The Challenges for US Supplement Companies in Canada

If you’re an integrative physician practicing in Canada, you may have noticed that not all professional brands of supplements from the US are available for you to sell in your dispensary. You may also have noticed that the formulas for the Canadian versions of products are different, and may offer lower doses of certain ingredients.

There’s a reason for this. Health Canada (the government agency which oversees dietary supplement and food regulation) regulates manufacturing, importing, sales and distribution to assure that products sold in Canada are safe. It’s the Canadian version of the US Food and Drug Administration, with different rules.

It’s critical that US manufacturers selling in Canada comply with Canadian regulations 100%, or they risk penalties or bans. This means that all products sold in Canada must have an entirely different label than their US counterpart, written in two languages. In many cases, the product is a different formula.

Compliance is no easy task for US manufacturers. Every vendor involved in the process must have a Canadian site license and follow GMP regulations: from manufacturing; to labeling; to distributors. Essentially, a US company must duplicate its entire production process to create the Canadian version of the same or similar product.

Any products sold in Canada must be approved and assigned a NPN (Natural Product Number) by Health Canada. Manufacturers must submit an application for a NPN and provide meticulous information about the product for Health Canada to review. If the formula is similar to an existing product, the review process takes up to 60 days. But if it is a unique formula, ingredient, or purpose, the process can take up to 180 days. This means that manufacturers need to plan far in advance to launch new products, which delays the sales cycle. In contrast, in the US there is not a formal review process to slow the launch of a product and manufacturers can recoup expenses more quickly.

Oftentimes, formulas must be modified to the Canadian version, as some nutrients have caps on dosages. For example, Canada has limits on doses for vitamin K, folate, and vitamin D, whereas these nutrients aren’t limited in US supplements. Canadian regulations require some ingredients to be listed differently, especially when it comes to extracts. And some ingredients, such as black pepper extract, are not permitted to be used in Canada. These differences in requirements can become costly because it forces manufacturers to run separate production lines, causing them to lose economies of scale.

This duplication can be an expensive undertaking that not all manufacturers are willing to invest in, especially when the Canadian market and sales potential is significantly smaller than the US. The Canadian regulations are stringent and the process of becoming compliant can be expensive, especially initially.

The good news is that the companies that do decide to distribute products in Canada tend to be high quality brands which can pass the high standards of Health Canada. They care about providing effective formulas to Canadian patients, even if the profit margins are ultimately lower.

Restorative Formulations is one of the US-based supplement manufacturers that produces Canadian versions of its products. To learn more, visit the Restorative Formulations booth at the Toronto Restorative Medicine Regional Conference, being held Feb. 10-12, 2017 at the University of Toronto Chestnut Conference Centre in downtown Toronto.