Checker
MoCRA Small Business Exemption Checker
Use this checklist to collect the facts that matter for a small-business exemption review. Do not use it as a legal determination.
Quick answer: FDA says certain small businesses are exempt from some MoCRA requirements, including facility registration and product listing, when average gross annual U.S. cosmetic-product sales for the previous 3-year period are less than $1,000,000, adjusted for inflation. FDA also lists product categories where the exemption does not apply. Your job is to document the facts and review them with current FDA sources or a qualified professional.
Gather average gross annual U.S. cosmetic-product sales for the previous 3-year period and keep source records.
List every cosmetic, skincare, lip balm, soap, and body-care product by SKU.
Check whether any products fall into FDA-listed exception categories.
Use "ready for review" or "needs review", not "exempt" or "compliant".
Exemption review worksheet
- Record average gross annual U.S. cosmetic-product sales for the previous 3-year period and where that number came from.
- Check current FDA materials for inflation-adjusted threshold handling before relying on the number.
- List every cosmetic product you manufacture, process, pack, distribute, or sell under your brand.
- Mark products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use.
- Mark any injected products.
- Mark products intended for internal use.
- Mark products intended to alter appearance for more than 24 hours when consumer removal is not part of usual use.
- Mark products with drug-like claims, such as treating acne, eczema, infection, pain, inflammation, or disease.
- Identify which facilities or manufacturers touch each product.
The four product flags that deserve extra attention
FDA's small-business materials identify categories where certain exemptions do not apply. For a small seller, these should be visible flags in the workbook, because one product can change the review path for that product line.
Products regularly coming into contact with the mucus membrane of the eye under customary or usual conditions of use need careful review.
Any product intended for injection should be escalated immediately for professional review.
Products intended for internal use should not be treated like ordinary topical cosmetics.
Products intended to alter appearance for more than 24 hours can raise exception questions.
Suggested status labels
- Information complete for review: The worksheet has enough data to discuss with a professional.
- Missing information: One or more product, sales, manufacturer, or claim fields is incomplete.
- Professional review recommended: The product has exception flags or unclear claims.
- Urgent review: The product appears to involve injection, internal use, regular contact with the mucus membrane of the eye, long-wear alteration, or disease-treatment claims.
What to capture in the spreadsheet
| Field | Why it matters | Safer output language |
|---|---|---|
| Average gross annual sales | Supports the small-business review discussion. | Revenue information entered |
| Product exception flags | Identifies products that may fall outside certain exemptions. | Exception flag present |
| Drug-like claims | Claims can change the regulatory review path. | Claims review needed |
| Manufacturer role | Clarifies who may have registration or listing information. | Manufacturer answer needed |
What not to do
Do not label a spreadsheet result as "exempt" or "not exempt" unless a qualified review has been completed. A safer workbook result is "review needed" or "information appears complete for review."
Recommended workbook logic
A good checker should produce operational statuses, not legal conclusions. Use conditional formatting to highlight missing revenue data, products with exception flags, products with uncertain intended use, and products with claim concerns.
- If revenue fields are blank, show "missing revenue information."
- If any exception flag is yes or unsure, show "professional review recommended."
- If all fields are complete but no review has happened, show "information complete for review."
- If a product has disease-treatment language, show "claims review needed."