The U.S. is one of the world’s largest cosmetics markets but entry follows a different, stricter regulatory framework (the FD&C Act and MoCRA) than the EU or Middle Eastern markets. The process generally breaks down into seven steps.
1. Confirm Your Product Classification
The first step is determining whether your product is legally a cosmetic or a drug under U.S. law. This distinction depends not on the formulation but on the intended use claims on the label. A moisturizer that simply “hydrates the skin” is a cosmetic; one that claims to be “anti-aging” or “SPF 30” automatically falls under the drug definition (21 CFR § 700.35). Misclassification at this stage is the single biggest cause of delay later on.
2. Designate a Responsible Person
Under MoCRA, every product must have a “responsible person” — the manufacturer, packer, or distributor. This person doesn’t need to be based in the U.S., but must be reachable by FDA. They’re responsible for facility registration and product listing.
3. Complete Facility Registration and Product Listing (MoCRA)
Under Section 607 of the FD&C Act (21 U.S.C. § 364c), any facility manufacturing or processing cosmetics for U.S. distribution must be registered with FDA, and each product must be separately listed through the Cosmetics Direct portal. A small business exemption (Section 612) may apply to some companies — but products that contact eye mucous membranes, are injected, or alter appearance for more than 24 hours don’t qualify.
4. Check Your Formulation Against U.S. Restricted/Banned Ingredients
An ingredient approved in your country or the EU may be banned in the U.S. (e.g., mercury, chloroform, methylene chloride, certain color additives — 21 U.S.C. § 361). Catching this before shipping significantly reduces the risk of rejection at customs.
5. Re-Prepare Your Label to U.S. Standards
U.S. labeling rules (21 CFR Part 701) differ from EU or probably your country of origin requirements:
- All required information must be in English (§701.2)
- Ingredients must be listed in descending order using INCI names (§701.3)
- The manufacturer/distributor name and a valid U.S. business address must be included (§701.12)
- Net quantity must use U.S. units (oz, fl oz) in the required format (§701.13)
- A clear statement of identity must appear on the principal display panel (§701.11)
Products shipped with only EU-compliant labels typically run into problems here.
6. Prepare Your Safety Substantiation File
Another MoCRA requirement: every product and each of its ingredients must have adequate safety substantiation (21 U.S.C. § 361(g)). This is usually compiled as a “Cosmetic Product Safety Substantiation File,” which must be available to FDA on request.
7. Plan Your Customs and Logistics Process
Once your product reaches the U.S., it undergoes joint review by CBP (Customs and Border Protection) and FDA. At this stage:
- An Importer of Record must be designated
- Any required FDA Prior Notice or other notifications must be filed on time
- Working with a customs broker helps avoid delays caused by paperwork gaps
Quick Checklist for the Brands
- Has the product been correctly classified: cosmetic or drug?
- Has a responsible person been designated?
- Is facility registration and product listing (MoCRA) complete?
- Has the formulation been checked against U.S. restricted ingredients?
- Is the label in English and formatted to U.S. requirements?
- Is the safety substantiation file ready?
- Has the importer and customs process been planned?
Sources: FD&C Act Sections 601, 602, 607, 612 (21 U.S.C. §§ 361, 362, 364c); 21 CFR Parts 700 and 701; FDA Guidance for Industry — Registration and Listing of Cosmetic Product Facilities and Products.
This content is for general informational purposes and does not constitute legal advice. Confirm current requirements at FDA.gov/cosmetics and eCFR.gov.
