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FDA ephedrine proposal

This article was originally published in The Tan Sheet

Executive Summary

Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) request staff briefing on dietary supplement issues, including FDA's proposed rule on ephedrine alkaloid-containing supplements, in Feb. 4 letter to agency. The letter says FDA's 1997 proposal to restrict serving sizes to 8 mg "appears to be based on 13 adverse event reports" and asks whether the number is "quantitatively sufficient, based on reasonable estimates of consumption for these products, to establish a causal relationship on which to base a serving limitation." The senators also ask whether the agency has "analyzed the trend in AERs to determine whether the number of scientifically reliable AERs" has changed since a 25 mg per serving, 100 mg per day standard was adopted by "major segments of the industry." They additionally seek updates on FDA regs on Good Manufacturing Practices for supplements and structure/function claims and request a briefing by Feb. 15

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