Guidance on US FDA Cosmetic Facility Registration under MoCRA

In December 2023, the U.S. Food and Drug Administration (FDA) released final guidance on cosmetic facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

This comprehensive document clarifies requirements, defines key terms such as “contract manufacturer,” “responsible person,” “facility,” and “Data Universal Numbering System (DUNS) number,” and provides detailed instructions on submission responsibilities, necessary documentation, submission methods, deadlines, and exemptions. The FDA has also launched “Cosmetics Direct,” an electronic portal designed to streamline the submission process for facility registrations and product listings.

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 offers several options for submitting cosmetic facility registrations and product listings under MoCRA:

1. Cosmetics Direct Portal – A user-friendly electronic platform for submitting registrations and listings without using the Electronic Submissions Gateway (ESG).

2. Electronic Submissions Gateway (ESG) – An alternative electronic method for submitting Structured Product Labeling (SPL) files.

3. SPL Xforms – An FDA-provided tool to assist in creating and submitting SPL files.

4. Paper Forms – Facilities can submit Form FDA 5066 (facility registration) and Form FDA 5067 (product listing) by mail or email:

   • Mail: FDA Office of Cosmetics and Colors, 5001 Campus Drive, College Park, MD 20740-3835

   • Email: RLC-PaperSubmissions@fda.hhs.gov

While MoCRA set an initial deadline of December 29, 2023, the FDA has delayed enforcement until July 1, 2024, allowing more time for compliance.

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 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

Since facility registration is officially required, businesses should take the necessary steps to comply. This includes obtaining FEI number, appointing a U.S. agent if needed, and gathering accurate product information. Preparing in advance will help ensure a smooth registration process and prevent any delays or compliance issues.