"The Canadian government recently implemented wide sweeping changes to the natural products sector, which have made launching a nutraceutical or cosmeceutical product in Canada significantly more complex than in the United States.
As seasoned manufacturers are aware, effective December 2013, Health Canada, the federal department that oversees health products sold to consumers, mandated that all nutraceuticals imported into the country carry a NPN, or Natural Product Number and be imported by a Health Canada site licensed registered facility.
The upside to securing a NPN and a Health Canada site licensed importer is that it translates to the fact that Health Canada has assessed and approved the product, and the Site Licensed Facility has conducted quality control measures guaranteeing its efficacy, quality and safety, demonstrating to consumers that they can trust the finished product and the manufacturer behind it.
More Changes, More Hurdles
The first significant change implemented since December 2013 was that companies could no longer sell natural health products in Canada without a Natural Product Number license. As marketers who have not imported nutraceuticals into Canada post-December 2013 attempt to get their ingestibles into Canada, they are beginning to realize that the second most significant change is the necessity to work with a Canadian site licensed facility who acts as the importer of record.
The site licensed facility ensures compliance related to GMP’s. Oftentimes, the facilities that have site licenses will also be able to help facilitate the process of obtaining a NPN, so a best practice is to first find a Canadian site licensed facility.
Nutraceuticals and Cosmeceuticals Were Not Created Equal in Canada
Selling cosmetics and cosmeceuticals in Canada is a less complex process than the nutraceutical regulatory environment surrounding importing product to Canada. Cosmetic products without SPF’s are still regulated, however there are shorter lead-times to begin selling in Canada, which makes the ramp-up process less time-intensive for manufacturers or distributors.
Assuming a cosmeceutical formulation meets Canadian guidelines, the only regulatory program that that needs to be followed is to obtain a Cosmetic Notification (CN) which provides specific information to Health Canada such as function, form and concentration of ingredients. The only situation where this differs is when the product contains SPF, which is merits another set of regulatory guidelines with a higher level of compliance.
Planning Ahead for Your Canadian Launch
What does the regulatory environment mean if you are launching a nutraceutical, cosmetic or cosmeceutical in Canada? First, you must have a Natural Product Number (NPN) if you are launching a nutraceutical product. Obtaining a NPN can take anywhere from two to six months, depending on whether the product mirrors existing monographs or has unique claims or unique ingredients.
Once you have your final formulation prepared and have submitted an application, be prepared for nearly six months of wait time before officially going to market. When submitting the application, businesses must also provide Health Canada with information about the product including any medicinal ingredients, source, dose, potency, non-medical ingredients and recommended uses.
Second, know your labeling requirements. All of the label information must also be submitted along with the application for a NPN. All natural health product labels must include the following:
Product name
Product license number
Quantity of product in the bottle
Complete list of medicinal and non-medicinal ingredients
Recommended use (including purpose or health claim, route of administration and dose)
Any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product
Any special storage conditions
Selecting a Site Licensed Partner in Canada
When it comes time to physically move product into Canada, the importer that you work with must have a site license. This requires the license holder to maintain proper distribution records, proper procedures for product recalls and for the handling, storage and delivery of products. They must also demonstrate that they meet Good Manufacturing Practice requirements which include the following:
Product specifications
Premises
Equipment
Personnel
Sanitation program
Operations
Quality assurance
Stability
Records
Sterile products
Lot or batch samples
Recall reporting
Gone are the days when unlicensed products filled the shelves and enforcement was not a priority; now Health Canada’s guidelines strictly regulate the marketplace. With the knowledge that Canadians spent a total of $300.3 billion in 2013 on exported products from the United States, businesses who have a strong inclination to enter Canada should be fully compliant with its regulations so they can efficiently and legally sell their products. Finding a site licensed facility should be a high priority as they will have the knowledge and expertise to guide you through and facilitate these processes.
Fortunately, these new laws have created opportunities for turnkey businesses like Stalco to help manufacturers navigate this new Canadian regulatory environment and provide product licensing and distribution support from Health Canada Site Licensed facilities."
Steven Page is the President of Stalco, a gateway to the Canadian Market, providing fulfillment and Canadian importing consultation for nutraceutical and cosmeceutical manufacturers: steven@stalco.ca.