The FDA oversees the regulation and safety of drugs, medical devices, many food items, and cosmetic products. While some products, such as life-saving medical devices, are strictly regulated, the regulation of cosmetic products is notoriously permissive.
But in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was enacted, and becomes effective on December 29, 2023. MoCRA is the first update to the FDA’s cosmetic regulations since 1938, and makes the FDA’s regulatory framework for cosmetics more stringent. The goal of the act is to increase consumer safety and ingredient transparency.
Why is MoCRA important?
The act covers the regulation of makeup, hair and hair removal products, nail products, soaps, lotions, and tanning products. It is long overdue and brings cosmetics regulations up to speed with many other FDA regulated products.
There are many notable provisions of MoCRA. Some of the most important concern two toxic chemicals commonly found in cosmetics: talc and PFAS. Finally, MoCRA directs the FDA to study, report on, and regulate talc and PFAS.
Why is regulation of PFAS important?
PFAS are synthetic chemicals commonly used in cosmetics because they are water and oil resistant. PFAS are known as “forever chemicals” because they do not break down in the body or the environment. They have been linked to an increased risk of cancer and other diseases.
The FDA has historically refused to regulate PFAS in cosmetics because the agency maintains that there is no evidence that such low levels pose a risk to consumers. Now, per MoCRA, the FDA must assess the use safety and risks of PFAS in cosmetics. The findings must be published by December 29, 2025.
Why is regulation of talc important?
Talc is an organic substance commonly used in cosmetics because of its soft and slippery properties. When talc is mined from the earth, it may be contaminated with asbestos, a known carcinogen.
Until now, the FDA has never regulated cosmetic grade talc. Under MoCRA, the FDA must establish regulations concerning testing cosmetics containing talc to determine if they contain asbestos. This must be done within a year.
Additional mandates under MoCRA include:
- Facility and product registration
- Safety testing
- Adverse event reporting
- Label requirements
- Good manufacturing practices
- Recall power
These mandates are substantial. They are excellent first steps in protecting the public from harmful chemicals.