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.

After MoCRA, Federal Cosmetics Regulatory Laws Due Overhaul

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,

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 UgarteRick BallAlyson LotmanKelly Bonner and Coleen Hill, please visit the firm website.

Following MOCRA’s Enactment, Unpacking Litigation and Regulatory Risk for Cosmetics Brands

On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.

Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products.

To read the full text of this article by Duane Morris attorneys  Rick Ball, Alyson Walker Lotman and Kelly Bonner, please visit the Duane Morris website.

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.

Testing Methods for Asbestos in Talc Will Be Subject of FDA Public Forum

On January 9, 2020, the U.S. Food and Drug Administration announced that it will host an all-day public forum to discuss testing methods for asbestos in talc and cosmetic products containing talc on February 4, 2020.

According to the FDA, the purpose of the meeting is to discuss testing methods, terminology, and criteria that can be used to characterize and measure asbestos, as well as what the FDA preliminarily states may be “other potentially harmful elongate mineral particles (EMPs)” that may contaminate talc and cosmetics products that contain talc.

Read more in the Beauty and Cosmetics category of the Duane Morris Fashion, Retail and Consumer Branded Products blog.

Neon Eyeshadow Has Never Been More Popular, But Is It Safe?

In 2016, it was muted monochromatic makeup. The next year ushered in a spectrum of sunset reds and dusty pinks, and 2018 was the year of technicolor highlighter. With bold beauty trends on the rise, it’s no surprise that 2019 has been declared the year of neon. Pinterest reports that searches for “neon eyeshadow” jumped a whopping 842% over the past few months. For fans, especially Gen Zers, the look is a celebration of fun, commitment-free expression: Daydream, create, wash it off, and repeat. But what happens when experimenting with the latest beauty trends could put your health at risk?

[…]

As for the brands that feature a disclaimer not to use on eyes, and then turn around and show models wearing the product on their eyes, Kelly Bonner, associate attorney at Duane Morris LLP in Philadelphia, had this to say: “All labelling must be truthful, not misleading, and contain all required information in a prominent and conspicuous place. Determining whether a label is misleading requires considering whether it contains deceptive representations, or leaves out material facts or consequences resulting from the intended use of the product.”

To read the full text of this article quoting Duane Morris attorney Kelly Bonner, please visit the Refinery29 website.

Contaminated Cosmetics: Recalls, Lawsuits And Legislation

In recent months, reports of asbestos-contaminated cosmetics[1] have illustrated the enduring challenges of manufacturing and marketing cosmetics as safe for consumers, particularly teens, children and expectant mothers. This is especially true where still-developing science, emotion and rapidly disseminated information (and misinformation) all play critical roles in shaping public perception, even influencing jury outcomes.

This article explores the potential legal challenges for supply chain participants arising from contaminated cosmetics, as well as significant proposals to change the way the U.S. Food and Drug Administration regulates cosmetic safety.

To read the full text of this article by Duane Morris attorney Kelly Bonner, 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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