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

Pamphlet by: Food and Drug Administration, March 19, 2001

* 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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