Cosmetics & The Law

Cosmetic brands and regulatory enthusiasts have been waiting with bated breath for an update regarding the December 29, 2023, deadline for cosmetic product listings and facility registrations. When will the portal be available? What information will be required? Will paper submittals be allowed? What if my manufacturer is a “small business” but I am not? So many questions seem to be circulating.

And finally… FDA has provided some answers.

On August 7, 2023, FDA released the Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. The non-binding guidance and recommendations are offered for public comment until September 7, 2023. 

In the Guidance, FDA provides a list of information intended to be mandatory for facility registrations and product listings, as well as what information intended to be optional. The following is the mandatory information for listings:

• FEI of facility where the cosmetic product is manufactured or processed;
• the name and contact number of the responsible person;
• 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 the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), 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).

The Guidance also reiterated many of the same facts answered in its early announcements with a few clarifications. For example, if your manufacturer qualifies as a small business, that small business may be exempt from registration and listing requirements, however, if your business, if the responsible person, is not a small business you will still be required to list your products. However, you will not have to provide the manufacturer’s registration number. Instead, you would simply provide the small business manufacturer’s name and address.  

In addition, the Guidance identified a number of cosmetic product categories and requests comment on the categories. We suggest reviewing the product categories to determine whether your products’ categories are clearly listed. If not, we suggest submitting comments.

Finally, the Guidance indicates that for the electronically submitted facility registration and product listing data the portal will utilize will be in the structured product labeling (SPL) format – the same format used for drug product listings. In addition, currently the portal is anticipated to be available in October. It is recommended companies have the data ready for submittal and to begin submittals far in advance of the December 29, 2023, deadline.

Would you like assistance submitting comments?  Amin Wasserman Gurnani, LLP is here to help! If you have questions, need assistance with registration or product listings, need help with putting together safety substantiation or updating operating procedures for maintaining records of adverse events, or have any other questions, we are here for you!

Email ADiesch@awglaw.com