Transcript Jelly Bean Rule” - Covington & Burling

Positioning Nutritional
Food Products
Sarah E. Taylor, Esq.
Covington & Burling
Washington, D.C.
Positioning Objectives:
 Avoid “drug” regulation
 Optimize health and nutritional claims
 Optimize nutritional formulation
 1998 Covington & Burling
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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.”
 1998 Covington & Burling
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Flow Chart
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?
YES
“Drug”
Premarket
approval of new
drug application
required.
 1998 Covington & Burling
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“Drug” Definition: “Intended
Use”
 Vendor's intent
 Determined from any relevant source




labeling
advertising
promotions
“circumstances” surrounding product distribution
 1998 Covington & Burling
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Drug Definition: “Disease”
 May include —
“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.”
 1998 Covington & Burling
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Categories of Prohibited
“Disease Claims”
 Claims suggesting “the product has an effect on
a specific disease or class of disease”
 Examples:
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
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
“Protective against the development of cancer”
“Reduces the pain and stiffness associated with
arthritis”
“Decreases the effects of alcohol intoxication”
“Alleviates constipation”
 1998 Covington & Burling
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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).
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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
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

“Aspirin”
“Digoxin”
“Laetrile”
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Claims suggesting that a product
“belongs to a class of products that is
intended to diagnose, mitigate, treat,
cure, or prevent a disease.”
 Examples

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


“antibiotic”
“laxative”
“analgesic”
“antiviral”
“vaccine”


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
“diuretic”
“antimicrobial”
“antiseptic”
“antidepressant”
 Permissible S/F Claims


“energizer”
“rejuvenative”


“revitalizer”
“adaptogen”
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Claims suggesting that a product has
an effect on disease through the
“use of picture, vignettes, symbols,
or other means.”
 Examples
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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
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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:
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
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
“Treats toxemia in pregnancy.”
“For decreased sexual function.”
“For hot flashes.”
“Alzheimer’s disease.”
 Permitted S/F Claims:
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
“For men over 50 years old.”
“To meet nutritional needs during pregnancy.”
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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”
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Position Product to Optimize
Health and Nutritional Claims
 Position product in optimal “nutritional food”
category.
 Options:
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Conventional Food
Food for Special Dietary Use
Dietary Supplement
Medical Food
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Conventional “Food:”
Definition
 Used for “Food” or “Drink” and Components
 “Chewing Gum” and Components
 “Food” — Consumed for “Taste, Aroma,
Nutritive Value.”
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Food for Special Dietary Use:
Definition
 Meets Conventional “Food” Definition
 Intended to meet special nutritional needs
associated with age, physiological conditions, or
disease.
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Food for Special Dietary Use:
Definition
 Distinction from Medical Food:
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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.”
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Food For Special Dietary Use:
Definition
 Distinction from Medical Food (cont.):
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No required “medical supervision”
FDA has attempted to narrow “medical food”
category, redefining as foods for special dietary use.
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Dietary Supplement: Definition
 Labeled as “Dietary Supplement”
“Vitamin C Supplement”
“Energy Bar Dietary Supplement”
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Dietary Supplement: Definition
 Intended to supplement the diet and contains a:

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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
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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
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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.
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Dietary Supplement:
Definition -- “Simulate"
FDA Statement:
“. . . 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.”
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Flow Chart
Does manufacturer
state/imply product is
intended for use in the
diagnosis, cure, migration,
treatment, or prevention of
disease?
NO
Is the product intended to
supplement the diet with a
dietary ingredient (e.g. herb,
botanical, amino acid, or
metabolite)?
YES
Represented as
conventional
food or as sole
item of meal or
diet?
NO
Dietary
Supplement
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Conventional Food: Claims
 Approved Nutrient Content Claims
 Amount/Percentage Claims
 Approved Health Claims
 Traditional Structure or Function Claims
 Dietary Guidance Claims
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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)
“Calcium helps build and maintain strong bones.”
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Dietary Supplement Claims
 “Statements of Nutritional Support” for non-DV
dietary ingredients (e.g., herbs):

Disclaimer
“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.”

30 Day Postmarket Notice
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Third Party Literature -Dietary Supplements
 “Publication”
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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.
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Scope of “Nutrient Content
Claims”
 Definition:
“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.
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Nutrient Content Claims Must
Be Specifically Authorized
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).
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Scope of “Health Claims”
 Definition:
“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.
 Implied health claims may include:



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third-party references
brand names
symbols
vignettes.
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“Health Claims” Must be
Specifically Authorized
 A health claim may not be made in labeling
unless:
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
specifically defined by FDA regulation, or
authorized under the premarket notification
procedure.
 An unapproved health claim = unlawful “drug”
claim.
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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.
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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.”
 1998 Covington & Burling
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FDAMA Health Claims
 Premarket Notification
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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.
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Dietary Guidance Claims
 Key: No reference is made to any specific
disease/condition.
“The USDA Food Guide Pyramid recommends at
least 5 servings of fruits and vegetables daily
to reduce the risk of certain chronic diseases.”
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“Structure Function” Claims
 Conventional “foods” and DV-nutrients:
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
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.
“Calcium helps build and maintain strong bones.”
 1998 Covington & Burling
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“Statements of Nutritional
Support” (S/F Claims)
 Non-DV Dietary Ingredients

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
Describes role in affecting the structure or function,
Characterizes the mechanism of action, or
Describes benefit to general well-being.
“Gingko biloba supports cerebral circulation
and alertness.”
 1998 Covington & Burling
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Permitted S/F Claims
Examples:
 “Helps promote urinary tract health”
 “Helps maintain cardiovascular function and a
healthy circulatory system”
 “Helps maintain intestinal flora”
 “Promotes relaxation”
 1998 Covington & Burling
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Permitted S/F Claims
Examples:
 “Reduces stress and frustration.”
 “Inhibits platelet aggregation.”
 “Improves absentmindedness.”
 “Helps maintain a healthy cholesterol level.”
 “Helps maintain regularity.”
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Position Product to Optimize
Nutritional Formulation
 Considerations:
 Dietary Supplements


More Flexible Safety Standards for Dietary
Ingredients
May Fortify to Support Claims
 Conventional Foods
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
Food Additive/GRAS Regulation
Standards for Identity
Fortification Policy
Cannot Fortify to Meet Criteria for Certain Claims
 1998 Covington & Burling
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Formulation: Conventional
“Foods”
Fortification Policy:
 “Guideline” to Promote “Rational Addition of
Nutrients to Food”
 Mandatory for “More,” “Healthy,” “High Potency”
 1998 Covington & Burling
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Formulation: Conventional
“Foods”
Fortification Policy:
 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
 1998 Covington & Burling
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Formulation: Conventional
“Foods”
Fortification Policy:
 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
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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.
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Formulation: Dietary
Supplements
 A Dietary Ingredient is Prohibited if it:
Presents Significant/Unreasonable
Risk of Illness/Injury Under Ordinary
Conditions of Use
OR
Causes Dietary Supplement to be
Unsafe Under Recommended/Ordinary
Conditions of Use
 1998 Covington & Burling
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Formulation: Dietary
Supplements
 A “New Dietary Ingredient” is Prohibited if:
Information Inadequate to Provide “Reasonable
Assurance” that there is no
Significant/Unreasonable Risk of Illness/Injury
Under Ordinary Conditions of Use
 “New Dietary Ingredient”
First Marketed in the United States
On/After October 15, 1994
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Formulation: Dietary
Supplements
 Ingredient in Food Supply
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
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
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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.
 1998 Covington & Burling
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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.
 1998 Covington & Burling
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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.
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