Cosmetic MoCRA Registration Assistance

Cosmetic MoCRA Registration

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 mandates that producers and processors of cosmetic products register their facilities with the U.S. Food and Drug Administration (FDA) and provide a comprehensive list of all cosmetic products they market. Cosmetic MoCRA registration is now a crucial process for any cosmetic company to ensure compliance with the law. To provide businesses with time to comply with these new regulations, the FDA has extended the compliance deadline to July 1, 2024. In this process, Masuu plays a pivotal role in facilitating MoCRA compliance by assisting cosmetic companies in registering their facilities with the FDA and ensuring that their product lists are accurately submitted. Additionally, Masuu helps streamline the entire process by offering branded URLs or QR codes for product labels, organizing reports for easy inspection, and managing the intricate task of FDA cosmetic listings and the gathering of adverse event reports.

One of the most significant updates under MoCRA is the requirement that all manufacturers, packers, and distributors of cosmetic products must register their facilities and list their cosmetic products with the FDA. This Cosmetic MoCRA registration process is like other FDA submission procedures, such as the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA), but specifically for cosmetic products. The FDA requires that manufacturers submit their registrations every two years, ensuring that their products and facilities are continually up to date with regulatory standards.

MoCRA also introduces an essential framework for reporting serious adverse events related to cosmetics. Companies must report any significant health issues caused by cosmetic products to the FDA within 15 business days. This requirement helps enhance the FDA’s ability to monitor the safety of cosmetic products and take swift corrective actions when necessary to protect consumers from harmful products.

Another key provision of MoCRA is the requirement for manufacturers to notify the FDA at least 120 days before introducing any new ingredient into their cosmetic products. This pre-market notification allows the FDA to assess the safety of new ingredients, ensuring that potentially harmful substances are not widely distributed in cosmetic products before their safety is thoroughly evaluated.

Masuu’s team of experienced professionals is dedicated to helping cosmetic businesses easily navigate the complexities of MoCRA registration and listing. With Masuu’s assistance, companies can efficiently adhere to the regulatory standards set forth by MoCRA, ensuring compliance while also maintaining high standards of consumer safety. Masuu’s support also simplifies the often-daunting task of updating product labels to comply with new requirements for cosmetic ingredients and labeling, helping businesses stay compliant with the evolving regulatory landscape. Additionally, Masuu ensures that your company’s Cosmetic MoCRA registration is accurately submitted and kept up to date.