The Changing Beauty Regulatory Landscape

Duane Morris attorney Kelly Bonner was quoted in an article in WWD on June 25, 2024.

“A big deadline in the beauty and personal care regulatory landscape is fast approaching, with much more to come — although some experts believe this still isn’t enough.

Under the Modernization of Cosmetics Regulation Act, or MoCRA, passed by Congress at the end of 2022, cosmetics companies across the U.S. are required to register their facilities to the Food and Drug Administration by Monday, pushed back from the original deadline of December. They must also list each marketed cosmetic product, including product ingredients, and provide any updates annually. […]

As for what else is still to come, the industry is awaiting the FDA to issue guidance on good manufacturing practices, set to be published in 2025.

On this, Kelly A. Bonner, an associate at law firm Duane Morris, said: “They’re not reinventing the wheel. There are standards out there. It’s just going to be what the FDA say is the standard in the United States.” […]

Bonner, for one, believes the industry has been taking the changes seriously and that the goal for the FDA is to get through the first few years of MoCRA and then take stock.

“Ultimately FDA is going to take a hard look at it and think, ‘OK, what are our enforcement priorities now that we have the data, now that we’ve got everything in place? How do we tweak this? How do we refine this to better assist the industry, to better aid consumers?’”

To read the full text of this article, please visit the WWD website

 

 

FDA Pushes Back Enforcement Deadline for MoCRA Facility Registration and Product Listing Requirements

Today, FDA announced updated guidance regarding its MoCRA rollout.

FDA  does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.

To read the full text of this post by Kelly Bonner,  please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog.

Rick Ball and Coleen Hill to Speak at MassMedic Regulatory Roundup Event

Duane Morris attorneys Rick Ball and Coleen Hill will speak at the MassMedic Regulatory Roundup Event webinar on February 16, 2023, starting at 9 a.m. Their presentation is titled “Recent Developments on the ‘Fraud on the FDA’ Theory of False Claim Liability” at 10:45 a.m.

This program is designed to give RA, QA and C-level executives updates on the global and domestic regulatory issues facing the industry. The agenda includes comprehensive presentations by CDRH, industry representatives and regulatory experts.

For  more information or to register, please visit the MassMedic website.

Year-End Appropriations Bill Overhauls FDA Cosmetics Authority

On December 23, 2022, Congress significantly expanded the FDA’s regulatory authority over cosmetics as part of its year-end Consolidated Appropriations Act of 2023, the first major statutory change to the Food, Drug and Cosmetics Act regarding the regulation of cosmetics since 1938. Passed with bipartisan support and garnering industry approval, the Modernization of Cosmetics Regulation Act contains a number of key provisions, requirements and dates for compliance.

To read the full text of this Duane Morris Alert, please visit the firm website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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