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Products Liability Law
• 3 years - PFAS: FDA has until January 2026 to “publish its report on the assessment of the use of PFAS in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use. In conducting such assessment, the Secretary may, as appropriate, consult with the National Center for Toxicological Research.” Per- and polyfluoroalkyl substances (PFAS) are man-made chemicals widely used or added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara. PFAS may also be present in cosmetics unintentionally as the result of raw material impurities or due to the breakdown of PFAS ingredients that form other types of PFAS. PFAS are used to condition and smooth the skin, making it appear shiny, or for product consistency and texture.
• Animal Testing: Congress found “it is the sense of Congress that animal testing should not be used” for safety testing and should be phased out but “with the exception of appropriate allowances.”
Enforcement
Cosmetics are now subject to adverse event reporting and 15-day reporting requirement for serious adverse events. Adverse event records must also be maintained for 6 years.
• Cosmetic manufacturers are now required to demonstrate an “adequate substantiation of safety.” The term “adequate” is defined to mean testing, research, or other evidence. For “substantiation” FDA relies on the standard the Federal Trade Commission has applied requiring “competent and reliable scientific evidence” to support claims of benefits and safety. The term “safe” is generally and broadly defined requiring that a cosmetic ingredient or cosmetic shall not be considered “injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users.”
• Recalls: MOCRA brings cosmetics into the fold of FDA regulated products subject to mandatory recall authority. For cosmetic manufacturers, this authority will require due diligence in auditing suppliers, manufacturers and ensuring insurance and the ability to handle a recall.
• Prohibited Acts: Section 331 is also amended to ensure a violation is a “prohibited act,” which is subject to criminal sanctions. The Act gives FDA power to suspend a registration which renders a manufacturer incapable of doing business.
As the marketplace strives for newer, more complex, novel, and effective ways to improve the appearance of humans and animals, FDA has a daunting task of keeping up. Prior to MOCRA, the cosmetics industry was not exempt from oversight, regulation and enforcement for adulteration and mislabeling. What the law does accomplish is to provide FDA and its state partners with a roadmap to what is in the marketplace and an efficient mechanism for removing products that do not comply.
The changes to the law under MOCRA are not merely “cosmetic” and, as with any significant change in the law and regulatory framework, it is not what you know but what you do not know that causes time consuming and expensive business disruption. Reach out with questions and for guidance before a compliance or litigation issue arises might ensure compliance, no disruption and peace of mind.
Michael Walsh is Senior Counsel at the Clark Hill firm in Dallas, TX. Contact him at: mwalsh@ClarkHill.com.
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FDCC ANNUAL INSIGHTS 2023