MoCRA Small Business Exemption Expired: What to Do Next

What Was the Small Business Exemption?

When MoCRA was signed into law on December 29, 2022, it included a two-year transition period for small businesses. Under FD&C Act Section 607(b)(5), businesses that had average annual gross sales of cosmetic products totaling less than $1,000,000 (calculated over the previous three-year period) were given until December 29, 2025, to comply with facility registration and product listing requirements.

This exemption applied only to registration and listing obligations. Other MoCRA requirements — including adverse event reporting, safety substantiation, and labeling — applied to all businesses from the start, regardless of size.

It is important to note that the exemption was based on cosmetic product sales specifically, not total company revenue. A company with $10 million in total revenue but less than $1 million in cosmetic product sales would have qualified.

What You Must Do Now

If your business relied on the small business exemption and has not yet registered, you must act immediately. Here is your action plan:

Step 1: Register Your Facility

Register every facility that manufactures or processes cosmetic products through FDA's Cosmetics Direct portal at access.fda.gov. This includes contract manufacturing facilities that produce products on your behalf (they must register separately, but you should verify their registration status).

Step 2: List All Products

Submit product listings for every cosmetic product you market in the United States. Each listing requires the product name, category, complete ingredient list, Responsible Person information, and the facility registration number where the product is manufactured.

Step 3: Designate a U.S. Agent (Foreign Facilities)

If your facility is outside the United States, you must designate a U.S. Agent before completing registration. Assurentry provides same-day U.S. Agent designation for MoCRA registrations.

Step 4: Set Up Adverse Event Reporting

Remember: the adverse event reporting obligation was never covered by the small business exemption. You should already have procedures in place. If you don't, establish them now. Serious adverse events must be reported to FDA within 15 business days of receipt.

What Happens If You Don't Comply?

Now that the exemption has expired, non-compliant small businesses face the same enforcement risks as any other cosmetics company:

• Warning letters: FDA can issue warning letters requiring you to register and list products within a specified timeframe
• Import detention: Foreign facilities without active registrations will have products detained at U.S. ports
• Product refusal: FDA can refuse entry of cosmetics from unregistered facilities
• Mandatory recall: Under MoCRA, FDA now has authority to order mandatory recalls of cosmetic products if necessary
• Injunctions: In serious cases, FDA can seek court injunctions to prevent the sale of products from non-compliant facilities

FDA has stated publicly that it is ramping up MoCRA enforcement in 2026 as the initial compliance periods have all passed. Small businesses are not exempt from enforcement simply because they are small — the exemption was a timing extension, not a permanent waiver.

Costs for Small Businesses

The good news: MoCRA registration and product listing are free from FDA. There is no government fee for cosmetics facility registration or product listing, unlike medical device or drug registrations.

The costs you may encounter include:

• U.S. Agent fees (foreign facilities): Assurentry offers U.S. Agent services starting at $249/year — significantly less than many competitors
• Label updates: Adding adverse event contact information to labels if not already present
• Registration service fees: If you use a third party to manage your registration (optional but helpful)
• Safety substantiation: If you need to commission safety testing or literature reviews for your products

For most small businesses, the total compliance cost is modest — especially compared to the potential cost of an FDA enforcement action.

Other MoCRA Obligations to Address

Beyond registration and listing, make sure you have addressed these MoCRA requirements as well:

• Safety substantiation: Document the safety data supporting each product (FD&C Act §608)
• Adverse event record-keeping: Maintain records of all adverse events for six years (FD&C Act §605)
• Label updates: Ensure contact information for adverse event reporting appears on all labels (FD&C Act §609)
• Biennial renewal preparation: Plan for your first biennial renewal in 2027 or 2028 depending on when you register

Assurentry's MoCRA compliance services cover every aspect of cosmetics regulation, from registration to ongoing compliance monitoring. We help businesses of all sizes navigate MoCRA with confidence.