How Are Supplements Regulated in Canada?

Though American supplement discourse tends to dominate the conversation, it would be a mistake to conflate it with what's happening with supplements in Canada. In fact, supplement regulation in Canada is very different from the U.S. Here's how supplements are regulated in Canada—and what makes it different (and more thorough) than the American model.

The short answer? Yes, dietary supplements sold in Canada are regulated by Health Canada under the Natural Health Product Regulations, and need to have an NPN (Natural Product Number) before they are sold.

An NPN is a natural product number and natural health products (including supplements, and other items like some topical products, makeup, toothpaste, and more) need to have one before they can be sold. An NPN functions as a license, and means that the product meets the regulatory requirements outlined by Health Canada. For any natural health product—including supplements—to be sold on shelves or online in Canada, it needs to have an NPN. And that NPN needs to be displayed on the packaging so consumers know it’s passed the rigorous inspection of Health Canada.

In order to get an NPN, a product must meet Health Canada’s strict requirements related to safety, efficacy, and responsible marketing and claims.

A brand must submit evidence (often in the form of medical research and peer-reviewed studies) to prove that the product is not only safe, but effective. Health Canada reviews the product formulation in tandem with the research to determine whether the product does what it claims and is safe to use. Health Canada will often push back, asking for more (or better quality) research or limiting what language can be used to promote the product.

There are strict dosage limits in Canada for certain vitamins and other compounds that are known to have adverse effects at higher doses. 

All ingredients need to be visible on the product packaging, and in order to get an NPN you need to demonstrate that the ingredients and active ingredient forms included in the formula are aligned with the evidence you presented and the claims you want to make. Health Canada will ask for changes if necessary. This includes all ingredients—even those that don’t have a health benefit must be approved by Health Canada. Think: flavours, colors, carriers, excipients, stabilizers, and more. They’re all regulated.

Claims are approved by Health Canada—once you get your NPN you also get a list of things you’re allowed to say on packaging and in marketing.

Yes, Health Canada can (and does) recall supplements. Many companies participate in voluntary recalls (where they instigate the recall themselves to correct any issues with packaging, formulas, or safety). But, if needed, Health Canada will order a recall and can seize products and revoke licenses, especially if there is a serious risk to public health and safety.

The differences between Health Canada and the FDA when it comes to supplement regulation comes down to pre-market approval. Health Canada takes a proactive approach to health and safety: products must meet strict standards and have a license before they are sold. The FDA has a more reactive approach: if concerns are raised by the public once a product is available for sale, then the FDA can step in and enforce consequences.