regulatory – Duane Morris Products Liability

June 26, 2024June 27, 2024 by Duane Morris

The Latest Changes to the 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

November 8, 2023 by Duane Morris

Deadline for MoCRA Facility Registration and Product Listing Requirements Pushed Back to July 1, 2024

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.

September 27, 2023September 27, 2023 by Will Heaston

FDA Releases New Draft Guidance Documents to Modernize the 510(k) Process

On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In issuing these draft guidance documents, the FDA has followed through on that promise.

Continue reading “FDA Releases New Draft Guidance Documents to Modernize the 510(k) Process”

July 26, 2023July 28, 2023 by Duane Morris

Business of Fashion Article Quotes Duane Morris Attorney Kelly Bonner

Duane Morris attorney Kelly A. Bonner was quoted in an article in The Business of Fashion titled “What Beauty Needs to Know About the Biggest New Regulations in 80 Years,” about the Modernization of Cosmetics Regulations Act (MoCRA) recently signed into law. To read the full text of this article, please visit the firm website.

July 6, 2023 by Duane Morris

Regulatory Compliance Checklist Post-MoCRA for Beauty and Personal Care Products

MoCRA, Pub. L. No. 117-328, represents the first major statutory change to the authority of the Food and Drug Administration (FDA) to regulate cosmetics since the Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 361 et seq., in 1938 and the Fair Packaging and Labeling Act (FPLA), 21 C.F.R. § 701.3, in 1966.

This checklist outlines key regulatory compliance considerations that are specific to personal care products marketed in the United States following the enactment of the federal Modernization of Cosmetics Regulation Act (MoCRA) on December 23, 2022.

To read the full text of this Lexis Nexis Practical Guidance Checklist by Duane Morris attorneys Driscoll Ugarte, Rick Ball, Alyson Lotman, Kelly Bonner and Coleen Hill, please visit the firm website.

December 7, 2022 by Duane Morris

L’Oreal Case Highlights Legal Risks Of Anti-Aging Claims

It is a truth universally acknowledged that a woman over 30 must be in want of an eye cream. Or a serum. Or anything, really, so long as it recreates the appearance of youth, vitality or an actual night’s sleep.

The global market for anti-aging cosmetics is expected to reach $93.1 billion by 2027. But as illustrated by a recent decision from the U.S. District Court for the Southern District of New York, Lopez v. L’Oréal USA Inc., promises that a product can turn back time by “restoring skin” or “promot[ing] cell regeneration” can prove costly for brands looking to capitalize on this growing market.

Brands should be mindful of litigation and regulatory risk when making certain anti-aging claims.

To read the full text of this article by Duane Morris associate Kelly Bonner, which was originally published in Law360, please visit the firm website.