positioning nutritional food products sarah e. taylor, esq. covington & burling washington, d.c

Positioning Nutritional Food Products

Sarah E. Taylor, Esq.Covington & Burling

Washington, D.C.

2 1998 Covington & Burling

Positioning Objectives: Avoid “drug” regulation

Optimize health and nutritional claims

Optimize nutritional formulation


Position Product to Avoid “Drug” Regulation “Drug” is any article “intended for use

in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

What is the manufacturer's “intended use “ for the product considering any “relevant source” of information (labeling, advertising, promotions, other)?

Does manufacturer state/imply product is intended for use in the diagnosis, cure, migration, treatment, or prevention of disease?

Premarket approval of new drug application required.

“Drug”YES

Flow Chart



“Drug” Definition: “Intended Use” Vendor's intent

Determined from any relevant source labeling advertising promotions “circumstances” surrounding product

distribution


“any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination

thereof) of the body that is manifested by a characteristic set

of one or more signs or symptoms, including laboratory

or clinical measurements that are characteristic of a disease.”

“any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination

thereof) of the body that is manifested by a characteristic set

of one or more signs or symptoms, including laboratory

or clinical measurements that are characteristic of a disease.”

Drug Definition: “Disease” May include —


Categories of Prohibited “Disease Claims” Claims suggesting “the product has an

effect on a specific disease or class of disease”

Examples: “Protective against the development of

cancer” “Reduces the pain and stiffness associated

with arthritis” “Decreases the effects of alcohol

intoxication” “Alleviates constipation”

Claims suggesting that “the product has an effect, using scientific or lay terminology, on . . . signs or symptoms that are recognizable to health care professionals or consumers as being characteristic of specific disease(s).”

Examples: “Improves urine flow in men over 50 years

old” — (characteristic symptom of, e.g., benign prostatic hypertrophy).

“Lowers cholesterol” — (characteristic sign of, e.g., hypercholesterolemia).

“Reduces joint pain” — (characteristic symptom of arthritis).

“Relieves headaches” — (characteristic symptom of, e.g., migraine or tension headache).


Claims suggesting that a product has an effect on disease through “a statement about the formulation of the product, including a claim that the product contains an ingredient that has been regulated by FDA as a drug and is well known to consumers for its use in preventing or treating disease.”

Examples “Aspirin” “Digoxin” “Laetrile”


Claims suggesting that a product “belongs to a class of products that is intended to diagnose, mitigate, treat, cure, or prevent a disease.”

Examples “antibiotic” “laxative” “analgesic” “antiviral” “vaccine”

“diuretic” “antimicrobial” “antiseptic” “antidepressant”

“revitalizer” “adaptogen”

Permissible S/F Claims “energizer” “rejuvenative”


Claims suggesting that a product has an effect on disease through the “use of picture, vignettes, symbols, or other means.”

Examples Electrocardiogram tracings Pictures of organs that suggest prevention

or treatment of a disease state The prescription symbol (RX) Any reference to prescription use of the

product

Permissible S/F Claims A picture of the human body


Claims suggesting that a product “has an effect on a consequence of a natural state that presents a characteristic set of signs or symptoms recognizable to health care professionals or consumers as constituting an abnormality of the body.”

Examples: “Treats toxemia in pregnancy.” “For decreased sexual function.” “For hot flashes.” “Alzheimer’s disease.”

Permitted S/F Claims: “For men over 50 years old.” “To meet nutritional needs during

pregnancy.”12 1998 Covington & Burling

Prohibits claims suggesting that a product has an effect on disease “through the name of the product.”

Examples: “Carpaltum” (Carpal Tunnel Syndrome). “Raynaudin” (Raynaud’s Phenomenon). “Hepatacure” (Liver Problems).

Permitted S/F Claims: “Cardiohealth” “Heart Tabs”



Position Product to Optimize Health and Nutritional Claims Position product in optimal “nutritional

food” category.

Options: Conventional Food Food for Special Dietary Use Dietary Supplement Medical Food


Conventional “Food:” Definition Used for “Food” or “Drink” and

Components

“Chewing Gum” and Components

“Food” — Consumed for “Taste, Aroma, Nutritive Value.”


Food for Special Dietary Use: Definition Meets Conventional “Food” Definition

Intended to meet special nutritional needs associated with age, physiological conditions, or disease.


Food for Special Dietary Use: Definition Distinction from Medical Food:

Useful in supplying special dietary needs for patient prevented from eating normally, BUT

“NOT specifically tailored for use as the nutritional component of the patient’s treatment.”


Food For Special Dietary Use: Definition Distinction from Medical Food (cont.):

No required “medical supervision” FDA has attempted to narrow “medical

food” category, redefining as foods for special dietary use.


“Vitamin C Supplement”“Vitamin C

Supplement”

“Energy Bar Dietary Supplement”

“Energy Bar Dietary Supplement”

Dietary Supplement: Definition Labeled as “Dietary Supplement”


Dietary Supplement: Definition Intended to supplement the diet and

contains a: vitamin/mineral herb/botanical amino acid dietary substance for use by man to

supplement the diet by increasing the total dietary intake, or

concentrate, metabolite, constituent, extract, or combination of the above


Dietary Supplement: Definition Intended for ingestion in tablet,

capsule powder, softgel, or liquid form, OR

Intended for ingestion in another form AND is not represented as a conventional food or the sole item of a meal or the diet


Dietary Supplement: Definition may not include a food which is

“represented for use” as a conventional food,

it may include a food that “simulates” a conventional food.


“. . . there may be dietary supplements for which the

presence of the term ‘dietary supplement’ constitutes the

primary, if not the only, means by which consumers will be able to determine that the food is a

dietary supplement.”

“. . . there may be dietary supplements for which the

presence of the term ‘dietary supplement’ constitutes the

primary, if not the only, means by which consumers will be able to determine that the food is a

dietary supplement.”

Dietary Supplement: Definition -- “Simulate"FDA Statement:

Does manufacturer state/imply product is intended for use in the diagnosis, cure, migration, treatment, or prevention of disease?

Is the product intended to supplement the diet with a dietary ingredient (e.g. herb, botanical, amino acid, or metabolite)?

Represented as conventional food or as sole item of meal or diet?

Dietary Supplement

NO

NOYES

Flow Chart



Conventional Food: Claims Approved Nutrient Content Claims

Amount/Percentage Claims

Approved Health Claims

Traditional Structure or Function Claims

Dietary Guidance Claims


“Calcium helps build and maintain strong bones.”


Dietary Supplement Claims Approved Nutrient Content & Health

Claims

Amount/Percentage Claims (“40 percent allicin, 10 mg per capsule”)

Dietary Guidance

Traditional Structure or Function Claims (i.e., for DV nutrients only)


“Statements of Nutritional Support” for non-DV dietary ingredients (e.g., herbs): Disclaimer

30 Day Postmarket Notice

“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Dietary Supplement Claims


Third Party Literature -- Dietary Supplements “Publication”

article book chapter official abstract/peer reviewed/appears in article

Reprinted in its Entirety

Not False/Misleading

Promotes No Specific Supplement Manufacturer or Brand

Displayed/Presented With “Other Such Items on Same Subject Matter” to present “balanced view” on supplement

If displayed in an Establishment is Physically Separate from the Dietary Supplements

Has no Information Appended/Attached to it.


“A claim that expressly or implicitly characterizes the

level of a nutrient of the type required to be in nutrition

labeling” for a food or dietary supplement.

“A claim that expressly or implicitly characterizes the

level of a nutrient of the type required to be in nutrition

labeling” for a food or dietary supplement.

Scope of “Nutrient Content Claims” Definition:


A nutrient content claim may not be made expressly or

impliedly on the label or in labeling unless specifically

authorized by FDA regulation (or in limited circumstances by

premarket notification).

A nutrient content claim may not be made expressly or

impliedly on the label or in labeling unless specifically

authorized by FDA regulation (or in limited circumstances by

premarket notification).

Nutrient Content Claims Must Be Specifically Authorized


Implied health claims may include: third-party references brand names symbols vignettes.

“Any claim made . . . in the labeling of food that expressly or impliedly

characterizes the relationship of any “substance” to a “disease” or a

health-related condition.

“Any claim made . . . in the labeling of food that expressly or impliedly

characterizes the relationship of any “substance” to a “disease” or a

health-related condition.

Scope of “Health Claims” Definition:


“Health Claims” Must be Specifically Authorized A health claim may not be made in

labeling unless: specifically defined by FDA regulation, or authorized under the premarket notification

procedure.

An unapproved health claim = unlawful “drug” claim.


FDA Modernization Act (FDAMA) Claims FDAMA Authorizes Health and Nutrient

Content Claims Based on the Authoritative Statement of a Federal Scientific Body Under a Premarket Notification Procedure.

Premarket Notification Must Be Filed 120 Days Before Claim Introduced to the Market.

FDA Guidance and Interim Final Rules Issued June 1998.


FDAMA Health Claims FDAMA provides that a health claim “shall be

authorized” if“a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has

published an authoritative statement which is currently in effect,

[which is] about the relationship between a nutrient and a disease or health-related condition to which the [health] claim refers.”


FDAMA Health Claims Premarket Notification

File 120 Days Before First Introduction of Labeled Food.

Exact Words of Claims. Concise Description of Basis of Claim. Copy of Authoritative Statement. Balanced Representation of Scientific

Literature.


“The USDA Food Guide Pyramid recommends at least 5 servings of

fruits and vegetables daily to reduce the risk of certain chronic

diseases.”

“The USDA Food Guide Pyramid recommends at least 5 servings of

fruits and vegetables daily to reduce the risk of certain chronic

diseases.”

Dietary Guidance Claims

Key: No reference is made to any specific disease/condition.




“Structure Function” Claims Conventional “foods” and DV-nutrients:

Claims indicating that the food affects the structure or any function of the body.

E.g., Role of food or nutrient in sustaining normal growth and metabolism.


“Gingko biloba supports cerebral circulation and alertness.”

“Gingko biloba supports cerebral circulation and alertness.”

“Statements of Nutritional Support” (S/F Claims) Non-DV Dietary Ingredients

Describes role in affecting the structure or function,

Characterizes the mechanism of action, or Describes benefit to general well-being.


Permitted S/F ClaimsExamples:

“Helps promote urinary tract health”

“Helps maintain cardiovascular function and a healthy circulatory system”

“Helps maintain intestinal flora”

“Promotes relaxation”


Permitted S/F ClaimsExamples:

“Reduces stress and frustration.”

“Inhibits platelet aggregation.”

“Improves absentmindedness.”

“Helps maintain a healthy cholesterol level.”

“Helps maintain regularity.”


Position Product to Optimize Nutritional Formulation Considerations:

Dietary Supplements More Flexible Safety Standards for Dietary

Ingredients May Fortify to Support Claims

Conventional Foods Food Additive/GRAS Regulation Standards for Identity Fortification Policy Cannot Fortify to Meet Criteria for Certain

Claims


Formulation: Conventional “Foods”Fortification Policy:

“Guideline” to Promote “Rational Addition of Nutrients to Food”

Mandatory for “More,” “Healthy,” “High Potency”



No fortification of fresh produce, meat, poultry, fish, sugars, snack foods

May correct a “scientifically recognized” dietary insufficiency

May fortify with prescribed nutrient package to “balance”nutrient composition of food



May use nutrients for nonnutritional purpose

Must conform with food additive regulations (e.g., folic acid)

Must conform with nutritional criteria for claims

Examine Precedents case-by-case


Formulation: Dietary Supplements Fortification Policy NA.

Dietary Ingredients Exempt from Food Additive/GRAS Requirements More Flexible Safety Standards Apply.

Ordinary Food Additive/GRAS Requirements Apply to Excipients, Binders, etc.

FDA has Burden of Proof to Establish Dietary Supplement is Unsafe.


Presents Significant/Unreasonable Risk

of Illness/Injury Under Ordinary Conditions of Use

Presents Significant/Unreasonable Risk

of Illness/Injury Under Ordinary Conditions of Use

ORCauses Dietary Supplement to

be Unsafe Under Recommended/Ordinary

Conditions of Use

Causes Dietary Supplement to be Unsafe Under

Recommended/Ordinary Conditions of Use

Formulation: Dietary Supplements A Dietary Ingredient is Prohibited if it:


Information Inadequate to Provide “Reasonable Assurance” that there is no Significant/Unreasonable Risk of

Illness/Injury Under Ordinary Conditions of Use

Information Inadequate to Provide “Reasonable Assurance” that there is no Significant/Unreasonable Risk of

Illness/Injury Under Ordinary Conditions of Use

First Marketed in the United States On/After October 15,

1994

First Marketed in the United States On/After October 15,

1994

“New Dietary Ingredient”

Formulation: Dietary Supplements A “New Dietary Ingredient” is

Prohibited if:


Formulation: Dietary Supplements Ingredient in Food Supply

As Article of Food Not Chemically Altered

OR History of Use/Evidence of Safety

Establishing “reasonably expected to be safe” under

recommended conditions of use

AND 75 Day Premarket Notice Filed


FTC Policy Governing Health and Nutritional Claims The FTC Food Advertising Enforcement

Policy Statement interprets and harmonizes FTC's general antideception policies with FDA regulations and policies governing health and nutrition related claims for foods.


FTC Policy: Nutrient Content Claims Applies FDA's definitions for nutrient content

claims (e.g., "low," "high," and "lean").

Requires synonyms ("packed with" or "lots of") to be used consistently with FDA-defined terms ("high").

Generally uses FDA's reference amounts as basis for claim.

Consults with FDA and other authorities in evaluating unapproved claims.

Requires the presence of a risk-increasing level of a nutrient to be disclosed.


FTC Policy: Health Claims Applies FDA's "significant scientific agreement"

standard as its principal guide in evaluating the support for unqualified health claims.

Requires unapproved health claims to be presented so that consumers understand the extent of scientific support and any significant contrary scientific evidence.

Prohibits qualified claims based on studies that are inconsistent with the larger body of scientific evidence.

Requires health claims to be qualified to account for nondietary risk factors.

Generally applies FDA's nutritional criteria for health claims except where claim qualified to avoid deception.

Requires health claims to disclose risk-increasing levels of nutrients.

positioning nutritional food products sarah e. taylor, esq. covington & burling washington, d.c

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