Natural Products Insider

NOV-DEC 2016

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66 INSIDER November/December 2016 According to Agriculture and Agri-Food Canada (AAFC), increasing 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 Inter@ctive Reid Report. More than half (56 percent) of Canadians said they were probably or defi nitely 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 fi rms was $7 million. A single NHP product line earned $200,000 on average. The average annual revenue of a functional food fi rm was $38 million. The average revenue of a functional food product line was $1.2 million. The average annual revenue of a fi rm involved in producing both functional foods and NHPs was $23 million. Regulation Health Canada's Food Directorate and its Natural and Non-prescription Health Products Directorate (NNHPD) are responsible for 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 Chinese and Ayurvedic medicines Probiotics Other products such as amino acids and EFAs Many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes, are also classifi ed as NHPs in Canada. All NHPs sold in Canada are subject to the NHP Regulations, which came into force on Jan. 1, 2004. To be legally sold in Canada, NHPs must have a product license, and the Canadian sites that manufacture, package, label and import these products must have site licenses. To get a product license, applicants must give detailed product information to Health Canada, including medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s). Once Health Canada is satisfi ed with a product's safety and effi cacy, it issues a product license, along with an eight-digit natural product number (NPN) or drug identifi cation number–homeopathic medicine number (DIN-HM), which must appear on the label. Application review times are based on how much is known to NNHPD about a product's benefi ts and risks, relying on information amassed from more than 70,000 authorized NHPs. 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. Class I: High level of certainty— lowest level of pre-market review with a 10-day processing period. Class II: Medium level of certainty— medium level of pre-market review, requiring a 30-day review period. Class III: Low level of certainty— high level of pre-market review, requiring a 180-day review period. The safety and effi cacy of NHPs and their health claims must be supported by proper evidence, which 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 scientifi c background support. Know your distribution channel. Find the right local partner for distributing and/or manufacturing. This reference information has no legal value. Davidia Healthtech LLC declines responsibility or liability for errors or defi ciencies. Authorities in various countries have the right to determine a product's regulatory status. Laws and the related guidance change constantly. The text should not be taken as an authoritative statement or interpretation of the law. 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 supplements and cosmetics, with which Deng has extensive global regulatory affairs experience. Global Market Insights: C anada Selling Natural Health Products in Canada by Hua Deng, Ph.D.

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