President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the MoCRA. MoCRA significantly changes the current regulatory framework for cosmetics in place since the enactment of the Federal Food, Drug, and Cosmetic Act FD&C Act in 1938.
Inner Mongolia Kingdomway Pharmaceutical Limited submitted new dietary ingredient NDI notification to FDA for β Nicotinamide Mononucleotide compound touted for anti-aging properties. Under Federal Food, Drug, and Cosmetic Act, NDI is required to market dietary supplements.
FTC provided additional guidance for mobile health app developers signaling its continued interest and focus on companies that collect health information but may not be a covered entity or business associate under HIPAA. The FTC will likely increase expectations of compliance.
Under Food Drug and Cosmetic Act, FDA may authorize unapproved medical products, including drugs, for use in an emergency to diagnose diseases COVID. FDA’s review process abbreviated and requirements for obtaining EUA less burdensome than for obtaining full FDA approval.
The Food and Drug Administration warned five companies illegally marketing products labeled with delta-8 tetrahydrocannabinol Delta-8 THC and violating Federal Food Drug and Cosmetic Act FDCA. FDA shared 5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC.