Regulatory
Health Canada reviews your product before it is sold. The FDA does not. That single sentence explains most of what follows.
A natural health product cannot be legally sold in Canada without a product licence and an NPN. Health Canada assesses the formula, the dose, the claims and the label, and issues a licence number that appears on the package. The review is real, the timelines are published, and an incomplete file comes back.
In the United States, a dietary supplement requires no pre-market approval. There is no licence, no product number, and no confirmation that anyone has looked at it. A company registers its facility, satisfies itself that the product complies, and sells. The FDA finds out afterwards.
Canadian brands entering the US often read this as the American market being easier. In practice it moves the risk rather than removing it. In Canada, a mistake surfaces as an information request during review, before any money is spent on inventory. In the US it surfaces as a warning letter, an import refusal, a retailer delisting or a class action, after the product is in the market.
Health Canada maintains monographs specifying acceptable ingredients, dose ranges, permitted claims and required risk statements. A formula that matches a monograph is straightforward. One that does not is a Class III submission requiring a full safety and efficacy dossier, with a target review of 210 days rather than 60 or 90.
The FDA works from a different premise. An ingredient marketed in the US before October 15, 1994 is grandfathered. Anything introduced after that is a new dietary ingredient requiring notification to the FDA at least 75 days before it enters commerce, with evidence supporting its safety. In practice, NDI notification is widely under-complied with, which is why ingredients circulate in the US market that would not survive a Canadian review.
The practical consequence for a brand selling in both markets is that the Canadian formula is usually the constrained one. Build to Canadian monograph parameters and the product will generally be sellable in the US. Build to US norms and expect reformulation before a Canadian file will clear.
This is where the two systems diverge most sharply.
Canadian claims come from the monograph. The wording is prescribed, the supporting evidence has already been assessed by Health Canada, and your approved claim set is published in a public database anyone can search.
US structure function claims are self-substantiated. You may say a product supports a function of the body provided you hold competent and reliable scientific evidence, notify the FDA within thirty days of first use, and carry the required disclaimer stating the claim has not been evaluated by the FDA. Nobody checks in advance. The evidence sits in your files until someone asks for it.
The trap is that this reads as freedom and behaves as exposure. The FTC regulates advertising to a stricter standard than the FDA applies to labels, and applies it to your website, your social media, your affiliates and your influencers. A claim that would never have been approved in Canada can run in the US for two years and then arrive as an FTC inquiry with a demand for the substantiation you never assembled.
Both countries require good manufacturing practice, and both back it with inspection, but the mechanism differs.
Canada licenses the site. A facility manufacturing, packaging, labelling or importing natural health products needs a site licence, granted on a documentation package demonstrating compliance with Part 3 of the Natural Health Products Regulations. The licence is a precondition of legal operation.
The US requires facility registration rather than licensing, with compliance to 21 CFR Part 111 assessed through inspection. A facility can register and operate without anyone having assessed its quality system until an inspector arrives.
One recent Canadian change matters for importers. On February 16, 2026, Health Canada ended the Foreign Site Reference Number process with immediate effect. Foreign sites can no longer obtain their own GMP designation, and evidence for a foreign manufacturer now goes through the Canadian importer’s site licence application. Importers who relied on a partner’s FSRN to shorten their own submission no longer have that option.
Canadian review targets are published. Class I, matching a single monograph, targets 60 days. Class II, combining multiple monograph ingredients, targets 90 days. Class III, falling outside monograph parameters, targets 210 days. These are service standards rather than guarantees, and an incomplete file resets the clock.
The US has no equivalent, because there is no review. The only pre-market waiting period is the 75 day NDI notification where one applies. A product can be formulated and on shelf in weeks.
For planning purposes, a Canadian launch needs four to five months of regulatory lead time for a Class II product once application preparation, review, possible resubmission and packaging production are counted. A US launch is constrained by manufacturing and packaging rather than by regulation.
Sequence matters more than most brands expect. Formulating to Canadian parameters first and then entering the US is usually cheaper than the reverse, because the Canadian constraints are tighter and the resulting documentation, specifications, stability data and claim substantiation transfer directly.
Going the other way means discovering at the point of Canadian submission that the ingredient is not permitted, the dose is out of range, or the claim has no monograph equivalent, after the artwork is printed and the inventory is made.