FDA issues draft guidance for upcoming cosmetics registration system

By Julia Wray | Published: 8-Aug-2023

The US authority has suspended its old Voluntary Cosmetic Registration Program and now intends to launch its replacement under MoCRA in October this year

The Food and Drug Administration (FDA) has unveiled a draft guidance for the registration and listing of cosmetic product facilities and products in the US, which it now anticipates will go live in October.

This guidance comes almost seven months after the Food and Drug Omnibus Reform Act of 2022 (FDORA) – which includes the Modernization of Cosmetic Regulations Act of 2022 (MoCRA) – was signed into law on 29 December 2022.

MoCRA requires, within one year of passage, that all facilities (owned or operated before 29 December 2022) engaged in the manufacturing or processing of a cosmetic product for distribution in the US and the products themselves be registered with the FDA.

Those owning or operating a facility that first engaged after 29 December 2022, meanwhile, must register within 60 days of first engaging, or by 27 February 2024, whichever is later.

In March this year, the FDA suspended its existing Voluntary Cosmetic Registration Program, but has not yet replaced it with a new system under MoCRA.

However, the newly-issued guidance provides recommendations and instructions to assist those submitting cosmetic product facility registrations and product listings to the FDA once the new system is up and running.

These include the statutory requirement to submit cosmetic product facility registrations and product listings; what definitions to apply; who is responsible for making the submissions; what information to include in the submissions; how to make the submissions; and when to make the submissions.

While the FDA "strongly encourages" electronic submissions, it said it is also developing a paper form as an alternative submission tool. 

The guidance further revealed that the FDA intends to make the new electronic submission portal available for submitting registration and product listing information under section 607 of the FD&C Act in October 2023.

The FDA stressed that this guidance describes its “current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited”.

“The use of the word ‘should’ in FDA guidances means that something is suggested or recommended, but not required,” it added.

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