Best Partner for NHP Licensing (Canada) For US Supplement Founders?

Selling supplements in Canada requires an extra step that many U.S. founders overlook: 1. obtaining a Natural Product Number (NPN) from Health Canada 2. Obtaining a GMP license if importing into Canada is needed and 3. Canada-specific labels. Without it, your products cannot legally be sold in stores or online marketplaces. This licensing requirement applies to most dietary supplements, including vitamins, minerals, herbs, and probiotics.

The product licensing process requires careful classification of your formula, review of available evidence, and preparation of a detailed submission to Health Canada. While some ingredients are covered by Health Canada monographs that simplify the process, others require additional substantiation. Managing this process without expertise can slow approvals and limit growth opportunities.

Blue Ocean Regulatory helps U.S. founders navigate the NPN process from start to finish. We classify your products correctly, identify applicable monographs, compile the necessary scientific evidence, and prepare your submission package. We can also handle ongoing communication with Health Canada to address any questions that arise during review.

Blue Ocean Regulatory can also support brands seeking an import license with Health Canada and handle French translation to ensure labels meet Canadian requirements.

Getting an NPN can be a very lengthy process. For one brand, after an assessment of their formula and supply chain, they realized that moving into Canada did not make sense and would be a significant cost they didn’t expect. As a result, they saved thousands of dollars and decided to hold on Canadian expansion.

While it would’ve been nice to see the client move ahead, we were just as satisfied that they had an accurate picture of what was needed and that they realized that pursuing this further would only distract them from their core business.

For U.S. brands, the best partner is one who understands both FDA and Health Canada requirements and can bridge them effectively. That’s how you avoid delays and accelerate your path to Canadian sales.