Source - Dietary Supplement & Cosmetics Legal Bulletin | Issue 69

FDA Takes Steps to Implement MoCRA

In 2023, the U.S. Food and Drug Administration (FDA) took several steps to implement the Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law in December 2022. The law requires cosmetic manufacturers to register each of their facilities and give FDA information about product ingredients. The law also gives FDA the authority to issue mandatory product recalls.

FDA Proposes Moving Cosmetics Regulation to Office of Chief Scientist

In late February 2023, FDA Commissioner Robert Califf announced the agency’s plans to restructure its Human Foods Program and Office of Regulatory Affairs. The agency said the proposed reorganization will help prepare for MoCRA implementation by moving cosmetics regulation and color certification out of the Center for Food Safety and Applied Nutrition and into the Office of Chief Scientist. Califf provided an update in December 2023 that FDA’s proposed reorganization package is now under review at the U.S. Department of Health and Human Services, which begins the formal external review process. In a release, he said the agency hopes to implement the reorganization in 2024.

FDA Issues Draft Guidance on Cosmetic Product Facility Registrations and Product Listings

In August 2023, FDA issued draft guidance on cosmetic product facility registrations and product listings. FDA issued final guidance for industry in December 2023 that explains the statutory requirement to submit cosmetic product facility registrations and product listings, definitions, details of submission requirements and methods of submission.

FDA Announces MoCRA Enforcement Delay

In November 2023, FDA issued guidance to industry delaying enforcement of MoCRA’s requirements regarding cosmetic product facility registration and cosmetic product listing requirements until July 1, 2024. FDA also will not enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetics products first marketed after December 29, 2022, until July 1, 2024.

FDA Announces Launch of Electronic Submission Portal

In December 2023, FDA announced the launch of its Cosmetics Direct electronic submission portal. The portal is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions. In preparation for the new portal, FDA announced in March 2023 that it had stopped accepting and processing submissions to the Voluntary Cosmetic Registration Program.

GAO Issues Report on MoCRA Implementation Process

The Government Accountability Office (GAO) released a December 2023 report reviewing FDA oversight of cosmetic safety. "Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law" examined research on the safety of selected substances in cosmetics and FDA actions to implement its new authorities and the extent to which these actions addressed selected leading practices for agency reforms. The agency found that FDA had not fully addressed leading practices that would help ensure the success of FDA's reforms, including the development of an implementation plan for MoCRA or a strategic workforce plan to ensure FDA has the necessary personnel to exercise its new authorities. GAO made seven recommendations to strengthen FDA's efforts to implement its new cosmetic safety oversight responsibilities, and FDA concurred with the recommendations.

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