Finding the right herbal contract manufacturer for US brands often leads across the northern border, where Canada's NHP framework already requires licensed, GMP-compliant production. However, making your product in Canada does not change who answers to the FDA. As the US brand owner, and usually the importer of record, you carry obligations that a Canadian manufacturer cannot carry for you. This guide covers the FDA, labelling, customs and currency points to settle before your first production run.
Key Takeaways
- A Health Canada site licence signals a GMP-compliant facility, but it is not FDA approval and does not satisfy US rules on its own.
- Any foreign facility making dietary supplements for the American market needs a current FDA food facility registration, renewed every even-numbered year.
- The US brand is usually the FSVP importer and keeps Part 111 responsibilities, even when manufacturing is fully outsourced.
- US and Canadian labels follow different rules, so plan a separate US label with a Supplement Facts panel and US contact details.
- Landed cost includes duties, brokerage, freight and currency movement, so compare quotes on total cost, not unit price.
Why US Brands Look North for a Herbal Contract Manufacturer
Canada regulates herbal supplements as natural health products (NHPs) under the Natural Health Products Regulations. As a result, any facility that manufactures, packages or labels NHPs for the Canadian market needs a Health Canada site licence and must meet GMP requirements. For a US buyer, that baseline makes a useful first filter.
Proximity matters too. Ground freight between Ontario and much of the US Northeast and Midwest moves in days rather than weeks. In addition, many Canadian manufacturers focus on liquid botanical formats such as tinctures and glycerites, which can be harder to source from US facilities built around capsules and powders.
Here's what that means in practice: a Canadian site licence tells you the facility operates under a recognised GMP regime. Still, the FDA treats a product made in Canada as an imported dietary supplement, so the US side of the equation sits with you. If you're a Canadian brand heading the other way, see our guide to selling Canadian NHP products in the USA.
FDA Rules for US Brands Using a Foreign Herbal Contract Manufacturer
Several FDA requirements apply once a dietary supplement made abroad heads for the US market. Most of them stem from the Bioterrorism Act and the Food Safety Modernization Act. So it pays to map them before you sign anything.
Foreign facilities that manufacture, process, pack or hold dietary supplements for US consumption must register with the FDA and name a U.S. agent. Facilities renew their registrations every two years, between October 1 and December 31 of each even-numbered year. Because 2026 is a renewal year, ask any prospective partner to confirm their current status in writing. The FDA explains the process on its food facility registration page.
Every commercial shipment of food, including dietary supplements, needs a prior notice filed with the FDA before it reaches the border. Usually your customs broker or the shipper files it. However, a missing or inaccurate notice can hold product at the port, so confirm early who owns this step.
Under the FSVP rule, the US importer must verify that a foreign supplier produces food that meets US safety standards. The rule includes specific provisions for dietary supplements, which tie back to the dietary supplement CGMP rule in 21 CFR Part 111. In most private-label setups, the brand owner acts as the FSVP importer. That means you, not your manufacturer, hold the verification records.
The FDA has stated that a firm which outsources manufacturing still carries Part 111 responsibilities for the products it releases under its name. For example, you need product specifications and a way to confirm each batch meets them before distribution. A manufacturer's batch documents support that work, but they don't replace it.
Labelling a Canadian-Made Herbal Supplement for the US Market
US and Canadian labels follow different rules, so a single label rarely works for both markets. In Canada, products follow the NHP label requirements. In the US, dietary supplement labels follow DSHEA and the FDA's labelling regulations instead. For instance, they require a Supplement Facts panel, and botanical ingredients must state the part of the plant used.
Claims differ as well. A structure/function claim on a US label needs the standard FDA disclaimer, and you must notify the FDA within 30 days of first marketing it. Meanwhile, licensed Canadian claim wording does not carry over automatically.
A few other details catch first-time importers:
The practical implication: budget for a separate US label and a US regulatory review, even when the formula stays identical.
Customs, Duties and Currency
Goods that qualify as originating under CUSMA (USMCA in the US) can generally enter without duty. However, qualifying depends on the rules of origin for the product's specific tariff classification. Botanicals grown overseas and extracted in Canada may or may not qualify, depending on how much the processing transforms them.
Tariff policy between the two countries has also shifted several times since 2025. So treat any duty assumption as provisional, and ask a licensed customs broker to confirm classification and origin before you set your retail price. Alcohol-based tinctures can also raise extra classification questions at the border.
Canadian manufacturers often quote in Canadian dollars, although some will quote in US dollars on request. Either way, exchange-rate movement can change your landed cost between quote and invoice. As a result, many US brands fix pricing per production run, add a currency clause to the agreement, or pay deposits in the quote currency to limit exposure.
Worth understanding before you proceed: your true landed cost includes freight, brokerage, duties, currency spread and the time FSVP compliance takes. Comparing a Canadian quote with a US quote on unit price alone will mislead you.
Vetting a Canadian Herbal Contract Manufacturer for US Brands
Once the regulatory map is clear, assess each herbal contract manufacturer for US brands with export questions in mind. Start with the standard checks in our list of questions to ask a herbal contract manufacturer, then add these:
The short version: a Canadian partner can make an excellent product for the US market, but compliance responsibility stays with the US brand. To talk through formats and minimums, visit our manufacturing page or get in touch.
This article is general information, not legal or regulatory advice. Have qualified US regulatory counsel and a licensed customs broker review your specific situation.
Published: October 4, 2026