What Comes First In FDA Land, Excessive Claims Finding Or Facility Inspection?
This article was originally published in The Rose Sheet
Recent warning letters to Reviva Labs and Ageless Derma manufacturer Crescent Health Center cite claims violations brought to FDA's attention through inspections of the companies' manufacturing facilities. It's possible, however, that conspicuous website claims that overstep cosmetic boundaries are prompting inspections – further reason for companies to keep their claims in check.
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Agency inspectors observed a range of insanitary conditions and practices at the Blacksburg, Virginia-based manufacturing site that turns out Bioque and Vouray skin-care products, causing the products to be adulterated, according to an FDA warning letter.
Cosmetic firms already are being closely watched by FDA for overreaching product claims, but if formal good manufacturing practices are established for the sector down the road under regulatory reform legislation, companies could be targeted increasingly with warning letters like that issued to Beauty & Health International for quality-control violations at its Garden Grove, California facility.
FDA cites Reviva for unapproved drug claims on eight of its products marketed as cosmetics. Included among targeted claims are familiar statements about collagen production, inflammation reduction and other benefits the agency views as structure/function effects. A number of the claims onceivably could be allowed under the revised "cosmetic" definition proposed by the Cosmetic Modernization Amendments of 2015.