The label of a dietary supplement must contain enough information
about the composition of the product so that consumers can make
informed choices. (The information must be presented in FDA-specified
format.) The manufacturer must make sure the label information is
truthful and not misleading. The manufacturer is also responsible
for making sure that all the dietary ingredients in the supplements are
safe. Manufacturers and distributors do not need to register with FDA or
get FDA approval before producing or selling dietary supplements.
FDA can be contacted to report general complaints or concerns about
food products, including dietary supplements. You may
telephone or write to FDA.
If you think you have suffered a serious harmful effect or illness from
a dietary supplement, your health care provider can report this by
calling FDA's MedWatch hotline at 1-800-FDA-1088 or using the
website
http://www.fda.gov/medwatch/report/hcp.htm. The
MedWatch program allows health care providers to report
problems possibly caused by FDA-regulated products such as
drugs, medical devices, medical foods and dietary supplements.
The identity of the patient is kept confidential.
Consumers may also report an adverse event or illness they believe
to be related to the use of a dietary supplement by calling FDA at
1-800-FDA-1088 or using the website
http://www.fda.gov/medwatch/report/consumer/consumer.htm.
FDA would like to know when a product causes a problem even if you
are unsure the product caused the problem or even if you do not
visit a doctor or clinic.
Are advertisements for dietary supplements regulated by FDA?
No. The Federal Trade Commission (FTC)
handles advertising for dietary supplements and most other products sold
to consumers. FDA works closely with FTC in this area, but their work
is directed by different laws.
Does FDA routinely analyze the content of Dietary Supplements?
FDA has limited resources to analyze the composition of food products,
including dietary supplements. So, FDA focuses first on public health
emergencies and products that may have caused injury or illness. Then
products thought to be fraudulent or in violation of the law are
analyzed. FDA uses the remaining funds for routine monitoring of
products pulled from store shelves. FDA does not analyze supplement
products before they are sold to consumers. The manufacturer is
responsible for ensuring that the ingredient list is accurate and that
the ingredients are safe. They are also required to make sure that the
content matches the amount declared on the label.
FDA does not have adequate resources to analyze dietary products sent by
consumers who want to know their content. Instead, consumers may contact
the manufacturer or a commercial laboratory.
Are all ingredients required to be declared on the label?
Other ingredients in the product must be listed in the ingredient
statement beneath the "Supplement Facts" panel. The types of
ingredients listed there would include gelatin, sugars, starch,
colors, stabilizers and preservatives.
Are there restrictions on size of the pill or how much of a
nutrient can be in one serving of a Dietary Supplement?
There are no rules that limit a serving size or the amount of
nutrients in any form of dietary supplements. This decision is made
by the manufacturer and does not require FDA review or approval.
For one dietary ingredient, ephedrine alkaloids, FDA has proposed
to permit serving sizes of 8 mg or less.
What kinds of claims can be made on the labels of Dietary
Supplements?
As with other food products, the manufacturer can put certain claims
on the product label. These claims tell consumers about the nutritional
value of the product. Claims defined by FDA to describe the nutrient
content of a product, like "good source" or "high", can appear on
the label if one serving meets the definition. There are specific
rules as to which substances can be listed using these nutrient
content claims.
Manufacturers can also put FDA-approved "health claims" on a product
label. Health claims describe the connection
between a nutrient or food substance and a disease or health-related
condition. Claims about these diet/disease relationships can appear
on the label if the content of the product meets the FDA
requirements and if the claim is one of the approved health claims.
Why do some supplements have wording that says: "This statement
has not been evaluated by the FDA. This product is not intended to
diagnose, treat, cure, or prevent any disease"?
Certain statements may be included on the label that give the
manufacturer's description of the role of the dietary supplement.
These statements are not authorized by FDA. The manufacturer is
responsible for ensuring that these statements are accurate and
truthful. For this reason, the law says that if a dietary supplement
label includes this information, it must also state that FDA has
not evaluated the statement.
Can I get information about a specific Dietary Supplement?
Manufacturers do not need FDA approval to sell their supplement products.
This means that FDA does not keep a list of manufacturers or products on
the market. If you want more specific information than the label tells
you about the products, you may contact the manufacturer directly.
Office of Special Nutritionals, May 1997; Updated April 1999
