In the US cosmetics industry, adherence to Good Manufacturing Practices (GMPs) has historically been voluntary, albeit highly encouraged. However, with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), there is a significant shift as GMP requirements will become mandatory for all cosmetic manufacturers.
What is MoCRA?
On December 29, 2022, U.S. President Joe Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) into law, amending Chapter VI: Cosmetics of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and introducing new provisions for cosmetic products. This marks the first substantial amendments to the U.S. Food and Drug Administration’s (FDA) regulatory oversight for cosmetic products since 1938, bringing cosmetic regulations in the country up to date with modern needs.
The regulatory changes brought by MoCRA impact various stages of the cosmetic product’s lifecycle, resulting in heightened scrutiny and more stringent compliance obligations on cosmetic businesses. Most provisions take effect one year from enactment, or by December 29, 2023. During this time, cosmetics enterprises should familiarize themselves with the new legislation and its key deadlines, and promptly prepare to take appropriate measures to comply with the new regulatory requirements, thereby successfully handling the evolving landscape of cosmetic regulation in the United States.
Understanding GMPs under US MoCRA for Cosmetics
GMPs are fundamental practices designed to ensure that cosmetic products are consistently produced under quality-controlled conditions. Previously, many manufacturers viewed GMPs as a best practice rather than a strict legal obligation. The upcoming changes under MoCRA will change that dynamic, making compliance with GMP measures a legal requirement.
Under the new regulations, the FDA will formulate and enforce mandatory GMP standards that align with both national and international standards, such as ISO 22716. This initiative is aimed at not only harmonizing US regulations with global benchmarks but also in reinforcing the overall quality and safety of cosmetic products available in the market.
Exemptions from MoCRA GMPs Guidelines
MoCRA exempts certain small businesses (a business with average gross annual sales for the previous three-year period of less than $1,000,000) from GMP.
Such exemptions do not apply to the manufacturers or facilities that manufacture the following cosmetic products:
- Products that regularly come into contact with mucus membrane of the eye
under customary or usual conditions of use; - Products that are injected;
- Products that are intended for internal use; and
- Products that are intended to alter the appearance for more than 24 hrs. under customary or usual conditions of use and removal by the consumer is
not part of such use.
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
Implementation Timeline
To facilitate the transition towards enhanced regulatory compliance, the FDA is expected to issue a proposed rule on the GMP regulations by December 29, 2024, with finalization anticipated by December 29, 2025. It is crucial to note that after this period, any cosmetic product manufactured or processed without meeting the GMP conditions will be deemed adulterated, underscoring the importance of strict adherence.
Conclusion
The move towards mandatory GMPs marks a transformative moment in the US cosmetics industry. By ensuring alignment with both national and international standards and addressing the unique needs of smaller businesses, the FDA is set to elevate product safety and quality. Manufacturers should stay proactive and informed to meet these new regulatory requirements, thereby safeguarding their market presence and consumer trust.
