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.
In December 2013, Health Canada imposed a 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 difficult to navigate for the uninformed. In fact, companies that 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.
It is important that natural health product companies completely understand these new regulations and the positive or negative ramifications associated with each change.
These Health Canada regulatory requirements have a direct impact on how natural health products are manufactured, imported and distributed throughout Canada. Each organization involved in the overall supply chain of these products (e.g., manufacturers, 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 compliant facility that has been licensed by Health Canada. Failure to do so will result in the goods not being allowed to enter the country.
Obtaining a Natural Product Number
These new regulations require 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 and concern formulation and labeling, must be followed. Health Canada is also being especially stringent about errors on the packaging for natural health products. If there are errors related to dosage miscalculations, incorrect ingredients, unproven claims, lack of visible warnings regarding side effects, drug interactions or other critical health information, Health Canada may not allow the product to be distributed.
Using 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 ensure 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 in place concerning the warehousing, handling and delivery of the company’s natural health products.
GMPs are Relevant in Canada
Natural health companies looking to sell or distribute their natural health products within Canada must be able to prove that they meet the good manufacturing practices (GMPs). 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. These changes impact a variety of products such as herbal tinctures, ointments, capsules, drops, tablets, vitamins, mineral supplements, traditional Ayurvedic or Chinese medicinal remedies, homeopathic remedies, probiotics, amino acids and essential fatty acids (EFAs) such as omega-3 fish oils.
All natural health products must have an eight-digit NPN, which must be labeled in both official languages, French and English. This NPN ensures 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 about any registered natural health products.
Health Canada performs spot testing to guarantee general natural health products are not suffering from faulty ingredients, contamination or mislabeling. Many products are also monitored once they are available on the market to guarantee they follow all natural health product regulations.
These regulatory changes not only influence whether 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 a product adheres to all of these regulations, it is important that a product manufacturer works closely with a licensed Canadian facility. 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 they are in place for a reason: to ensure the safety of anyone who utilizes these natural health products in Canada.
Steven Page ([email protected]) is the president of Stalco (Stalco.ca), a gateway to the Canadian Market, providing fulfillment and Canadian importing consultation for nutraceutical and cosmecutical manufacturers.