In a significant move on August 7, 2023, the U.S. Food and Drug Administration (FDA) unveiled a draft guidance on cosmetic facility registrations and product listings (draft guidance). As a crucial supporting document of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), this draft guidance is open for public consultation until September 7, 2023.
The draft guidance refines the requirement for cosmetic facility registration and product listing. It brings clarity to essential terms like “contract manufacturer,” “responsible person,” “facility,” and “Data Universal Numbering System (DUNS) number.” Moreover, it provides comprehensive guidance for the entities responsible for submitting the application for registration and listing, as well as necessary documentation, submission methods, submission deadlines, and exemptions from registration and listing requirements.
Who Must Register ?
All entities involved in the production or processing of cosmetics destined for the U.S. market register their facilities with the FDA. This mandate encompasses overseas enterprises as well, which are required to designate a U.S. agent to act as the communication intermediary with the FDA.
In case of contract manufacturing, only a single facility registration is required. This submission can be undertaken either by the contract manufacturer (entrustee) or the responsible person whose products undergo manufacturing or processing at the specified facility (entruster).
Significantly, there are two specific scenarios in which facilities can be exempted from registration:
Enterprises classified as “small businesses,” with the stipulation that their average gross annual cosmetics sales in the U.S. over the preceding three years are below $1 million. However, if a company manufactures mucus-membrane-contacting cosmetics, injected cosmetics, or cosmetics deemed high-risk, this exemption is not applicable.
Enterprises whose product categories satisfy the definitions of both cosmetics and drugs. However, if these enterprises concurrently produce products solely categorized as cosmetics, this exemption is not applicable.
Essential Registration Information
- Facility Owner and/or Operator’s name.
- Facility Information: Facility name, physical address, email address, and telephone number.
- Foreign Facility Contact: For foreign facilities, details of the United States agent for the facility, including name, phone number, and if available, electronic contact information (email).
- Facility Registration Number: It’s imperative to obtain the assigned facility registration number prior to commencing the registration submission. The FDA has adopted the FDA Establishment Identifier (FEI) as the obligatory facility registration number.
- Brand Names: All brand names under which cosmetic products manufactured or processed in the facility are sold.
- Product Category and Responsible Person: For each cosmetic product manufactured or processed at the facility, indicate the product category and the responsible person.
- Type of submission: initial, amended, biennial renewal, and abbreviated renewal.
Accuracy and truthfulness of all submitted data are of utmost importance. In addition to the mandatory information, certain information is optional for submission, including parent company (if applicable), facility’s DUNS Number, and additional contact details for associated individuals.
Submission Methods & Deadlines
The FDA is currently in the process of developing a new electronic submission portal for facility registration, projected for launch in October 2023. Once operational, enterprises will opt for either electronic or paper form submission. For international companies, electronic submission is recommended due to the convenience.
Furthermore, the FDA is recruiting cosmetics companies for participation in the internal test of the electronic submission portal. This initiative aims to gather valuable insights from participants to improve the portal. Interested stakeholders can submit an electronic application to eRLC.testing@fda.hhs.gov.
The time limits for facility registration depends on whether the enterprise is an existing enterprise or a new enterprise. With December 29, 2022 as the dividing line, those engaged in producing or processing cosmetics sold in the U.S. market before that are considered as existing enterprises.
FAQ
Q1: What is the Modernization of Cosmetics Regulation Act (MoCRA)?
A1: MoCRA is the legislative framework that modernizes cosmetic regulations in the U.S., and the draft guidance is a key supporting document for its implementation.
Q2: Who is required to register their facilities with the FDA?
A2: Any entity involved in the production or processing of cosmetics for the U.S. market must register. This includes both domestic and overseas facilities, with the latter needing to appoint a U.S. agent.
Q3: What submission methods are available for facility registration?
A3: The FDA will offer both electronic and paper submission options. However, electronic submission is encouraged for international companies due to its convenience and efficiency.
Q4: Are there any fees associated with registering a cosmetic facility?
A4: No, there are currently no fees required for cosmetic facility registration, making this an accessible process for businesses.
Conclusion
Enterprises are advised to prepare for the impending registration by engaging in preliminary tasks, such as applying for a business FEI number, appointing a U.S. agent, and sorting out product information. By undertaking these preparatory steps, businesses can ensure a smoother transition into the forthcoming registration process.
