Small entity compliance guides
This article was originally published in The Tan Sheet
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)...
You may also be interested in...
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
DIETARY SUPPLEMENT NEW LABELING REQUIREMENTS EFFECTIVE MARCH 23, 1999 under three final rules published in the Sept. 23 Federal Register. The rules implement some major provisions of the Dietary Supplement Health & Education Act of 1994 regarding the format and terms to be used in labeling. Proposed versions of the rules were published Dec. 28, 1995 ("The Tan Sheet" Jan. 1, 1996, pp. 16-20).
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.