Selling Canadian NHP products into the USA under FDA rules is one of the most common growth moves a herbal brand makes. It is also where the most expensive mistakes happen. A product that is fully compliant as a Natural Health Product in Canada does not automatically clear US customs. The two countries regulate the same bottle under entirely different frameworks. Here's what changes the moment your shipment crosses the border, and how to prepare for it before you commit to an order.
Key Takeaways
- In the US, your NHP is regulated by the FDA as a dietary supplement under DSHEA, not as a licensed natural health product.
- There is no US equivalent of an NPN; you cannot put your Health Canada licence number on a US label.
- US labels require a Supplement Facts panel and the FDA disclaimer, which differ from Canadian NHP labelling.
- Your manufacturing facility must register with the FDA, and an importer of record must handle US entry.
- Structure-function claims are allowed but must be substantiated and cannot be disease claims.
Two Regulators, One Bottle
The core thing to understand about selling Canadian NHP products into the USA is that the FDA does not recognise the NHP category at all. In Canada, a natural health product is a licensed therapeutic product with a Natural Product Number. In the US, that same formula is almost always a dietary supplement under the Dietary Supplement Health and Education Act, or DSHEA.
Here's what that means in practice: dietary supplements are not pre-approved before sale. The FDA regulates them after they reach the market, and the burden of safety and labelling sits squarely with the brand and manufacturer. Your Canadian product licence carries no weight south of the border.
The practical implication: you are not transferring a licence, you are entering a new regulatory system. Treat the US launch as a fresh compliance project rather than an extension of your Canadian one. For the Canadian side of the picture, our guide to Health Canada NHP compliance covers the baseline you are starting from.
Labelling: What Has to Change
Labelling is where selling Canadian NHP products into the USA most often goes wrong. The NPN, the bilingual Canadian panel, and the Health Canada recommended-use wording all have to come off, because none of them apply under FDA rules. The FDA can treat a US label that carries a Canadian licence number as misleading.
Instead, the FDA requires a Supplement Facts panel rather than Canada's drug-facts-style format. You also need the statement of identity, net quantity, the full ingredient list, and the manufacturer or distributor's name and address. Furthermore, any structure-function claim must carry the FDA disclaimer that the statement has not been evaluated by the FDA.
This is where most brands run into trouble. The wording that earned your NPN can read as a disease claim in the US context, which is not permitted for a supplement. Plan a separate US label artwork from the outset; the differences are too deep to patch onto a Canadian design. Our overview of NHP label requirements in Canada shows just how different the two systems are.
FDA Facility Registration for Canadian NHP Products
Beyond the label, the facility that makes the product has to satisfy the FDA. Any manufacturer shipping dietary supplements into the country must register with the FDA as a food facility. It must also operate under the supplement Good Manufacturing Practices set out in 21 CFR Part 111. A Canadian site licence does not replace this registration.
On top of that, the importer side matters. Someone has to act as the importer of record. US food importers also carry obligations under the Food Safety Modernization Act, including supplier verification. Worth understanding before you proceed: customs can refuse or detain entries when registration, labelling, or prior-notice filings are incomplete.
Here's how a typical engagement handles it: the brand confirms the manufacturer's FDA registration and GMP standing early. Then it aligns the importer, the label, and the claims as one package before the first run. Working with a GMP-compliant Canadian manufacturer that already understands US expectations removes most of the friction. You can talk through your specific product on our contact page.
Selling Canadian NHP Products in the USA: A Pre-Launch Sequence
Before you ship a single case, work through the crossover in order. First, confirm how the FDA will classify your product; most herbal NHPs land as dietary supplements, but some ingredients are restricted or treated as drugs in the US. Second, design US-specific label artwork with a Supplement Facts panel and compliant claims.
Third, verify your manufacturer's FDA food-facility registration and 21 CFR Part 111 compliance. Finally, line up your importer of record and confirm prior-notice and entry logistics with a customs broker. As a result of doing this up front, you avoid the detentions and relabelling costs that catch brands who treat the US as a simple reorder.
The short version: selling into the US is very achievable, but it is a parallel compliance track, not a copy-paste of your Canadian filing. Build it into your timeline and budget from day one. Our manufacturing services page outlines how we support brands planning cross-border production.
Published: June 30, 2026