MoCRA Cosmetics Act: Why Now? 8 PCPC Insights on the Legislation's Inner Workings

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, is now set into motion, starting with requirements for facility registrations and product listings. As the industry knows, this is the first major legislation for cosmetics in the U.S. since 1938. This made us wonder: After 85+ years, why implement it now? What were the drivers? What concerns is it built to address and how? Here, Karin Ross (KR), executive vice president for government affairs at the Personal Care Products Council (PCPC) responds.

See related: What MoCRA Got Wrong [opinion]

1. C&T: How was the PCPC involved in the development of MoCRA? What were the most critical topics to address and why?

KR: The Personal Care Products Council (PCPC) and our member companies actively collaborated with legislators, regulators and industry stakeholders on a bipartisan legislative process that led to the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. Our primary focus was to ensure that the legislation enhances the U.S. Food and Drug Administration’s (FDA) oversight to promote consumer safety, support scientific innovation and enhance transparency. These elements are essential to building consumer trust and advancing the industry's commitment to safety and quality.

2. C&T: Why is MoCRA happening now, after 86 years of the FD&C Act?

KR: MoCRA is a direct result of years-long advocacy, initiated by leadership of the Senate HELP Committee (at the time, Chair Senator Patty Murray and Ranking Member Burr), and stakeholders agreeing on the timely need to modernize cosmetics regulatory oversight due to advances in science and technology, along with increased consumer awareness and demand for transparency and reassurance about the safety of personal care products. MoCRA is the first major update to the FDA’s regulatory oversight since the FD&C Act was signed into law in 1938, giving the FDA new tools to regulate cosmetics and personal care products consistently.

3. C&T: The PCPC stated it was entering the MoCRA process to 'advocate for well-crafted, science-based federal reform' to enhance the industry’s 'ability to innovate.' How do you think MoCRA checks these boxes?

KR: PCPC believes MoCRA enhances consumer and product safety by providing the FDA with new authorities while maintaining and modernizing existing strong safety standards for cosmetics products in the U.S. MoCRA facilitates and encourages continuous improvement and innovation by providing clear and more dynamic regulatory guidelines that foster the development of new, safe and effective products.

4. C&T: Safety has always been a key priority for the FDA and cosmetics industry. Still, many checks and balances have been put into place for federal oversight within MoCRA. Why? Also, how will the FDA prioritize, monitor and enforce these checks and balances?

KR: The cosmetics industry continues to advocate for the harmonization of national and global standards. MoCRA’s requirements provide new opportunities to seek further harmonization and reinforce consumer trust in our products to ensure consistent compliance across the industry. These measures enhance consumer protection and confidence in cosmetics products. The FDA will prioritize, monitor and enforce these standards through a combination of regular inspections, compliance reporting and collaboration with industry stakeholders to ensure adherence to safety protocols.

5. C&T: MoCRA now requires fragrance allergens to be listed. Why was this requirement added now? What other issues could lend themselves to future labeling requirements?

KR: The requirement to list fragrance ingredients reflects increased consumer awareness and demand for detailed ingredient information. Future labeling requirements may come from evolving scientific research on allergenicity, environmental impact and social trends toward greater ingredient disclosure, ensuring consumers have the information they need to make informed choices.

See related: How Cosmetics Companies Can Avoid MoCRA Compliance Pitfalls and Litigation

6. C&T: Cosmetics have become more complex (or 'active'), considering the original definition of what constitutes a cosmetic. Was there discussion about revising this definition? In relation, what other regulatory schemes were reviewed to develop? (e.g., quasi-drugs in Asia?)

KR: While the original definition of cosmetics was reviewed, the consensus was to maintain it, focusing instead on enhancing the regulatory framework to accommodate advances in product complexity and efficacy measurement. MoCRA drew inspiration from global regulatory schemes to create a comprehensive and adaptable regulatory environment that supports innovation while ensuring product safety and effectiveness.

7. C&T: The U.S. has been criticized for not enacting a nationwide ban on animal testing for cosmetics. Why was this not included in MoCRA?

KR: While MoCRA did not include specific provisions related to animal testing, it notes that Congress believes manufacturers should not use animal testing for cosmetics. The beauty and personal care products industry is a leader in developing cutting-edge science and technology that millions of families benefit from every day, including scientifically advanced, non-animal testing methods that demonstrate product safety and effectiveness.

Our member companies are unwavering in their commitment to and advocate for the use of innovative and humane non-animal tests to ensure the safety of their products. Globally, advanced non-animal tests are the gold standard for assessing ingredient safety and have been trusted by scientists for years. Working closely with other stakeholders, including Cruelty Free International (CFI) and the Humane Society of the United States (HSUS), PCPC and our member companies continue to strongly advocate for new legislation like the Humane Cosmetics Act

8. C&T: MoCRA’s facility registration and product listing requirement came into force on July 1. What are the biggest hurdles for companies? Why?

KR: Although PCPC member companies have long provided more product information than was required by law, MoCRA’s facility registration and product listing requirement increases ingredient and manufacturing transparency. Cosmetics brand owners must list each product with the FDA, including its ingredients and where it is manufactured. These changes require adjustments in operations, documentation and internal processes. However, these challenges also present opportunities for companies to reinforce their commitment to safety, quality and transparency, ultimately benefiting consumers and industry.