MoCRA Registrants Encouraged By Glimpse Into Cosmetics Direct Portal, But Apprehensions Remain
Jessica O’Connell, partner at Covington & Burling, is getting questions from clients about the electronic system the FDA plans to launch in coming weeks for cosmetics manufacturers to register facilities and list products as required by new cosmetics regulations. It remains to be seen how hard the 29 December 2023 deadline will be for companies to get their information submitted.
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In comments on FDA draft guidance released in August, industry members raise questions about the agency’s capacity to deal with an anticipated flood of facility registrations and product listings. Confidentiality and international trade also figure among concerns.
“Lawmakers are not distinguishing between a cosmetic drug and a cosmetic that has no drug application at all,” says Carlos Gutierrez, CHPA’s state legislature lobby chief. Issues important to consumer health products industry can be found in unlikely places, he also tells HBW Insight.
The director of FDA’s Office of Cosmetics and Colors addressed questions on the responsible person required by the Modernization of Cosmetics Regulations Act, safety substantiation, adverse event reporting and more at the IBA virtual event.