On 7 August 2023, the US Food and Drug Administration (FDA) published a draft guidance on the registration of cosmetic facilities and products, which are new obligations under the Modernization of Cosmetics Regulation Act (MoCRA).
The MoCRA gave the FDA new powers to control cosmetics, including:
• Establishment registration: cosmetics manufacturers must register their facilities with the FDA, update their registration within 60 days of any change and renew it every two years
• Product registration: the person responsible must “list” each cosmetic product marketed with the FDA, specifying the ingredients, and provide annual updates
Once finalised, the guidance drawn up by the FDA is intended to help stakeholders carry out these registrations.
It indicates who is responsible for registration, what information needs to be included, when and how registration should be carried out, and specify existing exemptions.
It also contains information on the new electronic portal that the FDA intends to make available in October 2023 for making these registrations, a procedure that it encourages, although it will also make available an alternative paper form to the electronic submission portal.
Planning ahead
In its press release, the FDA invites stakeholders to consult and eventually comment on this guidance before 9 September 2023, and calls on them to plan to carry out these registrations well before the deadline of 29 December 2023.
It specifies that the person responsible for it must have an FDA Establishment …
