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.
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.
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.
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.
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.
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.
In recent months, reports of asbestos-contaminated cosmetics 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.
Conducting an online search for “things to avoid while pregnant” will bring back over 100 million hits, advising pregnant women to avoid, among other things, alcohol, caffeine, turkey sandwiches, certain hair dyes and “looking up ‘things to avoid while pregnant.’”
But increasingly, moms-to-be have been given reason to potentially avoid items as unexpected and as varied as shampoo, lipstick, nail polish, moisturizers, fragrances, deodorants and styling products, because of chemicals commonly found in these products that have been linked to potential gestational or developmental harm in unborn children.
Lacking conclusory information about the potential effects of these ingredients, industry participants are left to navigate the risks of promoting and/or labeling their products as safe for pregnant women. Meanwhile, consumers — primarily women, who control an estimated 85 percent of household purchases, and wield in excess of $5 trillion in purchasing power annually — are increasingly concerned about their ability to make informed decisions affecting their reproductive health, as well as the lives of their children. Consequently, these concerns are driving major changes in personal care spending, and creating new risks and opportunities for industry participants.
On Jan. 30, the U.S. Government Accountability Office issued a report on the threat of counterfeit products to consumers. 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.
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.
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. Yet, as cosmetics sales have steadily increased, so too have sales of counterfeit cosmetics.