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Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002)

Chapter: Appendix D Table of Food and Drug Administration Actions on Dietary Supplements

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Suggested Citation:"Appendix D Table of Food and Drug Administration Actions on Dietary Supplements." Institute of Medicine. 2002. Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment. Washington, DC: The National Academies Press. doi: 10.17226/10456.
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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

Suggested Citation:"Appendix D Table of Food and Drug Administration Actions on Dietary Supplements." Institute of Medicine. 2002. Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment. Washington, DC: The National Academies Press. doi: 10.17226/10456.
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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]).

Suggested Citation:"Appendix D Table of Food and Drug Administration Actions on Dietary Supplements." Institute of Medicine. 2002. Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment. Washington, DC: The National Academies Press. doi: 10.17226/10456.
×
Page 138
Suggested Citation:"Appendix D Table of Food and Drug Administration Actions on Dietary Supplements." Institute of Medicine. 2002. Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment. Washington, DC: The National Academies Press. doi: 10.17226/10456.
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Page 139
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