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Supplement GMP proposal "one-size-fits-all" approach is "naive," commenters maintain.

This article was originally published in The Tan Sheet

Executive Summary

SUPPLEMENT GMP PROPOSAL "ONE-SIZE-FITS-ALL" APPROACH "NAIVE" both technologically and scientifically, a group of joint commenters proclaim in May 7 comments to FDA on the Feb. 7 advance notice of proposed rulemaking suggesting Good Manufacturing Practices regulations for the dietary supplement industry ("The Tan Sheet" Feb. 10, p. 2). The one-size-fits-all approach of the ANPR -- i.e., the same regulatory oversight for companies that just fill capsules and those who grow botanicals and process them -- "is based on a faulty assumption that dietary supplements are, to a degree, fungible when they are extraordinarily diverse and are produced using vastly different techniques and methods of production," the commenters maintain.





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