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Small entity compliance guides

This article was originally published in The Tan Sheet

Executive Summary

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)...

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