FDA update: Draft guidance document issued on cosmetic facility registration and product listing submission
Today, the Food and Drug Administration (FDA) issued a draft guidance on cosmetic facility registrations and product listings in accordance with the regulatory requirements of the Modernization of Cosmetic Regulations Act (MoCRA). This draft guidance outlines the potential framework to replace the Voluntary Cosmetic Registration Program (VCRP), which the FDA suspended in March of this year.
Because the information previously required by the VCRP is different than the new information requirements for facility registration and product listings now stipulated under MoCRA, the FDA does not consider previous VCRP submissions to be sufficient. Instead, the 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, and is developing a paper form as an alternative submission tool.”
Unless the facility qualifies under the listed exemptions in the draft guidance document, cosmetic facility registrations and product listing submissions are required under MoCRA regulatory compliance and “stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline.”
Draft guidance document outline
The draft guidance document outlines the FDA’s recommendations to support facilities with cosmetic product facility registrations and product listings. The document explains, “the statutory requirement to submit cosmetic product facility registrations and product listings; definitions; 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.”
The draft guidance document is broken into three sections: an Introduction to the document, Background information, and a Question and Answer section followed by an Appendix of Cosmetic Product Categories and Codes. The Introduction establishes the draft guidance document’s purpose, and its status as being not legally enforceable but instead describing the FDA’s “current thinking on a topic and should be viewed only as recommendations.”
The Background section explains the FDA’s intention to establish a new electronic submission portal to replace the VCRP in accordance with section 607 of MoCRA “establishing requirements for cosmetic product facility registration and product listing.”
Applicable sections include “Section 607(a) of the FD&C Act,” which “requires every person that owns or operates a facility that ‘engages in the manufacturing or processing of a cosmetic product for distribution in the United States’ to register each facility with FDA,” as well as “Section 607(c) of the FD&C Act,” which “requires that for each cosmetic product, the responsible person must submit to FDA ‘a cosmetic product listing.’”
Further, the FDA “strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency,” as it did previously through the VCRP.
The Question and Answer section of the draft guidance document outlines applicable definitions, including exemptions for submissions to facility registration and product listings, as well as establishing who is responsible for the submissions into the newly established electronic system.
This section clarifies the status of products that qualify as both a drug and cosmetic product for potential submission and confirms there is no proposed fee required to submit either facility registration or product listings to the new electronic registration system under MoCRA.
Noteworthy submission deadlines
Additionally, the Question and Answer section stipulates what information is required for each submission type, what parts of the submitted information will be available for public disclosure, the FDA’s proposed established methods for sending in submissions, and important dates to note for submission timelines.
Important submission dates include the following: for cosmetic facility registrations, “every person that, on Dec. 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register each facility no later than Dec. 29, 2023 (section 607(a)(1)(A) of the FD&C Act).”
Further, “every person that owns or operates a facility that first engages, after Dec. 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, must register such facility within 60 days of first engaging in such activity or by Feb. 27, 2024, whichever is later (section 607(a)(1)(B) of the FD&C Act).” Amended registrations, including cancellations of facility registrations, must be filed no later than 60 days after the initial filing, and renewals are to be filed every two years.
For initial product listings, “the responsible person of a cosmetic product that is marketed on Dec. 29, 2022, must submit a cosmetic product listing not later than Dec. 29, 2023, or for a cosmetic product that is first marketed after Dec. 29, 2022, within 120 days of marketing such product in interstate commerce (section 607(c)(2) of the FD&C Act).”
Further, and “consistent with the approach for registration of a facility that starts manufacturing or processing cosmetic products after Dec. 29, 2022 (section 607(a)(1)(B) of the FD&C Act), FDA expects the product listing for a cosmetic product first marketed after Dec. 29, 2022 to be submitted within 120 days of marketing the product, or within 120 days of Dec. 29, 2023, whichever is later.” Updates to product listings are required to be submitted annually, including notice that the specific product has been discontinued.
Additional draft guidance document takeaways
Of important note, and as outlined in the draft guidance document, the “FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number.” For interested parties, the proposal explains that “to facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.”
To clarify this process or to receive more explicit guidance and further “information, including how to request an FEI number or determine if an entity already has an FEI number,” the draft guidance document refers to the FEI Search Portal. Further, “the responsible person will need to obtain the relevant facility registration (FEI) number(s) for each facility where their cosmetic products are manufactured or processed, because the facility registration number(s) is required for the product listing submission.”
In specific cases where “the facility is a small business that is exempt from registration and has no facility registration number, then facility name/address can be provided instead for the product listing.”
The draft guidance document also includes an Appendix section, which stipulates the FDA’s proposed list of applicable products that are eligible for product listing submission and facility registration submission. As noted in the document, the “FDA has created this list of categories and codes and requests comment or additional categories/codes.”
Draft guidance document commentary
The draft guidance is not final, and the FDA has established a 30-day commentary period to “ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.” Commentary can be submitted either electronically or written/paper including docket number FDA-2023-D-1716.
The draft guidance document is open for comments for 30 days following its publication on Aug. 8, 2023. Comments can be submitted electronically via https://www.regulations.gov, or via written documentation to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and must include docket number FDA-2023-D-1716.
All comments submitted will be posted publicly by default, but there is an alternative method for confidential comment submission which is outlined in the FDA’s guidelines for submitting commentary, which is linked here.
Additionally, “for access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number,” FDA-2023-D-1716.
Further information or questions can be directed to Jennifer Ross, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002. Telephone inquiries can be directed to 301-796-4880 (this is not a toll-free number) or via email at DhrfgvbafNobhgZbPEN@sqn.uuf.tbi.
Pilot Program for electronic submissions
In support of the FDA’s efforts to establish a new electronic submission portal to replace the VCRP, the FDA is requesting that interested parties sign up to participate in its “Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing.”
Applications are being solicited by “the Office of Cosmetics and Colors (OCAC) and the Office of the Chief Scientist (OCS) in the Food and Drug Administration,” and eligible applications will be considered from “members of the cosmetic product industry interested in participating in a voluntary pilot program to conduct user acceptance testing to help OCAC and OCS evaluate a potential new electronic submissions portal for cosmetic product facility registration and listing.”
Interested parties are encouraged to apply by Aug. 22, 2023, with pilot testing set to begin on or about Sept. 15, 2023. Those interested in applying should submit an electronic application to rEYP.grfgvat@sqn.uuf.tbi.
The pilot program is approximately two weeks, and up to nine applicants will be accepted to participate. For detailed information regarding the requirements for the submission statement to apply for the pilot program, participation requirements, and selection criteria, potential applicants should review the notice linked here.
