e-cigarette regulation: key priorities and alternative ... webinar - fda... · focus on electronic...

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Washington, DC ● Brussels ● San Francisco ● Shanghai ● Paris

E-Cigarette Regulation: Key Priorities andAlternative Frameworks for FDA

May 15, 2015

Azim ChowdhuryKeller and Heckman LLP

1001 G Street NWSuite 500W

Washington, DC 2001+1 202.434.4230

[email protected]

│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 20152

Preliminary Word

This presentation provides information about thelaw. Legal information is not the same as legaladvice, which involves the application of law to anindividual's specific circumstances and dependson many factors. This presentation is not intendedto provide, and should not be relied upon as, legaladvice. The information provided in thispresentation is drawn entirely from non-confidential sources. The views expressed in thispresentation are the authors’ alone and notnecessarily those of the authors’ clients.


Presenter

Azim Chowdhury practices in the areaof food, drug and tobacco law, with afocus on electronic cigaretteproducts. Mr. Chowdhury advisescorporations in matters of FDA andinternational regulatory compliance.

Mr. Chowdhury edited and co-authoredthe FDLI’s Tobacco Regulation andCompliance: An Essential Resource(Dec. 2011) as well as FDLI’s PrimerFDA Regulation of Tobacco: AComprehensive Guide (Oct. 2013)


Agenda

Overview of Keller and Heckman What are e-cigarettes? Tobacco Control Act Background The Deeming Regulation

• One-Size-Fits-All Approach

Legal Basis for Alternative RegulatoryFrameworks• FDA’s Enforcement Discretion• Congressional Intent/Legislative History

Key Concepts for Alternative RegulatoryFrameworks


Our Firm

Keller and Heckman LLP was established in1962 in Washington, DC.

A major part of the firm’s practice is food anddrug law – the regulation of products used in orconjunction with food, drugs, medical devices,cosmetics and now, tobacco and e-vapor.

In addition to 80+ attorneys firm-wide, there aremore than 25 staff scientists, most with Ph.D.'s,from the disciplines of chemistry, biology, andtoxicology.


Represent e-cigarette, e-liquid and tobaccocompanies in matters of FDA and globalregulatory compliance.

K&H represents companies in matters beforethe FDA Center for Tobacco Products, andassists clients in complying with TobaccoControl Act requirements, EU TobaccoProducts Directive, and regulations around theworld.

Visit www.khlaw.com/tobacco

K&H E-Cigarette and Tobacco Practice


Five Offices Worldwide

Washington DC office founded in 1962

Brussels office opened in 1992

San Francisco office opened in 2001

Shanghai office opened in 2004

Paris office opened in 2015

Serve clients in 26 countries

A Global Law Firm with a Scientific Advantage

Indianapolis

Washington DC

ShanghaiSan Francisco

Brussels

Paris


Virtually all of our practice in China (and Asiagenerally) is regulatory in nature

K&H has prepared many applications for productapproval before the following Chinese agencies:• China Food and Drug Administration (CFDA)

• National Health and Family Planning Commission (NHFPC)

• Ministry of Environmental Protection (MEP), and

• Ministry of Agriculture (MOA)

Forming “Working Group” of Chinese E-CigaretteIndustry Stakeholders

K&H Shanghai Office


Chinese E-Cigarette Working Group

We are developing a coalition of e-cigarette and e-liquidChinese manufacturers and other stakeholders to work withand educate the government in Beijing on e-cigarettes tocreate appropriate product standards and regulations.

We have much experience through our office in Shanghai andhave worked with the Chinese authorities in the NationalHealth and Family Planning Commission to developstandards for other industries.

For more information visit:http://www.khlaw.com/Chinese-Ecig-Working-Group

Conference Call on May 20, 2015 at 10 AM (China Time)


What is an E-Cigarette?

“Cig-a-like” – designed to mimic the lookand feel of a conventional cigarette



Cig-a-likes (often disposable) are what come tomind for most people when they think of e-cigarettes:


“Refillable” (Open-System) Products – providebetter nicotine delivery but are not intended tolook or feel like conventional cigarettes:



E-Cigarette Market Growth

2006: E-cigarettesintroduced into Europe

2007-08: E-cigarettesintroduced into US

Today: E-cigarettesales in US almost $4billion with ~500brands (the total UStobacco market wasworth approximately$90 billion in 2013)


The Growing E-Cig Market in the U.S.

Rapid growth over the last 6 years - someanalysts are predicting e-cigarette sales willsurpass conventional cigarettes in 10 years.

Future growth will be impacted by both Federaland State regulation.

In the absence of FDA regulation, statelegislatures and local/city councils haveincreasingly been restricting the use, sale,manufacture and taxation of e-cigarettes in theirjurisdictions.


Proliferation of Vape Shops


U.S. Food and Drug Administration Overview

FDA is a federal agency within theU.S. Department of Health andHuman Services and consists ofnine Centers and Offices.

FDA is responsible for ensuringthe safety and efficacy of:• Human and animal drugs• Biological products (biologics)• Medical devices• Food (including dietary

supplements)• Cosmetics• Tobacco – through the new CTP


Background: Tobacco Control Act

In 2009, the Family Smoking Preventionand Tobacco Control Act amended theFood, Drug and Cosmetic Act (FDCA)to give FDA authority to regulate themanufacture, distribution, andmarketing of tobacco products toprotect the public health.

But what is a “tobacco product”?Defined in the Act as anything made orderived from tobacco intended forhuman consumption, including anycomponent, part or accessory of atobacco product. But…


Background: Tobacco Control Act

The Tobacco Control Act onlygave FDA immediate authority toregulate certain types of tobaccoproducts:• Cigarettes• Cigarette tobacco• Smokeless tobacco• Roll-your-own tobacco

Not included: other tobaccoproducts, such as cigars, pipetobacco, hookah and e-cigarettesthat contain nicotine derived fromtobacco.


The Deeming Regulation

FDA may use its rulemakingauthority to “deem” any othertobacco products to be regulatedproducts subject to FDA’sauthority under the TobaccoControl Act.

On April 25, 2014, the Notice ofProposed Rulemaking for theDeeming Regulation was finallypublished.

The 105-day public commentperiod ended on August 8, 2014.Over 135,000 comments weresubmitted.


Notice and Comment Rulemaking

Once FDA has reviewed all the commentsit will prepare a final rule which will besubmitted to the White House Office ofManagement and Budget (OMB) forcost/benefit analysis. The final rule mustinclude analysis of the comments. If OMB approves (usually 3-6 months),

the final rule will become effective and willbe published in the Federal Register andeventually in the Code of FederalRegulations (21 CFR).

This entire “Notice and CommentRulemaking” process will likely take atleast 1-2 years; FDA has stated itexpects to take “final action” on the rule inJune 2015 (but later this year is morelikely).


Deeming Regulation: One-Size-Fits-All?

If the proposed rule becomeseffective as drafted, the newlycovered products and theircomponent and parts, will besubject to virtually the samerequirements that currentlyonly apply to regulatedtobacco products: a one-size-fits-all approach.

Premium cigars may beexempted (Option 2).

Same Grandfather Date


Deeming Regulation: Proposed Requirements

Under both options, “componentsand parts” would be subject toregulation, but not accessories.Components and parts of deemedtobacco products “are included aspart of a finished tobacco product orintended for consumer use in theconsumption of a tobacco product.”

The term also includes those itemssold separately or as part of kitssold or distributed for consumer useor further manufacturing or includedas part of a finished tobaccoproduct.



“WARNING: This productcontains nicotine derivedfrom tobacco. Nicotine isan addictive chemical.”

Ban on Youth Sales Ban on Vending Machine

Sales Ban on Free Samples Ban on Unauthorized

Modified Risk Claims



Deemed products would be subject to theGeneral Control requirements in the TobaccoControl Act:

• Adulteration and Misbranding provisions

• Facility Registration under Section 905(b)

• Product and Ingredient Listing underSection 904

• Harmful and Potentially HarmfulConstituents Reporting under Section904(a)(3)

• Good Manufacturing Practices underSection 906

• Premarket Authorization under Sections905 and 910


Legal Standards for Premarket Review

New Drug Application: Safe and effective forintended therapeutic use

Premarket Tobacco Product Application:Appropriate for the protection of the publichealth

Substantial Equivalence Report: Eitheridentical characteristics to grandfatheredpredicate product or show differentcharacteristics do not raise new questions ofpublic health

So, what is the “public health”?

• Population level impact

• Must consider both users and non-users(especially adolescents)

• Impact on initiation and cessation rates

• Who uses the product and how?


Will the Grandfather Date Apply to E-Cigs?

The Proposed DeemingRegulation imposes the existingFebruary 15, 2007 GrandfatherDate to newly deemed products

FDA stated it does not believe ithas the legal authority tochange the date.

Many comments submittedsuggested new GrandfatherDates for the deemed products.


Compliance Policy for Deemed Products

Recognizing the difficulty thatimposing the statutoryGrandfather Date will have onmanufacturers of deemedproducts that were not on themarket in early 2007, FDA hasproposed a “compliance policy”that would delay enforcementof the premarket authorizationrequirements.


Compliance Policy for Deemed Products

Any deemed product marketed after02/15/07 through two years after theeffective date of the DeemingRegulation can remain on the marketprovided that a PMTA for suchproduct is submitted by the two yearanniversary of the effective date.

Can remain on market unless FDAeventually rejects the premarketsubmission.

FDA stated it would consider revisingthis policy should it find that doing so iswarranted, such as to better protectthe public health.

Comments submitted suggestedstaggered compliance dates for smallbusinesses.


What’s not included in the ProposedDeeming Regulation?

Use of flavors in deemedtobacco products

Restrictions on Internetsales

Marketing andadvertising of e-cigarettes, particularlytoward youth


Alternative Frameworks for Regulation

Given the wide variety ofavailable tobacco productswith different public healthconcerns, does such a one-size-fits-all regulatoryapproach make sense?

Many comments submitted toFDA arguing that the Agencyshould tailor regulatoryrequirements based onproduct types.


Key Concepts for Alternative Frameworks

New “Grandfather Date”

Continuum of Risk

Evidence that e-cigs are“appropriate for theprotection of the publichealth”

Use of Product Standards

But is there legal authority for FDA to take analternative approach with e-cigs?


FDA’s Enforcement Discretion

FDA’s ability to choose the best way to enforcestatutory requirements.• FDCA § 701(a) gives FDA the authority to promulgate

substantive rules that will provide for the “efficientenforcement” of the Act.

• Section 3(4) of the Tobacco Control Act states that thepurpose of the law is to “provide new and flexible enforcementauthority to ensure that there is effective oversight of thetobacco industry’s efforts to develop, introduce, and promoteless harmful tobacco products.”

Agency decisions regarding whether or not to takeenforcement action and the criteria for makingsuch decisions has been supported by the courts.See e.g., Heckler v. Chaney, 470 U.S. 821 (1985)and Cmty. Nutrition Inst. v. Young, 818 F.2d 943(D.C. Cir. 1986).



There are numerous examples ofFDA using its rulemakingauthority to implementappropriate regulatory solutionsother than those anticipated byexplicit language in the Food,Drug and Cosmetic Act.



FDA has made ample use of its enforcementdiscretion with currently regulated tobacco products:

• No premarket authorization required for componentsmanufacturers, but only manufacturers of the finished tobaccoproduct

• Blending changes required to address natural variation oftobacco to maintain consistent product

• Changes made to tobacco product labels or product quantitychanges may submit streamlined Substantial EquivalenceReports

And even in the Proposed Deeming Regulation:

• 24-month Compliance Policy for premarket applications inProposed Deeming Regulation

• “Option 2” exempting “premium cigars” from deeming


FDA’s Enforcement Discretion – Why?

Regarding e-vapor products,the underlyingbasis for FDAto use itsenforcementdiscretion:CongressionalIntent


Congressional Intent

Neither the Tobacco Control Act’s plain language nor itslegislative history strictly require FDA to apply all of theAct’s requirements to all deemed products. Congressgave FDA ability to choose which tobacco products toregulate, which implies that it also intended FDA todetermine how best to regulate them. See Section906(e) re GMPs.

Plain language of the Act makes clear that therequirements intended to apply to tobacco leaf-containing products; there is no mention of e-cigarettesin the statute.

Strictly applying the Act’s requirements to e-vaporproducts would result in a tantamount ban, whichCongress did not intend, as its primary purpose is toreduce tobacco related disease and death.


Key Concepts for Alternative Frameworks

New “Grandfather Date”

Continuum of Risk

Evidence that e-cigs are“appropriate for theprotection of the publichealth”

Use of Product Standards


New Grandfather Date for E-Cigs?

FDA stated in the Proposed Deeming Regulation itdoes not believe it has the legal authority tochange the February 15, 2007 Grandfather Datefor the deemed products.

This was the date that the bill that eventuallybecame the Tobacco Control Act was firstintroduced in Congress, officially putting thetobacco industry on notice that it was going to beregulated by FDA.

Because e-cigs were being marketed and sold inthe U.S. when Congress debated and passed theAct in 2009, some have argued that Congressmust have intended the Grandfather Date to applyto these products as well.



At that time, however, it was not clear that e-cigswould even be considered tobacco products.

In 2008, FDA attempted to ban certain e-cigs frombeing imported from China, claiming they wereunapproved “drug delivery devices.” After theirshipments were seized on import, the e-cigcompanies filed a lawsuit, arguing that they were notdrug delivery devices, but tobacco products underthe new Tobacco Control Act.

This lead to the Sottera decision, where the D.C.Circuit agreed with the e-cig companies and held thatif the nicotine is derived from tobacco and theproducts are “customarily marketed” (i.e., forrecreational use) they are tobacco products and notdrugs. See Sottera Inc. v. FDA, 627 F.3d 891 (D.C.Cir. 2010).



It was not until April 25,2011 that FDAannounced in a letter toe-cig stakeholders on itswebsite that it would notappeal Sottera, andconceded that e-cigs thatcontain tobacco-derivednicotine are “tobaccoproducts” and would becaptured by the DeemingRegulation.

See:http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm



In other words, April 25, 2011 is the datethat the e-cigarette industry was put onfirst notice that it would be subject to theTobacco Control Act, not February 15,2007. Could FDA consider this a potentialGrandfather Date for e-cigs?

Other potential dates include the date theProposed Deeming Regulation waspublished (April 25, 2014) and theeffective date of the Regulation (TBD).


Regulation based on Continuum of Risk

The more harmful theproduct, the higher theregulatory burdenshould be

Nicotine-only productsvs. tobacco leaf-containing products

Combusted vs. non-combusted vs.vaporized

Source: RAI Services Company


Regulation based on Continuum of Risk

According to Mitch Zeller,Director of the Center forTobacco Products, thecenter is “exploringoptions” for “an expeditedpremarket review policybased on principle ofrelative toxicity and risk.”(Mitch Zeller, April 2015)

Image source: FDA


Evidence that e-cigs are “appropriate for theprotection of the public health”

For the individual consumers, no doubt that e-cigarettes are less harmful than smoking.

Burden of proof is on each manufacturer toestablish that each of its products meet the PMTAstandard.

Could FDA find that, generally, e-cigs areappropriate for the protection of the public healthbecause their availability provides a significantlyless harmful alternative to cigarettes for smokers?

CTP (Zeller): FDA’s primary concern with e-cigs iswho is using the products and how.


Evidence that e-cigs are “appropriate for theprotection of the public health”

Regarding the population-level “public health”impact, FDA should rely on the growing evidencethat e-cigs, particularly advanced “open systems,”are providing a public health benefit.• Benefits of flavored e-liquids?• Likelihood of “dual use”?• To date, no clear evidence that e-cigs are a gateway to

tobacco use for non-smokers.

Because of the potential for e-cigs to be used as avaluable tool for harm reduction, FDA shouldconsider only requiring e-cig and e-liquidcompanies prove that their products meetestablished safety and product standards in orderto demonstrate that they are “appropriate for theprotection of the public health.”


Product Standards

Section 907 of the Tobacco Control Act gives FDA authority todevelop tobacco product standards where appropriate for theprotection of public health.

E-Liquids• Positive/Negative Ingredient List?• Ingredients that pose potential for inhalation risk may be prohibited

as added ingredients (e.g., diacetyl and acetyl propionyl).• Good Manufacturing Practices – see AEMSA standards:

http://www.aemsa.org/standards/.• Child-resistant packaging (e-liquid bottles).

Devices• Temperature Monitoring and Limiting – we know that harmful

substances (formaldehyde) form when the heater coil getsexcessively hot (resulting in “dry puff”). Technology is on themarket today to monitor/control temperature.

• Safety features such as auto-shut off capabilities, short-circuitprotections, battery/charger standards, consistent aerosol delivery,etc.


Product Standards

FDA should work with industry andexisting standards-setting bodies todevelop science-based product standardsand specifications for e-cigs, componentparts and e-liquids.

Other industries have benefitted from thisapproach.


Product Standards

Electronic cigarette technology is rapidlyevolving, and it is important for FDA towork with the industry to establishappropriate manufacturing practices andproduct standards to ensure consumersafety without stifling innovation.

Any such product standard will need to gothrough FDA’s notice and commentrulemaking procedures before becomingeffective.


Quick Tips: What can you do now?

Do not make drug/health/therapeutic/smokingcessation/modified risk/”FDA approved” claims!

Ensure appropriate warnings on your labels,website and marketing materials (include Statewarnings like CA’s Proposition 65)

Use child-resistant packaging and closures on e-liquid bottles

Know what ingredients are being used in your e-liquids, including in the formulated flavors


Quick Tips: What can you do now?

Have the e-liquid as well as the aerosol producedwhen heated in a device tested by reputablelaboratory;

Prepare for eventual Good Manufacturing Practices(e.g., quality control and clean room standards)

Restrict access to website to adults only (over 18)and use reputable age-verificationsoftware/programs to prevent only purchases byminors;

Be proactive on state and federal level – continue tofile comments with FDA!

www.khlaw.com

Washington, DC ● Brussels ● San Francisco ● Shanghai ● Paris

Any Questions?Thank You!

Azim ChowdhuryKeller and Heckman LLP

1001 G Street NWSuite 500W

Washington, DC 2001+1 202.434.4230

[email protected] @ECIGattorney

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