MoCRA – Duane Morris Life Sciences Law

June 27, 2024 by Duane Morris

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

November 8, 2023 by Duane Morris

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.

October 20, 2023October 24, 2023 by Duane Morris

MoCRA featured on the Class Action Weekly Wire Podcast with Guest Kelly Bonner

In Episode 35 of the Class Action Weekly Wire podcast, host Jerry Maatman interviews Duane Morris associate Kelly Bonner about the Modernization of Cosmetics Regulation Act (MoCRA). Watch the episode below:

October 5, 2023 by Duane Morris

Federal Regulatory Laws Due Overhaul after MoCRA

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)—the first major statutory change to the U.S. federal government’s ability to regulate cosmetics since 1938. Passed with bipartisan
and industry support, MoCRA expands the Food and Drug Administration’s authority over cosmetics, and creates substantial new obligations for manufacturers, packers and distributors of cosmetics intended for sale in
the United States. Here’s what beauty companies need to know.

To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website,

September 15, 2023 by Duane Morris

FDA’s New Electronic Portal for Facility Registration and Product Listing of Cosmetic Product Facilities and Products Under MoCRA

Continuing its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA), and following on the heels of FDA’s Draft Guidance on Facility Registration and Product Listing (previously discussed here), on September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added Section 607 of the federal Food, Drug and Cosmetic Act (FD&C Act).

Draft screenshots of the electronic system, including example submissions, are available for review and comments, along with an interim Federal Register Notice, announcing the new system.draft guidance,

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

July 5, 2023 by Duane Morris

Beauty and Personal Care Products Post-MoCRA Regulatory Compliance Checklist

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.

March 6, 2023 by Duane Morris

US FDA Looks to Move Cosmetics Work

Duane Morris attorney Kelly Bonner was quoted in an article in Chemical Watch on March 3.

“The US Food and Drug Administration has started its search for a deputy commissioner for its new human foods programme, and plans to move certain cosmetics functions to another part of the agency to advance oversight of the products. […]

The inclusion of cosmetics in the proposed restructuring is “very significant”, said Kelly Bonner, associate with law firm Duane Morris.

The move will allow the FDA to implement MoCRA more efficiently and effectively, she told Chemical Watch. To this end, the agency “anticipates closer collaboration between cosmetics and other FDA subject matter experts” in the Center for Drug Evaluation and Research and the Office of Women’s Health, she said.”

To read the full text of this article, please visit the Chemical Watch website (subscription required).