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Ephedrine alkaloids

This article was originally published in The Tan Sheet

Executive Summary

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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Ephedra meeting

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)

Ephedrine alkaloids

Comment period extension for submitting new usage data and scientific information on ephedrine alkaloid-containing supplements sought by House Government Reform Committee Chair Dan Burton (R-Ind.) in an April 27 letter to FDA. Burton says the 45-day comment period is "considerably inadequate" for public review of more than 270 newly released AERs and FDA's analyses of the reports, which were made public April 3 (1"The Tan Sheet" April 10, p. 6). The congressman requests the May 18 deadline be extended through Dec. 31, and advises FDA allow at least one month after close of the comment period before holding a public forum. Burton warns the committee could request GAO "conduct an additional review of the scientific basis for any future FDA proposals for these products"

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