Aug 15, 2023 | FDA and USDA Regulatory Update, Tobacco
In a major win for the premium cigar industry, Judge Amit Mehta of the U.S. District Court for Washington D.C. has vacated FDA’s deeming regulations for premium, hand-rolled cigars. As a result, the regulations introduced by the FDA in 2016 do not apply to cigars that...
Aug 8, 2023 | Cosmetics, FDA and USDA Regulatory Update
On August 7, FDA issued a new draft guidance on the registration and listing of cosmetic product facilities and products, which is mandated by the Modernization of Cosmetic Regulations Act of 2022 (MoCRA). This guidance is not legally enforceable, but it provides...
Aug 3, 2023 | Cannabis, FDA and USDA Regulatory Update
On July 27, 2023, the U.S. Congress requested information to guide the assessment of the potential for a regulatory pathway for hemp-derived Cannabidiol (CBD) products with the goal to prioritize consumer safety and bring certainty to the U.S. market. Since the...
May 31, 2023 | Drugs, FDA and USDA Regulatory Update
A recent FDA warning letter concerning identity testing and contaminated glycerin highlights the significance of a recurring potential public health hazard. After several lethal poisonings worldwide, it is apparent that high-risk drug components contaminated with...
Mar 29, 2023 | Dietary Supplements, FDA and USDA Regulatory Update, Foods
FDA’s latest draft guidance document on Dietary Guidance Statements in Food Labeling shares FDA’s current thinking on label, labeling and marketing statements that aims to help Americans make informed food choices. FDA has long actively supported consumer awareness of...
Mar 29, 2023 | Cosmetics, FDA and USDA Regulatory Update
Contrary to the expectation in the cosmetic regulatory space, the FDA has stopped accepting submissions to the voluntary cosmetic registration and listing program and will not be transferring this data to the program the Agency is establishing for the mandatory...
