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On 07 August 2023, FDA released a Draft Guidance, announcing its new registration and listing requirements for manufacturers of cosmetic products

FDAs original program was discontinued in March of 2023, and manufacturers of cosmetic products are now required to register and list in a new system. 

Many firms that are required to register will need to do so before the end of 2023. 

Here's what you need to know:

  • All cosmetic manufacturers are required to register unless their average gross sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, and if they do not produce:

    • products that come into contact with the eye or mucus membrane of the eye

    • cosmetic products that are injected or intended for internal use

    • cosmetic products that alter appearance for more than 24hours

  • If your firm is not exempt from the requirements, and you were manufacturing or processing cosmetic products as of December 29. 2022, your facility must be registered and your products must be listed no later than December 29, 2023. If you began producing cosmetics after December 29, 2022, you must register and list by December 29, 2024.

  • Everyone required to register must renew their registration biennially (every two years); listings will be confirmed/verified at that time, as well

  • FDA has not yet released the system by which companies can register and list, but expects it to be available October 2023.

  • FDA is not charging a fee to register and list

Need to know if your facility is required to register or if your product requires listing?

Click this link or the button above to send us an inquiry about your firm and your products. We'll let you know if this new requirement applies to you, and if it does, we'll tell you what you need to do to be compliant.



Last updated: 07Aug2023


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