The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which...more
The recently enacted Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) requires FDA to adopt regulations governing Good Manufacturing Practices (“GMPs”) for the manufacture of cosmetic products and ingredients. H.R....more
The highly anticipated cosmetic regulatory overhaul, Modernization of Cosmetics Regulation Act (MoCRA), was signed into law on December 29, 2022, ushering heightened regulatory oversight of cosmetic products and facilities....more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more