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Products that consumers inquire about. (U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition).

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:

Ephedra or Ephedrine DHEA (dehydroepiandrosterone) Melatonin Dieter's Teas L-Tryptophan Folic Acid Gamma Hydroxybutyric Acid (GHB), Gamma Butyrolactone (GBL), and 1,4 Butanediol (BD)

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).

Ephedra or Ephedrine

Ephedra is a botanical (i.e., plant) product that is a source of ephedrine alkaloids. Because dietary supplements containing ephedrine alkaloids pose significant health risks to consumers, FDA has proposed rules for dietary supplements containing ephedrine alkaloids. These proposed rules would require warning statements on the label and require that the amount of ephedrine alkaloids in a serving of the supplement be below a specified level.

* see Consolidated Information on Ephedrine Alkaloids

For a copy of the transcript of the Oct. 1995 Special Working Group meeting or the August 27-29, 1996 meeting of the Food Advisory Committee on dietary supplements containing ephedrine alkaloids, you may wish to write to the Dockets Management Branch (HFA-305), Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, Maryland 20957; the specific docket for these materials is Docket Number 95N-0304, "Ephedrine Alkaloids: Reports of Adverse Events; Availability."

DHE (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.

* Dieter's Brews Make Tea Time a Dangerous Affair (FDA Consumer, July 1997)

* Status Report of the Special Working Group on Stimulant Laxative Substances in Foods (FDA Food Advisory Committee, June 8-9, 1995)

* Minutes of the Special Working Group on Stimulant Laxative Substances in Foods (FDA Food Advisory Committee, June 7-8, 1995)

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.

* Information Paper on L-tryptophan and 5-hydroxy-L-tryptophan (February 2001)

The information below contains historical background information on FDA's actions following the 1989 EMS outbreak.

* "Dear Colleague" letter regarding the Research on Eosinophilia-Myalgia Syndrome and Current Regulatory Status of L-Tryptophan (September 3, 1992)

* Testimony before the Subcommittee on Human Resources and Intergovernmental Relations Committee (July 1991)

* "Dear Colleague" letter on Legal and Regulatory Background on L-Tryptophan (February 2, 1990)

* "Dear Colleague" letter on L-Tryptophan and Eosinophilia-Myalgia Syndrome (January 17, 1990)

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.

* How Folate Can Help Prevent Birth Defects (FDA Consumer, September 1996)

* Final regulation--Federal Register of March 5, 1996 (61 FR 8750)

** 21 CFR Part 101 Food Labeling; Health Claims and Label Statements; Folate and Neural Tube Defects

** 21 CFR Part 136, 137 and 139 Food Standards: Amendment of Standards of Identity for Enriched Grain Products to Require Addition of Folic Acid

** 21 CFR Part 172 Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid (Folacin)

* Folic Acid to Fortify U.S. Food Products to Prevent Birth Defects (Press Release, February 29, 1996),

* Folic Acid Fortification (FDA Fact Sheet, February 29, 1996)

* FDA Announces Name Change for Lower-Fat Milks and Folic Acid Fortification for Bakery Products (HHS News, December 31, 1997

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.

* "The Death of the Party: All the Rave, GHB's Hazards Go Unheeded" (FDA Consumer Magazine, March-April 2000)

* Report Serious Adverse Events Associated with Dietary Supplements Containing GHB, GBL, or BD (August 25, 1999)

* FDA Issues Alert about Misuse of Consumer Products Containing Gamma Hydroxybutyric Acid (GHB), Gamma Butyrolactone (GBL), and 1,4 Butanediol (BD) (June 15, 1999) (Letter (PDF), Poster) (see also January 21, 1999 Talk Paper)

* Adverse Events Associated with the Use of GBL (MMWR Weekly-CDC, February 26, 1999)

* FDA Warns Consumers About Products Containing Gamma Butyrolactone or GBL and Asks Companies to Issue a Recall (FDA Talk Paper, January 21, 1999)

* "California Man Imprisoned After fX Drinks Injure Partygoers" (FDA Consumer Magazine article, July-August 1998)

* "FDA Reissues Warning on GHB." (FDA Talk Paper, February 18, 1997)

Additional information may be found at the Office of Dietary Supplements, National Institutes of Health.

For more recent information on Dietary Supplements See http://www.cfsan.fda.gov/~dms/supplmnt.html

Dietary Supplements

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Date:Mar 19, 2001
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