At Lachman Consultant Services, we pride ourselves on being a preferred partner for quality, compliance, and regulatory consulting services for the life-sciences sector. However, we provide services to every sector regulated by the FDA except food and tobacco, and there are a lot of changes coming down the pike in the regulation of cosmetic products as new requirements for cosmetics come into effect at the end of this month under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Considering this swiftly approaching deadline for compliance, this was the subject of keen interest at the Food and Drug Law Institute’s (FDLI) “Enforcement, Litigation, and Compliance Conference” held in Washington, D.C. on December 6 and 7, 2023. Lachman was there to capture the highlights impacting the cosmetics industry, and Lachman is poised to assist companies in understanding the requirements and implementing effective processes to comply with them.
MoCRA is the first significant change in the laws regulating cosmetics since 1938, greatly expanding the FDA’s authority to regulate these products, and creating plenty of new requirements for manufacturers of cosmetics products, including makeup, nail polishes, moisturizers, haircare products, and fragrances. Key provisions of the statute that go into effect on December 29, 2023 include requirements for cosmetics manufacturers to keep records of adverse events (and retain them for six years) and to report significant adverse events to the FDA within fifteen business days. Reporting can be made through the existing downloadable and fillable MedWatch Form 3500A.
The cosmetics manufacturer or distributor (the “responsible person” whose name appears on the label) must maintain records of adequate safety substantiation for the products. Manufacturers need not conduct clinical trials but may use relevant safety data that is already available to support the safety of their products. Additionally, there are new cosmetics labeling requirements, including declaration of fragrance allergens included in the product as well as clear and prominent statements for products intended to be administered or used only by licensed professionals.
Some relief for manufacturers is that there is an extension to the deadline for complying with MoCRA’s requirements for facility registration and product listing. The FDA has published, in its recent guidance, that it will not enforce the registration and product listing requirements until July 1, 2024.
MoCRA also expands the FDA’s authority to regulate cosmetics products, including authority to access and copy a company’s records concerning cosmetic products, and ordering a mandatory recall if the Agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and use of or exposure to the cosmetic will cause serious adverse health consequences or death. Importantly, MoCRA requires the FDA to issue a proposed rule for Good Manufacturing Practice (GMP) for cosmetics by December 29, 2024 and the final rule by December 29, 2025. The Agency appears to be contemplating existing national or international standards, such as ISO 22716:2007, as it looks to develop its regulations.
Some exemptions (including GMP, facility registration, and product listing requirements) are made for certain small businesses, but caution, reader: there are exceptions to the exemptions!
There is certainly plenty to watch for in this space as cosmetics manufacturers prepare to comply with MoCRA’s requirements and as we await the Agency’s proposed GMP rules next year. This long overdue attention to the multibillion-dollar cosmetics marketplace will help ensure that products are safe and comply with regulatory requirements. Lachman is here to assist you in preparing for and navigating the upcoming requirements in 2024 and beyond!