Ephedra Rule Cites Lack Of Safety Data In Vulnerable Subjects
This article was originally published in The Tan Sheet
Research weighed by FDA in evaluating the safety of ephedrine alkaloid-containing dietary supplements was lacking in subjects that were adequately representative of the broader population, the agency maintains in the 1final rule banning the botanical
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FDA's draft guidance on new dietary ingredient notifications already is arousing fierce pushback from the supplement industry over what constitutes an NDI and which substances cannot be dietary ingredients at all.
FDA proposes small entity compliance guides for separate final rules concerning ephedra and nutrition claims in order to help small businesses understand the regulations. In a July 17 Federal Register notice, FDA solicits comments on a 1guide for a 2004 final rule declaring dietary supplements containing ephedrine alkaloids adulterated for presenting an unreasonable risk of illness or injury under conditions of use recommended in labeling (2"The Tan Sheet" Feb. 16, 2004, p. 10). A July 18 notice says FDA is accepting comments on an 3SECG on a 1997 final rule amending regulations defining the terms "high potency" and "antioxidant" for use in supplement nutrient content claims (4"The Tan Sheet" Sept. 29, 1997, p. 1)...
A Utah federal court has barred FDA from enforcing its ban on ephedra products containing 10 mg or less of ephedrine alkaloids per daily dose