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What’s In and What’s Out? Cosmetic Companies Face Ingredient Compliance Conundrum

By Helen Ogunyanwo & Helena Alvarez on January 17, 2024
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For many years, personal care companies have used a wide variety of ingredients that are now under scrutiny. Recently, Per- and Polyfluoroalkyl substances (PFAS) have received increased attention. Once intentionally added to products, several state laws ban or modify the total amount of these ingredients permitted in various products. Now, a new bill introduced in U.S. Congress late last year aims to follow suit.

More specifically, on November 30, 2023, U.S. Representatives Debbie Dingell (D-MI), Brian Fitzpatrick (R-PA), and Annie Kuster (D-NH) reintroduced the “No PFAS in Cosmetics Act.” PFAS refer to a wide variety of manmade chemicals that are used in many cosmetic products, ranging from lotions to lipstick. PFAS are commonly added to products because of the ability to condition and smooth skin, making it appear soft and shiny. Previous versions of the bill were introduced in the Senate on June 14, 2021 and in the House on June 17, 2021. These bills directed the Secretary of Health and Human Services (HHS) to issue and finalize a rule banning the use of intentionally-added PFAS in cosmetics. Neither bill passed.

With the recent expansion of the U.S. Food & Drug Administration (FDA) authority over cosmetics, the new bill proposes to amend Section 601 of the Federal Food, Drug, and Cosmetic Act (FDCA) and require the FDA to ban the use of intentionally-added PFAS in cosmetics as of January 1, 2025. “Intentionally-added PFAS” includes a PFAS that (1) has been intentionally added by a manufacturer or supplier to an ingredient, raw material, product, or packaging and has a functional or technical effect on the product or packaging; or (2) is an intentional breakdown product of an added chemical.

On December 1, 2023, the proposed bill was referred to the Subcommittee on Health. Under Section 3506 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA must publish a report no later than December 29, 2025 assessing the use and safety of PFAS in cosmetics. The enactment of the “No PFAS in Cosmetics Act” would include intentionally-added PFAS on the list of prohibited, “adulterated cosmetics” under Section 601 of the FDCA, in advance and irrespective of any FDA assessment required under MoCRA.

With the ever-expanding list of banned ingredients in the U.S. and abroad, cosmetics and other personal care companies can expect increasing scrutiny by legislators and consumer-driven organizations in the near future.

Photo of Helen Ogunyanwo Helen Ogunyanwo
Read more about Helen OgunyanwoEmail
Photo of Helena Alvarez Helena Alvarez

Helena Alvarez helps clients meet their legal and business objectives by counseling them on Antitrust & Competition and Mass Tort, Product & Consumer Litigation matters.

Helena supports clients on a wide variety of antitrust and competition issues. Her antitrust and competition representative experience

…

Helena Alvarez helps clients meet their legal and business objectives by counseling them on Antitrust & Competition and Mass Tort, Product & Consumer Litigation matters.

Helena supports clients on a wide variety of antitrust and competition issues. Her antitrust and competition representative experience includes civil litigation, investigations, and transactions.

Within her torts practice, Helena assists clients in the pharmaceutical, consumer product, and transportation industries with their regulatory and litigation needs.

Helena maintains an active pro bono practice, primarily handling asylum matters.

Helena received her J.D., cum laude, from American University Washington College of Law. In law school, she was a student attorney in the Glushko-Samuelson Intellectual Property Law Clinic and on the executive board of the American University Business Law Review. She earned her B.S.F.S. from Georgetown University.

Born and raised in El Salvador, Helena is a native Spanish speaker.

Read more about Helena AlvarezEmail
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  • Posted in:
    Environmental and Climate, Health Care and Life Sciences
  • Blog:
    Retail & Consumer Products Law Observer
  • Organization:
    Crowell & Moring LLP
  • Article: View Original Source

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