Exporting Cosmetics to the US: MoCRA Compliance
A foreign brand's MoCRA pathway to the U.S. market — registration, listing, Responsible Person, labeling, and what's still coming.
Key Takeaways
- MoCRA is the framework — facility registration, product listing, Responsible Person, safety, adverse events, labeling.
- Facility registration (biennial) + product listing (annual) — via Cosmetics Direct; no FDA fee.
- Foreign brands need a U.S.-reachable Responsible Person + a U.S. Agent.
- Labels need a U.S. adverse-event contact — required since Dec 29, 2024.
- Small-business exemption (<$1M) drops registration/listing/GMP — not safety/adverse-event/labeling, and not for higher-risk products.
- Cosmetics aren't "FDA approved"; GMP & fragrance-allergen rules still pending.
The MoCRA Pillars
- Facility registration — manufacturers/processors register in Cosmetics Direct; biennial renewal; foreign facilities give a U.S. Agent contact
- Product listing — each product listed (Form FDA 5067/SPL): name, category, full ingredients, RP contact, facility FEI; updated annually
- Responsible Person — the manufacturer/packer/distributor named on the label; owns listing, safety, adverse events, labeling
- Safety substantiation — adequate substantiation of each product's safety, on record
- Serious adverse-event reporting — to FDA within 15 business days (with the label); records six years (three for small business)
- Labeling — a U.S. adverse-event contact (since Dec 29, 2024), plus standard cosmetic labeling
How a Foreign Brand Enters the U.S. Market
- Confirm it's a cosmetic — not an OTC drug. SPF, anti-dandruff, anti-acne, or drug claims make it a drug (or drug/cosmetic). See cosmetic vs OTC drug.
- Register your facility. In Cosmetics Direct (biennial), with a U.S. Agent contact for the foreign facility — unless small-business exempt. See the cosmetics registrar.
- List each product. Form FDA 5067/SPL, annually — ingredients, category, RP contact, facility FEI.
- Name a Responsible Person. U.S.-reachable; foreign brands need a U.S.-based RP or a U.S. Agent.
- Substantiate safety. Keep adequate safety records for each product.
- Get the label right. U.S. adverse-event contact (required since Dec 29, 2024), plus INCI ingredients and standard cosmetic labeling.
- Set up adverse-event reporting & import entry. Be ready to report serious AEs within 15 business days; then clear the import entry.
Limited — and Product-Dependent
A business with average gross annual U.S. cosmetic sales under $1 million (prior three years) is exempt from cosmetic GMP, facility registration, and product listing. But the exemption is narrow:
- Still required, even if exempt: adverse-event reporting, safety substantiation, and labeling (including the U.S. adverse-event contact)
- Does not apply — regardless of revenue — to higher-risk products: those that regularly contact the eye's mucous membrane, injected products, products for internal use, or products intended to alter appearance for more than 24 hours where consumer removal isn't customary
- Reduced records — qualifying small businesses keep adverse-event records three years (vs six)
Not "Approved," No Fee — and Rules Still Coming
- Cosmetics are not "FDA approved." FDA doesn't approve cosmetics (aside from color additives), and MoCRA registration/listing is not premarket approval — FDA issues no compliance certificate, so treat any third-party "MoCRA certificate" with suspicion
- No FDA fee. Cosmetic facility registration and product listing are free from the government; any cost is a service fee
- GMP rule — pending. FDA is still developing cosmetic GMP regulations
- Fragrance-allergen labeling — pending. FDA missed the Dec 29, 2025 deadline; a proposed rule is expected around mid-2026 and a final rule likely 2027 or later — so there's no federal fragrance-allergen disclosure requirement yet (some states differ)
Export Your Cosmetics to the U.S.
FDA Registration Assistance runs the MoCRA pathway for foreign cosmetic brands: confirming the product is a cosmetic (not an OTC drug), registering your facility in Cosmetics Direct (biennial), listing your products (annual), serving as your U.S. Agent and supporting a U.S.-reachable Responsible Person, reviewing labeling (including the U.S. adverse-event contact) and safety substantiation, and setting up adverse-event readiness. We keep clear that cosmetics aren't "FDA approved" and that MoCRA registration is free from the government.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333 for a quote. An independent compliance firm serving 1,000+ companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions — Exporting Cosmetics to the US (MoCRA)
1. What does a foreign brand need to sell cosmetics in the U.S.?
Compliance with MoCRA (the Modernization of Cosmetics Regulation Act of 2022). In short: confirm the product is a cosmetic (not an OTC drug), register your facility with FDA (via Cosmetics Direct, renewed every two years, with U.S. Agent contact for foreign facilities), list each product (annually), name a Responsible Person, substantiate each product's safety, put a U.S. adverse-event contact on the label, and be ready to report serious adverse events. Then clear the import entry. Cosmetics aren't "FDA approved," and there's no FDA fee for MoCRA registration.
2. What is MoCRA?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022 - the biggest expansion of FDA cosmetic authority in decades. It introduced mandatory facility registration, mandatory product listing, a named Responsible Person, safety substantiation, serious adverse-event reporting, and new labeling and FDA recordkeeping/recall powers. It also directs FDA to issue further rules (cosmetic GMP, fragrance-allergen labeling, talc testing) that are still being finalized. For any cosmetic sold in the U.S., MoCRA is now the core framework.
3. Do I have to register my (foreign) cosmetic facility?
Generally yes - a facility that manufactures or processes cosmetics for U.S. distribution must register with FDA through Cosmetics Direct, and registration renews every two years (biennially). Foreign facilities register too and must provide U.S. Agent contact details in the registration. There's no FDA fee to register. The main exception is the small-business exemption (below), which drops facility registration and product listing for qualifying small businesses - but not the other MoCRA duties.
4. What is product listing under MoCRA?
The Responsible Person must list each marketed cosmetic product with FDA (Form FDA 5067, in Structured Product Labeling format, via Cosmetics Direct), including the product name, cosmetic category (from FDA's official categories), the full ingredient list (including fragrances), the Responsible Person's contact, and the linked facility FEI. Product listing is updated annually, and a discontinued product is reported within 120 days. Listing is separate from - and in addition to - facility registration.
5. Who is the Responsible Person, and do foreign brands need a U.S. one?
The Responsible Person (RP) is the manufacturer, packer, or distributor whose name appears on the product label. The RP owns the core MoCRA duties: product listing, safety substantiation, adverse-event reporting, and label compliance. For a foreign brand, the practical requirement is a U.S.-reachable RP - and if you have no U.S. presence, you'll need a U.S.-based Responsible Person or a U.S. agent through which FDA and consumers can reach you. The label must carry a U.S. adverse-event contact regardless.
6. Do I need a U.S. Agent for MoCRA?
Yes - a foreign cosmetic facility must appoint a U.S. Agent, and the U.S. Agent contact details are provided as part of the facility registration. This is the same U.S. Agent concept used across FDA programs: a U.S.-based point of contact for FDA. So a foreign cosmetic brand's U.S.-side setup typically includes a U.S. Agent for the facility plus a U.S.-reachable Responsible Person (which may be the same or a different party).
7. What labeling does MoCRA require?
The headline change: since December 29, 2024, every cosmetic label must carry a U.S. contact - a domestic address, domestic phone number, or electronic contact (like a website) - through which the Responsible Person can receive adverse-event reports. Standard cosmetic labeling (identity, net quantity, ingredient/INCI list, warnings) still applies. Fragrance-allergen labeling is coming but not yet required (see below), and professional-use products have their own labeling. A missing U.S. adverse-event contact makes the product misbranded.
8. Is fragrance-allergen labeling required yet?
Not yet at the federal level. MoCRA directed FDA to issue fragrance-allergen labeling requirements by regulation, but FDA missed its statutory deadline (December 29, 2025); a proposed rule is expected around mid-2026 and a final rule likely in 2027 or later. So as of early 2026 there's no federal requirement to disclose specific fragrance allergens - though it's coming, and some states (e.g., California) have their own requirements. Build your labels to adapt when the federal rule lands.
9. What are the adverse-event reporting duties?
The Responsible Person must report a serious adverse event associated with a cosmetic used in the U.S. to FDA within 15 business days (including a copy of the product's label), and submit any significant new information within 15 business days of receiving it (up to a year). Records must be kept for six years (three years for qualifying small businesses). FDA can access these records during an inspection. So you need a working intake-and-reporting process before you sell, not after an incident.
10. Is there a small-business exemption?
Yes, but it's limited. A business with average gross annual U.S. cosmetic sales under $1 million (over the prior three years) is exempt from cosmetic GMP, facility registration, and product listing. But it remains fully subject to adverse-event reporting, safety substantiation, and labeling (including the U.S. adverse-event contact). And the exemption does not apply - regardless of revenue - to higher-risk products: those that regularly contact the eye's mucous membrane, injected products, products for internal use, or products intended to alter appearance for more than 24 hours where consumer removal isn't customary. Document your exemption in writing.
11. Is there an FDA fee for MoCRA registration?
No. There is currently no FDA fee for cosmetic facility registration or product listing under MoCRA - like food facility registration, it's free from the government. Any cost is a service fee if you have it handled for you. And be aware FDA does not issue a "compliance certificate" for MoCRA registration or listing - so treat any third-party "MoCRA certificate" with the same skepticism as a fake "FDA registration certificate."
12. Does MoCRA registration mean my cosmetic is FDA-approved?
No. FDA does not approve cosmetics (aside from color additives), and MoCRA facility registration and product listing are not premarket approval programs - they don't mean FDA reviewed or approved your facility or product. So don't market a cosmetic as "FDA approved" or "FDA registered" in a way that implies endorsement. The accurate description is that your facility is registered and your products are listed under MoCRA - not approved.
13. What if my "cosmetic" is actually an OTC drug?
Then MoCRA isn't the whole story - the drug framework applies. A product that makes a drug claim (treats a condition, affects the body's structure/function) or contains a drug active (e.g., SPF sunscreen, anti-dandruff, anti-acne) is an OTC drug, or a drug/cosmetic combination, and needs drug establishment registration, an NDC, Drug Facts labeling, and monograph compliance - on top of any cosmetic requirements. So step one is confirming your product is a cosmetic and not (also) a drug. See our cosmetic-vs-OTC-drug guide.
14. What can stop my cosmetics at the U.S. border?
A cosmetic that fails MoCRA can be considered misbranded or adulterated, and non-compliant shipments can be detained or seized at entry. Common triggers: the facility isn't registered (or the U.S. Agent is missing), products aren't listed, the label lacks the required U.S. adverse-event contact, no safety substantiation, drug claims that make it an unapproved drug, or a prohibited/unsafe ingredient. Getting MoCRA right before shipping is how you avoid detention.
15. What's still pending under MoCRA?
Two big rules are not yet final: cosmetic Good Manufacturing Practice (GMP) regulations, and fragrance-allergen labeling requirements (FDA missed the December 2025 deadline; expect a proposed rule around mid-2026 and a final rule in 2027 or later). Standardized talc/asbestos testing methods are also in progress. The core requirements - registration, listing, Responsible Person, safety substantiation, adverse-event reporting, and the U.S. adverse-event contact on labels - are already in effect, so comply with those now and prepare to adapt as the pending rules finalize.
16. How does FDA Registration Assistance help foreign cosmetic brands?
We run the MoCRA pathway for foreign cosmetic brands: confirming the product is a cosmetic (not an OTC drug), registering your facility in Cosmetics Direct (biennial), listing your products (annual), serving as your U.S. Agent and supporting a U.S.-reachable Responsible Person, reviewing labeling (including the U.S. adverse-event contact) and safety substantiation, and setting up adverse-event readiness - so shipments clear and you stay compliant. We keep clear that cosmetics aren't "FDA approved" and that MoCRA registration is free from the government. We're an independent compliance firm serving 1,000+ companies across 135+ countries with 15+ years of experience. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
