This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA. It describes the FDA’s current thoughts and is only final if regulatory requirements are mentioned. This guidance document explains, among other things:
•The statutory requirement to submit cosmetic product facility registrations and product listings;
•Who is responsible for making the submissions;
•What information to include in the submissions;
•How to make the submissions; and
•When to make the submissions.
Background:
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was included in the Consolidated Appropriations Act 2023 (Pub. L. 117-328), signed into law by the President on December 29, 2022. Section 607 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was added by MoCRA, among other provisions, and it establishes specifications for cosmetic product facility registration and product listing.
Every individual who owns or manages a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” must register the facility with the FDA, according to Section 607(a) of the FD&C Act. For each cosmetic product, the responsible party is required by Section 607(c) of the FD&C Act to submit to FDA “a cosmetic product listing.”
The FDA previously operated a voluntary cosmetic registration program (see 21 CFR Parts 710 and 720). As of March 27, 2023, the FDA stopped its optional registration program. We are working to build a new system, including a submission gateway for the MoCRA-mandated cosmetic product facility registrations and product listings. The voluntary cosmetics registration program’s data will be transferred to something other than the new platform. The FDA does not consider earlier submissions to the voluntary cosmetics registration program to satisfy the registration and listing requirements imposed by MoCRA because the information in those submissions differs from the information required to be submitted under MoCRA.
FDA intends to make the new electronic submission portal available for submitting registration and product listing information under Section 607 of the FD&C Act in October 2023.
Who must register and submit product listing information under section 607 of the FD&C Act?
Registration and Product Listing:
Every person who owns or maintains a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States is required under Section 607(a)(1) of the FD&C Act to register each facility, with the following exceptions:
• A facility that is exempt from registration as a “small business” as described in section III.A. above;
• A facility that is also subject to the requirements in Chapter V of the FD&C Act (for drugs and devices) unless the facility also manufactures or processes cosmetic products that are not subject to the requirements of Chapter V of the FD&C Act (see Section 613 of the FD&C Act).
According to Section 607(a)(3) of the FD&C Act, even if a facility manufactures or processes its own cosmetic products or cosmetic products on behalf of more than one responsible person, only a single registration is necessary for that facility if it does so on behalf of a responsible person (i.e., a contract manufacturer). The facility registration for such a facility may be submitted by a responsible person whose goods are produced at the facility. According to this method, if the appropriate party raised the issue of facility registration, neither the owner nor the operator of a contract manufacturing facility would register the facility.
The responsible person is required to file a cosmetic product listing for each cosmetic product under Section 607(c) of the FD&C Act, with the following exceptions:
• The responsible person that is exempt as a “small business” as described in section III.A. above;
• The cosmetic product is also subject to the requirements in Chapter V of the FD&C Act (for drugs and devices). For example, if the product is both a drug and a cosmetic product under the FD&C Act, a cosmetic product listing must not be submitted for such a product (see Section 613 of the FD&C Act).
What information will need to be submitted for facility registration or product listing?
(A) Registration Submission Information
• the name of the owner or operator of the facility;
• the facility’s name, physical address, email address, and telephone number;
• with respect to any foreign facility, the contact information for the United States agent of the facility (name and phone number) and, if available, the electronic contact information (email);
• the facility registration number, if any, previously assigned;
• all brand names under which cosmetic products manufactured or processed in the facility are sold;
• the product category or categories (refer to Appendix A below) and responsible person for each cosmetic product manufactured or processed at the facility; and
• type of submission (initial, amended, biennial renewal, or abbreviated renewal, for further information, see discussion in Section III.F.1).
• parent company name (if applicable);
• facility DUNS Number; and
• additional contact information for individuals associated with the registration.
(B) Product Listing Submission Information
• the facility registration number of each facility where the cosmetic product is manufactured or processed;
• the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
• the applicable cosmetic category or categories for the cosmetic product
How should this information be submitted?
The FDA is creating an electronic submission portal to simplify the filing and receipt of registration and product listing information required by Section 607 of the FD&C Act. Although unnecessary, the FDA highly encourages electronic submissions to improve the agency’s ability to organize and submit data quickly and efficiently. The structured product labeling (SPL) format electronically transmits registration and listing data. Future changes to industry submissions will be quick and easy to submit because the information from a prior submission can be incorporated without entering it all over again.
When will you need to register your facility or product?
(1) Registration
(a) The First Registration
Section 607(a)(1)(A) of the FD&C Act states that anybody who owns or manages a facility on December 29, 2022, that engages in the manufacture or processing of cosmetic products for distribution in the United States must register each facility by December 29, 2023.
Section 607(a)(1)(B) of the FD&C Act states that anyone who owns or manages a facility that, for the first time, after December 29, 2022, engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register the facility no later than 60 days after the activity first commences or by February 27, 2024, whichever comes later.
(b) Amendment to Registration
Section 607(a)(4) of the FD&C Act states that anybody who is obliged to register must update their registration (referred to as an “amended” registration) within 60 days of any changes to the information needed for registration. This includes any alterations that cause the registration to be canceled.
(c) Registration Renewal
According to Section 607(a)(2) of the FD&C Act, anyone obligated to register a facility must do so every two years. Under Section 607(a)(4) of the FD&C Act, FDA allows for a shortened renewal of registrations when there haven’t been any revisions since the most recent facility registration submission.
(2) Product Listing:
(a) Initial Listing
The person responsible for a cosmetic product that is marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023, or for a cosmetic product that is first sold after December 29, 2022, within 120 days of marketing such a product in interstate commerce (section 607(c)(2) of the FD&C Act). Consistent with the approach for registration of a facility that starts manufacturing or processing cosmetic products after December 29, 2022 (section 607(a)(1)(B) of the FD&C Act), FDA expects the product listing for a cosmetic product first marketed after December 29, 2022, to be submitted within 120 days of selling the product, or within 120 days of December 29, 2023, whichever is later.
(b) Update to Content and Renewal
The responsible person must provide any updates to such a listing annually (section 607(c)(5) of the FD&C Act). This includes an update that the product has been discontinued. The FDA is providing for an abbreviated process for the renewal of any cosmetic product listing, as required under Section 607(c)(3), for which the responsible person who submitted the previous listing has remained the same.
What if my product is both a drug and a cosmetic product?
Under Section 607 of the FD&C Act, listing requirements do not apply to cosmetic products or drugs. According to Section 613 of the FD&C Act, a facility that produces or processes decorative items that are also medications is not required to register unless it also makes or processes cosmetic products that are not drugs. The same electronic submission procedure used to register a business and list a medicine with the FDA will also be available for cosmetic product facility registration and product listing. This will make it easier for organizations providing information about medicine establishments and listings to register and list cosmetic facilities and items.
Does the FDA charge fees for cosmetic facility registration or product listing?
No. Submitting a registration or product listing to the FDA under Section 607 of the FD&C Act is free.
QSS offers regulatory services from registering your cosmetic products to reviewing your cosmetic labels and submitting a cosmetic notification application to Health Canada.
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