April 29, 2024 - In March, as part of its proposed public health funding budget for FY2025, the US FDA requested $8M to support the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). Not only will the funds be used to develop and manage the regulation of MoCRA provisions, but the FDA specifically announced its plan “to hire additional subject matter experts … [to assess] the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.” With new, enforceable PFAS regulations on the horizon, the cosmetics industry will need reliable partners, like ALS, to help navigate cosmetics compliance challenges.
The first major update to the US Federal Food, Drug, and Cosmetic (FD&C) Act since it established national cosmetics regulation in 1938, MoCRA was enacted in December 2022, and its phased roll-out is underway. Understanding the repercussions of MoCRA is critically important. Non-compliance with the Act’s stringent rules governing ingredients, manufacturing processes, documentation, testing, inspection, and certification of cosmetics products could place your company at risk given the FDA’s enhanced enforcement powers—including the new legal authority to require a mandatory recall of cosmetics.
The FDA’s plan to assess the presence of PFAS in cosmetics products under MoCRA presents cosmetics manufacturers with an important challenge. PFAS, commonly known as “forever chemicals” because they do not break down in the environment, are used in the manufacture of a wide variety of consumer goods, including cosmetics such as lipsticks, eyeshadows, moisturizers, rouges, nail polish and enamel, blushers, and cleansers. PFAS are added to cosmetics to condition and smooth skin and hair or affect product consistency and texture. Even for cosmetic products without added PFAS ingredients, PFAS may be present unintentionally as the result of raw material impurities and contamination during manufacturing and packaging.
Because they are so indestructible, PFAS accumulate in the environment and inside of us. According to the US Centers for Disease Control and Prevention (CDC), more than 97% of the US population has PFAS in their bodies. This prevalence of PFAS has led to ongoing investigation of their potential negative health impacts and given rise to public concern about PFAS contamination. While health effects are still being studied, some states have already banned the use of some PFAS, and more regulations are coming.
Because expert testing and reliable data are critical to developing the right strategies to meet your regulatory obligations, you need a partner that has the experience, knowledge and scale to help you navigate the coming challenges. At ALS, we are not only experts in providing professional beauty and personal care testing – from product efficacy to safety to the full scope of routine and specialty analysis for over-the-counter drugs (OTC), personal care product brands, and manufacturers – but as pioneers of PFAS testing in the US, we have over two decades of experience in providing PFAS sample testing and analysis services.
Other labs that perform environmental PFAS testing may lack experience with the unique testing challenges cosmetics present due to their variety of matrices: from solids and semi-solids to emulsions, propellants, serums, and liquids. Our work at the forefront of PFAS testing of beauty and personal care products gives us a legacy of knowledge and expertise that offers our clients confidence in our ability to provide quick turnaround times and highly accurate results for cosmetics as well as cosmetics packaging.
Constantly monitoring the latest developments on PFAS has enabled us to scale up in anticipation of new regulations and FDA enforcement powers, and to standardise practices at our globally unrivaled laboratory network.
Stay ahead of the competition by partnering with us to help enable your compliance and all cosmetic industry regulations. Contact us: beauty.usa ( @ ) alsglobal dot com
About ALS Limited
A global leader in testing, ALS provides comprehensive testing solutions to clients in a wide range of industries around the world. Using state-of-the-art technologies and innovative methodologies, our dedicated international teams deliver highest-quality testing services and personalized solutions supported by local expertise. We help our clients leverage the power of data-driven insights for a safer and healthier world.
References
https://www.fda.gov/news-events/press-announcements/fda-seeks-72-billion-enhance-food-safety-and-nutrition-advance-medical-product-safety-and-strengthen
https://www.fda.gov/cosmetics/cosmetic-ingredients/and-polyfluoroalkyl-substances-pfas-cosmetics
https://www.alsglobal.com/
Contact Information
David Klowden
ALS Limited
