Do you qualify for the small business exemption?
3-year average US cosmetics revenue
Under $1M
Average your gross US cosmetics sales over the past 3 fiscal years. Under $1M generally exempts you from facility registration and product listing, but not from every rule (see below).
Eye area cosmetics
No exemption
Removes the small business exemption entirely under MoCRA §612(b), regardless of revenue.
Injectables
No exemption
Removes the small business exemption entirely under MoCRA §612(b), regardless of revenue.
Prolonged-contact products
Case-by-case
Hair dye, nail treatments, semi-permanent makeup. Not explicitly excluded by statute, but FDA may apply heightened scrutiny. Consult a regulatory attorney if this is your category.
Applies to every business, no exemption
- File a Certificate of Analysis (CoA) and Safety Data Sheet (SDS) for every raw material
- Maintain formulation records showing ingredient percentages
- List full ingredients in descending order using INCI names on the label
- Include Responsible Person contact info on the label (§604)
- Give customers a way to report adverse events
- Report serious adverse events to FDA within 15 business days
- Retain adverse event and safety records, organized for FDA inspection
Only if you're not exempt
- Obtain an FDA Establishment Identifier (FEI) number
- Create an FDA Cosmetics Direct account, submit Form FDA 5066 (facility registration)
- Submit Form FDA 5067 for each product (product listing)
- Renew facility registration every 2 years. FDA does not send reminders
- Update product listings within 60 days of any formula or label change
Mistakes that cause problems
- ⚠Assuming the small business exemption means no obligations. Safety and adverse event rules still apply
- ⚠Not recalculating your 3-year revenue average annually. One strong year can remove your exemption mid-year
- ⚠Missing the 15-business-day adverse event reporting window
- ⚠Registration or product listing more than 60 days out of date after a change
- ⚠No documented safety records ready to produce during an FDA inspection
Quick self-check
- Know your 3-year average US cosmetics revenue
- Know whether your product type removes the exemption
- Safety documentation (CoA, SDS, formulation records) is organized and retrievable
- Have a working process for customers to report adverse events
- Registration/listing renewal dates are on your calendar, if applicable
This is a general reference, not legal advice. Consult a regulatory attorney for guidance specific to your business.
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