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What Comes First In Consumer Sector: FDA Excessive Claims Finding Or Facility Inspection?

This article was originally published in The Pink Sheet Daily & The Rose Sheet

Executive Summary

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' facilities. It's possible, however, that conspicuous website claims that overstep cosmetic boundaries are prompting inspections.

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FDA Warns Reviva Labs For Collagen-Building, Anti-Inflammatory Claims

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.

FDA Warning Cites Ageless Derma's Anti-Wrinkle, Brightening Claims

In a warning letter published on FDA's website May 2, the agency identifies two Ageless Derma products as unapproved new drugs due to label and website claims touting body structure/function effects. The laundry list of offending claims offers a resource for companies to use in their own claims-compliance efforts.

FDA Cites Adulteration In Warning Letter To Juice Beauty Manufacturer

FDA’s latest warning letter to a cosmetics firm departs from the agency’s crackdown on drug-like structure/function claims, targeting contract manufacturer Gemdo Cosmetics for facility conditions and evidence of microbial contamination that cause its products to be adulterated under the Federal Food, Drug and Cosmetic Act. In the April 16 letter, FDA cites eye products produced at the firm’s plant, including Juice Beauty offerings subject to a July 2014 recall.

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