The U.S. Food and Drug Administration (FDA) announced that it has issued a draft guidance to help cosmetic companies submit cosmetic product facility registrations and cosmetic product listings to the FDA. The new draft guidance—entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry—was designed to assist the FDA in better managing the safety of cosmetics, and detailed requirements for facility registration; product listings including makeup, nail polishes, shaving creams, perfumes, cleansers, moisturizers, and skin products; and exemptions for certain small businesses. In addition, updates to product listings are required to be submitted to the FDA annually. The FDA emphasized that the submission of information about current cosmetic product facilities and their products is expected no later than December 29, 2023. Further, facility registration information must be updated within 60 days of a change and renewed every 2 years thereafter. “The agency will rely on registration and listing information to accomplish several objectives, such as identifying facilities producing products [that may] cause adverse events, facilitating the recall of unsanitary products, administering product testing and surveillance programs, planning inspections, and identifying products marketed in violation of the law,” concluded Linda Katz, MD, PhD, Director of the Office of Cosmetics and Colors at the FDA. The FDA is currently accepting comments on the draft guidance until September 7, 2023. For more information about the new requirements and to view the draft guidance, cosmetics company leaders can visit fda.gov.
August 15, 2023