Appendix D
Table of Food and Drug Administration Actions on Dietary Supplements
This table provides an abbreviated list of some of the Food and Drug Administration (FDA) actions that have been described on the FDA Medwatch website: http//www.fda.gov/medwatch/safety.htm.
TABLE D-1 Abbreviated List of FDA Actions on Dietary Supplements
Year |
Dietary Supplement |
FDA Action |
2002 |
PC SPES |
FDA warned consumers to stop use |
2001 |
Aristolochic Acid |
FDA issued a Consumer Advisory advising consumers to immediately discontinue use FDA sent updated letters to industry and health care professionals (HCPs) about the safety concerns of these products FDA requested voluntary recall by manufacturers and distributors; several issued a recall |
2001 |
Comfrey |
FDA recommended that manufacturers remove product from the market and alert customers to immediately stop use |
2001 |
Kava |
FDA requested HCPs to review liver toxicity cases and to report possible kava-related cases to MedWatch |
2001 |
Lipokinetix |
FDA warned consumers to stop use immediately FDA alerted HCPs that Lipokinetix may be a serious health risk and asked HCPs to review and report cases of possible Lipokinetix-related hepatitis FDA recommended to distributor that it remove product from market and alert customers |
2001 |
Neo Concept Aller Relief |
FDA informed manufacturer of possible contamination of the product and manufacturer issued recall |
2000 |
St. John’s Wort |
FDA notified HCP of the risk of drug interactions |
2000 |
Tiratricol |
FDA warned consumers to stop use immediately |
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]). |