Checklist Before Your First US Cosmetic Shipment

You've got a US customer ready to place a bulk order, or maybe you're just tired of telling American followers you don't ship there yet. Before that first box crosses the border, there's a short list of things worth confirming, because US cosmetic rules run on a different framework than what you've been dealing with at home.

Start with MoCRA, not the label

The US passed the Modernization of Cosmetics Regulation Act in 2022, and it changed the baseline requirements for anyone selling cosmetics there. Two pieces matter most before you ship anything:

1. Facility registration. The facility that manufactures or processes your product needs to be registered with the FDA. If you make everything yourself in your own workshop, that's your facility. If you use a contract manufacturer, confirm they're already registered, since duplicate registrations aren't the goal, accuracy is.
2. Product listing. Each product (or product family, depending on how it's structured) gets listed with the FDA separately from facility registration. This is closer in spirit to Canada's notification concept, though the mechanics and portal are different.

Some small businesses are exempt from registration and listing requirements. Whether that exemption applies to you depends on factors like your sales volume, and it's worth confirming your actual status rather than assuming you qualify.

Line up a responsible person

MoCRA requires a named responsible person tied to the product, the entity responsible for maintaining safety and adverse event records and being the point of contact if the FDA has questions. For a lot of small Canadian brands, this ends up being the brand owner themselves, but if you're working through a distributor or importer arrangement, get clear on who that person is before launch, not after a complaint comes in.

Safety substantiation isn't optional

You need to be able to show your product is safe for its intended use, with adequate substantiation on file. This isn't a one-time hoop, it's an ongoing recordkeeping expectation. For most small-batch makers this looks like:

• Documentation of the formula and how it was assessed
• Any testing you've had done, even basic stability or challenge testing
• A system for logging adverse events reported by customers, however rare they've been

If your Canadian CNF process already got you thinking carefully about ingredient concentrations and Hotlist screening, you're partway there. The US doesn't use the Hotlist, but the discipline of tracking exactly what's in your formula and why it's safe carries over.

Know that sunscreen isn't a cosmetic here either

If your line includes an SPF product, remember that in the US, as in Canada, sunscreen is regulated as an OTC drug, not a cosmetic. That means MoCRA's cosmetic pathway doesn't apply to it, and it needs to meet drug monograph requirements instead. Don't assume your moisturizer-with-SPF ships under the same rules as your plain moisturizer.

Relabeling for a US audience

Canadian labels are built around bilingual English and French text. US labels don't require French, but they do have their own requirements around ingredient declaration order, net quantity statements, and where the responsible person's name and address appear. Don't just ship your Canadian-label stock south. Check whether your existing label already satisfies US content requirements or whether you need a US-specific version.

A pre-shipment checklist

Item	Status to confirm
Facility registered with FDA	Yes, and matches actual manufacturing site
Product listed with FDA	Yes, per product or product family
Responsible person named	Identified and documented
Safety substantiation file	Exists and is current
Adverse event recordkeeping system	In place before first sale
Label reviewed for US requirements	Confirmed separately from Canadian label
SPF products handled as drugs, if applicable	Verified against OTC monograph, not cosmetic rules

Don't let the two systems blur together

The easiest mistake is assuming that because you've already done a CNF in Canada, you understand what US compliance requires. The frameworks share a family resemblance, ingredient transparency, safety documentation, a named responsible party, but the actual mechanics of registration and listing are their own system. Cosmetic Comply's Canada notification tool is live today, with US registration and listing support on the way, so if you're building out your ingredient and INCI records now, that groundwork carries forward as more markets come online.

Give yourself a few weeks of lead time before that first shipment. Registration and listing aren't instant, and you don't want your first US order sitting in a warehouse while you scramble to file.