Importer of Record vs Responsible Person Under MoCRA

We keep running into overseas brands who assume that once they've got a customs broker and an importer of record sorted, they've covered their US regulatory bases. They haven't, and the gap between those two roles is exactly where compliance problems tend to start.

What an importer of record actually does

The importer of record is a customs concept. It's the entity that takes legal responsibility for a shipment clearing US customs: paying duties, ensuring the shipment matches its declared classification, and being the name customs holds accountable if something about the import itself is wrong. It's a role that exists at the border, tied to the movement of goods, not to the product's regulatory standing once it's in the country.

Nothing about being an importer of record requires you to know anything about cosmetic ingredient safety, FDA registration, or adverse event recordkeeping. It's a logistics and customs function, full stop.

What the responsible person does under MoCRA

The responsible person, sometimes written as "named responsible person," is a MoCRA requirement, and it's a completely different kind of obligation. Under MoCRA (the Modernization of Cosmetics Regulation Act, passed in 2022), a responsible person is tied to the product itself. This role is typically the manufacturer, packer, or distributor whose name appears on the label, and they carry specific duties:

• Ensuring safety substantiation exists for the product, meaning there's documented evidence the formula is safe for its intended use.
• Maintaining records of adverse events reported by consumers.
• Being the point of contact the FDA can reach for product listing and registration matters.

None of that overlaps with what a customs broker or importer of record handles. You can have a flawless customs process, zero delays, correct tariff codes, full duties paid, and still be completely out of compliance on the MoCRA side if nobody has taken on the responsible person function.

Why brands conflate the two

It's an understandable mistake. Both roles involve the word "responsible" in some sense, both are essentially the answer to "who do we call if something goes wrong," and for a small overseas brand, it's tempting to assume one partner (often the same freight forwarder or import agent handling customs) is also handling the regulatory side. Freight forwarders are not going to volunteer safety substantiation documentation. That's not their job, and most of them won't say so directly, they'll just quietly not do it because nobody asked.

Side by side

	Importer of Record	Responsible Person (MoCRA)
Governs	Customs clearance of a shipment	The product's regulatory standing under MoCRA
Tied to	The shipment crossing the border	The product listing and label
Key duties	Duties, tariff classification, customs paperwork	Safety substantiation, adverse event records, FDA point of contact
Who typically fills it	Customs broker or import agent	Manufacturer, packer, or distributor named on label
Does it require ingredient knowledge	No	Yes, at least enough to substantiate safety

What to actually do about it

If you're a cosmetic brand outside the US planning to sell into it, treat these as two separate hires or two separate internal assignments, not one bundled service. Concretely:

1. Confirm who your importer of record is for customs purposes, and confirm that's all they're doing.
2. Separately, designate a responsible person, someone (a company or an individual) who will be named on your labeling and who understands they're on the hook for safety substantiation and adverse event tracking.
3. Get facility registration and product listing done under MoCRA. Some small businesses are exempt from these requirements, so check whether that applies to you before assuming it does or doesn't.
4. Remember that sunscreen is regulated as an OTC drug in the US, not a cosmetic, so if any of your line includes SPF products, that's a different regulatory track entirely, separate from both of these roles.

The gap this creates in practice

We've seen brands find out about this gap the hard way, usually when a retailer's compliance team asks for the MoCRA listing number and the brand realizes nobody has one, despite years of smooth customs clearance. The shipments were fine. The regulatory filing underneath them was just never done, because everyone assumed someone else had it covered.

If your compliance process for one market is already handled through a tool that checks ingredients and files notifications for you, it's worth checking whether it extends to your next market before you assume the coverage carries over. Cosmetic Comply currently handles Canadian notifications end to end, with US, EU, and Australian filing support on the way, precisely because these market-specific roles and requirements don't transfer automatically from one country to the next.