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Ephedra meeting

This article was originally published in The Tan Sheet

Executive Summary

HHS Office on Women's Health to hold a public meeting on safety of ephedrine alkaloid-containing dietary supplements beginning Aug. 8, CFSAN says in a "Dear Colleagues" letter June 8. The meeting, to be held in the Washington, D.C. area, will last for two or three days. A Federal Register notice will provide specific scientific issues to be addressed; possible regulatory actions are not on the agenda. The meeting announcement will be posted on OWH's Web site (www.4woman.gov) on or about June 26. FDA has extended until July 3 the deadline for submitting new usage data and scientific evidence on ephedrine alkaloid-containing supplements; post-meeting comments will be accepted until Sept. 30 (1"The Tan Sheet" May 15, In Brief)

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Ephedrine/Caffeine Combos Safer Than Ephedrine Alone - Researcher

Combining ephedrine alkaloids with caffeine may actually diminish the potential adverse effects of taking ephedrine alone, suggested Arne Astrup, MD/PhD, University of Copenhagen, Denmark, at a Public Health Service meeting on the safety of ephedra supplements.

Ephedra studies

The Ephedra Education Council has assembled a panel of researchers to study the supplement ingredient's safety profile in light of FDA's recent AER review, the industry group announces July 25. EEC charges FDA's approach to ephedra safety "has serious scientific limitations," echoing past comments by Metabolife and the General Accounting Office (1"The Tan Sheet" Aug. 9, 1999, p. 3). The council has asked FDA that the panel, chaired by Stephen Kimmel, MD, University of Pennsylvania, be permitted to present its findings at the Aug. 8 public meeting on ephedra (2"The Tan Sheet" June 12, In Brief). Metabolife is among the sponsors of a safety study conducted by Carol Boozer, St. Lukes-Roosevelt Hospital Center, New York City, who is evaluating data and will attend the public meeting

Ephedrine alkaloids

Comment period extended 45 days to July 3 for submitting new usage data and scientific evidence on ephedrine alkaloid-containing supplements, FDA says in a May 5 letter to House Government Reform Committee Chair Dan Burton (R-Ind.). Burton's requested extension of the May 18 deadline through December "is too long given the potential public health issues in question," the agency replies (1"The Tan Sheet" May 8, In Brief). In separate letters, several Texas congressmen and Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) also sought longer comment periods than granted by FDA. Scientific issues related to ephedrine alkaloid-containing supplements will be discussed at a public meeting in July; an upcoming Federal Register notice will provide additional details. A 30-day comment period will follow the forum


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