DIETARY SUPPLEMENT
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What is a dietary supplement?
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 a "new dietary ingredient" in a dietary
supplement?
The Dietary Supplement Health and Education Act
(DSHEA) of 1994 defined both of the terms "dietary
ingredient" and "new dietary ingredient" as
components of dietary supplements. In order for an
ingredient of a dietary supplement to be a "dietary
ingredient," it must be one or any combination of the
following substances:

a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
a dietary substance for use by man to supplement the
diet by increasing the total dietary intake (e.g.,
enzymes or tissues from organs or glands), or
a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the
above definition for a "dietary ingredient" and was not
sold in the U.S. in a dietary supplement before
October 15, 1994.

What is FDA's role in regulating dietary supplements
versus the manufacturer's responsibility for marketing
them?
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 supplements.

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.

When must a manufacturer or distributor notify FDA
about a dietary supplement it intends to market in the
U.S.?
The Dietary Supplement Health and Education Act
(DSHEA) requires that a manufacturer or distributor
notify FDA if it intends to market a dietary supplement
in the U.S. that contains a "new dietary ingredient."
The manufacturer (and distributor) must demonstrate
to FDA why the ingredient is reasonably expected to
be safe for use in a dietary supplement, unless it has
been recognized as a food substance and is present
in the food supply.

There is no authoritative list of dietary ingredients that
were marketed before October 15, 1994. Therefore,
manufacturers and distributors are responsible for
determining if a dietary ingredient is "new", and if it is
not, for documenting that the dietary supplements its
sells, containing the dietary ingredient, were
marketed before October 15, 1994. For more
detailed information on new dietary ingredients, go to:
http://www.cfsan.fda.gov/~dms/ds-ingrd.html.

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 one serving?
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 or
approval.

Where can I get information about a specific dietary
supplement?
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 supplement.

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
marketplace.

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 dietary supplements).

What is FDA's oversight responsibility for dietary
supplements?
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 the
agency.

Does FDA routinely analyze the content of dietary
supplements?
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 claim.

How are advertisements for dietary supplements
regulated?
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.

How do I, my health care provider, or any informed
individual report a problem or illness caused by a
dietary supplement to FDA?
If you think you have suffered a serious harmful effect
or illness from a product FDA regulates, including
dietary supplements, the first thing you should do is
contact or see your healthcare provider immediately.
Then, you and your health care provider are
encouraged to report this problem to FDA.

Your health care provider can call FDA's MedWatch
hotline at 1-800-FDA-1088, submit a report by fax to
1-800-FDA-0178 or on-line at:
http://www.fda.gov/medwatch/report/hcp.htm. The
MedWatch program provides a way for health care
providers to report problems believed to be caused
by FDA-regulated products such as drugs, medical
devices, medical foods and dietary supplements.

You, or anyone, may report a serious adverse event
or illness directly to FDA if you believe it is related to
the use of any of the above-mentioned products, by
calling FDA at 1-800-FDA-1088, by fax at
1-800-FDA-0178 or reporting on-line at:
http://www.fda.gov/medwatch/report/consumer/consu
mer.htm. FDA would like to know when you think a
product caused you a serious problem, even if you
are not sure that the product was the cause, or even if
you do not visit a doctor or clinic. In addition to
communicating with FDA on-line or by phone, you
may use the postage-paid MedWatch form available
from the FDA Web site.

NOTE: The identity of the reporter and/or patient is
kept confidential.

For a general, not serious, complaint or concern
about food products, including dietary supplements,
you may contact the consumer complaint coordinator
at the local FDA District Office nearest you. See the
following Web address for the telephone number:
http://www.fda.gov/opacom/backgrounders/complain.h
tml.

SOURCE Overview of Dietary Supplements, FDA WebSite Online
Publication January 3, 2001.
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