On Aug. 7, 2023, the U.S. Food and Drug Administration (FDA) published new draft guidance related to the cosmetic facility registration and product listing in accordance with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This draft guidance aims to assist those submitting cosmetic facility registrations and product listings to the FDA by the Dec. 29, 2023 deadline.

MoCRA, which Congress enacted Dec. 29, 2022, among other things, requires that cosmetic product facilities register with and provide a list to the FDA of their cosmetic products distributed in the United States. Previously, the FDA had a voluntary cosmetics registration program, allowing cosmetic facilities to voluntarily register with and provide the FDA with a list of the ingredients used in cosmetic products. MoCRA’s new registration and product listing requirement replaces the prior voluntary registration program. As a result, the FDA ended this voluntary program March 27, 2023. Importantly, the FDA does not consider any previous voluntary registrations as satisfying MoCRA’s registration and product listing requirements. Cosmetic facilities that participated in the voluntary cosmetics registration program will need to re-register and list their products with the FDA.

According to the new guidance, anyone who owns or operates any establishment that manufactures or processes cosmetic products distributed in the United States must register with the FDA. However, this requirement does not apply to the following:

• Beauty shops and salons, unless manufacturing cosmetic products at the location;

• Cosmetic product retailers, including individual sales representatives, direct sellers, retail distribution facilities, and pharmacies, unless manufacturing cosmetic products at the location;

• Hospitals, physicians’ offices, and health care clinics;

• Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer;

• Trade shows and other venues where cosmetic product samples are provided free of charge;

• Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services;

• An establishment that manufactures or processes cosmetic products solely for research or evaluation;

• An establishment that solely performs one or more of the following: labeling, relabeling, packaging, repackaging, holding, or distributing cosmetic products;

• Small businesses (i.e., establishments whose average gross annual U.S. sales of cosmetic products for the previous three-year period is less than $1,000,000); and

• Establishments that manufacture or process drugs or devices.

Additionally, establishments that manufacture or process hybrid products (i.e., a product that is both a cosmetic and a drug or device according to the FDA) and not any other cosmetic products do not need to register as a cosmetic facility with the FDA—instead, they should register as a drug or device facility.

According to the new guidance, establishments registering with the FDA need to provide the following:

• The name of the owner and/or operator of the facility;

• The facility’s name, physical address, email address, and telephone number;

• With respect to foreign facilities, the contact for the U.S. agent (name and phone number) and email address (if available);

• The FDA Establishment Identifier number;

• All brand names under which cosmetic products manufactured or processed in the facility are sold;

• The product category for each product manufactured or sold;

• The name of the responsible person (i.e., the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product);

• The name of the parent company (if applicable); and

• The facility’s DUNS number.

Registration is free, and any changes need to be reflected in the registration within 60 days. Registrations will be renewed biennially.

To satisfy MoCRA’s cosmetic product listing requirements, the FDA will require that establishments provide the following:

• 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 both names appear on the label;

• The applicable cosmetic category or categories of the product;

• A list of ingredients in the cosmetic product;

• The product listing number, if any previously assigned;

• Parent company name (if applicable);

• Type of business (as listed on the label) (e.g., manufacturer, packer, or distributor);

• Product webpage link;

• Whether the cosmetic product is for professional use only;

• The DUNS number of the responsible person listed on the product label; and

• An image of the label.

Like cosmetic facility registration, the FDA will not charge a fee to list cosmetic products. Product listing information must be updated annually, including updates on product discontinuation.

The FDA stated that the product listing number will not be available for public disclosure. Further, the FDA will not disclose information from a facility registration or product listing in response to a request under the Freedom of Information Act.

Failure to register or submit product listing information to the FDA may be considered a prohibited act under the Food, Drug, and Cosmetic Act, leading to potential penalties.

The FDA intends to open the electronic portal in October 2023 for cosmetic facility registration and cosmetic product listing. At that time, the FDA also intends to publish a paper registration and listing application, but the FDA strongly recommends using the electronic portal.

This new draft guidance is not final. Interested parties may submit online comments by Sept. 7, 2023.