Download FredHDegnan

“FUNCTIONAL” AND HEALTH
CLAIMS IN THE UNITED STATES
Fred H. Degnan
King & Spalding LLP
[email protected]
Background
• Regulated claims can be made in
– “advertising” or
– “labeling”
• “Advertising” and “Labeling” are legal terms and are
broadly defined.
Advertising
• The act or practice of attracting public notice and
attention;
• Includes all forms of public announcement that are
intended to aid, directly or indirectly, the furtherance or
promulgation of an idea
• Examples: any promotional publication or broadcast
through audiovisual media such as radio, television,
telephone communication systems, etc.
Labeling
• “Labeling” includes “all labels and other written printed or graphic
material … accompanying” a product (Section 201(m) of the FDC Act)
• Thus, “labeling” encompasses
– any written, printed or graphic material
– brochures, bulletins
– literature reprints
– films, videos, CD-ROM disks
– PowerPoint presentations
– press releases
– automated telemarketing
• In short, anything that is any promotional material that is not
advertising is likely to be labeling
U.S. Regulators
• The Federal Trade Commission (FTC) regulates
advertising
• The Food and Drug Administration (FDA) regulates
labeling
U.S. Regulation of “Functional”/
Health-Related Benefit Claims
ADDITIONAL
BASIC
Federal Trade Commission (FTC)
•
Truthful, not misleading
•
Substantiated by competent and
reliable scientific evidence
Food and Drug Administration (FDA)
•
Is the claim permitted?
•
If so, does the claim comply with
applicable requirements?
 “Drug” claim
 “Health claim”: (including “Qualified
Health claim”)
 “Medical Food” claim
 “Structure/Function” claim
 “Nutrient Content” claim (including
“Healthy” claim)
* There is no precise regulatory category for
“functional foods.”
FTC Jurisdiction
• Advertisers must have substantiation for objective
product claims
• Making objective claims without a reasonable basis is
an unlawful deceptive practice
FTC Advertising:
Level of Substantiation
• A claim made in an advertisement represents either
expressly or by implication that the claim is supported by
a certain amount or level of substantiation, the
advertiser must possess, prior to dissemination of the
advertisement, at least that level of support for the claim
FTC: Substantiation Required for
Specific Disease-Related Claims
• Such claims are prohibited unless they have been
approved by FDA
FTC: Substantiation Required for
Specified Health Benefit Claims
• For claims that are not frank disease claims but
nonetheless convey a specific health benefit (e.g.,
weight loss claims, claims that a product will reduce
children’s sick day absences, etc.), there must be
– competent and reliable scientific evidence
– including at least two adequate and well controlled human
clinical studies
• This position by FTC is new and is being challenged in
the courts.
FTC: Substantiation Required for
Other Health-Related Claims
• Any claims about the health benefits, performance, or
functional efficacy of a food product must be supported
by “competent and reliable scientific evidence”:
– the evidence must be “sufficient in quality and
quantity based on standards generally accepted in
the relevant scientific fields; and
– must be considered in light of the entire body of
relevant evidence
FDA Regulation of
“Functional”/Health Benefit Claims
• FDA will review every claim (whether on a website, on a
product label, brochure, etc.) to determine the
manufacturer’s intent
• FDA then categorizes the product itself based primarily
on the manufacturer’s intent
• Thus, a product bearing a claim may be regulated as a
“drug,” a “food,” a “medical food,” a “dietary supplement”
or a combination of such categories
Drugs: Definition
• A product is a “drug” if, among other things, it is
“intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease”
• FDA interprets the term “disease” broadly
Food: Definition
• “Food” is defined as
– any article “used as food” and
– any “component” of such an article (i.e., ingredients)
Dietary Supplement: Definition
• A “dietary supplement” is defined as any product
– intended to supplement the diet
– containing one or more
 vitamin, mineral, herb/botanical, amino acids, etc.
– intended for ingestion, and
– is not represented as a conventional food
Drug Claims
•
Express and implied “drug claims” must be supported by “substantial
evidence” of “effectiveness” and, as a general rule, must be either
preapproved or preauthorized by FDA before the product may be lawfully
marketed
•
Even though a product may meet the definition of a “food” or the definition of
a “dietary supplement,” if the product bears a “drug” claim the product will
be regulated as a drug
•
Thus, foods and dietary supplements cannot, as a general rule, bear an
express or implied “drug/disease” claim
•
Exceptions to this rule include “health claims” (either on foods and dietary
supplements) and “medical food” claims
“Health Claims”
• A health claim describes the relationship between a food
or dietary supplement and the reduction in risk of a
disease or health-related condition
• A health claim must be based upon “significant scientific
agreement’ and be pre-reviewed and approved by FDA
via a petition process
• FDA approved health claims may be found in FDA’s
regulations, 21 CFR 101.72 - 101.83
Examples of Approved “Health
Claims”
• Fiber/cancer risk: “low fat diets rich in fiber containing
grain … may reduce the risk of some types of cancer …”
• Plant sterol esters/risk of coronary heart disease: “diets
low in saturated fat and cholesterol that include two
servings of foods providing a total of at least 1.3 grams
of vegetable oil sterol esters may reduce the risk of
heart disease”
“Qualified” Health Claims
• A “qualified” health claim must be preauthorized by FDA
via a petition process but requires less evidence than
“significant scientific agreement”
• A qualified health claim may be based on “emerging”
scientific evidence regarding the relationship between a
substance and a reduced risk of disease or a healthrelated condition
• A qualified health claim must be accompanied by an
explanation clarifying the level of scientific evidence in
support
Examples of FDA Authorized
Qualified Health Claims
• “Scientific evidence suggests but does not prove that
eating 1.5 ounces per day of nuts as part of a diet low in
saturated fat and cholesterol may reduce the risk of
heart disease”
• “Omega-3 fatty acids and cardiovascular disease:
supportive but not conclusive research shows that the
consumption of omega-3 fatty acids EPA and DHA may
reduce the risk of cardiovascular disease”
“Medical Food”: Definition
• A “medical food” is a
– food
– formulated to be consumed or administered enterally
– under a physician’s supervision and
– is intended for specific dietary management
– of a disease condition
– for which distinctive nutritional requirements
– are established by medical evidence
Medical Food Claims
• Medical foods are exempt from being considered “drugs”
and from “health claim” status; the exemption applies only
if product is
– specially formulated and processed for partial or exclusive feeding of
patient orally or by enteral tube; and
– intended for dietary management of a patient under medical supervision
when cannot be achieved by modifying the normal diet (e.g., chronic
medical needs; limited/impaired capacity to ingest, digest, etc.; other
special medically-determined nutrient needs); and
– provides nutritional support to manage unique nutrient needs resulting
from a specific disease/condition (per medical evaluation); and
– intended for use only under medical supervision; and
– intended only for patient receiving active/ongoing medical supervision
Medical Food Claims
• Although there is no approval process for medical foods,
– FDA takes the view that there must be meaningful scientific
evidence for the composition and effectiveness of medical foods.
– In FDA’s view, the scientific standard contained in the statutory
medical food definition may require some of the same types of
data for medical foods as are needed to support drug claims
(e.g., data from clinical investigations).
Examples of Medical Food Claims
• Restrict phenylalanine/PKU - “A phenylalanine-free food
to aid in the nutritional management of
hyperphenylalaninemia including PKU.”
• Hypermetabolic states, such as severe burns, trauma, or
infection - “A nutritionally complete formula that provides
a concentrated source of calories for patients with
restricted fluid allowance or increased energy needs …
useful in the dietary management of volume-restricted
patients, oncology patients, hypermetabolic conditions,
trauma, sepsis, and post major surgery.”
Other Permissible Functional/HealthRelated Claims
• With the exception of medical food claims, health claims,
and qualified health claims, only “drug” claims may
mention disease or imply a disease-related effect
• “Structure/function” claims and nutrient content claims
may discuss functional or health benefits as long as they
do not expressly or by implication suggest a drug or
disease endpoint
Structure/Function Claims
• Dietary supplements (“role of a nutrient”)
• Food (food function: e.g., “nutritive value”)
• Substantiation: truthful and not misleading (arguably
similar to FTC reasonable substantiation standard)
Structure/Function Claims (cont.)
• Focus:
A structure/function claim deals with how a substance
affects the body or characterizes the mechanism by which the
substance achieves that effect
Example:
– “inhibits platelet aggregation”
– “helps maintain intestinal flora”
Structure/Function Claims (cont.)
• Focus:
A structure/function claim may not imply or express
usefulness in the cure, mitigation, treatment or prevention of
disease.
Examples: these are “drug” claims, not “structure/function”
claims:
– “prevents the spread of neoplastic cells” [implies prevention of
cancer metastases]
– “improves joint mobility and reduces joint inflammation and
pain” [implies mitigation of rheumatoid arthritis]
Structure/Function or Drug/Disease
Claim?
• Supports the immune system
• Supports the body’s antiviral capabilities
• Supports the role white blood cells play in the disposal of
aging red blood cells or otherwise damaged cells
• Vitamin A helps maintain a healthy immune system
• Prevents wasting in persons with weakened immune
systems
Nutrient Content Claims
• A “nutrient content claim” characterizes the level of
nutrients
• Only FDA authorized nutrient content claims may be
used on a product label or in product labeling
• Examples of authorized nutrient content claims:
– “sodium free,” “low in fat”
– “more,” “reduced,” “light,” and other claims comparing the level of
a nutrient in food to that of another
“Healthy” Claims
• In the context of its authority over nutrient content
claims, FDA has recognized that the use of the term
“healthy” can implicitly characterize the level (including
the absence) of a nutrient in food
• As a result, FDA has promulgated a regulation (21 CFR
101.65(d)) governing the use of the term “healthy” (or
derivatives of the term, e.g., “healthful”) where
– the use of the term characterizes the level of a nutrient in food
and
– “implies a judgment about the food itself.”
“Healthy” Claims (cont.)
• For a food to bear a “healthy” claim
– at least one of the nutrients must provide at least 10% of the
recommended daily intake for Vitamin A, Vitamin C, calcium, iron,
or fiber and
– the food may not exceed FDA established levels for fat, saturated
fat, sodium, and cholesterol
• Moreover, for a food to bear the term “healthy,” the
addition of nutrients to the food must comply with FDA’s
“fortification policy” (21 CFR 104.20)
– i.e., the addition must be rational, e.g., “snack” foods and candies
cannot bear a “healthy” claim
Products/Claims
No Statutory Counterpart
• Although the following terms are popularly used to refer
to product categories, the terms have no legal status:
– “Cosmeceutical” - “Cosmetic” + “pharmaceutical”
– “Nutraceutical” - “Nutrition” + “pharmaceutical”
– “Functional Food” - Food supplying a health/disease
prevention benefit
U.S. Regulation of “Functional”/
Health-Related Benefit Claims
ADDITIONAL
BASIC
Federal Trade Commission (FTC)
•
Truthful, not misleading
•
Substantiated by competent and
reliable scientific evidence
Food and Drug Administration (FDA)
•
Is the claim permitted?
•
If so, does the claim comply with
applicable requirements?
 “Drug” claim
 “Health claim”: (including “Qualified
Health claim”)
 “Medical Food” claim
 “Structure/Function” claim
 “Nutrient Content” claim (including
“Healthy” claim)
* There is no precise regulatory category for
“functional foods.”
Summary
FDA Health-Related Claims:
A Continuum of Regulatory Categories
•
Drug Claim: Focuses on the “cure, mitigation, treatment, or prevention of disease”
•
Health or “Qualified” Health Claim: “Characterizes the relationship of any nutrient …
to a disease or health-related condition”
•
Structure/Function Claim
– Supplement: Describes the “role of a nutrient or dietary ingredient intended to
affect the structure or function in humans”
– Food: Describes the effect of a food or food component on the “structure or any
function of the body”
•
Medical Food Claim: For a patient under medical supervision for the “dietary
management of a disease or condition for which distinctive nutritional requirements
have been established by medical evaluation”
Conclusion
FTC: You must prove your claim, clinical data may be
necessary
FDA: You are what you claim – the proof standard and
degree of FDA focus depend on what regulatory
category i.e., “drug,” “health claim,”
“structure/function,” “medical food,” etc.) your claims
place you in