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

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.

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.

Counterfeit Cosmetics: Fake Beauty, Real Danger

On Jan. 30, the U.S. Government Accountability Office issued a report on the threat of counterfeit products to consumers.[1] Among other things, the report highlighted the prevalence of counterfeit cosmetics on popular e-commerce websites such as Amazon.com Inc. and eBay Inc., noting that 13 out of 13 samples purchased from third-party sellers with exceptional approval ratings were fake.[2]

In the age of e-commerce, counterfeit cosmetics present a growing challenge — not only do they pose significant health risks to consumers, but they raise serious legal concerns for brand manufacturers, distributors and retailers.

A Growing Problem

It is no secret that personal care is big business. According to a report commissioned by the Personal Care Products Council and prepared by PricewaterhouseCoopers, the U.S. personal care industry — which encompasses color cosmetics, perfumes, moisturizers, shampoos, hair color and deodorants — was alone responsible for $236.9 billion in gross domestic product in 2013.[3]

As of January 2018, individual spending on personal care products was forecast to grow at an annual compounded rate of four percent between 2018 and 2022.[4] Yet, as cosmetics sales have steadily increased, so too have sales of counterfeit cosmetics.[5]

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