As part of the Federal department that works to ensure the overall health of Canadian citizens, Health Canada has a direct influence on the manufacturing, importation, sale and distribution of natural health products throughout Canada. Health Canada often enacts new regulatory changes in order to guarantee that natural health products that are either made in Canada or are entering Canada are safe and effective.

What’s New?

In December of 2013, Health Canada imposed a new set of stringent regulations on natural health products that are sold throughout the Canadian marketplace. While Health Canada has the best intentions, these changes can be rather difficult to navigate for the uninformed. In fact, companies who violate these regulations may have difficulty conducting additional business in Canada, as penalties for non-compliance include fines, bans, FDA notifications and possible criminal charges.

For natural health product companies that have compliance concerns, it is important to completely understand these new regulations and the positive or negative ramifications associated with each change.

How Does This Affect My Supply Chain?

These new Health Canada regulatory requirements have a direct impact on how natural health products are manufactured, imported and distributed throughout Canada. Each organization that is involved in the overall supply chain of these products (i.e. manufactures, packagers, labelers and importers) must have valid site licenses. Additionally, in order for a product to be imported into Canada, the actual importation must be performed by a fully compliant facility that has been officially licensed by Health Canada. Failure to do so will result in the goods not being allowed to enter the country.

How Do I Obtain a Natural Product Number?

These new regulations require that all natural health products that enter or are distributed in Canada have registrations called Natural Product Numbers (NPNs), and all guidelines (which are listed on the Health Canada website) regarding formulation and labeling must be followed accordingly. Health Canada is also being especially stringent about errors on the packaging for natural health products. If there are any errors related to dosage miscalculations, incorrect ingredients, unproven claims, lack of visible warnings regarding side effects, drug interactions or other critical health information, then Health Canada may not allow the product to be distributed.

Why Should I Look for a Health Canada Site Licensed Facility?

If a company wishing to sell a natural health product in Canada is looking for a facility with a Health Canada Site License, which is a crucial part of moving natural health products into and within Canada, it is important to be sure the facility is able to maintain clearly labeled and documented distribution records, as well as clear procedures on how to recall products in the event of an emergency. The facility should also have controls already in place concerning the warehousing, handling and delivery of the company’s natural health products.

GMP is Still Relevant in Canada

Natural health companies that are looking to sell or distribute their natural health products within Canada must be able to prove that they meet the Good Manufacturing Practices (GMP). GMPs aid in assuring that a manufacturer has implemented a range of safety measures such as sanitation programs, quality assurance standards, product stability specifications and batch samples.

It’s also important that companies have a firm understanding of exactly which natural health products are impacted by these regulatory changes. For example, products such as herbal tinctures, ointments, capsules, drops, tablets, vitamins, mineral supplements, any traditional Ayurvedic or Chinese medicinal remedies, homeopathic remedies, probiotics, amino acids and essential fatty acids (EFAs) such as omega 3 fish oils are all impacted by these regulatory changes.

All natural health products must have an eight-digit NPN which must be labeled in both official languages, French and English. This NPN ensures that Health Canada has evaluated the product for ingredients and claims to show Canadian consumers that the product is safe and effective. Health Canada also houses an extensive database that consumers can utilize in order to learn more about any registered natural health products.

Random Testing?

Health Canada performs spot testing to guarantee that general natural health products are not suffering from faulty ingredients, contamination, or that they have been labeled incorrectly. Many products are also monitored once they are available on the market to guarantee that they follow all natural health product regulations.

These regulatory changes not only influence whether or not a natural health product will be made available in Canada, but they also have a dramatic logistical impact on the way products are assembled, packaged and transported into and within Canada. In order to guarantee that a product adheres to all of these regulations, it is important that the manufacturer of said product works closely with a licensed Canadian facility to make sure that all regulations are being met.

While these new health regulations are fairly complicated to a company that is looking to enter the Canadian natural health product marketplace for the first time, it is important to understand that these regulations are in place for a reason—these regulations ensure the safety of anyone who utilizes these natural health products in Canada. Adhering to these new regulations is not impossible, and foreign companies looking to sell their natural health products in Canada should consider working with turnkey partners like Stalco, who have a Canadian Site License and manage all of the regulatory and logistics requirements. This structure allows the U.S. company to focus on selling product.

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