What Is MoCRA?
The Modernization of Cosmetics Regulation Act (MoCRA), signed into law December 29, 2022, is the most significant expansion of FDA authority over cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938. Before MoCRA, the FDA couldn't require cosmetics companies to register, mandate safety testing, or issue recalls -- registration was purely voluntary.
MoCRA changed that. Facility registration and product listing became mandatory, with the statutory deadline passing December 29, 2023 and FDA enforcement active since July 1, 2024. As of 2026, FDA has moved into active enforcement mode -- warning letters, import alerts, and border holds for non-compliant products are now a real, ongoing risk, not a future possibility.
The Small Business Exemption
MoCRA includes a small business exemption: companies averaging under $1 million in annual gross US cosmetic sales over the preceding three years may be exempt from some registration and listing requirements. For a lot of new private-label nail brands -- often run by one or two people, selling through a handful of retailers or direct-to-consumer -- this sounds like it should apply to them.
For most cosmetic categories, it does. But MoCRA carves out specific product types that lose the exemption entirely, no matter how small the company is.
Why Gel & Acrylic Nails Are Excluded
Under FDA's small business guidance, any product that "alters appearance for more than 24 hours" loses the small business exemption automatically. That category explicitly includes:
Gel & Acrylic Nails
Any nail product designed to hold for multiple days or weeks -- which is the entire point of gel and acrylic systems -- falls squarely into this excluded category.
Permanent Hair Dye
Long-lasting color-altering hair products face the same exclusion, for the same reason: the effect lasts well beyond 24 hours.
Eye-Contact Products
Mascara, liquid eyeliner, and eyelash adhesive are excluded because they contact the mucous membrane of the eye -- a separate risk-based carve-out.
Injectables & Internal-Use Products
Injectable cosmetic products and products for internal use round out the excluded list.
The logic FDA applies is straightforward: exemptions exist to reduce burden on genuinely low-risk small businesses, but a product's risk profile doesn't shrink just because the company selling it is small. A gel manicure that lasts three weeks carries the same formulation and safety considerations whether it's made by a multinational or a two-person startup.
What You Actually Need to Do
If your brand sells gel or acrylic nail products in the US, two filings apply regardless of your revenue:
Facility Registration (FDA Form 5066) -- Mandatory for the manufacturing facility, filed through FDA's Cosmetics Direct portal, and renewed every two years. This requires an FEI (FDA Establishment Identifier) number.
Product Listing (FDA Form 5067) -- Filed by the "Responsible Person" (typically the brand owner), listing the product category and full ingredient list, tied to the manufacturing facility's FEI. New products must be listed within 120 days of being marketed, and listings must be updated annually.
If you manufacture through a third party, the facility registration is your manufacturer's responsibility -- but the product listing is still yours to file as the brand owner, and it depends on your manufacturer's facility actually being registered in the first place.
What Happens If You Don't Comply
As of 2026, FDA enforcement of MoCRA is active, not theoretical. Products from unregistered facilities or without a valid listing are legally considered misbranded or adulterated. In practice, that translates to:
- Import holds -- shipments can be detained at the border pending proof of registration and listing.
- Warning letters -- FDA has already issued warning letters to facilities manufacturing both drug and cosmetic products, signaling it expects strict compliance once GMP rules are finalized.
- Adverse event reporting exposure -- serious adverse events, including significant hair loss or nail damage, must be reported to FDA within 15 business days. Brands without a compliance process in place risk missing this window entirely.
How LuxeFormula Labs Helps
LuxeFormula Labs manufactures at an FDA-registered facility (FEI 3031525994). For private-label customers, that means the facility-registration half of MoCRA compliance is already handled by working with us -- you're not starting from zero. The product listing filing is still the brand owner's responsibility as the "Responsible Person," but it's a far simpler process when the facility side is already in order.
MoCRA Exemption FAQs
No. MoCRA's small business exemption does not apply to products that alter appearance for more than 24 hours, which explicitly includes gel and acrylic nail products. This exclusion applies regardless of revenue -- even a business well under the $1 million threshold must still fully register facilities and list products.
Businesses averaging under $1 million in annual gross US cosmetic sales over the preceding three years may qualify for a small business exemption from some registration and listing requirements. This exemption has explicit product-category exclusions that override the revenue test.
Alongside gel and acrylic nail products: products contacting the mucous membrane of the eye (mascara, liquid eyeliner, eyelash adhesive), injectable cosmetic products, products for internal use, and permanent hair dye -- any product altering appearance for more than 24 hours.
Register your manufacturing facility with FDA Form 5066 and submit a product listing with FDA Form 5067, both through FDA's Cosmetics Direct portal. Facility registration renews every two years; product listings update annually, with new products listed within 120 days.
FDA began active MoCRA enforcement in 2026. Non-compliant facilities and unlisted products can trigger warning letters, import alerts, and border detention of inventory -- unregistered or unlisted products are legally considered misbranded or adulterated.
Yes. LuxeFormula Labs manufactures at an FDA-registered facility (FEI 3031525994), which means the facility-registration side of MoCRA compliance is already handled for private-label customers. Contact us at (307) 533-0268 to discuss product listing for your specific formulation.
Manufacture With a Facility
That's Already Registered
LuxeFormula Labs is an FDA-registered facility (FEI 3031525994) -- the facility-registration half of MoCRA compliance is handled the moment you work with us. Gel polish, acrylic systems, and more, private-label ready.