Frequently Asked Questions on Supplements from
This page has details about the FDA, the law
passed in 1994 and who is responsible for regulating supplements.
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Congress defined the term "dietary
supplement" in the Dietary Supplement Health and Education Act
(DSHEA) of 1994. A dietary supplement is a product taken by mouth
that contains a "dietary ingredient" intended to
supplement the diet. The "dietary ingredients" in these
products may include: vitamins, minerals, herbs or other botanicals,
amino acids, and substances such as enzymes, organ tissues,
glandulars, and metabolites.
Dietary supplements can also be extracts or
concentrates, and may be found in many forms such as tablets,
capsules, softgels, gelcaps, liquids, or powders. They can also be
in other forms, such as a bar, but if they are, information on their
label must not represent the product as a conventional food or a
sole item of a meal or diet. Whatever their form may be, DSHEA
places dietary supplements in a special category under the general
umbrella of "foods," not drugs, and requires that every
supplement be labeled a dietary supplement.
What is FDA's role in regulating dietary
supplements versus the manufacturer's responsibility for marketing
In October 1994, the Dietary Supplement Health and
Education Act (DSHEA) was signed into law by President Clinton.
Before this time, dietary supplements were subject to the same
regulatory requirements as were other foods. This new law, which
amended the Federal Food, Drug, and Cosmetic Act, created a new
regulatory framework for the safety and labeling of dietary
Under DSHEA, a firm is responsible for determining
that the dietary supplements it manufactures or distributes are safe
and that any representations or claims made about them are
substantiated by adequate evidence to show that they are not false
or misleading. This means that dietary supplements do not need
approval from FDA before they are marketed. Except in the case of a
new dietary ingredient, where pre-market review for safety data and
other information is required by law, a firm does not have to
provide FDA with the evidence it relies on to substantiate safety or
effectiveness before or after it markets its products.
Also, manufacturers do not need to register
themselves nor their dietary supplement products with FDA before
producing or selling them. Currently, there are no FDA regulations
that are specific to dietary supplements that establish a minimum
standard of practice for manufacturing dietary supplements. However,
FDA intends to issue regulations on good manufacturing practices
that will focus on practices that ensure the identity, purity,
quality, strength and composition of dietary supplements. At
present, the manufacturer is responsible for establishing its own
manufacturing practice guidelines to ensure that the dietary
supplements it produces are safe and contain the ingredients listed
on the label.
What information must the manufacturer disclose
on the label of a dietary supplement?
FDA regulations require that certain information
appear on dietary supplement labels. Information that must be on a
dietary supplement label includes: a descriptive name of the product
stating that it is a "supplement;" the name and place of
business of the manufacturer, packer, or distributor; a complete
list of ingredients; and the net contents of the product.
In addition, each dietary supplement (except for
some small volume products or those produced by eligible small
businesses) must have nutrition labeling in the form of a
"Supplement Facts" panel. This label must identify each
dietary ingredient contained in the product.
Must all ingredients be declared on the label of
a dietary supplement?
Yes, ingredients not listed on the
"Supplement Facts" panel must be listed in the "other
ingredient" statement beneath the panel. The types of
ingredients listed there could include the source of dietary
ingredients, if not identified in the "Supplement Facts"
panel (e.g., rose hips as the source of vitamin C), other food
ingredients (e.g., water and sugar), and technical additives or
processing aids (e.g., gelatin, starch, colors, stabilizers,
preservatives, and flavors). For more details, see: http://www.cfsan.fda.gov/~lrd/fr97923a.html.
Are dietary supplement serving sizes standardized
or are there restrictions on the amount of a nutrient that can be in
Other than the manufacturer's responsibility to
ensure safety, there are no rules that limit a serving size or the
amount of a nutrient in any form of dietary supplements. This
decision is made by the manufacturer and does not require FDA review
Where can I get information about a specific
Manufacturers and distributors do not need FDA
approval to sell their dietary supplements. This means that FDA does
not keep a list of manufacturers, distributors or the dietary
supplement products they sell. If you want more detailed information
than the label tells you about a specific product, you may contact
the manufacturer of that brand directly. The name and address of the
manufacturer or distributor can be found on the label of the dietary
Who has the responsibility for ensuring that a
dietary supplement is safe?
By law (DSHEA), the manufacturer is responsible
for ensuring that its dietary supplement products are safe before
they are marketed. Unlike drug products that must be proven safe and
effective for their intended use before marketing, there are no
provisions in the law for FDA to "approve" dietary
supplements for safety or effectiveness before they reach the
consumer. Also unlike drug products, manufacturers and distributors
of dietary supplements are not currently required by law to record,
investigate or forward to FDA any reports they receive of injuries
or illnesses that may be related to the use of their products. Under
DSHEA, once the product is marketed, FDA has the responsibility for
showing that a dietary supplement is "unsafe," before it
can take action to restrict the product's use or removal from the
Do manufacturers or distributors of dietary
supplements have to tell FDA or consumers what evidence they have
about their product's safety or what evidence they have to back up
the claims they are making for them?
No, except for rules described above that govern
"new dietary ingredients," there is no provision under any
law or regulation that FDA enforces that requires a firm to disclose
to FDA or consumers the information they have about the safety or
purported benefits of their dietary supplement products. Likewise,
there is no prohibition against them making this information
available either to FDA or to their customers. It is up to each firm
to set its own policy on disclosure of such information. For more
information on claims that can be made for dietary supplements, see (http://www.cfsan.fda.gov/~dms/hclaims.html).
How can consumers inform themselves about safety
and other issues related to dietary supplements?
It is important to be well informed about products
before purchasing them. Because it is often difficult to know what
information is reliable and what is questionable, consumers may
first want to contact the manufacturer about the product they intend
to purchase (see previous question "Where can I get information
about a specific dietary supplement?"). In addition, to help
consumers in their search to be better informed, FDA is providing
the following sites: Tips For The Savvy Supplement User: Making
Informed Decisions And Evaluating Information -- http://www.cfsan.fda.gov/~dms/ds-savvy.html
(includes information on how to evaluate research findings and
health information on-line) and Claims That Can Be Made for
Conventional Foods and Dietary Supplements -- http://www.cfsan.fda.gov/~dms/hclaims.html,
(provides information on what types of claims can be made for
What is FDA's oversight responsibility for
Because dietary supplements are under the
"umbrella" of foods, FDA's Center for Food Safety and
Applied Nutrition (CFSAN) is responsible for the agency's oversight
of these products. FDA's efforts to monitor the marketplace for
potential illegal products (that is, products that may be
unsafe or make false or misleading claims) include obtaining
information from inspections of dietary supplement manufacturers and
distributors, the Internet, consumer and trade complaints,
occaisional laboratory analyses of selected products, and adverse
events associated with the use of supplements that are reported to
Does FDA routinely analyze the content of dietary
In that FDA has limited resources to analyze the
composition of food products, including dietary supplements, it
focuses these resources first on public health emergencies and
products that may have caused injury or illness. Enforcement
priorities then go to products thought to be unsafe or fraudulent or
in violation of the law. The remaining funds are used for routine
monitoring of products pulled from store shelves or collected during
inspections of manufacturing firms. The agency does not analyze
dietary supplements before they are sold to consumers. The
manufacturer is responsible for ensuring that the "Supplement
Facts" label and ingredient list are accurate, that the dietary
ingredients are safe, and that the content matches the amount
declared on the label. FDA does not have resources to analyze
dietary supplements sent to the agency by consumers who want to know
their content. Instead, consumers may contact the manufacturer or a
commercial laboratory for an analysis of the content.
Is it legal to market a dietary supplement
product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and
promoted on its label or in labeling* as a treatment, prevention or
cure for a specific disease or condition would be considered an
unapproved--and thus illegal--drug. To maintain the product's status
as a dietary supplement, the label and labeling must be consistent
with the provisions in the Dietary Supplement Health and Education
Act (DSHEA) of 1994.
*Labeling refers to the label as well as
accompanying material that is used by a manufacturer to promote and
market a specific product.
Who validates claims and what kinds of claims can
be made on dietary supplement labels?
FDA receives many consumer inquiries about the
validity of claims for dietary supplements, including product
labels, advertisements, media, and printed materials. The
responsibility for ensuring the validity of these claims rests with
the manufacturer, FDA, and, in the case of advertising, with the
Federal Trade Commission.
By law, manufacturers may make three types of
claims for their dietary supplement products: health claims,
structure/function claims, and nutrient content claims. Some of
these claims describe: the link between a food substance and disease
or a health-related condition; the intended benefits of using the
product; or the amount of a nutrient or dietary substance in a
product. Different requirements generally apply to each type of
claim, and are described in more detail at the following site: (http://www.cfsan.fda.gov/~dms/hclaims.html).
Why do some supplements have wording (a
disclaimer) that says: "This statement has not been evaluated
by the FDA. This product is not intended to diagnose, treat, cure,
or prevent any disease"?
This statement or "disclaimer" is
required by law (DSHEA) when a manufacturer makes a
structure/function claim on a dietary supplement label. In general,
these claims describe the role of a nutrient or dietary ingredient
intended to affect the structure or function of the body. The
manufacturer is responsible for ensuring the accuracy and
truthfulness of these claims; they are not approved by FDA. For this
reason, the law says that if a dietary supplement label includes
such a claim, it must state in a "disclaimer" that FDA has
not evaluated this claim. The disclaimer must also state that this
product is not intended to "diagnose, treat, cure or prevent
any disease," because only a drug can legally make such a
How are advertisements for dietary supplements
The Federal Trade Commission (FTC) regulates
advertising, including infomercials, for dietary supplements and
most other products sold to consumers. FDA works closely with FTC in
this area, but FTC's work is directed by different laws. For more
information on FTC, go to: http://www.ftc.gov/bcp/menu-health.htm.
Advertising and promotional material received in the mail are also
regulated under different laws and are subject to regulation by the
U.S. Postal Inspection Service.
Source of information