What is the Modernization of Cosmetics Regulation Act (MoCRA) of 2022?
Signed into law by President Biden on Dec. 29, 2022, MoCRA modernizes federal regulatory oversight of cosmetics and personal care products marketed in the U.S. It creates a comprehensive, and uniform national framework for cosmetics regulation. The new law advances product safety and innovation by enhancing the effectiveness of the U.S. Food and Drug Administration’s (FDA) regulatory authority and providing new tools to consistently regulate cosmetics and personal care products.
Why was the new law necessary?
The Federal Food, Drug and Cosmetic Act was enacted in 1938 – other than the Color Additives Amendment of 1960, no significant amendments relating to cosmetics have been enacted since. Comprehensive federal cosmetics reform has been a decade-long effort with a diverse group of stakeholders who came to the table in the true spirit of compromise and meaningful progress to advance science-based regulations. MoCRA ensures the cosmetics and personal care industry can continue to innovate and to provide the safe and effective products that consumers trust and rely on every day. This long-awaited, historic legislation gives the FDA new tools to ensure the safety of cosmetics, protect consumers and reinforce consumer confidence.
What are some of the key requirements of MoCRA on manufacturers?
Adverse Event Recordkeeping and Serious Adverse Event Reporting. Product manufacturers must maintain records of any health-related adverse events for six years (three years for some small businesses) and report any serious adverse events to the FDA no later than 15 days after learning about the issue.
Mandatory Facility Registration and Product and Ingredient Listing. Facilities that manufacture or process cosmetics products for distribution in the U.S. must register with the FDA. In addition, cosmetics manufacturers must list each product with the FDA, including its ingredients and where it is manufactured.
Cosmetics Safety Substantiation. Manufacturers must ensure a cosmetics product is “safe” and maintain records demonstrating “adequate substantiation” of safety standards that products must meet to be marketed in the U.S.
Cosmetics Labeling and Fragrance Allergen Transparency. Cosmetics product labels for consumers and professionals must include contact information to report potential adverse events and identify each fragrance allergen in the product. Professional product labels must state that only licensed professionals may use the product.
How does MoCRA address ingredient transparency?
Although PCPC member companies have long provided more product information than is required by law, MoCRA will significantly increase transparency and bring the FDA’s oversight of the beauty and personal care industry more in line with other categories the Agency regulates. Cosmetics manufacturers must list each product with the FDA, including its ingredients and where it is manufactured. Cosmetics product labels for consumers and professionals must identify ingredients including each fragrance allergen in the product.
By giving consumers more access to information from manufacturers, consumers can make informed choices about the best products for themselves and their families. Everyone deserves the right to know and understand what’s in their products.
When will the requirements of MoCRA go into effect?
The law goes into effect one year after enactment with varying dates for specific provisions. The FDA will propose detailed rules and requirements for public comment and then issue final regulations for implementation after the comment period has ended.
You mention new tools given to FDA for this new authority. Can you elaborate?
The Agency now has primary responsibility for implementing MoCRA, and the legislation outlines several specific new authorities, including:
Facility Suspension. The FDA has the authority to suspend a facility’s registration if a cosmetics product manufactured by that facility has a reasonable probability of causing serious adverse health consequences.
Records Access. The FDA has the authority to access product manufacturers’ records relating to a cosmetics product if the Agency reasonably believes the product presents a threat of serious adverse health consequences.
Recall Authority. The FDA has mandatory recall authority if the Agency determines a cosmetic product is adulterated or misbranded and that exposure to the product will cause serious adverse health consequences or death.
Does MoCRA make any accommodations for small businesses?
Under MoCRA, the Current Good Manufacturing Practices Rule (CGMP) regulations issued by the FDA must offer flexibility, simplified requirements, and a more extended compliance period for small businesses. They need to maintain health-related adverse event reports for three years rather than six years. Small businesses with average gross sales of less than $1M over three years are generally exempt from compliance with the GMP and facility/product registration requirements. Very small businesses (as defined by MoCRA) are generally exempt from compliance with the GMP and facility/product registration requirements.
Does MoCRA address animal testing?
MoCRA did not include any specific provisions related to animal testing but notes that Congress believes manufacturers should not use animal testing for cosmetics products. PCPC and its member companies have worked closely with key stakeholders, including Cruelty-Free International (CFI) and the Humane Society of the United States (HSUS), to advocate for the passage of the Humane Cosmetics Act.
Does MoCRA include preemption?
MoCRA preempts state and local laws that differ from federal law on registration, product listing, good manufacturing practice, records access, recalls, adverse event reporting, and safety substantiation. MoCRA does not prevent states from prohibiting or limiting the use of ingredients in cosmetic products or continuing existing laws that require reporting certain ingredients to states.
Do companies that manufacture both OTCs drugs and cosmetic products have to comply with the mandated requirements for both?
For products classified as drugs and cosmetics under the FDCA, the drug requirements take precedence over the cosmetic requirements.