According to Agriculture and Agri-Food Canada (AAFC), growing consumer interest, combined with a greater understanding of food-health relationships, rising health care costs and an aging population, are factors driving the market for functional foods and natural health products (FFNHP) in Canada. A census survey of the FFNHP sector conducted by Statistics Canada on behalf of AAFC found the sector generated US$11.3 billion in revenues in 2011.
More than eight in 10 Canadians consumed natural health products (NHPs), according to the 2012 Ipsos Canadian [email protected] Reid Report. More than half (56 percent) of Canadians said they were probably or definitely likely to purchase NHPs in the future. The most common NHP products in Canada are:
• Vitamins/minerals (71 percent)
• Omega-3s/essential fatty acids (EFAs) (45 percent)
• Probiotics (34 percent)
• Antioxidants (33 percent)
According to the Statistics Canada survey in 2011, 750 Canadian businesses were involved in activities related to FFNHP products.
• The average annual revenue of NHP firms was $7 million. A single NHP product line earned $200,000 on average.
• The average annual revenue of a functional food firm was $38 million. The average revenue of a functional food product line was $1.2 million.
• The average annual revenue of a firm involved in producing both functional foods and NHPs was $23 million.
Health Canada's Food Directorate and its Natural and Non-prescription Health Products Directorate (NNHPD) are responsible regulating the market. The Canadian Food Inspection Agency (CFIA) monitors and enforces regulatory compliance of foods (including functional foods), while Health Canada has the same responsibility for NHPs.
NHPs are naturally occurring substances used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms, such as tablets, capsules, tinctures, solutions, creams, ointments and drops.
NHPs, often called "complementary" or "alternative" medicines, include:
• Vitamins and minerals
• Herbal remedies
• Homeopathic medicines
• Traditional medicines, such as traditional Chinese and Ayurvedic medicines
• Other products such as amino acids and EFAs
Many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes, are also classified as NHPs in Canada.
All NHPs sold in Canada are subject to the NHP Regulations [online link to http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.php], which came into force on Jan. 1, 2004.
To be legally sold in Canada, all NHPs must have a product license, and the Canadian sites that manufacture, package, label and import these products must have site licenses.
To get product and site licenses, specific labeling and packaging requirements must be met, GMPs (good manufacturing practices) must be followed, and proper safety and efficacy evidence must be provided.
All NHPs must have a product license before they can be sold in Canada. To get a license, applicants must give detailed information about the product to Health Canada, including medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).
Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product license, along with an eight-digit natural product number (NPN) or drug identification number–homeopathic medicine number (DIN-HM), which must appear on the label. This number lets consumers know the product has been reviewed and approved by Health Canada.
Application review times are based on how much is known to NNHPD about a product's benefits and risks, relying on information amassed from more than 70,000 authorized NHPs. This means products with the greatest level of certainty are subject to the shortest review time, according to Health Canada.
A three-class system outlines the review targets, starting with Class I products attesting fully to an NHPD monograph, up to the more complex Class III products, which require more review. Applicants are encouraged to use NHPD monographs to ensure the fastest review. As more monographs become available and as further process improvements are implemented, NHPD will continue redefining and expanding the three-class system criteria. As of today, the following rules have been established to allow for shorter review times, where possible.
• Class I: High level of certainty—lowest level of pre-market review. Class I is comprised of products that can be indexed against an individual monograph.
• Class II: Medium level of certainty—medium level of pre-market review. Class II is comprised of applications with safety and efficacy profiles of medium certainty.
• Class III: Low level of certainty—high level of pre-market review. Class III is comprised of applications with safety and efficacy profiles of higher uncertainty.
The safety and efficacy of NHPs and their health claims must be supported by proper evidence so consumers and Health Canada know the products are indeed safe and effective. Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.
Market Entry Strategy Recommendation
• Get professional consultancy support
• Know the regulation for the country you are planning to enter
• Evaluate the formulation, use approved ingredients at a level that meets multiple countries’ requirements
• Prepare strong product dossier with solid scientific background support
• Know your distribution channel
• Find the right local partner for distributing and/or manufacturing
This information is for reference only. It has no legal value. Davidia Healthtech LLC declines all responsibility or liability for errors or deficiencies in this document. Authorities in various countries have the right to determine a product’s regulatory status. Laws and the related guidance change constantly. We cannot guarantee regulations referred to in the document remain unchanged. The text should not be taken as an authoritative statement or interpretation of the law, as only the courts have this power. Every effort has been made to ensure these guidance notes are as helpful as possible.
Hua Deng, Ph.D., is the president and founder of Davidia Healthtech LLC (davidiahealthtech.com), a professional service company for food, dietary supplement and cosmetics. Deng holds a doctorate from Lanzhou University in China with a major in analytical chemistry. She has extensive experience with global regulatory affairs in the food, dietary supplement and cosmetic industries.