May 16, 2024

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take,...
April 9, 2024

FDA Reports That No Asbestos Was Detected in Its 2023 Testing of Talc-Containing Cosmetic Products

The U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM). FDA states that “[a]sbestos was not detected in any of the 50 samples tested in 2023.” FDA states that it selected and purchased cosmetic products, and then it blinded and transferred the samples...
October 12, 2023

FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form...