FDA has not evaluated scientific data concerning the safety or purported benefits of most dietary supplement products. The law provides that the manufacturer must make sure that label information is truthful and not misleading. The manufacturer is also responsible for making sure that the dietary ingredients in the supplement are safe. Manufacturers and distributors do not need to register with FDA or get FDA approval before producing or selling dietary supplements.
Some information is provided below for several supplements about which consumers frequently have questions:
A list of selected dietary supplements associated with serious safety problems appeared in an out-of-print 1993 FDA document "Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace." The list is found in the document section entitled "Illnesses and Injuries Associated With the Use of Selected Dietary Supplements."
FDA does not have information about the safety or purported benefits of the following substances, which consumers frequently have questions about: blue-green algae, chromium picolinate, colloidal minerals, pycnogenol, creatine, HMB (beta-hydroxymethylbutyrate), cat's claw, echinacea, goldenseal and pyruvate. For information on a specific dietary supplement, you may wish to visit the International Bibiliographic Information on Dietary Supplements (IBIDS).
See Consolidated Information on Ephedrine Alkaloids
DHEA (dehydroepiandrosterone)
DHEA is a hormonal substance found in the adrenal glands and in the
gonads of primates and a few non-primate species. It is also produced
synthetically.
For more information on DHEA, you may call the National Institutes of Health Hotline number: 1-800-222-2225.
Melatonin
Melatonin is found in the pineal gland (that is, a gland in the brain) of
man and animals. It is also produced synthetically.
For more information on melatonin, you may call the National Institutes of Health Hotline number: 1-800-222-2225.
Dieter's Teas
Some dietary supplements and so-called dieter's teas that contain senna,
cascara, aloe, buckthorn and other plant-derived laxatives have been
associated with injury and illness when consumed in excessive amounts.
These products may be promoted for "bowel cleansing." The State of
California has proposed a regulation to require a warning label statement
on all food products (including dietary supplements) sold in that state
and containing stimulant laxatives.
L-Tryptophan
L-tryptophan is an amino acid. FDA took action to limit the availability
of L-tryptophan supplements because of the association between dietary
supplements containing L-tryptophan and the 1989 epidemic outbreak of
eosinophilia-myalgia syndrome (EMS) in the United States.
Folic Acid
Folate, or folic acid, is a B vitamin essential for health. Adequate
daily intake of folic acid by women of child-bearing age can help to
reduce the risk of having a baby with a serious birth defect.
Gamma Hydroxybutyric Acid (GHB), Gamma Butyrolactone
(GBL), and 1,4 Butanediol (BD)
FDA has been warning
the public about a group of products sold as dietary supplements for bodybuilding,
weight loss and sleep inducement which have been determined to pose a significant
public health hazard.
Additional information may be found at the
Office of Dietary
Supplements, National Institutes of Health.
Hypertext updated by dms/ear/kwg/cjm 2002-MAR-11
