On August 7, 2023, the FDA issued draft guidance for Registration and Listing of Cosmetic Product Facilities and Products to assist cosmetics companies in submitting cosmetic product facility registrations and cosmetic product listings, including ingredients, to the FDA.

The proposal outlines the statutory obligations, responsible parties, required information, submission procedures, and deadlines, and is open for consultation until September 7, 2023.

Background

In line with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), published on December 29, 2022, which introduced section 607 of the FD&C Act, this guidance establishes requirements for cosmetic product facility registration and listing.

Who Needs Facility Registration and Listing for Cosmetic Products?

Facility Registration

Any facility manufacturing or processing cosmetic products for the US market, except:

• “Small business” facilities
• Facilities subject to drug and device requirements (Chapter V of FD&C Act), if cosmetic products produced are exempt from Chapter V

Product Listing

Anyone manufacturing, packaging, or distributing cosmetics, except:

• “Small business” facilities
• Facilities subject to drug and device requirements (Chapter V of FD&C Act), if exempt cosmetics are produced

What Information is Required for Facility Registration and Listing?

Facility Registration:

• Owner and/or operator’s name
• Facility name, address, email, and phone number
• U.S. agent’s/in-country representative’s contact information (for foreign sites)
• Previous registration number (if applicable)
• Responsible person for each cosmetic product category
• Type of submission (initial, amended, biennial renewal, or abbreviated renewal)

Product Listing:

• Facility registration number for all cosmetic-producing facilities
• Name and contact information of responsible person
• Cosmetic category for each product
• List of ingredients, including fragrances, flavors, and colors
• Previous listing number (if applicable)
• Type of submission (initial, annual content update, abbreviated renewal)

Note: One submission can cover multiple cosmetics with identical or different formulations

Optional Information Requested by the FDA:

• Parent company name
• Business type (e.g., manufacturer, packager, labeler)
• Label image
• Product webpage URL
• Professional use indication
• DUNS number for product address
• Unique Ingredient Identifiers (UNIIs)
• Additional contact info for associated individuals

Public Disclosure

The FDA will not disclose product listing and facility registration numbers, or brand names under a facility registrion. All other information will be publicly disclosed.

When to Register and List a Cosmetic:

Facility Registration:

1. Initial Registrationserformance Characteristics/Laboratory Evaluation
   • Existing facility before Dec 29, 2022: Register by Dec 29, 2023
   • New facility after Dec 29, 2022: Register within 60 days of start of activity, or by Feb 27, 2024 (whichever comes first).
2. Amended Registrations
   • Update within 60 days of changes, including cancellations.
3. Registration Renewals:
   • Required biennially (every other year).

Product Listing:

1. Initial Registration
   • If the product was marketed before Dec 29, 2022: List by Dec 29, 2023.
   • If the product was marketed after Dec 29, 2022: List within 120 days of the product launch.
2. Content Update and Renewal
   • Responsible person must provide annual updates, even if the product is discontinued.

Dual Drug and Cosmetic Products:

If a cosmetic is also a drug/medical device:

• It is exempt from cosmetic listing if already subject to drug/device rules
• It is exempt from facility registration too, unless it produces non-drug cosmetics requiring registration

What You Can Do

In anticipation of the forthcoming FDA guidance on cosmetic product facility registration and listing, companies should proactively review and understand the new requirements, evaluate current practices, identify responsible personnel, and gather essential information. We also recommend any stakeholders with a vested interest in registration and listing of cosmetic product facilities and products submit their comments to the FDA before the September 7, 2023 deadline for comments.

To ensure seamless compliance with the new regulations, dicentra, can offer you tailored services to guide you through these changes. From comprehensive regulatory analysis and documentation review to submission preparation and ongoing compliance support, dicentra’s expertise streamlines the process, helping companies meet the deadlines and navigate the evolving regulatory landscape. Prepare confidently for the new FDA guidance by partnering with dicentra. Contact dicentra today.

This article provides a supplemental review of the FDA’s Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products and is not a substitute for reading the complete draft guidance document.