Who Should Register: Domestic and foreign facilities involved in the manufacturing, processing, packing, repacking, labeling, or relabeling of cosmetic products intended for distribution in the United States. This includes manufacturers, contract manufacturers, and private-label producers.
Governing Authority: Cosmetic facility registration and product listing requirements are governed under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, FD&C Act §607; 21 U.S.C. §364a.
Submission Method: Cosmetic facility registrations and product listings are submitted electronically through Form FDA 5066 and Form FDA 5067.
Eligibility Requirements: Facilities must maintain a valid DUNS Number associated with their physical business address. Foreign cosmetic facilities are also required to appoint a qualified U.S. Agent with a physical address in the United States.
Registration Outcome: Upon successful submission, FDA Establishment Registration Number and Cosmetic Product Listing Number, typically returned within 24–48 hours.
Renewal Cycle: Cosmetic facility registrations must be renewed annually between October 1 and December 31; product listings updated yearly or within 60 days of any material change.
Foreign Establishment Requirement: Foreign cosmetic manufacturers marketing products in the United States should ensure proper regulatory representation and maintain complete facility information to facilitate FDA communications and compliance activities.
Edge-Case Requirement: Foreign cosmetic facilities are also required to appoint a qualified U.S. Agent with a physical address in the United States. California sellers with ≥ $1M in annual sales must also file under CSCAR.
Consequences of Non-Compliance: Failure to comply with FDA cosmetic registration and listing requirements may result in regulatory actions, including import detention, product refusal, warning letters, mandatory recalls, adverse publicity, and restrictions on the sale or distribution of cosmetic products within the United States.
