The trade organization said the notices issued earlier this year were inconsistent with regulatory practice, and unenforceable because they violate due process.
MoCRA expands FDA’s authority over cosmetics with requirements for safety substantiation, adverse event reporting, facility registration, and product listing.
By Evelina J. Norwinski, Elizabeth Trentacost, and Ryan D. White, Arnold & Porter04.13.23
Compelling increases in online searches and social media discussions, especially among younger crowds, suggest people want more than just plant-based products.
Oral solids remain the preferred route of drug delivery due to their cost-effectiveness, ease of manufacturing, and patient-friendly dose form options.
The third-party testing organization will also expand its dietary supplement GMP program to include manufacturers of cosmetics, personal care, and over-the-counter products.
FDA reviewed supporting scientific data on the probiotic and has no questions or objections, allowing it to be considered ‘Generally Recognized As Safe.’