US Passes the MoCRA Act: Modernizing Cosmetic Regulations and Strengthening FDA Oversight

Recently, the United States passed the Comprehensive Food and Drug Reform Act of 2022, which includes the long-awaited Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA makes significant revisions to Chapter VI of the current Federal Food, Drug, and Cosmetic Act (FD&C Act) and proposes a series of new requirements and obligations for the cosmetics industry, aiming to promote modernization of cosmetic safety standards and regulatory frameworks in the United States. MoCRA's relevant requirements will gradually take effect within one year.

The release of MoCRA marks the first comprehensive upgrade of the US cosmetics regulatory framework and FDA's cosmetics regulatory authority since 1938.

The FD&C Act, enacted in 1938, included cosmetics in its regulatory scope, with FDA as the main regulatory agency. The FD&C Act is the core and foundation of US cosmetics regulations, and Chapter VI of the act defines the focus of US cosmetics regulation as "adulteration" and "misbranding." Section 601 of the FD&C Act defines violations involving product ingredients and product safety as "adulteration," while Section 602 defines violations involving improper cosmetic labeling or packaging as "misbranding."

Although the FD&C Act has undergone multiple revisions and continuous improvements since its enactment, the authority granted to FDA for regulating cosmetics has always been limited compared to industries such as food, drugs, and medical devices that are also regulated by FDA. For decades, FDA has been seeking more regulatory authority over cosmetics from the US Congress, proposing many related bills, but they have not become law. Therefore, the regulation of cosmetics in the United States has long been based on industry self-regulation, and FDA mainly implements a "post-market enforcement" regulatory strategy, that is, FDA does not have a pre-market approval process for cosmetics (excluding cosmetic color additives) and does not approve cosmetic safety or efficacy. Cosmetic companies are responsible for the quality and safety of their products, and cosmetics that comply with all applicable US regulations can be sold in the United States. FDA has the authority to take enforcement action when it finds that companies have violated relevant regulations.

MoCRA emphasizes cosmetic product safety and proposes a series of new compliance requirements for the cosmetics industry, expanding FDA's regulatory authority over cosmetics and effectively enhancing its ability to prevent harmful cosmetics from entering the US market. FDA will develop specific implementation rules and guidance documents to gradually achieve modernization of cosmetic safety standards and regulatory frameworks in the United States.