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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

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

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 00N-1200

FDA Docket 98N-0148


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

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 pdf icon 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


Last Updated: 2005-02-26

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