On March 29, 2021, the U.S. Food and Drug Administration (FDA) issued its draft guidance document on the facility registration and product listing requirements for cosmetic companies under the Modernization of Cosmetics Regulation Act (MoCRA). The move aims to streamline the process and ensure transparent reporting in the cosmetics industry. Alston & Bird, the esteemed law firm, provides a thorough understanding of the implications of this development.
The draft guidance document includes several exigent aspects legal professionals should take note of. For instance, it outlines who must register their facilities and list cosmetic products, besides elaborating on the submission procedures. The directive includes concise indications on how to submit a cosmetic product ingredient statement (CPIS).
Under MoCRA, both foreign and domestic firms that manufacture or process cosmetic items are required to enroll as cosmetic facilities. Exceptions to the registration include firms solely involved in activities such as packaging, labelling or retailing. While registration is biennial, companies are given the leeway to report changes to the FDA during the two-year period.
- Biennial registration: Companies need to register their facilities with the FDA every two years. This includes firms that manufacture, process, pack, or hold cosmetic items. There are few exceptions to this requirement.
- Product listing: Firms are expected to list cosmetic items that they manufacture or process for commercial distribution in the U.S. The list should include every ingredient used in the product, except for fragrances, flavors, and trade secrets.
- Submission of Documentation: The new draft guide stresses the requirement for firms to submit their cosmetic product ingredient statements to the FDA electronically. It also outlines optional content for this statement such as the function of each ingredient in the product.
Alston & Bird considers this guidance as a significant step towards the FDA gaining more regulatory control over the cosmetics industry. Over time, the guidelines should lead to improvements in product safety standards and reporting transparency, thus serving the interests of consumers and product manufacturers alike.
The draft guidance is currently available for public comment, and stakeholders from the cosmetics industry are encouraged to provide their input. Legal professionals representing corporations in the cosmetics industry or related sectors should pay close attention to the evolution of this guidance and its potential impacts on their clients’ operations.