MoCRA, or the Modernization of Cosmetics Regulation Act of 2022, is a significant legislative development in the United States that expands the authority of the Food and Drug Administration (FDA) to regulate cosmetics. This act represents the most substantial update to FDA's regulatory power over cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.

Key aspects of MoCRA include:

  1. Expansion of FDA Authority: MoCRA grants the FDA new powers to ensure the safety of cosmetic products, marking a major shift in the regulatory landscape for cosmetics in the U.S.

  2. Adverse Event Reporting: Responsible persons (manufacturers, packers, or distributors) are required to report serious adverse events associated with the use of cosmetic products to the FDA within 15 business days.

  3. Facility Registration: Manufacturers and processors of cosmetic products must register their facilities with the FDA and renew their registration every two years.

  4. Product Listing: Responsible persons must list each marketed cosmetic product with the FDA, including product ingredients, and provide updates annually.

  5. Safety Substantiation: Companies and individuals who manufacture or market cosmetics are responsible for ensuring the safety of their products and maintaining records to support this.

  6. Mandatory Recall Authority: The FDA has the authority to order a mandatory recall of cosmetic products if there's a reasonable probability that a product is adulterated or misbranded and can cause serious adverse health consequences or death.

  7. New Compliance Obligations: MoCRA introduces several new compliance obligations for cosmetic manufacturers, packers, and distributors, including good manufacturing practices, fragrance allergen labeling, and standardized testing methods for detecting asbestos in talc-containing products.

  8. Exemptions for Small Businesses: Some exemptions are provided for small businesses, although these do not apply to all types of cosmetic products.

  9. Phased Implementation: The FDA is using a phased approach to enforce MoCRA, giving businesses time to prepare and comply with the new requirements.

MoCRA is a comprehensive and significant reform that affects all aspects of the cosmetic industry, from product development to manufacturing, packaging, and distribution. It emphasizes the importance of product safety, transparency, and industry accountability.