Background President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022. The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see our prior blog post, Revamping of Cosmetics Regulation and Safety (January 23, 2023). In August 2023, the FDA released draft guidance, entitled Registration and Listing of Cosmetic Product F ..read more

President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022 (the enactment date). The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) which increases the authority of the United States Food and Drug Administration (“FDA”) to regulate cosmetics and provide enhanced protections for consumers. The new law includes funding authorizations for implementation totaling $165-millon over federal fiscal years 2023 through 2027. We have prepared a summary of the key updates in MOCRA, timing of the changes, and other insights the cosmetics i ..read more

In recognition of the infant formula crisis facing the United States supply chain, the Food and Drug Administration (“FDA”) issued guidance on May 16, 2022 providing for enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements. The guidance remains in effect until November 14, 2022. Under this guidance, three categories of manufacturers may submit information to FDA: Infant formula manufacturers who manufacture infant formula for export in domestic facilities; Infant formula manufacturers who present ..read more