Cosmetics & MoCRA

Cosmetics importers deal with two different kinds of problem at once. There is the regulatory side, where a registration that nobody renewed stops a container. And there is the volume side, where a single invoice carries four hundred stock keeping units and every one of them needs a tariff code and an FDA product code. Both are solved with the same thing: a clean item master, built once, kept current.

MoCRA is a registration regime

The cosmetics modernisation statute did not turn FDA into a pre-market approver. It created obligations that sit on named parties and that are checkable at entry.

• Every facility that manufactures or processes cosmetics for the US market has to be registered, including facilities abroad, and registration is renewed on a cycle rather than done once.
• Every product has to be listed by the responsible person, with its ingredients.
• The responsible person is a real role with an address on the label, an adverse event contact, a short deadline for reporting serious adverse events, and records substantiating safety.
• FDA can suspend a facility registration. When it does, product from that facility cannot be brought in. That is the sharpest edge in the statute and it lands at the port.

The remaining rulemakings under the statute, on manufacturing practice, on standardised talc testing, and on fragrance allergen labelling, are moving on their own timetable. When each one lands it changes what a listing or a label has to contain. None of them change whether you need to be registered, so there is no version of waiting that helps.

What actually travels on the entry

Cosmetics are not food, so there is no Prior Notice filing. What goes to FDA with the entry is the agency data set: the product code, the manufacturer and shipper as FDA knows them, intended use, and the registration and listing identifiers where they apply.

The most common reason a shipment sits is not a violation at all. It is a mismatch: an FDA product code that does not correspond to the tariff line, a manufacturer identified differently on the entry than in the registration, a listing number that belongs to a reformulated product. FDA does not send a “may proceed”, the freight sits, and the terminal starts its clock. We reconcile those fields before transmission rather than after.

The other frequent surprise is category. A sunscreen, an antiperspirant, an anti-dandruff shampoo, an acne wash or a fluoride toothpaste is a drug in the United States, whatever the brand calls it. That means monograph compliance, a drug listing and a national drug code, and an entry filed on the drug side. Importers usually learn this at the port, once.

Ingredients and labels that stop shipments

Colour additives are the largest single source of cosmetic refusals. Only listed additives may be used, only for the uses they are approved for, with the eye area treated separately, and the batch certifiable ones need a certified lot behind them. A colourant that is ordinary in another market can put a firm on a detention list, and coming off one is a documented petition rather than a phone call.

Labelling is checked against the ingredient declaration in descending order of predominance using the standard nomenclature, net contents, required warnings and the responsible party’s address. We would rather review artwork as a PDF three weeks before shipment than look at a photograph of a carton in a container yard.

Duty in 2026

Most Chapter 33 lines carry a low or free column one rate. What moves your cost is origin: the Section 301 lists where the goods are Chinese, and the country-based tariff actions taken under the emergency economic powers statute, which apply on top. For a cosmetic, origin is where the bulk was made and filled, not where the carton was printed or where the shipment was consolidated.

Where a rate is subject to challenge, the refund path matters as much as the rate. A post summary correction works while the entry is unliquidated, and a protest for one hundred and eighty days after liquidation. We track liquidation dates on your entries so that path stays open. If you want the mechanics, our Section 301 guide covers where the lists stand.

Four hundred lines is a data problem, once

High line counts are normal here and they are not an obstacle. We build the classification, the FDA product code and the ingredient flags per stock keeping unit the first time, and then the second shipment is a reconciliation instead of a research project. New items get added deliberately, with a decision recorded against them. Nothing gets guessed at the last minute because the vessel is berthing.

What we need from you

• An item master: stock keeping unit, description, function, full ingredient list, net contents.
• Facility registration numbers, product listing numbers, and who the responsible person is.
• Label artwork for each item, front and back.
• Invoice and packing list keyed to the same item numbers as the master.
• Monograph and listing documentation for anything with an active ingredient.