The U.S. Food and Drug Administration (FDA) has issued a formal clarification stating that it does not provide certificates or any other documents to verify compliance for cosmetic product facility registration. The clarification, published by the FDA, responds to a rising volume of inquiries from facility owners, responsible persons, and retailers who have been seeking such documentation, in some cases at the request of ecommerce platforms requiring proof of registration status.
The agency’s announcement has direct implications for cosmetic brands manufacturing or distributing in the United States, particularly those selling through online marketplaces. Understanding what the FDA does and does not provide under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is now a practical business matter for anyone operating in this space.
What Mocra Actually Requires
Under section 607 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), owners and operators of facilities that manufacture or process cosmetic products are generally required to register those facilities with the FDA and renew that registration every two years. Separately, the responsible person for each marketed cosmetic product must list that product with the FDA, including its ingredients, and submit updates annually.
Registering a facility or listing a product does not mean the FDA has reviewed or approved anything made there. The FDA has been direct on this point: a facility registration number or a product listing number is not a mark of approval, and cosmetic product facility registration and listing are not approval programs or promotional tools.
Why The FDA Issued This Clarification
The FDA says it has received a growing number of requests from individuals and companies asking for documents confirming their registration status, or confirming that they are exempt from the registration requirement. Separately, the agency is aware that ecommerce platforms, including TikTok Shop, have been asking sellers for proof of FDA registration or, for those not required to register, a letter or email from the FDA confirming that exemption.
The FDA does not issue any of that. There is no certificate, letter, or email confirming registration, listing, or exemption status, and the agency will not create one on request.
What the FDA will not issue
The FDA has confirmed it will not provide, in connection with cosmetic product facility registration or product listing:
- A certificate as proof of facility registration or product listing
- A verification document, such as a letter or email, stating that a facility is registered or a product is listed
- Any document confirming that a facility or responsible person is exempt from the registration or listing requirement
What This Means For Your Business
If a platform or retail partner asks for an FDA certificate or verification letter, tell them it doesn’t exist, the FDA has confirmed this directly. Keep the confirmation and registration number Cosmetics Direct generated when you registered. That’s your own record, and it’s what you should share, along with a short explanation of how MoCRA’s framework works, instead of requesting a document the FDA has said it won’t produce.
If your company qualifies for an exemption from registration, that determination comes from the criteria set out in the FD&C Act itself, not from a confirmation letter. It’s worth documenting your basis for the exemption in your own records so you’re prepared to explain it clearly if a platform or partner asks.
Either way, registration and approval are two different things. A registration number tells the FDA you exist and are being tracked. It doesn’t mean your products have been reviewed or approved, and it shouldn’t be presented that way in marketing materials or to trading partners.
If you’d rather have a second set of eyes on your registration status or need help preparing an explanation for a platform, our team can help. See our U.S. Cosmetics Facility Registration services or contact us directly.
Frequently Asked Questions
Can a company get a letter from the FDA confirming it's exempt from cosmetic facility registration?
No. The FDA has confirmed it does not issue letters, emails, or any other documentation confirming that a facility or responsible person is exempt from registration under section 607. If you believe you qualify for an exemption, that determination rests on the criteria in the statute and FDA guidance, not on a document from the agency.
What should we do if a platform asks for proof of FDA registration?
Point them to your own registration confirmation from Cosmetics Direct and explain, in writing, that FDA does not issue certificates or verification letters for this purpose. Preparing a short, clear explanation of the MoCRA registration and listing framework in advance can save time when a platform's compliance team raises this.
Does a facility registration number mean the FDA approved our products?
No. The FDA has been explicit that a facility registration number or product listing number does not indicate approval of the facility or the products made there. Representing it that way in marketing materials or to trading partners would be inaccurate.
Key Takeaways
- The FDA does not issue certificates, letters, or verification documents of any kind confirming cosmetic facility registration or product listing status.
- MoCRA requires facility registration renewed every two years and product listings updated annually, but both are administrative requirements, not an approval process.
- Ecommerce platforms such as TikTok Shop have been asking sellers for documentation the FDA does not produce, so it’s worth having your own explanation ready.
- A registration or listing number is not evidence of FDA approval and shouldn’t be presented as such.
- If you’re exempt from registration, document the basis using the criteria in the FD&C Act rather than seeking a confirmation letter that doesn’t exist.
If you want help confirming your registration and listing status, understanding whether an exemption applies to you, or preparing documentation to share with a platform or trading partner, our team can walk through it with you. Learn more about our U.S. Cosmetics Facility Registration services, or contact us to talk it through.
