Year

Dietary Supplement

FDA Action

1999

Asian Remedy for Menstrual Cramps—Koo Sar

Centers for Diseaase Control and Prevention report attributed lead poisoning case to product (posted on FDA website)

1999

Gamma Butyrolactone (GBL)

FDA warned consumers not to consume

FDA requested manufacturers to voluntarily recall products (at least one manufacturer agreed to recall)

1999

GBL, Gamma Hydroxybutyric Acid (GHB) and 1,4 Gutanediol (BD)

FDA notified HCPs and continues to warn public that these substances are unapproved new drugs that may cause harm

FDA conducted seizures of product

1999

GBL-Related Products

FDA warned the public that these are unapproved new drugs that may cause harm

FDA conducted seizures of product

1998

“Sleeping Buddha”

FDA warned consumers not to use product because it contains an unlabeled prescription drug ingredient

1998

5-hydroxy-L-tryptophan

FDA noted the presence of impurities in some products

1998

Cholestin

FDA determined product was an unapproved drug (later upheld by court rulinga)

1997

Chomper

FDA warned consumers not to consume product

1997

Ephedrine Dietary Supplements

FDA proposed limits to epedrine alkaloids allowed in products. Proposes adding warnings and information in labeling and marketing

1997

Gamma Hydroxybutyric Acid (GHB)

FDA reissued warning against use of substance because it is an unapproved and potentially dangerous new drug

FDA and Department of Justice took enforcement actions (restrict importation, embargoes, etc.)

1997

“Herbal Fen-Phen”

FDA warned consumers that product is an unapproved and potentially dangerous new drug

FDA took action to remove product from the market

1997

Infant Formula (homemade)

FDA informed pediatricians about safety concerns with use

1997

“Plantain” Containing Dietary Supplements

FDA warned consumers not to consume dietary supplement products containing plantain because of possible digitalis contamination

FDA worked with manufacturers to identify and recall possibly contaminated products

1996

Street Drugs Containing Botanical Ephedrine

FDA warned consumers not to consume products

1992

Chaparral

FDA warned consumers to stop use immediately

a The most recent court ruling held that cholestin was a drug and would be subject to regulation by FDA; however, the case is being appealed (Pharmanex v. Shalala, No. 2:97CV262k, 2001 WL 741419 [D. Utah March 30, 2001], appeal docketed, No. 01–4108 [10th Cir. May 31, 2001]).



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