MoCRA Small Business Exemption Check
A written check of whether the MoCRA small business exemption applies to your business and products.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
MoCRA exempts some small businesses from facility registration and product listing, based on average annual US sales over three years, but not for certain products such as eye-area, injected or long-lasting products. We check your sales and product range against section 612 and confirm the current threshold at order. £295.
What's included in your exemption check
| Document | What it is |
|---|---|
| Sales test | Your average annual US gross sales over three years compared with the current threshold |
| Product test | Each product checked against the categories that are never exempt |
| Duties that still apply | Adverse event reporting, labelling and safety substantiation |
| Written conclusion | Whether you appear exempt from registration and listing |
Who this check is for
- Small and new brands starting to sell in the US
- Brands unsure whether they must register and list
- Brands whose US sales are growing
What this check does not include
- Legal advice. This is a regulatory assessment, not a legal opinion.
- Registration or listing. Available separately if you are not exempt.
- Verification of your accounts. We rely on the sales figures you provide.
How it works
- Send your details US sales for the last three years and your product list.
- Check We apply the sales and product tests.
- Report You receive a written conclusion and the duties that still apply.
What is the MoCRA small business exemption?
FD&C Act section 612, added by MoCRA, exempts certain small businesses from facility registration and product listing, and from some GMP requirements. It is based on average annual gross sales in the US over the previous three years, with a threshold adjusted for inflation, which we confirm at order. The exemption does not apply to products that contact the eye, are injected, are for internal use, or alter appearance for more than 24 hours. Small businesses must still report serious adverse events, label correctly and keep safety substantiation records.
What we assess
Sales:
- Three-year average of US gross sales.
- Threshold: Current inflation-adjusted figure, confirmed at order.
Products never exempt:
- Eye-area products.
- Injected products.
- Products for internal use.
- Products altering appearance for more than 24 hours.
What you receive
- Written exemption assessment
- Product-by-product notes
- List of MoCRA duties that still apply
Legal framework
- FD&C Act section 612 — small business exemptions and excluded products
- Section 605 — adverse event reporting still applies
- Section 608 — safety substantiation still applies
Official sources:
- Modernization of Cosmetics Regulation Act of 2022 (FDA)
- Registration and Listing of Cosmetic Product Facilities and Products (FDA)
Why brands choose Phoenix
- A clear answer in writing.
- Product-level check — not just sales.
- Next steps priced if you are not exempt.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Know before you register. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
Am I exempt from MoCRA registration and listing as a small business?
Possibly, if your average annual US sales over three years are below the current threshold and none of your products is in an excluded category. We confirm the threshold at order.
Which products are never exempt?
Products that contact the eye, are injected, are for internal use, or alter appearance for more than 24 hours.
What duties still apply if I am exempt?
Serious adverse event reporting, labelling requirements including the US contact, and safety substantiation records.
What is the sales threshold?
It is set in section 612 and adjusted for inflation. We confirm the current figure when you order.
Is this legal advice?
No. It is a regulatory assessment based on the information you give us.
How much does the check cost?
£295.