Attorneys react to FDA draft steerage on beauty facility registration & product itemizing submission necessities


Earlier this week​, the US Meals and Drug Administration (FDA) issued a draft steerage doc​ outlining its suggestions for necessary beauty facility registration and beauty product itemizing submissions in accordance with the Modernization of Beauty Regulation Act (MoCRA) which was signed on the finish of final 12 months. As detailed within the FDA’s most up-to-date press launch, the draft steerage doc “describes MoCRA necessities for facility registration and product itemizing, and the exemptions beneath MoCRA for sure small companies​,” together with vital definitions, deadlines for compliance, and a proposed digital submission framework to exchange the Voluntary Beauty Registration Program (VCRP)​ which the FDA suspended in March of this 12 months. 

To greatest perceive an important takeaways from the FDA’s draft steerage doc concerning the potential affect on US cosmetics manufacturing and provide corporations, CosmeticsDesign interviewed two members of the trade authorized neighborhood for his or her insights.  

We spoke to Kelly Bonner, an affiliate at Duane Morris LLP who focuses on litigation threat and regulatory points affecting companies within the cosmetics and private care industries, in addition to cross-jurisdictional and sophisticated industrial disputes involving FDA-regulated and consumer-branded merchandise.  

Moreover, we interviewed Jessica O’Connell, a regulatory accomplice at Covington & Burling LLP who has beforehand served as Affiliate Chief Counsel for the FDA and at present works in non-public observe helping shoppers in complying with U.S. regulatory necessities for meals, dietary dietary supplements, cosmetics, OTC medicine, and animal merchandise with particular experience advising on FDA’s import and export necessities throughout all product classes. 


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