FDA Warns Reviva Labs For Collagen-Building, Anti-Inflammatory Claims
This article was originally published in The Rose Sheet
Executive Summary
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.
You may also be interested in...
MGC Navigates Regulatory Uncertainty With Cannabis Skin Care
US regulations concerning use of cannabinoid CBD in consumer products are complex and hazily defined, representing an additional set of challenges for companies launching CBD-based skin care to an already heavily regulated market. MGC Derma does not expect FDA to come down on its CBD use per se, but the firm's specific product claims could still be subject to scrutiny.
What Comes First In Consumer Sector: FDA Excessive Claims Finding Or Facility Inspection?
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.
What Comes First In Consumer Sector: FDA Excessive Claims Finding Or Facility Inspection?
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.