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.
