HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.
![handle is hein.crs/goverdu0001 and id is 1 raw text is:
a a Congressional Research Service
Infmming the legisiitive debate since 1914
0
October 31, 2024
Health Claims on Food and Dietary Supplement Labels:
FDA Regulation and Select Legal Issues
A food or dietary supplement manufacturer may seek to
market a product through a statement on its product's label
that suggests a link between a nutrient in that product and a
disease or health-related condition. Such a statement may
qualify as a health claim under the Federal Food, Drug,
and Cosmetic Act (FD&C Act; ).
which the Food and Drug Administration (FDA)
administers. Generally, the FD&C Act the
introduction into interstate commerce of misbranded foods
and dietary supplements, which generally relates to how the
product is labeled or marketed. The FD&C Act and the
relevant regulations deem a product to be misbranded if it
contains an unauthorized health claim.
In 1990, Congress passed the Nutrition Labeling and
Education Act (NLEA; P.L. 101-535), which amended the
FD&C Act to provide specific requirements for using
certain types of marketing claims on food, including health
claims. Prior to the NLEA, if a product claimed a
connection between a nutrient in the product and a disease
or health-related condition, FDA could either regulate it as
a drug, subjecting it to the rigorous drug approval process,
or treat it as food and allow it to bear the claim without any
preapproval. Today, the FD&C Act provides procedures
and standards for FDA to regulate the use of such claims
without subjecting the products to the drug approval
process. The FD&C Act addresses health claims on food
labels and authorizes FDA to establish standards and
procedures for such claims on dietary supplements. FDA
eu apply the same standards and procedures for
health claims on food to dietary supplements.
This In Focus discusses the legal framework governing
health claims and certain legal issues that have arisen
regarding FDA's regulation of them.
The Hea th Claim Regulatory Scheme
A expressly states or implies a relationship
between a nutrient in a food or dietary supplement and a
specific disease or health-related condition. An example of
such a claim would be stating that a product that is high in
calcium (e.g., milk) may reduce the risk of osteoporosis. A
health claim may also be implied by using symbols (e.g., a
heart symbol) or written statements (e.g., including heart
in the brand name) that suggest a relationship between the
product and a disease or health-related condition.
Section 403(r) of the FD&C Act ( ) and
the relevant regulations ( , )
permit a manufacturer to include a health claim on a
product's label only when FDA has promulgated a
regulation approving the health claim. FDA may approve a
health claim if it determines based on the totality of
publicly available scientific evidence that there is
significant scientific agreement among qualified experts
that the claim is supported. Any person may petition FDA
to authorize a health claim, and FDA must issue a final
decision on any such petition within 100 days. To date,
FDA has promulgated regulations approving 12 health
claims (see 21 ). Each regulation
lists the specific requirements a product must satisfy in
order to use the approved health claim on its labeling.
Federal law prohibits including health claims on food or
dietary supplement products that contain certain t
in amounts that may increase the risk of another
disease. If a product has a
(i.e., greater than a certain level of total fat, saturated fat,
cholesterol, or sodium per reference amount), then the
product's label cannot include any health claim. This
requirement is intended to protect a consumer from buying
a product based on labeling that indicates it could reduce
the risk of one disease when that product could increase the
risk of some other disease.
Health Claims Versus Drug Claims
The criteria for qualifying as a health claim and the
definition of drug under the FD&C Act are sufficiently
similar that questions persist regarding when a product may
be marketed as a food or dietary supplement with a health
claim versus requiring premarket approval as a drug. The
FD&C Act defines to include articles intended for
use in the diagnosis, cure, mitigation, treatment, or
prevention of disease, whereas a health claim
characterize[s] the relationship of any nutrient ... to a
disease or health-related condition. In some cases, these
requirements may effectively overlap. For example, a claim
that a nutrient in a product treats a disease may cause the
product to be considered a drug while also qualifying as a
product bearing a health claim that characterize[s] the
relationship between the nutrient and disease.
FDA considered the potential overlap between these two
types of claims for the fis m when evaluating a petition
for a health claim that palmetto extract may improve certain
symptoms associated with mild benign prostatic
hyperplasia. Prior approved health claims had claimed that
the nutrient reduced the risk of a future disease rather than
affected an existing disease. FDA denied the petition and
that the claim was a drug claim. FDA
the statutory provisions such that a product marketed as
diagnosing, curing, mitigating, or treating disease would
generally be considered a drug, even if it would otherwise
qualify as a food or dietary supplement, and a product
marketed only as reducing the risk of a disease would be
considered to bear a health claim.](ViewImageLocal?handle=hein.crs/goverdu0001&div=1&collection=&method=preview&ext=.png&size=3)