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Agency says claims found online establish product as a drug.
February 11, 2021
By: Christine Esposito
Editor-in-Chief
Clarke Pharmaceutical Manufacturing, Inc., Webster, TX, has been sent a warning letter by the FDA following a review of the company’s website in December 2020 and January 2021 in which the agency flagged select products, including a topical skin cream. According to FDA’s letter, claims made on Clarke Pharmaceutical Manufacturing’s website establish its Natural Progesterone Skin Cream as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act because it is intended for u...
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