The first substantial changes to FDA’s regulatory authority over cosmetics makers and products since 1938 passed Congress in December 2022, in the form of the Modernization of Cosmetics Regulation Act (MoCRA). MoCRA culminates more than a decade of work among Congress, FDA, consumer and environmental groups, and the beauty and personal care industry.
With MoCRA, the cosmetics industry will soon be expected to:
- Maintain records, with adequate substantiation, to demonstrate that the cosmetic product is “safe”
- Maintain records of adverse events associated with product use, and report serious events
- Register facilities that produce or process cosmetics products for U.S. distribution
- Comply with new labeling requirements related to points of contact, professional use designations, and fragrance allergens.
Additional provisions in MoCRA relate to the evaluation of PFAS in cosmetics, testing of talc products for asbestos, and the development of new regulations for the establishment of good manufacturing practice regulations and disclosure of fragrance allergens.
ToxStrategies staff have been supporting domestic and international personal care product companies for more than a decade and are prepared to assist industry in complying with the upcoming changes to the regulatory landscape. Please see selected corporate qualifications here and here. If assistance is needed, please contact Lauren Brown.