[UPDATED] US MoCRA; how to get prepared now that the draft guidance on registration is published?
On the 7th August 2023, the US Food and Drug Administration (FDA), issued draft guidance regarding facility registrations and product listings of cosmetic products, as required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For further information on MoCRA please visit our blog ‘US MoCRA – What Can You Do Now?’ at https://www.bloomregulatory.com/post/us-mocra-what-can-you-do-now.
Whilst this is a daunting time for businesses to understand their legal obligations, the draft guidance offers insight into how these requirements will look like in practice. The draft primarily focuses on two key areas of MoCRA: facility registration and product listing.
Facility registration
Facility registration will be required for every entity that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US. A single registration is required per facility even if the facility is manufacturing or processing cosmetic products on behalf of more than one responsible person. The guidance also provides the option for a responsible person whose products are manufactured or processed at such a facility to submit a registration on behalf of the facility.
The information required to submit a facility registration will be mostly readily available however a US agent is required. At this time, the FDA has not provided a definition of this agent however as we interpret the text, we understand that the US agent would have to be based in the US. Their name and contact details will have to be included in the registration. However no role or responsibility apart from being a local contact is currently included in the Law or the guidance.
The initial registration is a one-time submission but should be updated within 60 days of any changes, and registration should be renewed every two years.
Product listing
Similar to UK/ EU notification, a product listing will be required to be submitted by the responsible person. The portal is not yet available however FDA intends to make the new electronic submission portal available in October 2023. [UPDATE 8 Nov 2023: Portal not yet available and date of enforcement delayed]
Much less information and detail is required than the respective EU/UK systems;
the facility registration number of each facility where the cosmetic product is manufactured or processed
the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label
the cosmetic category or categories for the cosmetic product
The cosmetic product ingredients list the product listing number, if any previously assigned
type of submission (initial, update to content (annual), abbreviated renewal).
There have been questions around the ‘responsible person’ who is required to submit the notification and whether this person needs to be based in the US. The guidance defines ‘Responsible person’ as ‘the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.’ According to this definition it is not suggested that such a person be based in the US.
Can I be exempt from these requirements?
MoCRA exempts certain small businesses (those with an average gross annual sales in the U.S. of cosmetic products for the previous 3-year period less than $1,000,000) from these requirements.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
Products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use (e.g. eye makeup).
Products that are injected.
Products that are intended for internal use.
Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
If I am not exempt, what deadlines are in place?
UPDATE: On 8 November 2023 the FDA announced enforcement delays for both facility registrations and product listing. The original statutory deadlines remain in place but the FDA will not carry out enforcement prior to the new ‘deadlines’, allowing industry greater time to comply with the requirements.
What can I do now?
It is important to remember at this moment in time, this guidance is still in draft form. The final content is still under discussion.
There is nothing to do right now however it will be important to be prepared for the upcoming requirements and their respective deadlines. For facility registration we recommend to reach out to your manufacturers now and check with them if they intend to register as soon as the portal is available. Once manufacturers have registered, they will then be able to share with you their registration number for inclusion in your own product listing. Facility registration will be needed prior to listing a product.
Bloom Regulatory along with our trusted partners will be able to support you with both product listing and facility registration.
Written by Laila Manshi