The US Food and Drug Administration (FDA) has issued a draft guidance to assist “responsible persons” that are required to submit a cosmetic manufacturing facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Every cosmetic manufacturer and private labeler will be required to make a submission regardless of prior participation in the previous voluntary registration program.

The submissions can be filed and will be due between October 2023 (when FDA expects to provide the electronic process and the paper form) and December 29, 2023.

COSMETIC PRODUCT LISTING

As we have previously communicated, MoCRA requires “responsible persons” (defined as the manufacturer, packer, distributor, or importer of a cosmetic product whose name appears on the product label) to submit a cosmetic product listing to FDA.

Exemptions

In accordance with the draft guidance, the product listing requirements do not apply to “small businesses,” which includes responsible persons and owners and operators of facilities whose average gross annual sales in the United States of cosmetic products for the previous three-year period is less than $1 million, adjusted for inflation, and who do not manufacture or process cosmetic products that (1) regularly come into contact with the mucus membrane of the eye, (2) are injected or intended for internal use, or (3) are intended to alter the appearance for more than 24 hours.

Products that are both over-the-counter drugs and cosmetics are also exempt from the product listing requirement, assuming they have been listed with FDA under the electronic drug registration and listing system.

Contents of a Listing Submission

A cosmetic product listing must include the following:

• The name of the product as it appears on its label;
• The cosmetic product category based on an FDA listing of categories (e.g., perfume, hair tint, shaving cream, temporary tattoo inks; see appendix A in the guidance for the full listing of categories);
• A list of ingredients in the cosmetic product, including any fragrances, flavors, or colors;
• The product listing number, if one was previously assigned;
• The facility registration number of each facility where the product is manufactured or processed;
• The name and contact information of the responsible person for the product; and
• The type of the submission (initial, annual update to content, abbreviated renewal).

FDA also requests that the responsible person provide the following voluntary information:

• Parent company name, if applicable;
• Type of business listed on the label (manufacturer, packer, or distributor);
• An image of the product label;
• A product webpage link;
• Whether the cosmetic product is for professional use only;
• The Data Universal Numbering System (DUNS) number for the address listed on the product label;
• Applicable Unique Ingredient Identifiers (UNIIs); or
• The contact information for individuals associated with the listing.

Product listing numbers and the facility registration number of the manufacturer or processor will not be made publicly available by FDA. All other information may be disclosed pursuant to a Freedom of Information Act (FOIA) request.

Timing

For cosmetic products marketed as of December 29, 2022, the listing must be submitted by December 29, 2023. For cosmetic products that are first marketed after December 29, 2022, the listing must be filed within 120 days of introducing the product in interstate commerce or within 120 days of December 29, 2023, whichever is later.

Renewal

The responsible person must provide an update to the listing annually, including an update that the product was discontinued.

FACILITY REGISTRATION

MoCRA also requires the owners or operators of certain facilities to register with FDA. “Facilities” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

Exemptions

The following entities do not need to register if they do not also “manufacture or process” cosmetics:

• Packagers and repackagers (the terms “packaging” and “repackaging” do not include filling a product container with a cosmetic product);
• Labelers;
• Relabelers;
• Holders;
• Distributors;
• Retailers, retail distribution facilities, direct sellers, and pharmacies unless these facilities manufacture or process cosmetics that are not sold directly to consumers at that location;
• Hospitals, physicians’ offices, and healthcare clinics;
• Entities (e.g., hotels, airlines) that provide complimentary cosmetic products to customers incidental to other services;
• Venues where cosmetic product samples are provided free of charge;
• Facilities that produce or handle cosmetic products exclusively for research or evaluation purposes, including production testing, and not intended for retail sale;
• Facilities registered as drug establishments, unless they also manufacture or process cosmetic products that are not also drugs; and
• Facilities that are exempt from registration as a “small business” (see the definition above).

Information from a facility registration on the brand names of products manufactured or processed in the facility will not be made publicly available by FDA. All other information may be disclosed pursuant to a FOIA request.

Content of Registration

A facility registration must include the following:

• The name of the owner and/or operator of the facility;
• The facility’s name, physical address, email address, and telephone number;
• For foreign facilities, the contact information for the US agent;
• The facility FDA Establishment Identifier (FEI), if any was previously assigned;
• All brand names under which cosmetic products manufactured or processed in the facility are sold;
• The cosmetic product category or categories and responsible person for each cosmetic product manufactured or processed at the facility; and
• The type of submission (initial, amended, biennial renewal, abbreviated renewal).

Timing

Facilities that were already manufacturing or processing cosmetic products for US distribution on December 29, 2022 must be registered by December 29, 2023. For facilities that began manufacturing or processing cosmetic products for US distribution after December 29, 2022, the owner or operator must register the relevant facilities within 60 days of first engaging in such activities or by February 27, 2024, whichever is later. Every responsible person that is required to register must update their registration within 60 days of any changes to the submitted information or to cancel the registration.

Renewal

All registrations must be renewed biennially.

ELECTRONIC AND PAPER SUBMISSION

FDA is developing an electronic submission portal (utilizing structured product labeling (SPL)) to streamline the submission and receipt of registration and product listing information, as well as a paper form, both of which will be available in October 2023.

FDA encourages electronic submissions and has set up a voluntary pilot program to conduct user acceptance testing of the new electronic portal. Applications to participate in the pilot program will be accepted until August 22, 2023.

The industry should expect certain “bugs” with the electronic submissions portal when the portal is first implemented, and should not wait until the final day to register. There may be a number of unanswered questions related to the scope of exemptions and business types as well as ingredient nomenclature and product categories. Morgan Lewis lawyers can assist companies with evaluating these questions and with contacting FDA’s Office of Cosmetics and Colors and the Office of the Chief Scientist to vet such questions in advance.

KEY TAKEAWAYS

FDA’s registration and listing requirements for cosmetic products introduce substantial new requirements for cosmetic product manufacturers, packers, distributors, and importers. These requirements align the regulation of cosmetic products more closely with other FDA-regulated products that are already subject to similar registration and listing rules.

The new registration and listing information will allow for increased scrutiny over the industry, including identifying facilities producing products potentially causing adverse events, facilitating the recall of unsanitary products, administering product testing and surveillance programs, and planning facility inspections.

Notably, FDA is asking for a significant amount of “voluntary” information. Each company will need to determine if it is prudent to provide such information, especially when FDA has stated that much of the submitted information will be available to the public via a FOIA request.

ACTION ITEMS

• Cosmetics companies can begin gathering the detailed information required to be ready to submit during the short 8-week to 10-week window when the registration and listing portal is available. This includes gathering detailed ingredient and formulation information and identifying any products that are already drug-listed or fall outside of the “cosmetic” definition.
• Own-label distributors and on-label packers and importers should determine if any product flavors, fragrances, or colors are protected by intellectual property owned by third parties or confidentiality agreements with suppliers and determine how they will be identified in the submissions and/or require supply contract amendments to allow disclosure to FDA. Companies with contract manufacturers should confirm in writing that relevant contractors and suppliers are prepared to register and provide formulation details, if applicable.
• Companies should assess whether any exemptions apply to their specific activities.

Comments on the Draft Guidance should be submitted to FDA by September 7, 2023 at docket number FDA-2023-D-1716. Since there is a statutory mandate that cosmetic manufacturers be registered by December 29, 2023, it is likely there will not be significant changes to these draft guidelines between now and that deadline.

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