THE SOLUTION TO LICENSE DIETARY SUPPLEMENTS IN CANADA
According to a 2010 Ipsos-Reid survey, over 70% of Canadians regularly take natural health products (NHPs), also known as dietary supplements in the United States. . The category of NHPs includes vitamins, minerals, herbal products, homeopathic medicines (designated with a HM-DIN), traditional medicines such as ayurvedic and traditional Chinese medicines, probiotics and other products like amino acids and essential fatty acids. Revenue in 2007 was $3.7 billion for the NHP and functional food category with annual continued growth.
In Canada there are several distinct differences in the regulations and categorization of dietary supplements. First, dietary supplements (often called food supplements in other countries such as in Europe) are called Natural Health Products and require a Natural Product Number (NPN) license to legally sell and market in Canada. Licenses are issued by the Non-Prescription and Natural Health Products Directorate (NNHPD) which is a department within in Health Canada. Licensing is based on at least one health claim to support at least one of the medicinal ingredients in the product. This health claim can be structure-function, therapeutic or preventative in nature. For example, a claim of reducing pain related to osteoarthritis would be allowed if evidence is presented to support such a claim. The route of administration for Natural Health Products is broader than in other countries. It includes topical products. Some sunscreens, eczema creams, acne products are classified as NHPs. Licensing can vary from as fast as 10 days or as long as 6 months depending on various factors and level of evidence that must be provided.
There are 3 requirements to legally sell a Natural Health Product in Canada.
Natural Product Number
A Natural Product Number (NPN) must be obtained. License issuance timeline varies between 10 days to 6 months.
NHP compliant Label
A bilingual, NHP compliant label on the Natural Health Product is required. This includes the NPN on the front panel, medicinal ingredients listings (in either tabular or linear format), directions of use, recommended use or purpose, cautions and warnings and other details.
Licensed Importer of Record
If the Natural Health Product is manufactured outside of Canada a Health Canada licensed importer of record must be used. The NHP must land into a warehouse/storage facility that is annexed to the importer’s license. The foreign manufacturing site must also be annexed to the importer’s license attesting to following Good Manufacturing Practices (GMP). Note that if the NHP is made in Canada, an importer is not required. However, the NHP must be manufactured, packaged and labelled at a facility that holds a valid site license for these respective activities.
There is presently no charge by Health Canada for submitting NPNs.
Bars, beverages, gums and other food format products fall outside the scope of Natural Health Products. These are under the jurisdiction of the Food directorate and the Canadian Food Inspection Agency. Fortified foods may qualify for a Temporary Market Authorization License (TMAL). Ask us for details.
Our fees start at $650 and will be based on number of ingredients and the classification of the NHP.
Both official languages, English and French, are required on labels. This can be enforced starting at the border through to the various jurisdictions with the most stringent and impactful enforcement being in Quebec, a predominantly French speaking province, where stop sale, recall and even fines can result. There are also specific NHP labelling requirements that differ from other countries so it’s advised that label be completely compliant both in language and NHP regulations.
Our first phase in licensing your product is to conduct a feasibility evaluation to determine if your product would qualify for NPN. There are some ingredients that are considered scheduled drugs in Canada and would have to be removed from the formula before it can proceed to be licensed as a Natural Health Product. Only after the NPN is issued can the Natural Health Product be legally allowed to be sold at any retail outline (stores or online).
Expertise to License Your Supplement
As the premiere NHP licensing and consulting expert we are your end-to-end solution from NPN licensing to being your importer of record. We do it all! Having successfully licensed thousands of NPNs for clients representing every continent we have the experience to find solutions to all your Health Product license needs. Our label compliance solution includes French translation from our Quebec native translator who has 25 years experience in the consumer packaged goods industry. We offer a fast, cost effective and simple process to get your health product legally on retail shelves or for online sales.