After several decades, the U.S. Food and Drug Administration (FDA) will soon be required to update its regulation of cosmetic products following the amendment to Chapter VI of the federal Food, Drug, and Cosmetic Act (FDCA) as a part of the “Modernization of Cosmetics Regulation Act of 2022,” (or, MOCRA), the first piece of legislation of this kind since 1938. On December 29, 2022, President Biden signed into law the omnibus “Consolidated Appropriations Act, 2023,” which contains the provisions for the roll out MOCRA over time.
This legislation supports preventive measures for cosmetics but will, generally speaking, not preempt product liability litigation over same. Moreover, there will be exemptions from Current Good Manufacturing Practices (CGMP) and also from the registration/listing requirements for certain entities, including qualifying small businesses (similar to other FDA regulations). These changes notwithstanding, while cosmetics gained a qualified preemption provision in MOCRA, (there are some exceptions for state laws such as California’s Proposition 65), the legislation also includes a number of specific new, and potentially challenging, regulatory compliance obligations.
With these pending changes, it is imperative that cosmetic manufacturers and importers to begin the process of obtaining proper documentation and representation to ensure their products will be complaint in advance of the requirements MOCRA being implemented and enforced by FDA. The good news is, implementing these actions will take time, with the effective date of enforcement being postponed for one year – even up to two years for other labeling requirements. Additionally, the CGMP requirements likely be subject to enforcement for an indeterminate initial period given the inherent need to interlace the new requirements with those already established under FDA’s authority. Lastly, but perhaps quite significantly, this legislation also does not include any additional funding; FDA would need to obtain funding from Congress to the extent necessary to fully implement the new regulatory regime.
Once MOCRA takes effect, it will require cosmetic producers to adhere to or maintain:
- Current Good Manufacturing Practices
- Documentation of product safety substantiation
- Records and reports of adverse events
- Registration and listing requirements (set to commence one-year after enactment)
- Mandatory recall requirements – (when FDA determines a reasonable probability that a cosmetic product is adulterated or misbranded and the use or exposure to the product will cause serious adverse health consequences or death)
- Additional labeling requirements
- Records inspection requirements – (expands FDA’s access to certain records)
If you are concerned about how these new requirements will affect you and what you need to do to prepare, please do not hesitate to contact us. Our Regulatory Specialists and Attorneys have the experience and knowledge to help you evaluate this emerging regulatory framework from the outset through to implementation.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
