To facilitate cosmetic product facility registration and product listing submissions as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA intends to make a new electronic submission portal available in October 2023. Although, FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency, they are also developing a paper form as an alternative submission tool. Both the electronic submission portal and the paper form will be accessible online. There are no fees to register a cosmetic facility or list a cosmetic product.
A draft guidance for registration and listing of cosmetic product facilities and products was recently released by the FDA and it lists high level details required to navigate this process. This guidance is open for comments until 7th September 2023 and outlines the following requirements needed:
Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing (including filling) of a cosmetic product for distribution in the USA must register each facility no later than December 29, 2023, or if they first engage in such activity after December 29, 2022, within 60 days or by February 27, 2024, whichever is later. Every person who is required to register must update their registration within 60 days of any changes (including any changes that result in cancellation of the registration) under ‘amended registration’. A single registration is required for a facility undertaking activities on behalf of more than one Responsible Person. Facility registrations will need to be renewed biennially.
The following mandatory information will be required as part of a facility registration:
- the name of the owner and/or operator of the facility and all the contact details of the facility
- the contact for the US Agent of any foreign facility
- the facility registration number, if any, previously assigned – note that each facility will need to obtain an FDA Establishment Identifier (FEI) number before submitting the facility registration and have a DUNS number
- all brand names under which cosmetic products manufactured or processed in the facility are sold
- the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility; and
- type of submission (initial, amended, biennial renewal, or abbreviated renewal)
Additional optional information may also be submitted including the parent company name (if applicable), facility DUNS number and additional contact information for individuals associated with the registration.
The Responsible Person of a cosmetic product that is marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce. A single listing for a cosmetic product may be filed to include identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents. Product listings will need to be renewed annually.
The following mandatory information will be required as part of a product listing:
- the facility registration number of each facility where the cosmetic product is manufactured or processed (if 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 name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label.
- the applicable cosmetic category or categories for the cosmetic product
- a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by an approved name, or by the common or usual name of the ingredient.
- the product listing number, if any previously assigned; and
- type of submission (initial, update to content (annual), abbreviated renewal).
Additional optional information may also be submitted including the parent company name (if applicable), type of business, image of the label, product webpage link, whether the product is for professional use only, Responsible Person DUNS Number, Unique Ingredient Identifiers (UNIIs), any additional contact information for individuals associated with the listing.
When submitting registration and listing information, there will be a requirement to attest to the accuracy and veracity of the information submitted.
Failure to register or submit listing information is a prohibited, thus stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline. If you need any help to understand and plan your approach to these new requirements, please reach out to us.