The FDA recently clarified that if you make eye shadow, you are not qualified for the small business exemption. That means facility registration, product listing, and good manufacturing practices apply.
Small Business Exemption
MoCRA established required cosmetic facility registration and product listing with the FDA along with Good Manufacturing Practices regulations (when they are set). There is a small business exemption from these requirements IF you meet the following requirements:
- Less than $1 million annual revenue (averaged over the previous 3 years), AND
- You don’t make any of the following types of products:
- Cosmetic products that are injectable,
- Cosmetic products that are intended for internal use,
- Cosmetic products that are intended to stay on the body for more that 24 hours and are normally removed by a professional, and
- Cosmetic products that regularly come in contact with the mucous membranes of the eye when normal use conditions.
It’s this last one that they recently clarified.
Non-Exempt Eye Products
The “mucous membrane of the eye” includes the waterline (the area between the lash line and the inside of the eyelids), inside the eyelids, and all parts of the eyeball.
When the FDA first came out with the Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products in December 2023, the FAQ in Appendix B gave some clarification as to what products the FDA considered would be “regularly in contact with the mucous membrane of the eye.”
The December 2024 update was changed, and added “eye shadow” to the list of items. It now says:
FAQ, Question 6:
Q6. What are examples of products that regularly come into contact with the mucus [sic] membrane of the eye?
While there may be certain exceptions, we expect that products that are intended to be applied in the proximity of the eye such as eye shadow, an eye makeup remover, a liquid or mucosal eyeliner, or a false eyelash adhesive would regularly come into contact with the mucous membrane of the eye under conditions of use that are customary or usual.
(Emphasis added)
Eye Shadow
Based on this new guidance from the FDA, if you make eye shadow, or if you sell eye shadow with your name on the package as the responsible person, you cannot be exempt as a small business.
If you manufacture eyeshadow, you must register your facility with the FDA and will be required to follow good manufacturing practices when they are issued.
If you sell eye shadow with your name on the label as the responsible person (the business name and address on the label), you must list your product(s) with the FDA.
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