In the US cosmetics industry, adherence to Good Manufacturing Practices (GMPs) has historically been voluntary, albeit highly encouraged. However, with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), there is a significant shift as GMP requirements will become mandatory for all cosmetic manufacturers. What is MoCRA? On December 29, 2022, U.S. President Joe Biden signed the Modernization of

In December 2023, the U.S. Food and Drug Administration (FDA) released final guidance on cosmetic facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This comprehensive document clarifies requirements, defines key terms such as “contract manufacturer,” “responsible person,” “facility,” and “Data Universal Numbering System (DUNS) number,” and provides detailed instructions on submission

In December 2023, the U.S. Food and Drug Administration (FDA) released final guidance on cosmetic facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This comprehensive document clarifies requirements, defines key terms such as “contract manufacturer,” “responsible person,” “facility,” and “Data Universal Numbering System (DUNS) number,” and provides detailed instructions on submission

The INCI Name is a systematic designation employed worldwide to identify cosmetic ingredients. Developed, reviewed, and assigned by the International Nomenclature Committee (INC), the INCI Name is officially published in the International Cosmetic Ingredient Dictionary and Handbook by the Personal Care Products Council (PCPC) and is available through the wINCI online database. It is important to note that the INCI

Understanding the regulatory landscape is crucial for companies operating in the U.S. cosmetic industry. This article provides an overview of the federal regulations, the role of the FDA, the definition of cosmetic products, and the recent changes brought about by the Modernization of Cosmetics Regulation Act (MoCRA). We also highlight the importance of facility registration, product listing, and the services offered by

Under the Food, Drug, and Cosmetic Act (FD&C Act), the U.S. Food and Drug Administration (FDA) has the authority to detain and refuse entry to any product found to be non-compliant with the Act. When a product is detained, the FDA issues a “Notice of FDA Action” to the product’s owner or consignee, detailing the violation nature. The recipient is then given an opportunity for an informal