INTERNATIONAL TRADE LAW
How to Import Cosmetics: FDA and MoCRA Rules
Importing cosmetics means meeting FDA requirements under the Federal Food, Drug, and Cosmetic Act and the newer Modernization of Cosmetics Regulation Act (MoCRA). Cosmetics don’t get pre-approved by the FDA the way drugs do — with one major exception, color additives — but a product still cannot be adulterated or misbranded, and as of 2024 the responsible person must register the facility, list the product, substantiate its safety, and report serious adverse events. The rules apply to imported cosmetics the same as domestic ones, and non-compliant products can be refused at the border.
“Not FDA-Approved” Does Not Mean “Unregulated”
A common and costly misconception is that because cosmetics aren’t FDA-approved, they can be imported freely. In reality, cosmetic products and ingredients do not require FDA premarket approval — except color additives, which must be FDA-approved for their intended use, and many of which must be batch-certified for purity in FDA labs. Everything else turns on two prohibitions: a cosmetic may not be adulterated (unsafe, contaminated, or containing a prohibited substance) or misbranded (falsely or inadequately labeled). An imported cosmetic that is adulterated or misbranded can be detained and refused.
What MoCRA Added in 2024
MoCRA, enacted at the end of 2022, was the most significant expansion of FDA cosmetics authority in decades. Its core obligations became enforceable on July 1, 2024, and registrations are now in their biennial renewal cycle in 2026. The duties fall on the “responsible person” — the manufacturer, packer, or distributor whose name is on the label — and for many imported brands, the U.S. importer is the responsible person.
| MoCRA obligation | What it requires |
|---|---|
| Facility registration | Register the manufacturing/processing facility with FDA; renew every two years |
| Product listing | List each cosmetic product and its ingredients with FDA |
| Safety substantiation | Maintain records adequate to support that the product is safe |
| Adverse event reporting | Report serious adverse events to FDA, generally within 15 business days |
| Good Manufacturing Practices | Meet FDA GMP requirements (being phased in by rulemaking) |
The safety substantiation requirement is the one that trips up importers of private-label or overseas brands: you must hold the tests, studies, or other evidence supporting a reasonable certainty that the product is safe. If your foreign supplier holds that evidence, get it in writing before you import.
Labeling and the “Drug-Cosmetic” Trap
A cosmetic must be properly labeled before it enters U.S. commerce. Under the Fair Packaging and Labeling Act, cosmetics sold at retail need an ingredient declaration, and labels must carry any required warnings and accurate identity and net-quantity statements. Our guide to import labeling requirements covers the general framework.
Watch for the drug-cosmetic overlap. A product that makes a therapeutic claim or affects the body’s structure or function — sunscreen, anti-dandruff shampoo, antiperspirant, anti-acne treatments — is regulated as a drug (often an over-the-counter monograph drug), which carries far heavier requirements than a cosmetic. If your product straddles that line, classify it correctly before you ship, because importing an unapproved drug as if it were a cosmetic is a serious problem.
The Customs Side Still Applies
The FDA rules sit on top of the ordinary customs entry. You remain the importer of record, classify the cosmetics under the correct HTS code, post a bond on formal entries, and pay duty. The FDA clearance and the customs entry are parallel tracks — both have to be clean before the goods move.
Frequently Asked Questions
Do imported cosmetics need FDA approval?
No, with one exception. Cosmetic products and ingredients don’t require FDA premarket approval, but color additives do — they must be approved for the intended use and are often subject to FDA batch certification. All cosmetics must still avoid being adulterated or misbranded.
What does MoCRA require of importers?
If the U.S. importer is the “responsible person,” it must register the facility, list the product and ingredients with FDA, maintain adequate safety substantiation, and report serious adverse events (generally within 15 business days). GMP requirements are being phased in by rulemaking.
When did MoCRA take effect?
MoCRA was enacted in December 2022, and its facility registration and product listing requirements became enforceable on July 1, 2024. Those registrations are on a two-year renewal cycle.
When is a “cosmetic” actually regulated as a drug?
When it makes a therapeutic claim or is intended to affect the body’s structure or function — sunscreens, anti-dandruff and anti-acne products, and antiperspirants are common examples. These are regulated as drugs (often OTC monograph drugs) with stricter requirements, and misclassifying one as a cosmetic at import is a serious compliance risk.
Importing cosmetics cleanly means lining up MoCRA registration and listing, safety substantiation, and compliant labeling before the customs entry is filed. Reidel Law Firm helps cosmetics importers map those obligations on flat-fee terms, with a plain-English compliance memo and direct attorney access. Get a flat-fee import compliance memo.
