Ephedra Research I: FDA/HHS Documents

A good introduction to the issue: FDA White Paper on Ephedra (2003-02-23)

Most recent action : FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products (2004-02-06)

** The blue star indicates particularly interesting material; our comments are in Arial font grey text.

FDA Dockets

This is a selective listing; to see all the docket entries search the FDA Docket Dailies

FDA Docket 95N-0304

• FDA Docket 95N-0304, Senators Kennedy and Durbin and Representative Waxman, 2003-05-03 (Deposition of Carol Boozer DsC, pp 38 ff)
• FDA Docket 95N-0304 - Metabolife Serious Adverse Events (Full Report) (6 March 2003)
• FDA Docket 95N-0304 - Metabolife Serious Adverse Events (Appendix 2) (6 March 2003)
• FDA Docket 95N-0304, Dr George Blackburn, Beth Israel Deaconess Medical Center, 4 April 2003
• FDA Docket 95N-0304, American Society for Clinical Nutrition, 7 April 2003
• FDA Docket 95N-0304, American Society for Clinical Pharmacology, 7 April 2003
• FDA Docket 95N-0304, National Nutritional Foods Association, 7 April 2003
• FDA Docket 95N-0304, Metagenics Inc, 7 April 2003
• FDA Docket 95N-0304, American Academy of Pharmaceutical Physicians, 7 April 2003
• FDA Docket 95N-0304, Pennsylvania Medical Society, 7 April 2003
• FDA Docket 95N-0304, National Association of Boards of Pharmacy, 7 April 2003
• FDA Docket 95N-0304, Orange County Medical Association, 7 April 2003
• FDA Docket 95N-0304, Metabolife International Inc, 8 April 2003
• FDA Docket 95N-0304, American Academy of Family Physicians, 8 April 2003
• FDA Docket 95N-0304, California Department of Health Services, 9 April 2003
• FDA Docket 95N-0304, Massachusetts Medical Society, 9 April 2003
• FDA Docket 95N-0304, National Organization of Rare Diseases, 18 March 2003
• FDA Docket 95N-0304, Christopher Grell Esq., 2003-03-28

Form letters anyone? Christopher Grell, calling FDA's attention to an industry form letter

• FDA Docket 95N-0304, American Medical Association, 28 March 2003
• FDA Docket 95N-0304 - Use of Ephedra-Containing Products in the U.S. Population: Date From the Slone Survey. A Comment Submitted to FDA Docket No. 95N-0304, David W. Kaufman, Sc.D., Judith P. Kelly, M.S., Allen A. Mitchell, M.D. (Word file; check our Tools link if you need a viewer to read this file)
• FDA Docket 95N-0304, Dr Arthur Grollman, SUNY Stonybrook University, 19 March 2003
• FDA Docket 95N-0304, Dr Arthur Grollman, SUNY Stonybrook University, 4 April 2003
• FDA Docket 95N-0304 - Richard Kreider PhD, CENPHR, Baylor University, 3 March 2003

Related: The Alleged Role of Ephedra in the Death of a Professional Baseball Player, Richard B. Kreider, Ph.D., FACSM, EPC, FASEP Mike Greenwood, PhD, CSCS*D, Lori Greenwood, PhD, ATC, LAT, Brian Leutholtz, PhD, FACSM. Exercise & Sport Nutrition Lab Center for Exercise, Nutrition & Preventive Health Research, Baylor University (February 21, 2003)

• FDA Docket 95N-0304, Dr Donald Marcus, Baylor College of Medicine, 31 March 2003
• FDA Docket 95N-0304, Dr. Raymond Woosley, University of Arizona HEalth Sciences Center, 2003-04-03
• FDA Docket 95N-0304, Dr John J Cienki, Associate Professor of Medicine , University of Miami, Associate Medical Director of Clinical Research, Jackson Memorial Hospital, 7 April 2003
• FDA Docket 01N3222, Thomas Tiedt PhD, Med Tox Inc, 2 July 2002 (pervasive violations of ethical guidelines, research protections, FDA and HHS regulations, fraud, scientific misconduct, IRB shopping, and IRB/sponsor collusion alleged from depositions in epdedra litigation)

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FDA Docket 00N-1200

• FDA Docket 00N-1200 Dietary Supplements Containing Ephedrine Alkaloids
• Public Meeting on the Safety of Dietary Supplements Containing Ephedrine Alkaloids, Volume I of II (HHS Office on Women's Health, August 8, 2000)
• Public Meeting on the Safety of Dietary Supplements Containing Ephedrine Alkaloids, Volume II of II (HHS Office on Women's Health, August 9, 2000)
• FDA Docket 00N-1200 Dietary Supplements Containing Ephedrine Alkaloids - Adverse Event Reports

FDA Docket 98N-0148

• FDA Docket 98N-0148 - Dietary Supplement Safety & Science Coalition, Garry T Pay (26 January 1999)
• FDA Docket 98N-0148 - Hyman, Phelps & McNamara, A. Wes Siegner, Jr (26 January 1999)
• FDA Docket 98N-0148 - WHO's Critical Review of Substances considered by the 31th ECDD in June 1998 (2 February 1999)
• FDA Docket 98N-0148 - Summary of info submitted to WHO 5/1998 (2 February 1999)
• FDA Docket 98N-0148 – Index

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HHS and Additional Related Material

Adverse Events with Ephedra and Other Botanical Dietary Supplements FDA Medical Bulletin September 1994

FDA/CFSAN Minutes of the Special Working Group on Food Products containing Ephedrine Alkaloids of the FDA Food Advisory Committee 11-12 October 1995

Food Advisory Committee Meeting on Dietary Supplements Containing Ephedrine Alkaloids. August 27-28, 1996

• Transcript, Food Advisory Committee Meeting on Dietary Supplements Containing Ephedrine Alkaloids (1996-08-27)
• Transcript, Food Advisory Committee Meeting on Dietary Supplements Containing Ephedrine Alkaloids (1996-08-28)

Statement from FDA Deputy Commissioner Crawford Regarding Metabolife (2002-08-15):

Three weeks ago, we asked the Department of Justice to pursue a criminal investigation of Metabolife – whether they made false statements to FDA regarding the existence of adverse event reports.

Since at least 1997, the FDA has tried to get these adverse event reports from industry. We also unsuccessfully sought these reports through litigation. Metabolife has refused and resisted us every step of the way.

Given their long history of being uncooperative, we view their offer to make these reports available now to be disingenuous. We are greatly disturbed that Metabolife has repeatedly refused to cooperate with the FDA, and news that so many reports exist greatly heightens our concern.

Once we get these reports, the FDA will have a special task force review them.

Remember, Congress placed the burden on the Secretary of Health and Human Services to prove that these products are unsafe. Thus, the Secretary called for an extensive scientific review of ephedra in June to establish a scientific base for addressing health concerns around ephedra. The Rand Corporation is conducting a comprehensive review of the existing science on ephedra, and the NIH will use this information to guide an expanded research effort on the safety of the product.

Consumers may wish to consult their physicians before using this product.

Meeting Minutes of the National Advisory Committee for Complementary and Alternative Medicine (NCCAM at NIH), Report of the Ephedra Working Group 17 March 2003

Report of the Ephedra Working Group NCCAM/NIH as per above (March 2003)

Project Title: Case-control Study To Investigate the Safety of Ephedra NCCAM/NIH Research Concept (under consideration 2003)

Background Summary for Nomination of Ephedra Substances Nominated to the NTP for Toxicological Studies and Testing Recommendations Made by the NTP Interagency Committee for Chemical Evaluation and Coordination (ICCEC) on April 17, 2002

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Last Updated: 2005-02-26

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