evidence standard is generally interpreted to require that the party with the burden of persuasion—here, that party is the petitioner—must establish that a fact in question is more likely true than not. See 29 Am. Jur. 2d Evid. § 173. This standard is used for VICP claims in a manner similar to its use in civil court but without regard to fault. 14The agency must provide for notice and opportunity for a public hearing and at least 180 days of public comment, as well as provide the Advisory Commission on Childhood Vaccines at least 90 days to provide recommendations and comment on proposed rules to modify the table. 1542 U.S.C. § 300aa-14(e). The effective date for a vaccine added to the vaccine injury table is the effective date of an excise tax on the vaccine. The Omnibus Budget Reconciliation Act of 1993. Pub. L. No. 103-66 § 13632 (a)(3), 107 Stat. 312, 646 (codified at 42 U.S.C. § 300aa-14 note). When a new vaccine or a new injury is added to the vaccine injury table, claims that do not meet the general filing deadlines must be filed within 2 years from the date the vaccine or injury is added to the table for injuries or deaths that occurred up to 8 years before the table change. 16Pub. L. No. 99-660, § 311(a), 100 Stat. 3771 (codified as amended at 42 U.S.C. § 300aa-19). 17GAO/HEHS-00-8.

VICP Claims Process



making a claim with the USCFC.18 In general, to be eligible for compensation, a petition must be filed (1) for a vaccine-related injury within 3 years of the first symptom of the injury (or significant aggravation of an injury), or (2) for a death within 2 years of the death and within 4 years after the first symptom of the vaccine-related injury (or signification aggravation of an injury) from which the death resulted.19

HHS, as the respondent in the process, receives a copy of the petition, including medical records, and other documentation filed with the USCFC. HRSA sends a report of its medical review including HHS’s recommendation regarding the claim to DOJ. DOJ lawyers, representing HHS in the proceedings, review the HRSA report and the legal aspects of the claim and produce a report that outlines the government’s position as to why compensation should or should not be awarded, provides a summary and medical analysis of the petitioner’s claims, and asserts applicable legal arguments.

After the claim is filed in USCFC, it is assigned to a special master, a judicial officer who examines the evidence and adjudicates the claim.20 The special master reviews the petition and may order the petitioner to provide additional records if they are missing or if they are insufficient.21

18Individuals eligible to file a VICP claim include the person who sustained the vaccine-related injury or that person’s legal representative if that person is a child, disabled, or deceased. 42 U.S.C. § 300aa-11(b)(1)(A).

Additionally, petitioners and DOJ may file expert reports including additional medical evidence from scientific literature or studies. The

19See 42 U.S.C. § 300aa-16. 20The Office of Special Masters is an office within the USCFC, part of the judiciary, comprising up to eight court-appointed special masters who develop expertise in vaccine-injury claims. According to the Office of Special Masters, most claims are assigned to special masters on a random basis, but to the extent that a special master has acquired expertise in a specific injury or vaccine, claims may be directed to a particular special master. 21A special master may suspend activity on a claim while waiting for additional documentation.


special master then determines whether a claim should be compensated.22

For claims that are compensated, there are three adjudication categories:

• Concession. In a concession, HHS’s review of medical records, scientific literature, and other documents finds that the petitioner is entitled to compensation, because the evidence meets the criteria of the vaccine injury table or because it is more likely than not that the vaccine caused the injury.

• Negotiated settlement. In a negotiated settlement, the petition is resolved via negotiation between HHS (represented by DOJ) and the petitioner.23

• Contested decision in favor of the petitioner. If HHS does not concede that a petition should be compensated or if both parties do not agree to settle, the special master issues a decision after weighing the evidence presented by both sides, which may involve conducting a hearing.

24

If the petitioner is entitled to compensation as a result of a concession or contested decision in favor of the petitioner, the proceeding then moves to the damages phase, in which the amount of compensation is determined.

25

22Even when HHS concedes a case or a case is settled, the USCFC issues a decision and judgment awarding compensation. A claim is not compensated if the court determines the petitioner is not entitled to compensation or in certain other circumstances, such as where the petitioner elects not to receive compensation or withdraws the petition.

In a negotiated settlement, the amount of compensation is

23According to HRSA, such a settlement is not an admission by HHS that the vaccine caused the petitioner’s alleged injuries, and in settlements, the court does not determine that the vaccine caused the injury. See Health Resources and Services Administration, Statistics Report-August 1, 2014, http://www.hrsa.gov/vaccinecompensation/statisticsreport.pdf, p. 9, accessed Sept. 8, 2014. Once a settlement is reached, it must be formally approved by the decision of the special master, provided the special master determines it is reasonable. 24If the special master rules that a petitioner is not entitled to compensation, the petitioner may request to have the decision reviewed by a judge of the USCFC who may issue a decision in favor of the petitioner. HHS may appeal the decision of the special master if the petitioner is awarded compensation. 25Damages may be agreed to by the parties, or the special master may hold another hearing or rule upon the record without conducting a hearing.

http://www.hrsa.gov/vaccinecompensation/statisticsreport.pdf�


included in the settlement presented to the special master. VICP may also pay for attorneys’ fees and costs deemed reasonable even for unsuccessful petitioners, and the amounts of these fees and costs may be part of a settlement between the parties or determined by the special masters.26 After the claim has been adjudicated within VICP, the petitioner may choose to file a suit in civil court. Even if found to be entitled to compensation, the petitioner may elect to reject the compensation awarded and file a suit in civil court.27

The Vaccine Injury Compensation Trust Fund, managed by Treasury, is funded by an excise tax imposed on each dose of vaccine sold in the United States that is routinely recommended for administration to children.

28 Appropriations from the trust fund to HRSA pay compensation awarded under VICP for vaccine-related injury or death to the petitioner and may also pay for petitioner attorneys’ fees and costs. Appropriations from the trust fund to HRSA, DOJ, and USCFC (for the Office of Special Masters) also pay for administrative and other expenses associated with processing VICP claims.29

USCFC has managed large influxes of similar vaccine injury claims through omnibus proceedings or groupings of claims. According to the Office of Special Masters, many of the claims alleging that a particular vaccine caused the same injury will rely on similar evidence, so by using omnibus proceedings or groupings to examine evidence for similar claims, the courts can more efficiently review the evidence.

30

26Attorney fees and costs may be paid if the court determines there is a reasonable basis for the petition and the petition was filed in good faith. These payments generally reflect the actual time and expense devoted to the case.

In omnibus

27See 42 U.S.C. § 300aa-21(a). 28The Vaccine Injury Compensation Trust Fund is funded by a $0.75 excise tax on each dose of vaccine recommended by HHS’s Centers for Disease Control and Prevention for routine administration to children. The excise tax is imposed on each disease that is prevented in a vaccine. Influenza vaccine, for example, is taxed $0.75 because it prevents one disease; measles-mumps-rubella vaccine, which prevents three diseases, is taxed $2.25. The trust fund receives net revenues from the excise tax, plus interest on investments in government securities. 29Within USCFC, only the Office of Special Masters receives appropriations from the trust fund. 30The Chief Special Master is responsible to provide for the efficient, expeditious, and effective handling of petitions under VICP. 41 U.S.C. § 300aa-12(c)(6).


proceedings, petitioners select a lead claim in each category of injury, and develop these lead claims while the remaining petitioners choosing to participate in the omnibus elect for their remaining claims to be stayed, or put on hold, until the lead claim reaches a final disposition.

HHS is required to include a statement of the availability of VICP in the vaccine information materials that health care providers are to distribute to the parent or legal representatives of a child or to any other individual to whom the provider intends to administer a covered vaccine.31 These materials—referred to as vaccine information statements by HHS—are intended to explain both the benefits and risks of a vaccine covered by VICP. HHS is also required to undertake reasonable efforts to inform the public of the availability of the program.32

Most of the VICP claims filed since fiscal year 1999 have taken multiple years to adjudicate, but those filed since fiscal year 2009 have taken less time. For many claims, the parties have concluded the proceeding through a negotiated settlement, rather than a contested decision adjudicated by a special master or the courts. Additionally, certain claims were addressed along with similar claims as part of an omnibus proceeding or informal grouping.

VICP claims filed since fiscal year 1999 took an average of about 5 and a half years to adjudicate, according to USCFC data for the nearly 8,800 claims filed since fiscal year 1999 that were adjudicated as of March 31, 2014.33

31See 42 U.S.C. § 300aa-26.

There was wide variation in the amount of time to adjudicate these claims. The claim that took the shortest time to adjudicate was filed in fiscal year 1999 and took 2 days, and the claim that took the longest time to adjudicate was filed in fiscal year 1999 and took 5,276 days (more

3242 U.S.C. § 300aa-10(c). 33USCFC data on processing times for claims runs from the time the petition was filed until judgment was entered.

Requirements for Disseminating Information on the Program

Most Claims Took Multiple Years to Adjudicate and Many Were Adjudicated by Settlement or Addressed by an Omnibus Proceeding

Most Claims Filed Since Fiscal Year 1999 Have Taken Multiple Years to Adjudicate


than 14 years). More than 1,000 (11 percent) of the claims filed since fiscal year 1999 were still in process (pending) as of March 31, 2014; most of these had been pending for 2 years or less (see fig. 1.)

Figure 1: Time Taken to Adjudicate National Vaccine Injury Compensation Program Claims Filed Fiscal Years 1999-2014, as of March 31, 2014

Note: This figure shows the time (as of March 31, 2014) to adjudicate claims for which petitions were filed in fiscal year 1999 through March 31, 2014, based on data from the U.S. Court of Federal Claims. Figures do not sum to 100 due to rounding.

For claims filed since fiscal year 2009, a greater percentage of claims were resolved within 1 or 2 years. One possible reason is that the vast majority of claims alleging autism as the injury were filed prior to fiscal year 2009. Autism claims may have taken longer because they were part of an omnibus proceeding, which suspended activity on most autism claims for a period of time. According to USCFC data, for the more than 1,400 claims filed since fiscal year 2009 that were adjudicated as of March 31, 2014, the average amount of time to adjudicate a claim was 587 days (about 1.6 years). More than 900 (40 percent) of the claims filed


since fiscal year 1999 were still pending, which could cause this average to increase over time as these pending claims are resolved (see fig. 2).34

Figure 2: Status of National Vaccine Injury Compensation Program Claims Filed Fiscal Years 2009-2014, as of March 31, 2014

Of the pending claims, nearly half had been pending for 1 year or less as of March 31, 2014.

Note: This figure shows the status (as of March 31, 2014) of nearly 2,400 claims for which petitions were filed in fiscal year 2009 through March 31, 2014, based on data from the U.S. Court of Federal Claims.

HHS has reported the program has met its annual target of 1,300 days (about 3.5 years) for the average time to adjudicate non-autism claims in all but 1 year since fiscal year 2009. This target (1,300 days) has been in

34Of the claims filed since fiscal year 2009 that were adjudicated as of March 31, 2014, the claim that took the shortest time to adjudicate took 3 days, and the claim that took the longest time to adjudicate took 1,981 days (nearly 5 and a half years).


place since fiscal year 2009, and applies to claims concluded in a given fiscal year, regardless of the year they were filed, excluding claims that alleged autism as the vaccine-related injury.35

Organizations representing petitioners have criticized the program for taking a long time to resolve claims. Petitioners report that long processing times delay receiving compensation to pay medical bills and other expenses related to the alleged injury. A HRSA-contracted survey of petitioners whose claims were adjudicated (regardless of whether or not they received compensation under VICP), found that nearly two-thirds of the 103 respondents indicated they were somewhat or very dissatisfied with the length of the process.

HRSA has reported meeting this goal since fiscal year 2009, except in fiscal year 2012, when VICP claims concluded that year took an average of 1,309 days to complete.

36 Petitioners may withdraw if a VICP decision is not made on their claim within specific time periods but according to the Office of Special Masters, petitioners rarely exercise this option.37

Officials cite certain delays within the process as factors that can increase average claims processing times. Officials at USCFC and DOJ told us

35Performance measures, including a measure for average claims processing time, were developed for VICP during the Program Assessment Rating Tool review conducted by the Office of Management and Budget for the fiscal year 2007 budget. HHS reports the targets and tracks the program’s performance for average claims processing time in HRSA’s annual congressional budget justifications. 36Altarum Institute, Determining the Feasibility of Evaluating the National Vaccine Injury Compensation Program, Final Report, a report prepared for the Health Resources and Services Administration, June 15, 2009. Of 716 petitioners the researchers identified as meeting their inclusion criteria,107 responded to their survey and 103 responded to this question on the length of the process. The results of this study cannot be generalized to the population of all petitioners who completed the VICP process; instead, they reflect only the VICP petitioners who responded to the survey. According to HRSA, petitioners were included in the sample if they (1) had filed a claim that had been compensated or dismissed in fiscal years 2004-2008 and (2) were represented by an attorney. 37If a special master fails to make a decision on a petition within 240 days (excluding any period of suspension), or if USCFC fails to enter a judgment on a petition within 420 days after the date on which the petition was filed (excluding any period of suspension), petitioners can withdraw their claim from VICP. 42 U.S.C. § 300aa-12(g). While USCFC officials report that most claims exceed both the 240-day and the 420-day limits when periods of suspension are not excluded, USCFC does not track suspensions so available data do not show how much time a case was suspended and how many cases met the statutory time frames.


that the time petitioners spend gathering supporting documentation or evidence can add significantly to the amount of time required to process a claim. These delays may occur at multiple points in the claims process, from petitioners needing to gather sufficient documentation for the court to begin an initial review, to the court needing documentation to determine the amount of compensation that a successful petitioner will receive.38 According to HRSA, for claims adjudicated as of March 31, 2014, its medical review process averaged over 700 days for claims filed in fiscal year 2010. HRSA attributes the length of time for medical review primarily to time spent waiting for petitioners to submit requested documentation. During the medical review, HRSA may also consult with external experts, who require additional time to review the details of the case; HRSA’s data indicate that over 1,200 outside reviews were conducted from fiscal years 2009 to 2014. Additionally, when special masters are reviewing the claim, a party may request that the special master delay a decision until additional documentation is available.39

Special masters may also request additional information from petitioners—such as a specialist physician’s opinion.

According to HRSA data for claims filed since 2006, most compensated claims were adjudicated through negotiated settlement rather than a concession or a contested decision. HRSA’s data indicated that about 80 percent of the more than 1,500 non-autism VICP claims filed since 2006 for which compensation was awarded were adjudicated through a negotiated settlement between the parties, compared to about 10 percent involving a contested decision in favor of the petitioner and about 10 percent conceded by HHS.40

38Petitioners are required by statute to submit their supporting documentation or evidence at the time they file their petition. See 42 U.S.C. § 300aa-11(c)(2). According to DOJ, petitions are frequently filed without documentation, which delays adjudication.

According to HRSA, claims which HHS does not concede may be resolved via a negotiated settlement for several reasons, including a desire by both parties to resolve a case quickly and efficiently. According to the Office of Special Masters, a special master

39Special masters report allowing these delays in order to accumulate sufficient evidence to adjudicate a claim, but they could not provide a precise number. 40See Health Resources and Services Administration, Statistics Report-October 2, 2014, http://www.hrsa.gov/vaccinecompensation/statisticsreport.pdf, accessed October 8, 2014.

Many Claims Were Adjudicated through Settlement or Grouped in an Omnibus Autism Proceeding


may recommend parties settle as an expeditious and efficient method of resolving certain claims.

The Office of Special Masters created an omnibus proceeding in order to address thousands of autism cases systematically and efficiently.41 Beginning in 1999, parents began filing petitions for compensation under VICP alleging that autism or neurodevelopmental disorders similar to autism were caused by the measles-mumps-rubella vaccine or vaccines containing thimerosal, a mercury-containing preservative used in some vaccines, covered by the program, or both. In 2002, the Office of Special Masters held a series of meetings with an informal advisory committee, including attorneys who represented many potential petitioners and legal and medical representatives of HHS, to address the task of dealing with these claims. The Office of Special Masters decided to utilize a two-step procedure: first, looking into whether the vaccinations in question can cause autism and, if so, the circumstances under which this occurs, and second, applying the conclusions from the first step to the individual claims. The omnibus autism proceeding included test cases for two different theories by which vaccines were alleged to cause autism.42 Some petitioners withdrew from the omnibus proceeding and elected to proceed within the vaccine program on other theories of causation. Some petitioners withdrew from the program entirely, as was their statutory right, which enabled them to pursue claims against vaccine manufacturers in civil court.43

41The omnibus autism proceeding was the largest of several instances in which the courts addressed groupings of similar claims. Since 1999, the USCFC has grouped similar claims to manage hepatitis B vaccine injury claims, claims alleging an injury of type 1 diabetes, and claims that certain childhood vaccinations have caused or contributed to autism. According to the Office of Special Masters, the omnibus autism proceeding was the largest of these groupings, involving over 5,000 claims, with the hepatitis B grouping involving several hundred and the type 1 diabetes grouping involving fewer than 50 claims.

42According to the Office of Special Masters, petitioners withdrew a third theory of causation. 43See 42 U.S.C. § 300aa-21(b). By filing a “Short-Form Autism Petition for Vaccine Compensation,” a petitioner could elect to be part of the Omnibus Autism Proceeding and simultaneously choose to stay his or her case-specific proceeding on his own petition until the conclusion of the Omnibus Autism Proceeding. See Office of Special Masters, Autism General Order #1, July 3, 2002 (http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf), accessed October 14, 2014.

http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf�


The influx of new VICP claims for autism continued in fiscal years 2002-2005, while the number of new non-autism claims remained relatively stable (see fig. 3). HRSA data show that during this period, nearly 90 percent of VICP claims filed alleged autism as the vaccine-related injury. Ultimately, the special masters did not award compensation in any of the test cases,44 and most remaining omnibus autism proceeding claims were dismissed. However, according to the Office of Special Masters, some petitioners who had been part of the omnibus autism proceeding continued with claims separate from the omnibus proceeding.45

44See In Re: Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar Neurodevelopmental Disorder, Fed. Cl. Spec. Mstr. Update, p. 3, Jan. 12, 2011 (indicating that proceedings in all test cases had concluded and that decisions in all such cases rejected petitioners’ theories of causation).

45According to the Office of Special Masters, these petitioners proceeded on other theories of causation.


Figure 3: Number of National Vaccine Injury Compensation Program Claims Filed Alleging Autism, Fiscal Years 1999-2014, as of March 31, 2014

Note: Data for fiscal year 2014 are as of March 31, 2014.

HHS has added vaccines to the vaccine injury table without adding covered injuries associated with those vaccines. Following their addition to the table, more claims were filed for off-table injuries.

Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries, Resulting in More Off-Table Claims


Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table (but has not added covered injuries associated with these vaccines to the table).46 This means that while individuals may file VICP claims for those vaccines, each petitioner must demonstrate that the vaccine that was administered caused the alleged injury. In general, each of the six vaccines was added within 2 years of the Centers for Disease Control and Prevention’s recommending it for routine administration to children and having an excise tax imposed.47 Since 1999, two vaccines, both of which had covered injuries associated with them, were removed from the vaccine injury table.48 See appendix II for the vaccines and injuries added and removed from the vaccine injury table since 1999. At the end of the fiscal year 2014, 16 vaccines were covered by the program, 8 of which did not have associated covered injuries on the table.49

HHS has been considering adding injuries to the table in association with the eight vaccines that are listed without covered injuries.

50

• In July 2013, HRSA published a proposed rule to add intussusception (obstruction of the bowels) as an injury associated with the rotavirus

Specifically, HRSA officials said they are working on a final rule to add an injury associated with one vaccine and a proposed rule that would add injuries associated with several other vaccines.

46Although the rhesus-based rotavirus vaccine was added to the table with an associated injury in 2002, it was removed in 2008. See 67 Fed. Reg. 48558 (Jul. 25, 2002) (addition to table); 73 Fed. Reg. 59528 (Oct. 9, 2008) (removal from table). 47In October 1999, the Centers for Disease Control and Prevention recommended the hepatitis A vaccine be administered to children in states, counties, and communities with rates of hepatitis A that were twice the 1987-1997 national average or greater. However, the hepatitis A vaccine was not covered by VICP until 2004, when the American Jobs Creation Act of 2004 imposed an excise tax for all hepatitis A vaccines. Pub. L. No. 108-357, § 889(a), 118 Stat. 1418, 1643 (codified at 26 U.S.C. § 4132(a)(I)). 48In addition to the rhesus-based rotavirus vaccine, which was removed in 2008, unconjugated Hemophilus influenza type b (Hib) polysaccharide vaccine was removed from the vaccine injury table in 2002. See 67 Fed. Reg. 48558 (Jul. 25, 2002). 49There were two vaccines on the table prior to fiscal year 1999 that had no covered injuries listed: Hemophilus influenza type b (Hib) vaccine (which prevents meningitis and other serious infections) and varicella vaccine (which prevents chicken pox). 50HHS has also been considering adding injuries in association to covered vaccines that already have associated injuries on the vaccine injury table.

Six Vaccines Have Been Added to the Vaccine Injury Table since Fiscal Year 1999 without Covered Injuries; HHS Is Considering Additional Changes


vaccine.51

• HRSA officials said they are developing a proposed rule to add covered injuries for all seven of the remaining vaccines on the table without covered injuries. For example, HRSA is considering proposing to add Guillain-Barré Syndrome (a disorder in which the body’s immune system attacks part of the nervous system and is characterized by muscle weakness and paralysis), as an injury associated with the influenza vaccine. The agency is also considering proposing to add other injuries associated with the influenza, hemophilus influenza type b conjugate, varicella, pneumococcal conjugate, hepatitis A, meningococcal, and human papillomavirus vaccines.

In proposing the addition, HRSA considered reviews and injury claims attributed to another vaccine that protected against rotavirus but had been removed from the table in fiscal year 2009. According to HRSA, the agency is working on a final rule to add this injury.

5178 Fed. Reg. 44512 (Jul. 24, 2013) (to be codified at 42 U.S.C. § 100.3).


According to HRSA officials, the factors informing the table changes that they are considering proposing include (1) an Institute of Medicine study of certain vaccines;52 (2) HHS’s independent review of vaccine causation and medical and scientific evidence; (3) the need to clarify injury definitions on the table53

As of September 30, 2014, HRSA had not promulgated regulations to make these changes to the vaccine injury table. According to HRSA officials, the agency plans

; and (4) recent studies related to injuries associated with the influenza vaccine.

• to publish the final rule to add the injury associated with the rotavirus vaccine to the table by July 2015,54

• to publish a proposed rule for the other injuries it is considering adding to the table by August 2015.

and

According to HRSA officials, the process to publish such a proposed rule can take about 9 months to 1.5 years. The officials also said that the process for publishing such a final rule can take about 1.5 years to 2.5 years after the proposed rule is published. In its justification accompanying its fiscal year 2013 budget request, HRSA acknowledged that many stakeholders, including Congress, have voiced interest and concern over keeping the injury table in line with current science. At that time, HRSA reported that other VICP activities, including medical reviews and court deadlines, have taken priority over updating the table.55

52In 2009, HHS commissioned the Institute of Medicine to review specific injuries in association with vaccines that are currently on the table. These vaccines include varicella; influenza, hepatitis B; human papillomavirus; measles, mumps, and rubella; hepatitis A; meningococcal; and vaccines containing tetanus. See Institute of Medicine, Adverse Effects of Vaccines: Evidence and Causality (Washington, D.C.: The National Academies Press: 2012).

53HRSA officials said they are also considering changes in the language defining injuries on the table. 54Public hearings on the proposed rule for adding intussusception as a covered injury associated with the rotavirus vaccine took place on January 13, 2014, and April 28, 2014. 55Health Resources and Services Administration, Justification of Estimates to Appropriations Committees, Fiscal Year 2013, accessed November 4, 2014 http://www.hrsa.gov/about/budget/budgetjustification2013.pdf.

http://www.hrsa.gov/about/budget/budgetjustification2013.pdf�


While the injuries HRSA is considering have not yet been added to the table, HRSA and DOJ officials report that many claims alleging these injuries that HRSA is considering adding to the table have been conceded or settled. For example, according to DOJ officials, there have been numerous settlements for cases alleging Guillain-Barré Syndrome as an injury associated with the influenza vaccine.

The addition of the six vaccines to the vaccine injury table without associated injuries has contributed to an increase in off-table claims. When we reported on this program in 1999, 2 of the 12 vaccines on the injury table were without associated injuries listed on the table. We reported that about one-quarter (28 percent) of claims filed as of February 1999 were for off-table injuries.56 In contrast, of the 3,007 claims filed since fiscal year 2005 (the year that trivalent influenza vaccine was added to the table) for which the covered vaccine associated with the alleged injury was specified, at least 59 percent were associated with one of five vaccines added to the table without associated table injuries, according to HRSA data.57

Claims alleging injuries to adults also increased as a result of the addition of vaccines that are recommended for administration in adults (as well as children) to the vaccine injury table. Several of the vaccines added to the injury table—in particular, the vaccine to prevent influenza—are

To receive compensation, the petitioners in these claims would not have the presumption of causation associated with an on-table claim. Overall, since 2009, more than 98 percent of the new claims filed alleged off-table injuries that required the petitioner to prove their injury was caused by the vaccine they received, according to the Office of Special Masters.

56GAO/HEHS-00-8. 57The five vaccines included hepatitis A, human pappilomavirus, influenza, meningococcal, and pneumococcal conjugate vaccines. According to HRSA data, 1,245 claims filed since fiscal year 2005, including claims filed as part of the Omnibus Autism Proceeding, did not specify a vaccine and 30 claims specified a nonqualified vaccine—that is, a vaccine not covered under VICP.

Changes in the Vaccine Injury Table Contributed to More Claims for Off-Table Injuries and for Injuries in Adults



recommended for routine administration to adults as well as children.58 As a result, although the vaccines were added to the table because they were recommended for children, adults who are vaccinated with them are also eligible for compensation under VICP. More than half (51 percent) of the 4,402 VICP claims filed since fiscal year 1999 (for which the covered vaccine associated with the alleged injury was specified) were for injuries to adults and 1,287 (29 percent) were for adults alleging injuries in association with influenza vaccine, according to HRSA data.59

The Vaccine Injury Compensation Trust Fund balance increased to more than $3 billion in fiscal year 2013 despite increased spending by HRSA, DOJ, and USCFC on petitioner compensation, attorneys’ fees and costs, and other VICP-related expenses.

58Vaccines generally recommended for adults (as well as children) and currently covered by VICP include vaccines to protect against influenza, tetanus, diphtheria, pertussis, varicella, human papillomavirus, pneumococcal disease (pneumococcal conjugate vaccine), measles, mumps, and rubella. See http://www.cdc.gov/vaccines/schedules/downloads/adult/adult-schedule-easy-read-bw.pdf, accessed Oct. 9, 2014. 59According to HRSA data, 5,377 claims filed since fiscal year 1999 (as of March 31, 2014) did not specify which covered vaccine caused an alleged injury and 57 claims specified a vaccine not covered by the program.

Trust Fund Balance Has Increased since 2009, As Has Petitioner and Attorney Compensation and Other VICP-Related Spending

http://www.cdc.gov/vaccines/schedules/downloads/adult/adult-schedule-easy-read-bw.pdf�


The balance in the trust fund increased from $2.9 billion at the end of fiscal year 2009 to nearly $3.3 billion at the end of fiscal year 2013.60 The balance increased because the trust fund’s income outpaced its disbursements to HRSA, DOJ, and USCFC, although disbursements also increased during this period (see fig. 4).61 Treasury reported over $200 million in net revenues from the vaccine excise tax in each of fiscal years 2009-2013. As required by applicable law pertaining to the management of trust funds, Treasury oversees the investment of part of the net revenue from vaccine excise taxes.62

60In this report, investments in U.S. securities issued by the Bureau of Fiscal Service and the fund balance with Treasury comprise the balance of the trust fund at the end of the fiscal year.

Interest from these investments ranged from about $49 million in fiscal year 2012 to about $126 million in fiscal year 2011.

61Net revenue from vaccine excise taxes and interest on investments comprise income for the trust fund. Disbursements to HRSA—for compensation to petitioners, attorneys’ fees and costs, and administrative expenses, and to DOJ and the USCFC for the Office of Special Masters—for expenses associated with processing National Vaccine Injury Compensation Program (VICP) claims, comprise disbursements from the trust fund. 62See 26 U.S.C. § 9602.

From Fiscal Year 2009 to 2013 the Trust Fund Balance Gradually Increased to More than $3 Billion


Figure 4: Vaccine Injury Compensation Trust Fund Income, Disbursements, and Balance for Fiscal Years 2009–2013

Note: This figure presents the Vaccine Injury Compensation Trust Fund balance (in terms of investment in U.S. securities issued by the Bureau of Fiscal Service and the fund balance with Treasury) at the end of the fiscal year. It also presents the income to trust fund (in terms of net revenue from excise taxes on vaccines and interest on investments) as well as disbursements to the


Health Resources and Services Administration (HRSA)—for compensation to petitioners, attorneys’ fees and costs, and administrative expenses, and to the Department of Justice (DOJ) and the U.S. Court of Federal Claims (USCFC) for the Office of Special Masters—for expenses associated with processing National Vaccine Injury Compensation Program (VICP) claims, as reported in the Treasury reports.

Total compensation to petitioners and the number of claims compensated have both increased since fiscal year 1999. Petitioners’ compensation paid by HRSA using appropriations from the trust fund increased to over $254 million in fiscal year 2013. With the exception of fiscal year 2000, the total amount spent on compensation awarded to petitioners remained under $125 million between fiscal years 1999 and 2009. The total amount spent on compensation to petitioners increased to nearly $180 million in fiscal year 2010 and to more than $250 million in fiscal year 2013 (see fig. 5 and app. III).63

63There is no cap on the amount of an award in a vaccine injury case, but the law does provide certain restrictions, such as a prohibition on punitive damages and limits on pain and suffering and emotional distress. Awards may include compensation for actual and anticipated loss of earnings. In some cases, compensation may be provided in the form of an annuity. In the event of a vaccine-related death, VICP will award $250,000 to the estate of the deceased. See 42 U.S.C.§ 300aa–15. Injury-related damages in addition to the statutory death benefit may be awarded.

Spending on Compensation to Petitioners and Attorneys Has Increased since Fiscal Year 1999


Figure 5: Compensation to Petitioners under the National Vaccine Injury Compensation Program

Note: This figure presents the total amounts and numbers of claims paid by the Health Resources and Services Administration to petitioners under the National Vaccine Injury Compensation Program for each of fiscal years 1999-2013. Data are presented by the fiscal year in which the compensation was paid.

According to the Office of Special Masters, the increase in the total amount paid to petitioners in compensation and number of compensated claims is related to the addition of the influenza vaccine to the vaccine injury table. The influenza vaccine, which is administered to millions of people each year, was added to the injury table in fiscal year 2005.

The annual amount the VICP program paid for attorneys’ fees and costs remained relatively steady from fiscal year 1999 to fiscal year 2007, but started to increase in fiscal year 2008, consistent with an increase in the total number of payments to attorneys (see fig. 6 and app. III). In order to help ensure access to the program, VICP may pay for reasonable attorney fees and costs upon a determination that the petition was brought in good faith and there was a reasonable basis for the claim for


which the petition was brought, regardless of whether the petitioner’s claim is compensated or dismissed.64 The majority of VICP payments for attorneys’ fees and costs have been for compensated or dismissed claims; however, since fiscal year 2008, VICP has also paid some interim attorneys’ fees and costs for selected ongoing claims at the special master’s discretion.65

64Attorneys are prohibited from taking a contingent fee on compensation awarded to a petitioner. 42 U.S.C. § 300aa-15(e).

Compensation for attorneys’ fees and costs must be reasonable such that it generally reflects the actual time and expense devoted to the case.

65According to the Office of Special Masters, interim awards are made at the special master’s discretion, depending on a variety of factors, including but not limited to the duration of the litigation (e.g., lengthy proceedings), the stage of the proceedings, the amounts sought (e.g., demonstrating that substantial costs have been incurred), and the documented need for an interim award (e.g., demonstrating undue hardship).


Figure 6: Payments to Attorneys under the National Vaccine Injury Compensation Program

Note: This figure presents the total amounts paid in attorneys’ fees and costs for each fiscal year (based on the fiscal year in which the payment was made). Attorneys’ fees and costs reflect the actual time and expense devoted to the case as opposed to a percentage of the compensation.

The total amount obligated by HRSA, DOJ, and USCFC (for the Office of Special Masters) to pay for staff and other expenses related to processing VICP claims increased from $17 million in fiscal year 2009 to about $19 million in fiscal year 2013.66

66The total obligation to each agency may not match the amount that Treasury reported it disbursed from the trust fund during a given fiscal year because the agencies’ obligations for petitioners’ compensation, attorneys’ fees, and other expenses associated with the program do not always occur in the same fiscal year that Treasury disburses funding to the agencies.

The three departments obligated a total of about $91 million for expenses associated with processing VICP claims during those 5 fiscal years. About two-thirds of VICP-related expenses

Spending on Agency Staff and Other VICP-Related Expenses Has Increased


($61 million) was obligated to pay the salaries and benefits of full-time equivalent (FTE) agency staff and about one-third ($30 million) was obligated for other VICP-related expenses (see table 1).

Table 1: Amounts Obligated by HRSA, DOJ, and USCFC for the National Vaccine Injury Compensation Program Administrative Expenses

Dollars in millions HRSAa DOJ USCFCb

Fiscal year FTE staff (number)

Other expenses

FTE staff (number)

Other expenses

FTE staff (number)

Other expenses

Total obligations

2009 $2.8 (18) $2.6 $4.5 (34) $3.2 $3.2 (24) $0.8 $17.0 2010 3.4 (22) 3.1 5.0 (34) 2.5 3.3 (25) 1.7 19.0 2011 3.8 (22) 2.7 5.4 (33) 2.4 3.4 (26) 0.8 18.5 2012 4.2 (22) 2.3 5.4 (34) 1.6 3.7 (29) 1.0 18.1 2013 3.8 (20) 2.5 5.5 (34) 2.1 3.7 (29) 1.1 18.7 Total $17.9 $13.2 $25.8 $11.9 $17.3 $5.4 $91.4

Source: GAO summary of HHS, DOJ, and USCFC data. | GAO-15-142

Legend: HRSA = Health Resources and Services Administration; DOJ = Department of Justice; USCFC = U.S. Court of Federal Claims; FTE = Full-time equivalent. Notes: Figures do not sum to totals due to rounding. aAmounts obligated by HRSA do not include compensation to petitioners or attorney costs. bAmounts obligated by USCFC were for the Office of Special Masters.

The amounts obligated for FTE salaries and benefits were for staff of HRSA, DOJ, and USCFC’s Office of Special Masters who process the claims and represent the government’s interest in legal proceedings. For example, USCFC’s Office of Special Masters paid the salaries and benefits for special masters and clerks. The average number of full-time equivalent (FTE) staff supported across the three agencies was 81 per fiscal year.

Each agency also had other VICP-related spending reimbursed by the trust fund. For example, HRSA reported obligating about $9.6 million for medical experts to review petitioner claims and provide expert testimony during adjudication proceedings for fiscal years 2009 through 2013. HRSA also obligated funds to support the Advisory Commission on Childhood Vaccines, including compensation and travel expenses for commission members. The departments reported obligating funds for costs for travel, processing documents, maintaining records, rent, supplies, and equipment. For example, obligations include rental


payments to the General Services Administration by DOJ and the cost of court reporters funded by USCFC’s Office of Special Masters.

Information on petitioners’ experience with VICP is limited. HRSA has taken some steps to undertake outreach activities, but the agency has not yet assessed the effect of these efforts.

Other than a study for HRSA on petitioners’ satisfaction with VICP, the agency officials and stakeholders we interviewed and the documents we reviewed did not identify any data or studies regarding the experience of individuals who have filed VICP claims. The study prepared for HRSA, dated 2009, reported the responses from 107 petitioners whose claims were compensated or dismissed in fiscal years 2004-2008. Because this was a voluntary survey with a low response rate, its results cannot be generalized to all petitioners who completed the VICP process; instead, it reflects only the experience of the VICP petitioners who responded to the survey.67

67Altarum Institute, Determining the Feasibility of Evaluating the National Vaccine Injury Compensation Program. HRSA contracted for this study in 2005, which surveyed petitioners regarding their perceptions of access to VICP information, program implementation and processes, financial award decision, and overall satisfaction. According to HRSA, petitioners were included in the sample if they (1) had filed a claim that had been compensated or dismissed in fiscal years 2004-2008 and (2) were represented by an attorney. Of 716 petitioners the researchers identified as meeting their inclusion criteria, 107 responded to their survey.

We also obtained comments from stakeholders, including officials from organizations representing providers, petitioners’ attorneys, and parents. These stakeholder comments, while providing insight into petitioner experiences, are anecdotal and do not represent the experience of all petitioners who have filed VICP claims. Members of the Advisory Commission on Childhood Vaccines we interviewed expressed interest in obtaining additional information on petitioner’s experience with VICP; however, they told us they had not done so, citing concerns about confidentiality and other issues.

Information on VICP Petitioner Experience Is Limited; HHS Is Taking Steps to Address Criticism of Its Outreach Efforts

Information on Petitioners’ Experiences with VICP Is Limited


The limited comments on petitioners’ experience from those who responded to the survey prepared for HRSA and from stakeholders included the following:

• Some petitioners responding to the HRSA survey reported being dissatisfied with the claims process and some commented that the process places too great a burden on petitioners and family members, with requests for additional information after the claims were filed. Similarly, one stakeholder said that petitioners view the vaccine injury claims process as confusing, time-consuming, too lengthy, and traumatic. Another stakeholder, on the other hand, commented that while vaccine-related injuries do not happen often, the program handles them efficiently and fairly when they do happen.

• Other comments from petitioners responding to the HRSA survey and stakeholders were related to the payment process and amount of compensation. More than half of the 61 petitioners who responded to a question on the method of payment in the HRSA survey reported being somewhat or very satisfied with the method of award payment; however, 14 respondents suggested more timely and flexible payment mechanisms. About half of the 63 respondents to the question on the amount of compensation reported the award amount was inadequate to cover past and future medical care. Similarly, stakeholders we interviewed reported concerns with the amounts petitioners receive, the method of payment, and a perceived lack of transparency regarding how the money from the Vaccine Injury Compensation Trust Fund has been spent. For example, one stakeholder told us that petitioners felt forced to settle for less than what it will cost them to care for their children or themselves for their lifetimes, and another stakeholder raised concerns about the choice of annuities for petitioners.

• Other comments on the program from stakeholders were related to the perception of an adversarial or unfriendly environment throughout the process, the use of settlements and perceived pressure to settle claims, the use of omnibus proceedings to group claims together, and concerns about confidentiality of the medical information filed by the petitioner. Some petitioners responding to the HRSA survey and some stakeholders also reported difficulties finding an attorney to represent petitioners in the process; however, petitioners responding to the survey were split on this issue—about the same number reported that finding an attorney was difficult as reported that finding an attorney was easy.


HRSA has acknowledged being criticized for years for not adequately promoting public awareness of VICP, and has recently taken some steps, such as developing and starting to implement an outreach plan for fiscal year 2014 and developing an outreach plan for fiscal year 2015, to improve its efforts to reach out to providers and the public.68 In its 2006 VICP strategic plan, HRSA noted that one of the critical issues facing the program from 2005 to 2010 was that many parents, the general public, attorneys, and health care professionals were not aware VICP existed.69 In 2009, HRSA contracted for the development of a comprehensive national marketing and outreach communication plan; the contactor presented the plan to HRSA in November 2010.70 According to HRSA, the agency used this plan to guide outreach efforts.71 Prior to the fiscal year 2014 plan, HRSA also reported exhibiting at professional conferences; updating the VICP website and the VICP booklet that is available from the website (including translating the booklet into Spanish); facilitating the review of vaccine information statements (which include a statement on VICP) by the Advisory Commission on Childhood Vaccines; and responding to media inquiries and inquiries received via e-mail, letters, and the program’s toll-free number.72

68In each of HRSA’s annual justification of estimates for appropriations committees for fiscal years 2011-2014, HRSA noted that the agency has been criticized for not adequately promoting public awareness of the VICP.

HRSA officials also noted the need to carefully balance messages that increase awareness of VICP with public health messages that encourage and promote immunizations.

69Division of Vaccine Injury Compensation, National Vaccine Injury Compensation Program Strategic Plan (April 2006). 70Banyan Communications, Inc., The Comprehensive National Vaccine Injury Compensation Program Marketing and Outreach Communication Plan, a report prepared for the Health Resources and Services Administration, (Nov. 2010). 71According to HRSA officials, the agency has been implementing some of the activities recommended in the November 2010 plans since that plan was issued, but the agency did not formally document its outreach efforts until the fiscal year 2014 VICP outreach plan. Agency officials report that the 2014 plan was developed because HRSA is taking a more strategic approach to its outreach and wanted to formally document these efforts. 72As part of its fiscal year 2011 budget justification, HRSA reported that exhibiting at conferences had proven beneficial in increasing knowledge of the availability of the program and that it planned exhibiting at medical and legal conferences in fiscal year 2011.

HHS Is Taking Steps to Address Criticism of Its Efforts to Inform the Public of the Program


HRSA shared an overview of its outreach plans with its Advisory Commission on Childhood Vaccines in September 2014. HRSA reported that many of the activities in the agency’s 2014 outreach plan were in process at the end of the fiscal year. These activities included reviewing the VICP booklets to use plain language and make them more user-friendly, reviewing and upgrading the VICP website to improve navigation, developing VICP message points for target audiences and slides about the program to be used in speeches and other presentations by HRSA staff, and requesting federal websites to provide information on the program and to link to the VICP website. In its outreach plan for fiscal year 2015, the agency is targeting health care providers, parents and expectant parents, adults aged 50 years and older (including Spanish-speaking older adults), and civil litigation and health attorneys, with the goal of informing target audiences of the availability of the program. According to HRSA, these target audiences were selected because they include individuals who administer vaccines and individuals (or their caregivers) who receive vaccinations. HRSA has identified a number of measures to assist in tracking performance of its fiscal year 2015 plan, including website metrics, the number of “retweets” and “shares” from social media initiatives, the number of media inquiries, and the number of attendees or participants at outreach events. Because the agency has not completed many of its planned efforts to improve how it informs the public of the availability of the program, it is too early to determine the effect of HRSA’s current and planned outreach efforts.

Without awareness of the program, individuals who might otherwise receive compensation for a vaccine-related injury or death could be denied compensation because of a failure to file their claim within the statutory deadlines. One stakeholder commented that the public is largely unaware of the program, and this lack of awareness contributes to missing filing deadlines and individuals being denied the opportunity for compensation. Members of the Advisory Commission on Childhood Vaccines also told us that many individuals may not know there is a statute of limitations on filing a claim and many miss the opportunity to file


a claim because of the statute of limitations.73 In December 2013, the commission recommended extending the statute of limitations for vaccine-related injuries and deaths. Extending the statute of limitations would require amending the applicable statutory provision.74

It has been more than 25 years since VICP went into effect in 1988. In that time, the program has awarded more than $2.8 billion to thousands of petitioners. Several aspects of the program have changed over the years. First, while claims alleging injuries on the vaccine injury table made up the majority of claims filed in the first decade of the program, today—after the addition of new vaccines, particularly influenza vaccine, to the table without associated injuries—the majority of the claims filed involve off-table injuries. Stakeholders report that the program has an adversarial environment, as petitioners are required to demonstrate a covered vaccine caused the injury on their VICP claim when there are no associated injuries on the table. The extent to which this will change if HHS updates the vaccine injury table to include more injuries, as expected, is yet to be seen. Second, most of the compensated cases are now adjudicated through negotiated settlement, rather than contested decisions before the special master. And while the vaccines covered by the program are included because they are recommended for children, many of the program’s petitioners in recent years are adults who received covered vaccines.

Addressing one criticism of the program by stakeholders—specifically the need to increase the statute of limitations—would require a statutory change in the program. Regardless of whether the statute of limitations is

73The current statute of limitations, in general, requires that claims be filed within 3 years of the date of the first symptom or manifestation of the onset or significant aggravation of an injury and within 2 years of a death (and within 4 years of the date of the first symptom or manifestation of the onset or significant aggravation of the injury from which a death resulted). Generally, when a vaccine or injury is added to the vaccine injury table, petitioners are required to file claims within 2 years from the date the vaccine or injury is added to the table for injuries or deaths that occurred up to 8 years before the table change. See 42 U.S.C. § 300aa-16. 74HHS has proposed extending the statutory time limits for filing a VICP claim in the past. For example, in commenting on a draft of our 1999 report, the department stated that the legislative proposals it had sent to the Congress included doubling the statutory time limit for filing a claim. GAO/HEHS-00-8, 39. DOJ officials also reported they believed their department had supported previous proposals to extend the program’s statute of limitations.

Concluding Observations



increased, HHS’s efforts to increase awareness of the availability of the program will be important to help ensure that potential petitioners are aware of the program and can file claims in time. While HHS has recently taken or planned steps to improve its outreach activities, what effect, if any, these efforts will have remains to be seen. As the agency moves forward, it will be important for HRSA to identify which activities are reaching its target audiences.

We provided a draft of this report to HHS, DOJ, USCFC, and Treasury. HHS and USCFC agreed with our findings and provided written comments, which are reprinted in appendixes IV and V, respectively. In its comments, HHS emphasized that it administers VICP jointly with DOJ and USCFC, with HHS responsible for reviewing petitioners’ claims, providing recommendations for entitlement to compensation, and making payments to petitioners and attorneys. In commenting on our identification of its efforts on VICP outreach, HHS noted that it is strengthening its outreach efforts by implementing its fiscal year 2015 VICP outreach plan, which increases outreach to target populations and includes performance measures. In its written comments, USCFC noted that the Administrative Office of the United States Courts and USCFC both supply administrative support to the Office of Special Masters and VICP without reimbursement from the trust fund. The court also commented that, while considerable strides have been made in reducing the average processing time for claims in recent years, the climbing and changing nature of the caseload, coupled with the statutory cap on the number of special masters, present a continuing challenge to the Office of Special Masters’ ability to continue to reduce average processing times. USCFC also commented that following omnibus proceedings, claims have been resolved more expeditiously in recent years, and often through settlements. USCFC also commented that the Office of Special Masters strives to resolve all cases fairly and expeditiously. HHS, USCFC, DOJ, and Treasury also provided technical comments that were incorporated, as appropriate.

We are sending copies of this report to the Secretary of Health and Human Services, the Attorney General of the United States, the Chief Judge of the United States Court of Federal Claims, and the Secretary of the Treasury. In addition, the report is available at no charge on the GAO website at http://www.gao.gov.

Agency Comments

http://www.gao.gov/�


If you or your staff have any questions about this report, please contact me at (202) 512-7114 or [email protected]. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix VI.

Sincerely yours,

Marcia Crosse Director, Health Care

Appendix I: Vaccine Injury Table, September 2014

Page 36 GAO-15-142 National Vaccine Injury Compensation Program

Vaccine Injurya Time periodb Vaccines against tetanus (e.g., DTaP, DTP, DT, Td, or TT) Anaphylaxis or anaphylactic shock 4 hours Brachial neuritis 2-28 days Vaccines against pertussis (e.g., DTP, DTaP, P, DTP-Hib) Anaphylaxis or anaphylactic shock 4 hours Encephalopathy (or encephalitis) 72 hours Vaccines against measles, mumps, rubella in any combination (e.g., MMR, MR, M, R)

Anaphylaxis or anaphylactic shock 4 hours Encephalopathy (or encephalitis) 5-15 days

Vaccines against measles (e.g., MMR, MR, M) Thrombocytopenic purpura 7-30 days Vaccine-strain measles viral infection in an

immunodeficient recipient 6 months

Vaccines against rubella (e.g., MMR, MR, R) Chronic arthritis 7-42 days Vaccines against polio (polio live virus-containing (OPV)) Paralytic Polio —In a nonimmunodeficient recipient 30 days —In an immunodeficient recipient 6 months —In a vaccine-associated community case Not applicable Vaccine-strain polio viral infection —In a nonimmunodeficient recipient 30 days —In an immunodeficient recipient 6 months —In a vaccine-associated community case Not applicable Vaccines against polio (polio inactivated virus-containing (IPV)) Anaphylaxis or anaphylactic shock 4 hours Vaccines against hepatitis B Anaphylaxis or anaphylactic shock 4 hours Vaccines against hemophilus influenzae type b (Hib conjugate vaccine)

No condition specified Not applicable

Vaccines against varicella No condition specified Not applicable Vaccines against rotavirusa No condition specified Not applicable Vaccines against pneumococcal disease (pneumococcal conjugate vaccine)a

No condition specified Not applicable

Vaccines against hepatitis Aa No condition specified Not applicable Vaccines against influenza (trivalent vaccine)a,c No condition specified Not applicable Vaccines against meningococcal diseasea No condition specified Not applicable Vaccines against human papillomavirus (HPV) No condition specified Not applicable

Source: GAO summary of information from the Health Resources and Services Administration. | GAO-15-142

Notes: In addition to the specific vaccines currently listed on the table, the National Vaccine Injury Compensation Program (VICP) also covers new vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children after publication by the Secretary of a notice of coverage, effective on the date of an applicable excise tax. aThis column includes the illness, disability, injury, or condition covered by the program. In addition, covered injuries include any acute complication or sequela (including death) of the listed injuries (for all but the Hib, varicella, rotavirus, pneumococcal conjugate, hepatitis A, trivalent influenza, meningococcal, and HPV vaccines).




bFor first symptom, onset, or aggravation of injury after vaccination. cTrivalent influenza vaccine was added to the table effective July 1, 2005. All additional seasonal influenza vaccines, including quadrivalent vaccine, are covered by VICP, effective November 12, 2013.

Appendix II: Covered Vaccines and Injuries on the Vaccine Injury Table, Fiscal Years 1999-2014


Fiscal year Vaccine 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014a Vaccines and Injuries Added to the Table before Fiscal Year 1999 Tetanus-containing

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Pertussis-containing

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Measles, mumps, rubella in any combination

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Measles-containing

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Rubella-containing

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Polio live virus-containing

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Polio inactivated virus-containing

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Hepatitis B ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Hemophilus influenza type b (Hib) conjugateb

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Varicellab ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Vaccines and Injuries Added and Proposed to be Added to the Table During and After Fiscal Year 1999 Rotavirusc ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ◐c ◐c Pneumococcal conjugate

— ○d ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Hepatitis A — — — — — — ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ Trivalent influenzae

— — — — — — ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Meningococcal — — — — — — — — ○ ○ ○ ○ ○ ○ ○ ○ Human Papillomavirus

— — — — — — — — ○ ○ ○ ○ ○ ○ ○ ○

Vaccines and Injuries Added and Removed from the Table since Fiscal Year 1999 Hib polysaccharide (unconjugated)

● ● ● ● — — — — — — — — — — — —

Rotavirus rhesus-based

— — — ● ● ● ● ● ● ● ● — — — — —

Source: GAO analysis. | GAO-15-142




Legend: ● = at least one injury specified for this vaccine on the table at any point during the fiscal year ◐ = HHS issued a proposed rule to add an injury to the table during the fiscal year ○ = there are no table injuries specified for this vaccine — = the vaccine is not on the table Notes: When no injury is identified or specified for the vaccine, the petitioner must prove that the injury was caused by the vaccine. In addition to the vaccines listed on the table, the National Vaccine Injury Compensation Program (VICP) may also cover any new vaccines that are recommended by the Centers for Disease Control and Prevention’s for routine administration to children and which are subject to an excise tax, but are not yet specifically listed on the vaccine injury table. aThe information in this column is up to date as of September 17, 2014. bHemophilus influenza type b conjugate and varicella vaccines were added to the table effective August 6, 1997. cRotavirus was added to the table effective October 22, 1998. HHS issued a proposed rule on July 24, 2013, to add an injury to the table associated with rotavirus vaccine. However, the rule was not finalized before the end of fiscal year 2014. dPneumococcal conjugate vaccine was added to the table effective December 18, 1999. eTrivalent influenza vaccine was added to the table effective July 1, 2005. All additional seasonal influenza vaccines, including quadrivalent vaccine, are covered by VICP, effective November 12, 2013.

Appendix III: Compensation to Petitioners and Attorneys’ Fees and Costs, Fiscal Years 1999-2013


This appendix shows the total amount paid in compensation to petitioners under the National Vaccine Injury Compensation Program and the number of compensated claims in fiscal years 1999-2013 (see table 2). It also shows the amounts the program paid in attorneys’ fees and costs for those same fiscal years (see table 3).

Table 2: Compensation to Petitioners under the National Vaccine Injury Compensation Program, Fiscal Years 1999-2013

Fiscal year Petitioners’ award amount Number of compensated claims 1999 $95,917,681 96 2000 $125,945,196 136 2001 $105,878,633 97 2002 $59,799,604 80 2003 $82,816,240 65 2004 $61,933,764 57 2005 $55,065,797 64 2006 $48,746,163 68 2007 $91,449,434 82 2008 $75,716,552 141 2009 $74,142,491 131 2010 $179,387,341 173 2011 $216,319,428 251 2012 $163,511,999 250 2013 $254,666,327 375 Total $1,691,296,649 2,066

Source: HRSA Data and Statistics Report, August 1, 2014. | GAO-15-142




Table 3: Payments to Attorneys under the National Vaccine Injury Compensation Program, Fiscal Years 1999-2013

Fiscal year

Compensated attorneys’ fees/cost

payments

Dismissed attorneys’ fees/cost

payments

Interim attorneys’ fees/cost

payments

Number of payments to

attorneys 1999 $2,799,911 $2,306,957 $0.00 213 2000 $4,112,369 $1,724,451 $0.00 216 2001 $3,373,866 $2,066,225 $0.00 154 2002 $2,653,599 $656,245 $0.00 130 2003 $3,147,755 $1,545,655 $0.00 134 2004 $3,079,329 $1,198,616 $0.00 126 2005 $2,694,664 $1,790,587 $0.00 135 2006 $2,441,199 $1,353,633 $0.00 122 2007 $4,034,154 $1,692,020 $0.00 143 2008 $5,191,771 $2,511,313 $117,265 216 2009 $5,404,712 $1,557,140 $4,241,363 195 2010 $5,961,744 $1,886,240 $1,978,804 251 2011 $9,572,043 $5,589,417 $2,001,771 682 2012 $9,104,489 $8,621,182 $5,420,258 1,304 2013 $13,333,180 $6,970,279 $1,454,852 1,128 Total $76,904,784 $41,469,960 $15,214,312 5,149

Source: HRSA Data and Statistics Report, August 1, 2014. | GAO-15-142

Appendix IV: Comments from the Department of Health and Human Services



Appendix V: Comments from the United States Court of Federal Claims



Appendix VI: GAO Contact and Staff Acknowledgments


Marcia Crosse, (202) 512-7114 or [email protected]

In addition to the contact named above, Kim Yamane, Assistant Director; George Bogart; Carolyn Garvey; Cathleen Hamann; Katherine Perry; Fatima Sharif; and Eric Wedum made key contributions to this report.

Appendix VI: GAO Contact and Staff Acknowledgments

GAO Contact

Staff Acknowledgments

(100007)

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Contains Nonbinding Recommendations

Use of the Term “Healthy” in the Labeling of Human Food Products:

Guidance for Industry

Additional copies are available from: Office of Nutrition and Food Labeling

Nutrition Program Staff, HFS-830 Center for Food Safety and Applied Nutrition

Food and Drug Administration 5001 Campus Drive

College Park, MD 20740 (Tel) 240-402 -1450

http://www.fda.gov/FoodGuidances

U.S. Department of Health and Human Services Food and Drug Administration

Center for Food Safety and Applied Nutrition

September 2016

http://www.fda.gov/FoodGuidances


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Table of Contents

I. Introduction II. Background III. Discussion

A. Low Fat B. Beneficial Nutrients

IV. References


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Use of the Term “Healthy” in the Labeling of Human Food Products:

Guidance for Industry1

This guidance represents the current thinking of the Food and Drug Administration's (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

I. Introduction

The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations. More specifically, this guidance is intended to advise food manufacturers of our intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

This guidance is immediately effective because the agency has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

II. Background

Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(r)(1)(A)), a food2 is misbranded if it bears claims, either express or implied, that characterize the level of a nutrient which is of a type required to be declared in nutrition

1 This guidance has been prepared by the Office of Nutrition and Food Labeling, Nutrition Program Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 2 Section 201(f) of the FD&C Act (21 U.S.C. 321(f)) defines the term “food” to mean articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.


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labeling3 unless the claim is made in accordance with a regulatory definition established by FDA (see section 403(r)(2) of the FD&C Act, 21 U.S.C. 343(r)(2)). 21 CFR 101.65(d) provides such regulatory definition for use of the term “healthy” or related terms (such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) as an implied nutrient content claim on the label or in labeling of a food. The “healthy” nutrient content claim can be used if the food meets certain nutrient conditions; and, when used with an explicit or implicit claim or statement about a nutrient (e.g. “healthy, contains 3 grams of fat”), suggests that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations. The nutrient conditions for bearing a “healthy” nutrient content claim include specific criteria for nutrients to limit in the diet, such as total fat, saturated fat, cholesterol, sodium, as well as requirements for nutrients to encourage in the diet, including vitamin A, vitamin C, calcium, iron, protein, and fiber. The criteria are linked to elements in the Nutrition Facts label and serving size regulations (see 21 CFR §§ 101.9 and 101.12). The nutrient criteria to use the claim can vary for different food categories (e.g., fruits and vegetables, or seafood and game meat) (see 21 CFR 101.65(d)(2)).

In addition, it is also important to note that under section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)), a food is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) provides that labeling is misleading if, among other things, it fails to reveal facts that are material in light of representations made or suggested in the labeling, or material with respect to consequences that may result from the use of the food to which the labeling relates under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual.

III. Discussion In the Federal Register of May 27, 2016, we issued final rules updating the Nutrition Facts label and serving size information for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease (see 81 FR 33742, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels”; 81 FR 34000, “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments”). Updates to the Nutrition Facts label include changes in the individual nutrients that must be declared and also changes to the Daily Value (DV) of other individual nutrients, reflecting changes in recommended intake levels, based on current science. The individual nutrients included in Nutrition Facts and their DVs significantly influence the regulations on nutrient content and health claims. Because the framework for many of FDA’s other nutrition labeling regulations is linked to elements in the Nutrition Facts label and serving size regulations, we plan to update those other regulations, such as those for health claims and nutrient content claims (including the implied nutrient content claim “healthy”), to align with these most recent updates.

3 Section 201(m) of the FD&C Act (21 U.S.C. 321(m)) defines “labeling” as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers or accompanying such article.


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The science underlying the final rules, referenced above, is also reflected in the 2015-2020 Dietary Guidelines for Americans (2015-2020 Dietary Guidelines) (Ref. 1). The Dietary Guidelines is designed for professionals to help all individuals ages 2 years and older and their families consume a healthy, nutritionally adequate diet. The Dietary Guidelines is the foundation of federal nutrition guidance and is fundamental in shaping federal policies and programs related to food, nutrition, and health. The Dietary Guidelines provides information and perspectives on healthy eating patterns and consumption of foods from various food groups, as well as the intake of specific macronutrients such as fats, sugars, and micronutrients such as vitamins and minerals. Specific recommendations in the Dietary Guidelines have evolved over time, as nutrition science has advanced. For example, scientific understanding and nutrition guidance has shifted from recommending diets low in total fat (2005 Dietary Guidelines) (Ref. 2) to no longer recommending limiting overall fat intake, and instead prioritizing increasing intakes of polyunsaturated and monounsaturated fats and decreasing intakes of saturated fat and trans fat (2015-2020 Dietary Guidelines). The 2015-2020 Dietary Guidelines, also emphasizes the importance of dietary patterns as a whole, the combination of foods and drinks that people consume over time. The body of scientific evidence and the recommendations based on that science in the Dietary Guidelines will help FDA shape additional updates to regulations on nutrition related claims and information that are permitted on the food label. We are re-evaluating the regulatory criteria for use of the implied nutrient content claim “healthy” in light of the latest nutrition science and the current dietary recommendations and seek input on possible future rulemaking to update the existing regulations for this claim. Because the rulemaking process can sometimes be lengthy, we intend to exercise enforcement discretion in the interim with respect to some of the existing criteria for the nutrient content claim “healthy” if the alternative nutrient criteria described below are met. We intend to exercise enforcement discretion until we amend 21 CFR 101.65(d)(2). A. Low Fat As stated above, since we published the final rule defining “healthy” (58 FR 2302, January 6, 1993), the science related to public health recommendations for intake of dietary fats has evolved. The focus of the most recent dietary fat recommendations has shifted away from limiting total fat intake to encouraging intakes of mono and polyunsaturated fats. Foods that use the term “healthy” on their labels that are not low in total fat should have a fat profile makeup of predominantly mono and polyunsaturated fats (i.e., sum of monounsaturated fats and polyunsaturated fats are greater than the total saturated fat content of food). Consistent with consensus science and public health recommendations for dietary fats which no longer recommend low total fat intake, we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim “healthy” meet the low fat requirement (§101.65(d)(2)(i)), provided that: (1) The amounts of mono and polyunsaturated fats are declared on the label and (2) the amounts declared constitute the majority of the fat content. These conditions are necessary so that consumers are made aware that the total fat is mostly made up of fats that are encouraged by current dietary recommendations.


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B. Beneficial Nutrients The definition for “healthy” also includes a nutrient contribution criterion. Healthy dietary patterns not only restrict nutrients that increase risk of chronic disease, but also help assure nutrient adequacy to ensure sufficient intake of nutrients that are important in sustaining body function and reducing the risk of disease. The current definition of “healthy” has focused on foods providing a good or excellent source of nutrients for which there had been public health concern. Historically, these nutrients have been vitamin A, vitamin C, iron, calcium, and dietary fiber. Nutrient intakes have shifted over time, however, and vitamins A and C are no longer nutrients of public health concern. The nutrients of public health concern now include potassium and vitamin D, in addition to iron and calcium (2015-2020 Dietary Guidelines). This change in nutrients of public health concern has been reflected in the mandatory nutrients to be labeled in the Nutrition Facts Label (see 81 FR 33742, May 27, 2016). In recognition of this change, we intend to exercise enforcement discretion with respect to the current requirement that any food bearing the nutrient content claim “healthy” contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the food instead contains at least ten percent of the DV per RACC of potassium or vitamin D. The regulations updating the Nutrition Facts label have provided for new DVs for potassium and vitamin D and manufacturers have been given some time to come into compliance with these regulations. If a manufacturer has not yet implemented the updated Nutrition Facts label, they may use the old DVs for potassium and vitamin D. If a manufacturer has already implemented the updated Nutrition Facts label, they must use the new, updated DVs for potassium and vitamin D. In either case, if a food is basing its eligibility for bearing a “healthy” claim on potassium or vitamin D, whichever nutrient is being used as the basis for eligibility should be declared in the Nutrition Facts label.

IV. References

We have placed the following references on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may see them at that location between 9 a.m. and 4 p.m., Monday through Friday. As of June 1, 2016, FDA had verified the Web site address for the references we make available as hyperlinks from the Internet copy of this guidance, but we are not responsible for any subsequent changes to Non-FDA Web site references after June 1, 2016. 1. U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015 –

2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at http://health.gov/dietaryguidelines/2015/guidelines/.

2. U.S. Department of Health and Human Services and U.S. Department of Agriculture. Dietary Guidelines for Americans, 2005. 6th Edition, Washington, DC: U.S. Government Printing Office, January 2005. Available at http://health.gov/dietaryguidelines/dga2005/.

http://health.gov/dietaryguidelines/2015/guidelines/

http://health.gov/dietaryguidelines/dga2005/