On March 24, 2025, West Virginia Gov. Patrick Morrisey signed House Bill 2354 into law, prohibiting the sale and distribution of food products with certain artificial food dyes and chemicals. The signing of HB 2354 means West...more
Across the United States, nitrous oxide (N2O), also known as laughing gas or nitrous, continues to be sold in convenience stores, gas stations and other easy-to-access locations with limited national enforcement. N2O serves a...more
On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more
The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation under 21 CFR 820....more
The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more
On Oct. 7, 2023, Gov. Gavin Newsom signed the California Food Safety Act (CFSA) into law, making California the first state to ban the manufacture, sale, distribution or delivery of food products containing four food...more
In response to a growing number of cyberattacks in the healthcare and life sciences industries, on Sept. 27, 2023, the U.S. Food and Drug Administration (FDA) released updated guidance regarding cybersecurity safety...more
On Aug. 7, 2023, the U.S. Food and Drug Administration (FDA) released draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry,” which would require facilities that...more
In January 2022, the U.S. Food and Drug Administration (FDA) released finalized guidance on premarket pathways for combination products.
While the guidance is not binding, it provides industry participants with valuable...more
This second McGuireWoods alert discussing regulation of hand sanitizer manufacture and distribution addresses new considerations from the Food and Drug Administration (FDA) published in a June 2020 update to its March 2020...more
Under the Public Readiness and Emergency Preparedness Act, the secretary of the U.S. Department of Health and Human Services can issue a declaration to provide immunity for individuals and entities from any liability arising...more
The U.S. Food and Drug Administration (FDA) recently released a draft guidance document regarding transdermal and topical delivery systems, outlining the agency’s thoughts on process and product development. FDA considers...more