FDA Draft Guidance Provides Further Details on New Cosmetic Product Facility Registration and Product Listing Requirements
As we reported last year, MoCRA significantly expanded FDA’s regulation of cosmetic products and imposed extensive new requirements related to cosmetic products marketed in the United States. Our comprehensive overview of MoCRA’s numerous requirements is available here.
Among MoCRA’s many provisions are requirements that cosmetic manufacturing facilities be registered with FDA and cosmetic products in commercial distribution be listed with FDA. These requirements take effect later this year, but until recently there was little information available regarding how the agency intended to implement them (e.g., what systems and processes manufacturers would be required to use).
In the recently issued draft guidance, FDA states that it intends to make a new electronic registration and listing submission portal available in October 2023. While electronic submission is not required, the agency nonetheless strongly encourages companies to make submissions in this manner.
The draft guidance additionally provides additional details regarding:
- The entity responsible for submitting facility registration and cosmetic product listing(s);
- Information that must be included in a facility registration submission (e.g., facility name, name of owner and/or operator, and brand names under which cosmetic products manufactured or processed in the facility are sold);
- Information that FDA requests be included in a facility registration submission (e.g., name of parent company (if any) and facility DUNS Number);
- Information that must be included in a cosmetic product listing (e.g., facility registration number, applicable cosmetic category/categories for the cosmetic product, and a list of ingredients in the cosmetic product);
- Information that FDA requests be included in a cosmetic product listing (e.g., type of business as listed on the label, image of label, and product webpage link);
- How and when to make registration and listing submissions;
- Applicable exemptions to the registration and listing requirements;
- Requirements for products that are both drugs and cosmetics (i.e., combination products); and
- Cosmetic product categories and codes.
Finally, the draft guidance reiterates that product listing numbers will not be available for public disclosure, nor will FDA disclose information (1) from a facility registration on the brand names under which cosmetic products manufactured or processed in the facility are sold, or (2) from a product listing on the facility registration number of the facility where the cosmetic product is manufactured or processed, in response to a request under the Freedom of Information Act (FOIA). However, all other information from cosmetic product facility registrations and listings will be available for public disclosure consistent with FOIA, FDA’s disclosure regulations under 21 C.F.R. Part 20, and other applicable federal law.
While comments may be submitted on any FDA guidance at any time, comments should be submitted on the draft guidance by September 7, 2023, to ensure that FDA considers them before beginning work on the final version.
If you are interested in more information about MoCRA, would like guidance on complying with these new requirements, or would like assistance preparing a comment on the draft guidance, please contact ArentFox Schiff’s FDA Practice Group.
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