Thinking about exporting dietary supplements to Canada? Here is what you need to know.

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Canada, like the United States, has a thriving dietary supplements industry. Industry growth stems largely from an aging population and rising consumer health-consciousness coupled with a growing readiness to practice self-care.

This bodes well for U.S. firms looking to sell dietary supplements in Canada. Sales opportunities are vast, whether for vitamins and minerals, food supplements, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines (TCMs), probiotics, or other products like amino acids and essential fatty acids (EFAs).

Given that Canadian shoppers share similar demographics and attitudes with U.S. shoppers, it would be easy to assume that selling supplements into Canada is as simple as shipping across the border, opening a warehouse, or partnering with a local fulfillment center. However, that’s not the case.

Whereas dietary supplements are classified as foods in the U.S., in Canada they are considered a class of drugs called Natural Health Products (NHPs), and companies are required to submit evidence of their safety and efficacy prior to sale.

Canada’s robust regulatory system governs the manufacture and sale of Natural Health Products, and understanding the requirements or having a seasoned partner to guide you through its complexities is key to avoiding missteps, delays, or recalls.

Health Canada regulates Natural Health Products under the country’s Food and Drugs Act and is responsible for ensuring that products made in Canada or entering Canada are safe and effective. Oversight starts with registration and licensing for each product (a Natural Product Number, or NPN) and having a site license which covers manufacturing, importation, and distribution of your products.

Brands can choose to either apply for their own site license, or they can outsource manufacturing services. A site license requires that the Canadian facility meet good manufacturing practice (GMP) requirements. A site license allows brands to operate as an Importer of Record within Canada. As an Importer of Record, a manufacturer is responsible for all aspects of the products produced, including warehousing, handling, delivery, and distribution as well as managing recalls, consumer complaints, and returned goods. Companies are required to have clear distribution records that are lot number traceable.

Outsourcing Your Site License

For small to medium-sized businesses, getting and maintaining a site license is often time-consuming and expensive and can be a risky investment when entering into a new market. Outsourcing services to a well-established, reputable, and experienced Canadian partner that can provide cost-effective turnkey options can help brands get products into Canada quickly, compliantly, and with less risk.

There are two factors that brands need to consider when choosing an outsourced facility. First, the facility must be fully compliant with Canada’s Good Manufacturing Practices, regardless of their specific activity, as regulated by the country’s Natural and Non-Prescription Health Products Directorate (NNHPD). Second, ensuring you have a full-time onsite quality assurance team to review receiving reports, execute required sampling protocols, and render release/reject decisions can help get product onto the market quickly and efficiently.

An outsourced facility and team can act as an extension of the U.S. firm by providing an assurance of a seamless supply chain, from product manufacturing to exportation and distribution.

Getting Started

But is dealing with Canada’s stringent supplement regulations worth the effort? It can be. A robust system like Canada’s is good for quality brands interested in expanding into new markets. Prior to exporting supplements to Canada, several preparation steps need to be taken. Failing to do so can result in the goods not being allowed to enter Canada.

First and foremost, the company must have evidence that products were manufactured, packaged, and labeled in accordance with all sections of Canadian GMP requirements. This includes:

• A valid Natural Product Number
• Quality control documents and analytical test results from an accredited laboratory confirming finished product specifications to provide evidence of identity, purity, potency, and quality of ingredients. This includes assessment of your formula in accordance with Canada’s Natural Health Product regulations to confirm eligibility for sale. This also requires preparing evidence reports to support health claims and dosage.
• Providing documentation supporting sanitation programs, quality assurance standards, product stability specifications, and batch samples.
• Written product release specifications for your dietary supplements as per Health Canada’s Quality of Natural Health Products Guide
• Stability data showing that your dietary supplement meets its shelf life at expiry
• Bilingual product labels are required, in both English and French, prior to exportation and must well meet permissible package claims on the principle and side display panels and advertising statements.

After your products have been approved and made available for sale, there are ongoing regulatory obligations such as reporting of adverse events and recordkeeping.

Having a clear understanding of how dietary supplements are regulated in Canada, and getting the support needed to export products into Canada, plays an important role in avoiding costly delays and recalls.

About the Author

Christian Sood, PhD, is president of MCS Associates (Mississauga, ON, Canada; www.mcs-associates.com). MCS Associates is a leading Canadian full-service regulatory affairs, quality control, and quality assurance consultancy supporting, small, medium, and multinational regulated health product brands. The company is an affiliate of the Reena Group, which offers an allied services model for regulatory services, analytical testing, and Natural Health Product contract manufacturing.