Cosmetic Product Listing and Facility Registration - FDA MoCRA Requirements

Section 607 of MoCRA outlines mandatory facility registration and product listing requirements. The Cosmetic Product Listing and Facility Registration requirement applies to both US-based and international companies that manufacture or process any cosmetic products sold in the US.

Facilities that exclusively manufacture OTC drug products like Acne, Dandruff and SPF care, are not subject to the facility registration requirement under MoCRA. However, facilities that manufacture both OTC drug products and cosmetic products are subject to the registration requirement.

When: Facility Registration Timelines, Renewals, and Updates

Facilities which opened and were operational before December 29, 2022 must register with the FDA before December 29, 2023.

Facilities which began operations during the year 2023 must register before February 27, 2024.

Any new cosmetics and personal care manufacturing facility must register with the FDA within 60 days of beginning operations.

Facility registrations with the FDA must be renewed/updated any time there is a change to FDA-registered facility, or at least every two years. Changes that warrant an update include changes to facility contact information, changes to product types produced in the facility, changes to brands produced in the facility, etc. These changes must be reflected in an updated registration within 60 days of occurring.

How: FDA Facility Registration Logistics

The US FDA will launch its electronic submission portal, FDA Direct (Cosmetics Direct) in October 2023. Electronic facility registration is encouraged, however paper form submission will also be accepted. Both the electronic submission portal and the paper form will be accessible at https://www.fda.gov . Cosmetic facility registration with the FDA is free of charge.

What: Facility Registration Details

The FDA facility registration process requires an FDA Establishment Identifier (FEI) number unique to every facility. A facility may look-up or request an FEI number via the FDA’s FEI Search Portal.

Once a facility has obtained its FEI, it must provide the following information:

• Facility name
• Facility FEI number
• Physical address
• E-mail address
• Phone number
• Name of the owner and/or operator of the facility
• If the facility is not located in the US, it must identify a US-based agent, its physical address, e-mail, and phone number
• All brands for which the facility manufactures products, along with every brand’s responsible person name and all product category codes produced for each brand
• The product category or categories as listed in Appendix A of the Guidance

FDA requires that individuals submitting registration and listing information attest to the accuracy and veracity of the information submitted.

Cosmetic Product Listing - FDA Requirements

Each product produced or imported in the US is now subject to a mandatory cosmetic product listing that details everything from the ingredients, including fragrance or flavor, and responsible party to the facility of manufacture and its location.

When: Cosmetic Product Listing Timelines

Cosmetic products currently sold on the US market must be listed before December 29, 2023.

New cosmetics and personal care products must be listed with the FDA listing within 120 days of their commercial introduction in the USA.

Product listings must be renewed or updated annually, including updates for discontinuation.

How: FDA Cosmetic Product Listing Logistics

The US FDA will launch its electronic submission portal, FDA Direct (Cosmetics Direct) in October 2023. Electronic product listing is encouraged, however paper form submission will also be accepted. Both the electronic submission portal and the paper form will be accessible at https://www.fda.gov . Cosmetic Product Listing with the FDA is free of charge.

What: Cosmetic Product Listing Details

The FDA cosmetic product listing process will generate an FDA Product Listing Number unique to each product. If a product has been previously registered, the product number can be found via the FDA’s Search Portal.

All product listings must provide the following information:

• The facility name(s) and respective FEI number(s) of each facility where the product is manufactured or processed
• The product name, responsible person and their phone number, as it appears on the product label
• The relevant product category code(s) as listed in Appendix A of the Guidance
• Complete ingredient list with UNII, Unique Ingredient Identifier

FDA requires that individuals submitting registration and listing information attest to the accuracy and veracity of the information submitted.

Cosmetic Facility Registration, and Product Listing Exemptions

Facilities and brands with average gross annual sales in the United States below $1,000,000 USD over the past three years are now defined as a small business for the purposes of MoCRA. Small cosmetics businesses are exempt from the mandatory facility registration and product listing requirements.

Nevertheless, if a company produces or handles any type of cosmetic product falling into the following categories, it forfeits its exemption, irrespective of its yearly sales:

• Cosmetic products that come in contact with the mucous membrane of the eye.
• Injectable cosmetic products.
• Cosmetic products intended for internal consumption.
• Cosmetic products meant to modify one's appearance for a duration exceeding 24 hours.

What Next: Navigating MoCRA with Good Face

Good Face’s technology is uniquely situated to support many facets of MoCRA. Below you’ll find specifics for Facility Registration and Product Listings.

Facility Registration under MoCRA requires each Manufacturer to provide the names of all brands for which the facility produces products, and respective product types for each brand. Manufacturers that use Good Face and have uploaded all in-market client formulas can instantly generate a list of brands produced and their respective FDA product codes. With Good Face, companies can also track changes to their business that warrant facility registration updates with the FDA.

Product Listing under MoCRA requires each brand to provide all products currently sold in the US market, with respective product type(s) and a list of ingredients with UNII codes. Brands that use Good Face can instantly obtain FDA product codes and Ingredient UNII mappings for all products. With Good Face, brands can store all FDA-required data in one central location (label images, responsible persons) and track changes to their products that warrant product listing updates with the FDA.

Soon users of Good Face can uploadable SPL files for single or bulk Facility Registration and Product Listings without expensive and lengthy consulting projects.

With Good Face, cosmetic brands and manufacturers are able to automate and streamline their MoCRA compliance processes. What is more, our solution uniquely provides companies with the functionality to repeatably create and maintain product listings and facility registration records at scale.