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Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles Dietary Supplements: A Framework for Evaluating Safety Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Other Related Titles Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) Food and Nutrition Board (FNB) Institute of Medicine (IOM) Board on Life Sciences (BLS) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 138   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. 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 Page 138 Front Matter (R1-R12) Executive Summary (1-12) 1 Introduction and Background (13-28) 2 Approaches Used by Others to Consider Dietary Supplement Safety and Other Existing Safety Frameworks (29-38) 3 Outline of the Overall Process for Evaluation of Dietary Supplement Ingredients (39-46) 4 Factors Considered in Screening, Setting Priorities, and Safety Evaluation (47-76) 5 Framework Steps One and Two: Screening/Flagging and Priority Setting (77-90) 6 Framework Step 3: Critical Safety Evaluation of Dietary Supplement Ingredients (91-98) 7 Attributes and Limitations of the Proposed Framework (99-102) 8 Dietary Supplement Ingredients Selected for Prototype Safety Monographs (103-105) Appendix A Other Approaches to Considering the Safety of Dietary Supplements (106-115) Appendix B Existing Frameworks of Systems for Evaluating the Safety of Other Substances (116-123) Appendix C Possible Combinations of Scores (124-137) Appendix D Table of Food and Drug Administration Actions on Dietary Supplements (138-139) Appendix E Presenters at the Open Sessions of the Project on the Framework for Evaluating the Safety of Dietary Supplements (140-140) Appendix F Biographical Sketches of Committee Members (141-144)

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OCR for page 138
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements 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

OCR for page 139
For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements 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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warned consumers