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Dietary supplement GMP exemption for small companies requested by botanical firm.

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT GMP EXEMPTION REQUESTED FOR SMALL COMPANIES with less than $5 mil. per year in sales in April 4 comments to FDA from Herbalist & Alchemist, Inc., a botanicals company. The comments discuss aspects of the agency's Feb. 6 ANPR on Good Manufacturing Practices regulations for dietary supplements ("The Tan Sheet" Feb. 10, p. 2). The Broadway, N.J.-based company "strongly urges" a small company exemption, noting that "to adopt [the proposed GMPs] in their entirety would be financially devastating to our company."
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