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Natural Health Products
Introduction.................................................................................................................................... 2 Scope of the Report ................................................................................................................. 2
The Canadian Market .................................................................................................................. 4 Imports ....................................................................................................................................... 4 Trends and Opportunities ....................................................................................................... 8 Corporate Social Responsibility ........................................................................................... 10
Trade Practices........................................................................................................................... 11 Trade Shows ........................................................................................................................... 11
Quality ...................................................................................................................................... 11
The Buyer ................................................................................................................................ 12 Price.......................................................................................................................................... 12 Packaging and Transportation ............................................................................................. 13 Labelling ................................................................................................................................... 13
Distribution................................................................................................................................... 14 Import Regulations ..................................................................................................................... 16
Importing .................................................................................................................................. 16 Relevant Canadian Laws and Regulations ........................................................................ 18 Tariffs........................................................................................................................................ 18 Sources of Information .......................................................................................................... 20
Trade Shows ........................................................................................................................... 20
Publications ............................................................................................................................. 21 Other Useful Internet Sources .............................................................................................. 21
This publication has been produced with the financial support of the Government of Canada prov ided through the Department of Foreign Affairs, Trade and Development (DFATD). All information provided in this document is based on the best available at the time of preparation
and is offered without responsibility on the part of TFO Canada. The reader is advised to check periodically with TFO Canada for updates.
This publication is distributed subject to the condition that it shall not, by way of trade or by any means, be lent, sold, hired out or otherwise
circulated in any form other than that in which it is published, including this notice. This publication shall only be made available to assistbusinesses, trade support organizations, and government agencies which have their head office and operations residing in countries eligible forinternational development assistance from the Canadian government. In no case may it be sold or distributed at any cost, direct or implied, nor
may it be published on a publicly accessible website or equivalent, without TFO Canada’s consent.
© Trade Facilitation Office Canada, 2014
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Introduction
TFO Canada offers a series of product-specific marketreports to exporters in client countries identified by theCanadian Government. This list of countries and thereports are available through TFO Canada or on requestby writing to TFO Canada. They are also distributedthrough export promotion organizations and Canadianembassies in the client countries as well as through clientcountry embassies accredited to Canada.
The market reports are intended to provide the exporterwith background information on the Canadian market fora product; advice on how to go about finding a Canadianbuyer; and suggestions on what to do once a buyer isfound. The reports offer exporters enough information topursue the Canadian market on their own and to seek further details from suggested sources throughwebsites, electronic mail, fax, mail or telephone. These reports are intended for the experienced exporterwho is serious about trying to enter the Canadian market. Canada is not the market to test your first exportexperience; a history of exporting to a market closer to home is invaluable before attempting this one. Showthe potential buyer that you have done your homework and are serious about a long-term relationship.Research, planning and commitment are essential in establishing a good reputation in trade with thiscountry.
Scope of the Report
Health Canada defines natural health products (NHPs) as “products made from natural sources, sold indosage form and are designed to maintain or promote health; to restore or correct human health function;or to diagnose, treat or prevent disease.” According to Canada’s 2004 Natural Health Products Regulations,the definition of natural health products encompasses the following product areas:
vitamin and mineral supplements; herb and plant-based remedies; traditional medicines like traditional Chinese medicines or Ayurvedic (Indian) medicines; amino acids, omega 3 and essential fatty acids; probiotics; homeopathic medicines; many everyday consumer products, like certain toothpastes, antiperspirants, shampoos, facial
products, and mouthwashes.
To be considered a natural health product, it must be manufactured, sold or represented for use in:
the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state orits symptoms in humans;
restoring or correcting organic functions in humans; or modifying organic functions in humans, such as modifying those functions in a manner that maintains
or promotes health.
In January 2014, Canada’s population was estimated at 35.3million, up from 34.5 million in the previous year.
Nearly 80% of Canadians live within 160 kilometers of theborder with the United States, mainly in large urban centresthroughout the central and western parts of the country. In2012, six cities had over a million inhabitants: Toronto (5.9million), Montréal (3.9 million), Vancouver (2.5 million),Calgary and Ottawa-Gatineau (about 1.3 million each), andEdmonton (1.2 million). Together, these six cities account formore than 46% of the country ’s population.
Canada’s two official languages are English and French. M oreinformation on Canada’s population is available through
Statistics Canada.
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This report covers the natural health products market in Canada as outlined in the table below. This reportshould be used in conjunction with TFO Canada’s Handbook on Exporting to Canada which providesinformation on how to enter the Canadian market, along with other practical information on trading with thiscountry. As well, TFO Canada provides relevant market information on products such as cosmetic products,organic foods, fresh fruits and vegetables, manufactured foods, and beverages. These are all available for
free to members at: http://www.tfocanada.ca/docs.php.
Selected Health Products (including NHPs) by Harmonized System (HS) Code
HS 2936 - v itamins, provitamins and their deriv atives
HS 121110 - licorice roots used primarily in pharmacy, perfumery, insecticides, fungicides or similar purposes
HS 121120 - ginseng roots used primarily in pharmacy, perfumery, insecticides, fungicides or similar purposes
HS 121130 - coca leaf
HS 121140 - poppy straw
HS 121190 - plants and parts of plants, including seed and fruit used in pharmaceuticals, etc., nes
HS 150410 – fish liv er oils and their fractions - not chemically modified
HS 150420 - fish fats and oils (excluding from liv er) and their fractions - not chemically modified HS 150430 - marine animal fats and oils and their fractions - not chemically modified
HS 300340 - medicaments (bulk) containing alkaloids but no hormones or antibiotics
HS 300390 - medicaments (bulk) nes
HS 300440 - alkaloids or their derivatives - other than antibiotics or hormones - in dosage
HS 300450 - v itamins and their derivatives - in dosage
HS 300490 - medicaments nes - in dosage
Source: Trade Data Online - Trade by Product , Industry Canada, 2014
Exporters should note that CBSA requires individual imports to be identified by 10 digit Harmonized System(HS) codes and/or by their eight digit Natural Product Number (NPN) or Homeopathic Medicine Number(DIN-HM); importers could be fined if these are not provided. Current codes are available from CBSA orfrom your buyer.
The following definitions are commonly used in Canada:
Traditional medicine: This refers to drugs that contain a plant, mineral or animal substance for which
therapeutic activity or disease prevention activity is claimed. This includes traditional herbal medicines,traditional Chinese medicines, Ayurvedic (East Indian) medicines, and traditional aboriginal North Americanmedicines, where the medical use is based solely on historical and ethnological evidence from referencesrelating to a medical system other than the one based on conventional scientific standards.
Homeopathic preparations: This refers to preparations used in a system of medical practice that treatdisease by the administration of minute doses of a remedy that would, in healthy persons, producesymptoms of the disease treated.
Products subject to special measures: This refers to traditional medicines, homeopathic preparations,and vitamin and mineral supplements for human use, when in dosage form for which prescriptions are notrequired.
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The Canadian Market
According to Consumer Health Products Canada, the natural health productsmarket in Canada is currently valued at $4.7 billion. In addition, the CanadianHealth Food Association reports that 71% of Canadians have used a naturalhealth product with more than 10,000 retail establishments in Canada sellingnatural health products. There has been a recent surge in purchases of over-the-counter (OTC) health products and a shift from brand names towardsprivate labels, demonstrating drive towards lower-price options by theconsumer.
Growth in the natural health sector is fuelled by:
new Canadian regulations that add credibility to natural health products; access to more thorough and reliable sources of information, for example, over the internet; an aging population with high interest in healthy lifestyles and self-care; interest in controlling health care costs; increasing acceptance of ‘alternative’ treatments; effective marketing by producers and suppliers; rising acceptance by medical professionals; and consumer disenchantment with traditional drugs and treatments.
For more information, Canadian Health Food Association provides some quick facts on natural healthproducts in Canada. More information is also available through the Canadian Health Food Associationwhich has commissioned a report on the Natural Health Products Industry 2011 (available for a fee).
Imports1
Important Note on Statistics Used In This Report
Natural Health Products are not yet consistently separated from other medicaments in terms of Harmonized System codes. Separateclassification is still being worked on globally. As such, the import statistics used herein include general categories of medicaments, v itamins
and other such health products and should be used with caution.Statistics were obtained from Trade Data Online - Trade by Product, Industry Canada, 2014.
Over the past five years, Canada has consistently imported more of the natural health products covered inthis report than it has exported. The trade decifit reached a five year high in 2011 before a stronger exportmarket in 2012 and 2013 reduced the need for imports as shown below.
Trade Balance of Selected Health Products (including NHPs), 2009-2013 ($millions)
2009 2010 2011 2012 2013
Total Ex ports 5,239 3,594 3,133 3,555 3,727
Total Imports 9,151 8,523 8,589 8,096 7,825
Trade Balance -3,912 -4,929 -5,456 -4,541 -4,098
1 All import statistics are obtained from Statistics Canada, Trade Data Online: Trade by Product (HS Code), 2014
Users generally choose the followingsources of information for natural healthproducts: family members or friends; the internet; pharmacists; medical doctors; health food stores; magazines; books; and
naturopaths or naturopathic doctors.
http://www.chpcanada.ca/en/industry-productshttp://www.chpcanada.ca/en/industry-productshttp://www.chpcanada.ca/en/industry-productshttps://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/http://www.euromonitor.com/consumer-health-in-canada/reporthttp://www.euromonitor.com/consumer-health-in-canada/reporthttp://www.euromonitor.com/consumer-health-in-canada/reporthttps://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/publications/natural-health-products-study-2011/https://www.chfa.ca/publications/natural-health-products-study-2011/https://www.chfa.ca/publications/natural-health-products-study-2011/http://www.ic.gc.ca/eic/site/tdo-dcd.nsf/eng/homehttp://www.ic.gc.ca/eic/site/tdo-dcd.nsf/eng/homehttp://www.ic.gc.ca/eic/site/tdo-dcd.nsf/eng/homehttp://www.ic.gc.ca/eic/site/tdo-dcd.nsf/eng/homehttps://www.chfa.ca/publications/natural-health-products-study-2011/https://www.chfa.ca/nhp/nhp-fast-facts/http://www.euromonitor.com/consumer-health-in-canada/reporthttps://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/http://www.chpcanada.ca/en/industry-products
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The Canadian import market for natural healthproducts offers many opportunities for exporters fromdeveloping countries.
On the whole, imports of products selected for this
report declined over the past five years after reachinga peak of $9.2 billion in 2009. However, the vastmajority of this decline was driven by losses in the‘medication not elsewhere specified (nes)’ categoryfor medicaments of cardiovascular and nervoussystem conditions, which are not considered to be anatural health product, as well as moderate losses inamino acids, which are considered a natural healthproduct.
Taking these factors into account, the actual import market for natural health products appears to havegrown by $43 million between 2009 and 2013, at an average of 1.2% per year.
The table below outlines the value of imports by type over the past five years. The fastest growing marketsegments from 2009 to 2013 were fish fats and oils (12.3%) and ginseng roots (11.9%), with significantincreases also seen in vitamins and plant-based products. Imports in the remaining categories declined.
Imports of Natural Health Products by Type 2009-2013 ($ mil lions)
2009 2010 2011 2012 2013
HS 300490 - medicaments nes - in dosage 8,436.2 7,776.7 7,817.8 7,348.9 7,067.1
HS 2936 - v itamins, provitamins and their derivatives 218.4 201.5 206.3 201.3 203.1
HS 300440 - alkaloids or their derivatives - other than antibiotics orhormones - in dosage
174.9 193.3 214.1 177.6 159.3
HS 150420 - fish fats and oils (excluding from liver) and their fractions -not chemically modified
63.0 69.1 87.8 111.3 112.5
HS 300450 - v itamins and their derivatives - in dosage 96.6 107.6 108.2 102.9 111.4
HS 121190 - plants & parts of plants, including seed & fruit used inpharm, perfumery, insect , etc. - nes
68.1 64.7 71.0 73.0 78.3
HS 300390 - bulk medicaments - nes 71.1 88.0 57.1 59.1 67.8
HS 121120 - ginseng roots used primarily in pharmacy, perfumery,insecticides, fungicides or similar purposes
8.5 8.5 11.6 11.4 14.9
HS 300340 - bulk medicaments containing alkaloids but no hormonesor antibiotics
7.4 6.5 6.6 4.7 4.9
HS 150410 - fish-liver oils and their fractions - not Chemically Modified 4.3 6.5 7.3 5.2 4.6
HS 150430 - marine animal fats and oils and their fractions - notchemically modified
2.2 0.6 1.1 0.9 1.0
*nes = not elsewhere specified
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In the first 5 months of 2014, impressive growth has been experienced in ginseng (43%), fish fats and oils(31%), and vitamins (12%), while the ‘medicaments not elsewhere’ specified cateogry appears to berecovering some growth (11%). Imports in the remaining categories declined. The table below providesdetails of these changes.
Imports of Natural Health Products Jan/Mar 2013-2014 ($ mil lions)Jan-Mar 2013 Jan-Mar 2014 % Change 2014/13
HS 121120 - Ginseng Roots Used Primarily In Pharmacy,Perfumery, Insecticides, Fungicides or Similar Purposes
2.8 4.0 43%
HS 150420 - Fish Fats And Oils (Excluding From Liver) And TheirFractions - Not Chemically M odified
19.6 25.7 31%
HS 300450 - Vitamins And Their Derivatives - In Dosage 21.4 23.9 12%
HS 2936 - Vitamins, Provitamins And Their Derivatives 47.9 52.9 11%
HS 300490 - Medicaments Nes - In Dosage 1,751 1,938 11%
HS 121190 - Plants & Pts Of Plants,Incl Seed & Fruit Used InPharm, Perfumery, Insect,Etc,Nes
19.8 18.7 -6%
HS 300390 - Medicaments (Bulk) Nes 18.5 16.7 -10%
HS 300340 - Medicaments (Bulk) Containing Alkaloids But NoHormones Or Antibiotics
0.7 0.6 -11%
HS 150430 - Marine Animal Fats And Oils And Their Fractions -Not Chemically Modified
0.4 0.4 -12%
HS 150410 - Fish-Liver Oils And Their Fractions - Not ChemicallyModified
1.1 0.9 -19%
HS 300440 - Alkaloids Or Their Derivatives - Other Than Antibiotics Or Hormones - In Dosage
30.6 16.2 -47%
Major suppliers to this market in 2013 were theUnited States, Germany and Switzerland (seetable to the left). The vast majority of importsfrom these top three countries remainconcentrated in medications not elsewhere
specified as well as vitamins and theirderivaties.
This leaves significant opportunities fordeveloping countries to enter the Canadianmarketplace in the remaining segments ofnatural health products. When controlling for
the ‘medications not elsewhere specified’, Peru and India rise to fourth and ninth top sources to Canada.Peru’s exports are concentrated in natural fish fats and oils, while India exports a range of vitamins,alkaloids and plant-based products.
Top 10 Sources of Natural Health Products Imports 2013 ($ millions)
United States 2,452
Germany 1,045
Switzerland 811
United Kingdom 540
France (incl. Monaco, French Antilles) 419Sweden 307
Italy (incl. Vatican City State) 296
Ireland 228
Spain 207
Israel 170
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From TFO Canada client countries, India, China and Peru were the top three suppliers in 2013 (see tablebelow). Imports from India rose by 18% between 2012 and 2013 to $167.2 million. Imports from China andPeru decreased slighly in 2013 after reaching a five year high of $100.5 million at $63.5 million in 2012,respectively. Significant increases in supply were also noted from Turkey ($11.8 million to $27.5 million),Malta ($18.1 million to $26.4 million) and South Korea ($2.2 million to $10.5 million).
Buyers in Ontario ($6 million), Québec ($1.5 million)and Brit ish Columbia ($132,933) were the majorpurchasers of imported natural health products in2013. Industry sources indicate that over two thirds ofCanadian importers of natural health products arelocated in the metropolis cities of Toronto andMontreal.
Ontario remains the leading destination overall for
natural health products. One important exception isnatural fish fats and oils, which are imported primarily
to British Columbia and the maritime provinces of New Brunswick and Nova Scotia. British Columbia is alsoa primary destination for ginseng roots and plant-based products, while Québec imports are concentratedin vitamins and alkaloids.
Imports of Natural Health Products from Selected TFO Canada Client Countries, 2013 ($ '000)
India 167,241 Thailand 1,171 Philippines 266
China 92,317 Chile 1,126 Malaysia 213
Peru 59,407 Vietnam 1,103 Nigeria 160
Mexico 55,226 Brazil 1,078 Sri Lanka 148
Turkey 27,447 Bangladesh 1,009 Iran 140
Malta 26,433 Pakistan 869 Jamaica 134
Korea, South 10,514 Dom. Republic 707 Cyprus 86
Ecuador 6,642 Venezuela 651 Jordan 86
Colombia 4,310 Uruguay 626 Sudan 51
Morocco 3,157 Indonesia 621 Guyana 49
South Africa 2,000 Costa Rica 433 Lebanon 38
Egypt 1,758 Guatemala 330 Paraguay 32
Argentina 1,627 Tunisia 309 Ukraine 29Thailand 1,171 Philippines 266 Serbia 15
Imports of Natural Health Products by Province 2013 ($ '000)
Ontario 6,013,509
Québec 1,530,972
British Columbia 132,933
Alberta 38,135
New Brunswick 36,712
Manitoba 33,378
Nov a Scotia 31,702
Saskatchewan 7,720
Newfoundland and Labrador 41
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Trends and Opportunities
Superfoods: Growing public awareness of the health benefits of “superfoods” (e.g. , kale, ginseng, chia,maca, ginger, acai, goji, etc.) is driving market demand for derivatives and supplements of these items.Many of the most popular superfoods do not grow in Canada, presenting a significant opportunity for
exporters from developing countries to supply raw ingredients and/or final products. Those who can offerorganic and fair trade certifications will be particularly successful in this market. Natural health productsbased on superfoods come in a variety of forms including capsules, powders, and liquids and often includepamphlets outlining associated health benefits, particularly for products that are new to the marketplace.Green concentrates that combine the benefits of several superfoods into one nutrient-rich product areincreasingly in demand. Emerging additions to this area include extracts from bee pollen and oregano oil, which offer a potent source of antioxidants for boosting the immune system, and green coffee beans, arecent craze in the diet and weight loss community.
Flavour and Convenience: Canadians who have begun to use natural health products on a daily basisare on the lookout for products that offer convenience and also taste good. Natural health products areavailable in an ever-increasing range of flavours including chocolate, lemon and berries. While vitamincapsules remain commonplace, innovative products are emerging. For instance, soft chews for calcium
supplements resemble toffees or “gummies for grown-ups”, while concentrated vitamin drinks offer higherabsorption rates due to their liquid form. Single serve packages and highly concentrated formulas such asthe NutraSea “Omega-3 made easy” offer an all-in-one dosage of health benefits that appeals to busyCanadians on-the-go.
Ageing Population: The ageing Canadian population is at the core of consumer demand for NHPs, asCanadians seek out natural remedies that offer self-care and prevention for a wide range of ailments relatedto old age. There is a growing trend of Canadians turning to vitamins and dietary supplements to helpstrengthen the immune system, improve digestion, and lower cholesterol. Many types of probiotics,enzymes and herbs, such as ginger root capsules, are marketed to an ageing population as digestive aidsthat help to break down food and effectively absorb nutrients. Another example of this trend are naturalproducts such as LaKOTA that are used to relieve joint and arthritis pain.
Ethnicity: Canada’s rapidly growing immigrant populations and multicultural values have a strong influenceon consumer preferences for NHPs, particularly for traditional herbal medicines, traditional Chinesemedicines and Ayurvedic (East Indian) medicines. As these diverse cultures continue to come together andtheir traditional methods of healing become better know, interest in alternative medicines and natural healthproducts from diverse traditions is expected to rise even more.
Holistic Health: Canadians are embracing a more holistic approach to healthcare that goes beyondWestern medicine to include a healthier diet, exercise and stress relief as well as alternative and traditionaltherapies. Demand for naturopathic care is growing in every province, as Canadians seek out the benefitsof disease prevention and alternative therapies offered by over 1,600 naturopathic doctors who practice inCanada. It is common for employers’ benefit plans and health insurance to cover the costs of naturopaths,homeopaths and traditional medicine to the same level as other healthcare professionals.
Sports Supplements: Canadians are generally active. As such, natural health products that are speciallyformulated for sports and athletics present an important opportunity. Protein supplements used for post -workout muscle repair and recovery are available in a range of natural and plant-based forms and marketedin various combinations of “raw” formulas that are vegan, organic, gluten-free, dairy-free, soy-free and/orGMO-free. Some examples include Webber Naturals’ 100% Natural Vegan Protein and Garden of Life’sRaw Protein Powder , which is packaged with a free shaker cup. Weight-loss and diet products that containnatural “superfood” extracts such as green tea and acai berry are also used for burning fat, cleansing anddetoxification benefits.
http://www.vitasave.ca/greens-concentrate.htmlhttp://www.vitasave.ca/greens-concentrate.htmlhttp://www.costco.ca/Organika%C2%AE-Bee-Propolis-500-mg.product.10339583.htmlhttp://www.costco.ca/Organika%C2%AE-Bee-Propolis-500-mg.product.10339583.htmlhttp://www.holista.ca/images/HHCanadaEnglish/Articles/Multimedia/HolistaOreganoOil_82.pdfhttp://www.holista.ca/images/HHCanadaEnglish/Articles/Multimedia/HolistaOreganoOil_82.pdfhttp://www.holista.ca/images/HHCanadaEnglish/Articles/Multimedia/HolistaOreganoOil_82.pdfhttp://www.greenbeanery.ca/bean/home.phphttp://www.greenbeanery.ca/bean/home.phphttp://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Vitamins-And-Supplements/Multivitamins/products/100/062107055925http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Vitamins-And-Supplements/Multivitamins/products/100/062107055925http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Vitamins-And-Supplements/Multivitamins/products/100/062107055925http://www.costco.com/LIQUID-reViva%C2%AE-Calcium%2c-64-Ounces.product.11706458.htmlhttp://www.costco.com/LIQUID-reViva%C2%AE-Calcium%2c-64-Ounces.product.11706458.htmlhttp://www.costco.com/LIQUID-reViva%C2%AE-Calcium%2c-64-Ounces.product.11706458.htmlhttp://www.ascentahealth.com/product-info/nutrasea/nutrasea-main/http://www.ascentahealth.com/product-info/nutrasea/nutrasea-main/http://www.euromonitor.com/vitamins-and-dietary-supplements-in-canada/reporthttp://www.euromonitor.com/vitamins-and-dietary-supplements-in-canada/reporthttp://www.euromonitor.com/vitamins-and-dietary-supplements-in-canada/reporthttp://www.costco.ca/webber-naturals%C2%AE-Ginger-Root-1200-mg.product.100033608.htmlhttp://www.costco.ca/webber-naturals%C2%AE-Ginger-Root-1200-mg.product.100033608.htmlhttp://www.costco.ca/webber-naturals%C2%AE-Ginger-Root-1200-mg.product.100033608.htmlhttp://lakotaherbs.com/collections/lakota-arthritis-pain-reliefhttp://lakotaherbs.com/collections/lakota-arthritis-pain-reliefhttp://lakotaherbs.com/collections/lakota-arthritis-pain-reliefhttp://www.exploreyourhealth.ca/viewpage.cfm?pageID=56http://www.exploreyourhealth.ca/viewpage.cfm?pageID=56http://www.costco.ca/webber-naturals%C2%AE-100%25-Natural-Vegan-Protein-Powder-.product.10395728.htmlhttp://www.costco.ca/webber-naturals%C2%AE-100%25-Natural-Vegan-Protein-Powder-.product.10395728.htmlhttp://www.nationalnutrition.ca/detail.aspx?ID=3936http://www.nationalnutrition.ca/detail.aspx?ID=3936http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363565039http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363565039http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363565039http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363573942http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363573942http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363573942http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363573942http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Diet-And-Fitness/Sports-Supplements/products/127/710363565039http://www.nationalnutrition.ca/detail.aspx?ID=3936http://www.costco.ca/webber-naturals%C2%AE-100%25-Natural-Vegan-Protein-Powder-.product.10395728.htmlhttp://www.exploreyourhealth.ca/viewpage.cfm?pageID=56http://lakotaherbs.com/collections/lakota-arthritis-pain-reliefhttp://www.costco.ca/webber-naturals%C2%AE-Ginger-Root-1200-mg.product.100033608.htmlhttp://www.euromonitor.com/vitamins-and-dietary-supplements-in-canada/reporthttp://www.ascentahealth.com/product-info/nutrasea/nutrasea-main/http://www.costco.com/LIQUID-reViva%C2%AE-Calcium%2c-64-Ounces.product.11706458.htmlhttp://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Vitamins-And-Supplements/Multivitamins/products/100/062107055925http://www.greenbeanery.ca/bean/home.phphttp://www.holista.ca/images/HHCanadaEnglish/Articles/Multimedia/HolistaOreganoOil_82.pdfhttp://www.costco.ca/Organika%C2%AE-Bee-Propolis-500-mg.product.10339583.htmlhttp://www.vitasave.ca/greens-concentrate.html
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Target Markets: As natural health products become more mainstream, companies are increasinglytargeting specialty products to specific consumer groups in Canada. For women, a range of products areavailable to provide natural health benefits during pregnancy and to relieve symptoms from menstruationand menopause. Pink packaging and female figures are increasingly used to differentiate vitamin formulasthat are specially designed for women. Natural health products are also targeted at children using formulas
that promote brain development and marketing techniques including kid-friendly flavours and popularcartoon characters are commonly used.
Scientific Claims: According to the Canadian Food Industry Report 2014 (available for purchase),Canadians consumers increasingly look for scientifically proven claims when purchasing food and otherproducts that make health claims. Canadians are well-educated consumers and will actively conduct theirown research and/or consult a natural health specialis t in order to determine the best NHPs for theirpersonal use. Slower growth in herbal and traditional products has been affected by cautious attitudes ofconsumers and disappointment over the claimed benefits of such products.
Given the above factors, exporters are presented with significant opportunity to supply mass and nichemarkets in this market, including products such as:
raw ingredients and extracts from superfoods; vitamin and mineral supplements in capsules, powder, chewable and liquid forms; innovative products in flavour and convenience, such as single-serve packages; niche products for women and children; anti-aging, anti-inflammatory and anti-oxidant products; sleep and digestive aids, anti-stress, and joint pain relief for an ageing population; and athletic, diet and weight loss products;
http://www.newchapter.ca/fish-oil/wholemega-prenatalhttp://www.newchapter.ca/fish-oil/wholemega-prenatalhttp://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Vitamins-And-Supplements/Fish-Oil-And-Omegas/products/103/063935011152http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Vitamins-And-Supplements/Fish-Oil-And-Omegas/products/103/063935011152http://www.businessinformationgroup.ca/shop/item.aspx?itemid=1505http://www.businessinformationgroup.ca/shop/item.aspx?itemid=1505http://www.euromonitor.com/herbal-traditional-products-in-canada/reporthttp://www.euromonitor.com/herbal-traditional-products-in-canada/reporthttp://www.euromonitor.com/herbal-traditional-products-in-canada/reporthttp://www.euromonitor.com/herbal-traditional-products-in-canada/reporthttp://www.businessinformationgroup.ca/shop/item.aspx?itemid=1505http://www1.shoppersdrugmart.ca/en/Health-And-Pharmacy/Vitamins-And-Supplements/Fish-Oil-And-Omegas/products/103/063935011152http://www.newchapter.ca/fish-oil/wholemega-prenatal
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Corporate Social Responsibility
Corporate Social Responsibility (CSR) consists of voluntary activities undertaken by a company to operate in aneconomic, social and environmentally sustainable manner. For the natural health sector, sustainability means theharvesting of raw ingredients and disposing of packaging in way that meets the needs of the present without
compromising the ability of future generations to meet their own needs.
With growing public concerns over chemical ingredients in consumer items, natural health products are well-positionedas a safer and less-hazardous alternative to synthetic products. Natural health products that use new substances mustundergo assessment under the Canadian Environmental Protection Act to ensure they do not pose a risk to theenvironment or human health. This includes imported substances that are organic and/or living such as bacteria andsome plant varieties that are genetically modified or not native species to Canada. With increasing pressure to ensurelabel transparency, the Canadian Health Food Association predicts a continuous shift towards the voluntary self-declaring of all ingredients in natural health products. Canadians increasingly look for additional certification, including the CanadianOrganic Symbol and recognized fair trade labels, to increase their confidence of purchasing products that meet minimumCSR thresholds. Many of the fastest growing products in the natural health category, including derivatives fromsuperfoods such as ginseng, acai and maca, are sourced from developing countries. It is common for manufacturers ofNHPs to tell the story of local producers and farmers on their packaging and promotional items. Companies that can
leverage sound CSR policies to demonstrate shared values with their consumers will have the most success in thismarket.
Post-consumer waste management legislation exists at the provincial level, including Stewardship Ontario and the ToxicReduction Act (Ontario), which may require natural health producers to offset the disposal and packaging wastemanagement costs of their products. In addition to contributing to the costs of waste pick-up and recycling, ConsumerHealth Products Canada indicates that many companies in the industry are taking a proactive approach to divert naturalhealth products away from landfills and waterway systems, by funding specialized collection and disposal programs suchas the British Columbia Medications Return Program and the Alberta EnvirRx Program. In light of these environment alconcerns and to leverage the eco-friendly values of their consumers, many producers of natural health products opt touse partial or 100% natural and recycled packaging.
Jamieson Ltd., one of the largest and most recognized Canadian brands of vitamins and supplements, has established
a comprehensive CSR policy that is considered a benchmark in the natural health sector. The company’s JamiesonCares “Good for you, Good for the planet” campaign includes donating 4% of its annual revenue to reforestat ion,protection and rehabilitation of ecosystems and animal species, including a replanting project of 72,000 seedlings nearLake Erie in Canada. The company also promotes CSR through packaging made from recycled materials and an annualgrant competition for non-profit organizations involved in preserving Canada’s environmental diversity.
It is important to note that the Government of Canada has made CSR a priority in international trade, not only forCanadian companies operating domestically and abroad, but also for foreign companies selling their products in theCanadian market. To that end, Canada has provided funding to numerous CSR projects and initiatives in countriesaround the world, such as an $8,000 project through the Canadian Embassy in Dakar, Senegal to develop and promotea Mining Toolkit in West African Communities. Canada also promotes CSR at multilateral and bilateral levels.Multilaterally, Canada promotes international CSR standards through the OECD, the Group of Eight, the Asia PacificEconomic Co-operation, the Organization of American States, la Francophonie, and the Commonwealth. This allowsCanada to share knowledge and work with other countries to promote and strengthen international CSR guidelines. Atthe bilateral level, voluntary provisions for CSR are included in Foreign Investment Promotion and Protect ion Agreements (FIPAs) and Free Trade Agreements (FTAs), including those with Peru, Colombia, Panama and Honduras.
More information is available through the Corporate Social Responsibility site at Foreign Affairs, Trade and DevelopmentCanada. To succeed in this market, exporters should ensure that their company is CSR compliant.
http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=7AEF6108-1http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=7AEF6108-1http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=7AEF6108-1http://laws-lois.justice.gc.ca/eng/acts/C-15.31/http://laws-lois.justice.gc.ca/eng/acts/C-15.31/https://www.chfa.ca/news/chfas-top-five-natural-health-trends-for-summer-2014/https://www.chfa.ca/news/chfas-top-five-natural-health-trends-for-summer-2014/http://www.chpcanada.ca/en/advocacy-action/taking-environmental-responsibilityhttp://www.chpcanada.ca/en/advocacy-action/taking-environmental-responsibilityhttp://www.chpcanada.ca/en/advocacy-action/taking-environmental-responsibilityhttp://www.jamiesonvitamins.com/jamieson-careshttp://www.jamiesonvitamins.com/jamieson-careshttp://www.jamiesonvitamins.com/jamieson-careshttp://www.jamiesonvitamins.com/node/1155http://www.jamiesonvitamins.com/node/1155http://www.jamiesonvitamins.com/node/1155http://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/other-autre/csr-proj-rse.aspx?lang=enghttp://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/other-autre/csr-proj-rse.aspx?lang=enghttp://www.international.gc.ca/trade-agreements-accords-commerciaux/agr-acc/index.aspxhttp://www.international.gc.ca/trade-agreements-accords-commerciaux/agr-acc/index.aspxhttp://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/other-autre/csr-rse.aspx?lang=enghttp://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/other-autre/csr-rse.aspx?lang=enghttp://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/other-autre/csr-rse.aspx?lang=enghttp://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/other-autre/csr-rse.aspx?lang=enghttp://www.international.gc.ca/trade-agreements-accords-commerciaux/agr-acc/index.aspxhttp://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/other-autre/csr-proj-rse.aspx?lang=enghttp://www.jamiesonvitamins.com/node/1155http://www.jamiesonvitamins.com/jamieson-careshttp://www.jamiesonvitamins.com/jamieson-careshttp://www.chpcanada.ca/en/advocacy-action/taking-environmental-responsibilityhttp://www.chpcanada.ca/en/advocacy-action/taking-environmental-responsibilityhttps://www.chfa.ca/news/chfas-top-five-natural-health-trends-for-summer-2014/http://laws-lois.justice.gc.ca/eng/acts/C-15.31/http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=7AEF6108-1
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Trade Practices
Trade Shows
Please note that TFO Canada does not provide letters of invitation to assistwith obtaining travel or entry visas. These must come from the buyer directly,
or from proof of registration at a trade show.
Canadian importers and a number of retail buyers usually visit foreign markets and their suppliers once ayear. They normally organize such trips to coincide with the most important foreign trade shows where theycan explore possibilities for imports, as well as assess industry trends. It is advisable to check with youragent, buyer or Embassy’s commercial counsellor to fully assess the documentation requirements, costs
and benefits of your participation in trade shows. Major trade shows in Canada include:
Body, Soul and Spirit Expo which showcases a variety of products, services and resources for a holisticand spiritual lifestyle. Exhibits include business, spa, clinic, retreat, products, healing modality, orvirtually anything that helps people grow and live a better life. The show tours to a host of majorCanadian cities each season, including Calgary, Vancouver, Regina, Edmonton and Saskatoon.Industries include fitness, green living, natural and health products, healing arts, alternative therapies,crystals, aromatherapy, and personal growth. The next 2014 shows are in Saskatoon in September,Vancouver in October, and Edmonton and Calgary in November.
Canadian Health Food Association Expositions, Canada’s largest trade shows in natural health andorganic products, showcase the best of the industry and bring together, retailers, suppliers and industryexperts . CHFA’s three major events per year span the country from Western Canada (Vancouver), to
Eastern Canada (Toronto in September 2014), to Québec (Montreal in February 2015). Major productscategories include natural health products, food and beverage, organic foods and products, andpersonal care products.
Wellness Expo brings together companies, groups and individuals who are in the business of promotinghealth and wellness products and services and is hosted in multiple cities in Western Canadathroughout the year.
TFO Canada provides more information and dates on trade shows on its website.
Quality
Exporters should consult the Natural and Non-prescription Health Products Directorate (NNHPD) and theirguidance document on quality standards for NHPs. The license holder is ultimately responsible for ensuringthat product quality complies with Canada’s Natural Health Products Regulations and Good ManufacturingPractices. NNHPD monitors quality during the license application process based on over 250 monographsof commonly used NHPs and medicinal ingredients. Products and ingredients that correspond to higher-risk monographs will undergo a more thorough review. Post-licensing audits may also be undertaken bythe NNHPD to ensure quality control is consistent with specifications in the product license. For moreinformation on licensing and monographs, see Section 5 on Regulation.
Suppliers should note that thenatural health market is facingever increasing consumerexpectations for quality, price,
product selection and serv ice.
http://www.bodysoulspiritexpo.com/http://www.bodysoulspiritexpo.com/https://www.chfa.ca/tradeshows/https://www.chfa.ca/tradeshows/http://www.wellnessexpo.com/http://www.wellnessexpo.com/http://www.tfocanada.ca/events.phphttp://www.tfocanada.ca/events.phphttp://www.tfocanada.ca/events.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.phphttp://www.tfocanada.ca/events.phphttp://www.wellnessexpo.com/https://www.chfa.ca/tradeshows/http://www.bodysoulspiritexpo.com/
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The Buyer
Detailed information on finding and dealing with a buyer is provided in the TFO Canada Handbook onExporting to Canada 2013 as well as the Canadian Importer Database accessible to registered membersthrough our website (www.tfocanada.ca). Exporters can identify Canadian buyers who are listed on the
internet by sector or the list members of Consumer Health Products Canada or through buyers’ guides suchas the Natural Health Products Canada Guide. This guide includes a directory of companies and coversproducts in encapsulating, enzymes, functional foods, herbals, homeopathy, minerals, nutritionals, rawmaterials, sports nutrition, organics, vitamins, and more.
Exporters can target the following retail outlets and health care professionals either directly or through animport agent:
health food stores; pharmacies and grocery stores; health care practitioners nutritionists;
health clubs; personal trainers; beauty and hair salons; and spas.
Products in this sector may be distributed through mass market, specialty or professional channels,including:
the internet; mass merchandisers and discount stores; department and grocery stores; drugstores; salons;
specialty stores, e.g., health food stores; convenience stores; direct television-to-retail; and licensing, e.g., kiosks in malls and airports.
For all imported natural health products, an agent or distributor located in Canada must assume responsibility for the product and possess a site license. To get a licence, sites must maintain proper distribution records, have proper procedures for product recallsas well as for the handling, storage and delivery of their products, and demonstrate that they meet good manufacturing practice
requirements.
Price
Since the Canadian market is relatively small, Canadian importers attempt to obtain exclusive importingrights for the specific items they agree to import. There are no fixed margins in Canada but in general, thewholesale price mark-up is about 10% to the ex-factory price, while retailers add another 30%. Consumerhealth products are taxable, with approximately 13% added to the retail price. The taxes consist of a Goodand Services Tax (GST) of approximately 5%, plus a provincial sales tax or combined Harmonized SalesTax (HST) which varies by province. The exporter may also be requested to provide rebates as a result ofpoor product quality , damage before or during shipping or late delivery. An exporter may initiate special
terms which allow the exporter to shift warehousing or inventory costs over to the retailers. Large volumeorders may accompany these terms.
http://www.tfocanada.ca/http://www.tfocanada.ca/http://www.tfocanada.ca/http://www.chpcanada.ca/en/about/membershttp://www.chpcanada.ca/en/about/membershttp://www.chpcanada.ca/en/about/membershttp://www.contactcanada.com/guides/health/http://www.contactcanada.com/guides/health/http://www.contactcanada.com/guides/health/http://www.contactcanada.com/database/companies.php?portal=3&s=0&l=90http://www.contactcanada.com/database/companies.php?portal=3&s=0&l=90http://www.contactcanada.com/database/companies.php?portal=3&s=0&l=90http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php#1.3http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php#1.3http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php#1.3http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.cra-arc.gc.ca/tx/bsnss/tpcs/gst-tps/rts-eng.htmlhttp://www.cra-arc.gc.ca/tx/bsnss/tpcs/gst-tps/rts-eng.htmlhttp://www.cra-arc.gc.ca/tx/bsnss/tpcs/gst-tps/rts-eng.htmlhttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php#1.3http://www.contactcanada.com/database/companies.php?portal=3&s=0&l=90http://www.contactcanada.com/guides/health/http://www.chpcanada.ca/en/about/membershttp://www.tfocanada.ca/
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Packaging and Transportation
Natural health products must be packaged to ensure that they are not affected by temperature, light,transportation and storage. Ideally, all products should be hermetically packed since oxygen causes theproduct to deteriorate. Polyethylene packages are most often used in conjunction with paperboard cartons,
fiberboard corrugated boxes or multi-wall paper sacks. To reduce breakage, packaging waste and the costof waste disposal, importers increasingly request out-of-case packaging, i.e., trays of 12 or 24 units whichare shrink wrapped. The Corporate Social Responsibility section earlier in this report contains some usefulinformation related to packaging of natural health products.
Further information on packaging and transportation is available in TFO Canada’s Handbook on Exportingto Canada 2013. Requirements for customs documentation (invoice, certificate of origin, import declarationform, etc.) are detailed by the Canada Border Services Agency. Since the rate of duty depends on the originof the product, the certificate of origin is crucial for both exporter and importer.
Labelling
All NHPs must meet specific labelling requirements including:
product name; product licence 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; and any special storage conditions.
More information on labelling and packaging requirements for natural health products is available in
the Labelling Guidance Document.
Health Claims: Therapeutic claims must be consistent with those approved of in the Product Licence forthe NHP. Claims submitted in the product licence application that have not been authorized by HealthCanada cannot be used in advertising. Non-compliance is strictly enforced. More information on advertisingcan be found in the Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription
Drugs including Natural Health Products).
http://www.cbsa-asfc.gc.ca/import/acc-resp-eng.htmlhttp://www.cbsa-asfc.gc.ca/import/acc-resp-eng.htmlhttp://www.cbsa-asfc.gc.ca/import/acc-resp-eng.htmlhttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/labelling-etiquetage-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/labelling-etiquetage-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/labelling-etiquetage-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/guide-ldir_consom_consum-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/labelling-etiquetage-eng.phphttp://www.cbsa-asfc.gc.ca/import/acc-resp-eng.html
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4
Distribution
The supply chain for natural health products in Canada ranges from direct to indirect depending on productarea. Direct channels where Canadian manufacturers buy from producers and sell to retailers are possiblefor certain organizations and businesses who source directly from cooperatives or fair trade producers aspart of their corporate mandate. However, it is more common for producers to supply natural ingredientsindirectly through a range of intermediaries such as brokers and agents, importers, and wholesalers, whohave established relationships with retailers and brand holders in the Canadian market.
Typical Supply Chains
Source: International Trade Centre
Canada has become a world leader in R&D and manufacturing of natural health products throughgovernment-run laboratories, research institutes such as CRDC-Probiotics , and the success of privatebrand names like Jamieson Ltd, which has laboratories situated in Windsor, Ontario. In total, the Canadian
Health Food Association (CHFA) estimates there are over 10,000 retail establishments in Canada that sellNHPs, including superstores, pharmacies, health food stores, traditional Chinese retailers, and health carepractitioners.
According to a report published by Statistics Canada in 2013:
750 firms were active in the field of functional foods and natural health products (FFNHP). Ofthese, 422 establishments produced natural health products, 144 establishments produced productsin both fields and 66 establishments provided only services to either field.
Direct retailers, used as a distribution channel, generated the highest proportion of FFNHP sales(37%) followed by direct selling (14%). Natural health product establishments reported distributingdirect to other manufacturers and wholesalers as their second preferred method of distribution.
Broker and Agents: Brokers and agents such as Algart International Inc. (example drawn from the IndustryCanada Database of Wholesalers/Distributers) are often used either by the exporter or the importer. Thebroker charges a fee for his work but cannot take title to the goods. In some cases, a dealer holding abroker permit could, if declared at the time of the transaction and indicated on the Confirmation of Sale(COS), take title to the goods and work for a profit. In this case, a brokerage fee cannot be charged sincea dealer cannot take both profit and a brokerage fee. Other types of brokers could also be used in transitcountries to secure needed documentation and services.
http://www.intracen.org/The-North-American-Market-for-Natural-Products-Prospects-for-Andean-and-African-Products/http://www.intracen.org/The-North-American-Market-for-Natural-Products-Prospects-for-Andean-and-African-Products/http://publications.gc.ca/collections/collection_2012/aecic-faitc/FR5-38-19-2012-eng.pdfhttp://publications.gc.ca/collections/collection_2012/aecic-faitc/FR5-38-19-2012-eng.pdfhttp://www.crdc-probiotics.ca/http://www.crdc-probiotics.ca/http://www.crdc-probiotics.ca/http://www.jamiesonvitamins.com/node/1155http://www.jamiesonvitamins.com/node/1155http://www.jamiesonvitamins.com/node/1155https://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/http://www.statcan.gc.ca/pub/18-001-x/18-001-x2013001-eng.htmhttp://www.statcan.gc.ca/pub/18-001-x/18-001-x2013001-eng.htmhttp://www.statcan.gc.ca/pub/18-001-x/18-001-x2013001-eng.htmhttp://www.algart.ca/index.htmlhttp://www.algart.ca/index.htmlhttp://www.algart.ca/index.htmlhttp://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.algart.ca/index.htmlhttp://www.statcan.gc.ca/pub/18-001-x/18-001-x2013001-eng.htmhttps://www.chfa.ca/nhp/nhp-fast-facts/https://www.chfa.ca/nhp/nhp-fast-facts/http://www.jamiesonvitamins.com/node/1155http://www.crdc-probiotics.ca/http://publications.gc.ca/collections/collection_2012/aecic-faitc/FR5-38-19-2012-eng.pdfhttp://www.intracen.org/The-North-American-Market-for-Natural-Products-Prospects-for-Andean-and-African-Products/
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Importers: Once you have shown a potential buyer what you are capable of producing and they expressan interest in taking the relationship further, it is considered normal and prudent to request references fromthe buyer or agent. Take the time to follow up on these to avoid potential problems in any future dealingswith the importer. Importers and agents such as Altra Foods Inc. (example drawn from the CanadianImporters Database) have an extensive knowledge of the trade network and account for a large portion of
imports from TFO Canada client countries. They are generally more willing to take the risks involved indealing with new suppliers. They are, however, likely to subject suppliers to careful study before doingbusiness. They expect references and will want to know about the supplier’s export experience, financialstanding, and other such details. Exporters who do not supply references will likely not be well-received.Importers/agents are also more aware of potential problems that may arise in meeting Canadianrequirements for quality, etc., and might be willing to assist suppliers with hints on adapting the product,providing labels to assist in penetrating the Canadian market, and providing production order guaranteesto allow the factory to plan labour and materials . In addition to the regular importer, there are a fewcompanies that offer multiple services such as producing, importing, reprocessing, wholesaling,repackaging and even re-exporting. In general, these companies undertake a considerable amount of workto improve the quality of or adapt their products to meet market demands.
Wholesalers: An important key in the distribution chain are wholesalers such as Purity Life, which suppliesnatural health products to over 7,000 stores across Canada and won the Canadian Health Food Association’s Supplier of Excellence Award in 2013 (example drawn from the Industry Canada Databaseof Wholesalers/Distributors). Wholesalers will distribute to and sometimes organize promotional activitieswith many networks including chain stores, specialty stores, and natural health professionals.
Chain Stores (Supermarkets and Pharmacies): Many Canadians buy natural health products in largesupermarkets such as Costco and Walmart. In a move to compete with the growing number of specialtyhealth food stores in the country, two of Canada’s grocery giants s trategically incorporated pharmacies in
2013, with the acquisition of Shoppers Drug Mart by Loblaw’s and Safeway by Sobeys. These stores carrya wide range of products including vitamins, supplements, plant-based products, and everyday consumeritems with natural health additives. While some chain stores buy directly from exporters, many are reluctantto do so as supplies are often unreliable with respect to quality and delivery, which can be sporadic. Forthese reasons, most deal with local importers.
Specialty Stores and Independents: Specialty health food stores such as Kardish in Ottawa, Ontario andNature’s Fare in Vancouver, British Columbia generally deal with a more limited range of high-quality naturalhealth products and account for a growing volume of sales in Canada. Another example is the U.S.-basedWhole Foods, which recently announced plans to open 40 more stores in Canada. Specialty storesgenerally make purchases through importers or wholesalers. Industry sources have indicated thatpurchases of natural health products in pharmacies are much more significant in the Eastern regions ofCanada while health food stores dominate in the Western parts of the country. This means consumers inBritish Columbia and Alberta shop for their NHPs at health food stores, while drug stores are clearly thefavourite sources of supplies for Canadians living in Ontario, Québec and the Atlant ic provinces .
Product sourcing is done through a combination of various resources (ranked from highest to lowestsource):
Distributor sales force; Internet/Websites; Trade shows; Trade magazines; Directly from the source.
Apart from registering with TFO Canada’s database for marketing purposes, exporters should find that t heCanadian Importers Database might be useful for identifying Canadian retailers of natural health products;many of these companies import for resale.
More information on distribution channels is available in the Handbook on Exporting to Canada 2013.
http://www.altrafoods.com/http://www.altrafoods.com/http://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145https://www.costcopharmacy.ca/HealthInformationNHP.aspx?type=Natural&search_alpha=Mhttps://www.costcopharmacy.ca/HealthInformationNHP.aspx?type=Natural&search_alpha=Mhttps://www.costcopharmacy.ca/HealthInformationNHP.aspx?type=Natural&search_alpha=Mhttp://www.walmart.ca/en/health-beauty/pharmacy/supplements/N-1055http://www.walmart.ca/en/health-beauty/pharmacy/supplements/N-1055http://kardish.com/http://kardish.com/http://kardish.com/http://www.naturesfare.com/http://www.naturesfare.com/http://business.financialpost.com/2013/05/22/whole-foods-says-grocer-wants-to-open-40-more-canadian-stores/http://business.financialpost.com/2013/05/22/whole-foods-says-grocer-wants-to-open-40-more-canadian-stores/http://www.ic.gc.ca/cidhttp://www.ic.gc.ca/cidhttp://www.ic.gc.ca/cidhttp://business.financialpost.com/2013/05/22/whole-foods-says-grocer-wants-to-open-40-more-canadian-stores/http://www.naturesfare.com/http://kardish.com/http://www.walmart.ca/en/health-beauty/pharmacy/supplements/N-1055https://www.costcopharmacy.ca/HealthInformationNHP.aspx?type=Natural&search_alpha=Mhttp://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/app/ccc/sld/cmpny.do?lang=eng&profileId=1921&naics=4145http://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.ic.gc.ca/cgi-bin/sc_mrkti/cid/cid_e.cgi?func=check_buttons&prodsearch_method=keyword&keyword=vitamins&hs_code=293690&button_create_report_from_product=datahttp://www.altrafoods.com/
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5
Import Regulations
Regulations
Important Note on Upcoming Changes to Regulations for Natural Health Products in Canada
At the time of writing this report, the Natural and Non-prescription Health Products Directorate (NNHPD) is undertaking a public consultation toseek stakeholder feedback on proposed changes to the Site Licensing guidance document, Quality Assurance Report Form, and Good
Manufacturing Practices guidance document. Consultation is open for comment until September 12, 2014, after w hich the NNHPD will issuenew versions of these documents. Ex porters should consult the NNHPD website for up-to-date information on regulations.
Canada has one of the most developed regulatory systems for natural health products in the world. Theindustry is regulated by the Natural and Non-prescript ion Health Products Directorate (NNHPD) of HealthCanada under the authority of the 2004 Natural Health Products Regulations to ensure all NHPs are safe,effective and of high quality . To be legally sold in Canada, all NHPs must have pre-market authorizationthrough a product licence and must only contain medicinal substances approved by Health Canada. HealthCanada maintains a Natural Health Product Ingredient Database and provides periodic summaries ofchanges to approved ingredients, such as newly added or removed ingredients or revised names.
Product Licensing: All natural health products, whether manufactured domestically or in a foreign site,must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidenc edemonstrating this must be submitted to Health Canada by means of a product licence application (one foreach product). Products which meet the required criteria will be authorized for sale and each issued aNatural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Exporters should be aware
that Health Canada will no longer issue new exemption numbers (ENs) and as of September 1, 2014, allnatural health products sold in Canada will be expected to have a NPN or DIN-HM. Since 2004, HealthCanada has authorized over 70,000 NHPs for sale in the Canadian market.
The NNHPD maintains an active database of licensed natural health products listed by their NPNs or DIN-HMs. For every licensed product listed in the database, the following details are provided:
product name and llicence holder; Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM); product’s medicinal ingredients; product's non-medicinal ingredients; product's dosage form; product's recommended use or purpose (i.e. , its health claim or indication);
risk information associated with the product's use (i.e. , cautions, warnings, contra-indications andknown adverse reactions).
Application review times for new product licenses are determined by a three-class system that is based onhow much is already known about the NHP’s benefits and risks. Products with the greatest level of certaintyare subject to the shortest review time. Exporters should refer to the NNHPD’s Compendium ofMonographs, which provides pre-cleared information on over 250 products and medicinal ingredientscommonly used in NHPs, as this will significant speed up the evaluation process.
http://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-licence-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-licence-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-licence-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-qar-raq-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-qar-raq-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-qar-raq-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.phphttp://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.phphttp://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.phphttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do?lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do?lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=whats.quoi&lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=whats.quoi&lang=enghttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/prodnatur/lett-complian-conform-pol-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/prodnatur/lett-complian-conform-pol-eng.phphttp://www.mondaq.com/canada/x/226922/Life+Sciences+Biotechnology/No+More+Exemptions+For+Unlicensed+Natural+Health+Productshttp://www.mondaq.com/canada/x/226922/Life+Sciences+Biotechnology/No+More+Exemptions+For+Unlicensed+Natural+Health+Productshttp://www.mondaq.com/canada/x/226922/Life+Sciences+Biotechnology/No+More+Exemptions+For+Unlicensed+Natural+Health+Productshttp://hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.phphttp://webprod5.hc-sc.gc.ca/lnhpd-bdpsnh/index-eng.jsphttp://webprod5.hc-sc.gc.ca/lnhpd-bdpsnh/index-eng.jsphttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.do?lang=enghttp://webprod5.hc-sc.gc.ca/lnhpd-bdpsnh/index-eng.jsphttp://hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.phphttp://www.mondaq.com/canada/x/226922/Life+Sciences+Biotechnology/No+More+Exemptions+For+Unlicensed+Natural+Health+Productshttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/prodnatur/lett-complian-conform-pol-eng.phphttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=whats.quoi&lang=enghttp://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do?lang=enghttp://hc-sc.gc.ca/dhp-mps/prodnatur/legislation/acts-lois/prodnatur/index-eng.phphttp://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-qar-raq-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/consultation/natur/consult-licence-eng.php
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NNHPD’s Three-Class Review System for Product Licence Application
Class I: High level of certainty - lowest level of pre-market review (10 day processing)
products can be indexed agains t an individual monograph
well-es tablished safety and efficacy profile
applications submitted using the electronic Product Licence Application form (ePLA)
Class II: Medium level of certainty - medium level of pre-market review (30 day review)
medium certainty of safety and efficacy profile
applicants requi red to submit attestation to confirm their product meets individual monograph parameters
Class III: Low level of certainty - higher level of pre-market review (180 day review)
high uncertainty of safety and efficacy profile
e.g., products with previously unlicensed claims, never before seen ingredients or combinations, productswith s ignificant safety concerns
applicants requi red to attest in standalone form that product meets parameters of relevant monographsand/or subm it supporting evidence for novel portions
Source: Health Canada (2014)
Site Licence: The Canadian importer is responsible for submitting a Quality Assurance Report for eachsite (foreign and domestic) with their site licence application. They must ensure that these reports arecomplete and that all requirements are met. Since site licences are only issued to Canadian sites (none areissued to foreign sites), foreign manufacturers are covered under the Canadian importer’s site licence.Further information on the importation of natural health products is outlined in the Site Licence GuidanceDocument. All manufacturers, packagers, labellers and importers of natural health products are responsiblefor ensuring that their quality assurance persons and third party auditors are qualified under the NaturalHealth Products Regulations. Only manufacturers, packagers, labellers and importers that meet thesestandards will be allowed to continue to operate in Canada.
Importing: To be legally sold in Canada, all natural health products must have a product licence, and theCanadian sites that manufacture, package, label and import these products must have site licences. To get
product and site licences, specific labelling and packaging requirements must be met, good manufacturingpractices must be followed, and proper safety and efficacy evidence must be provided. Suppliers shouldensure that importers have all valid licences issued by the Natural and Non-prescription Health ProductsDirectorate prior to shipping products. Importers must maintain records of all recalls and complaints, as wellas documentation and evidence. Such documentation must precede or accompany the first shipment fromeach supplier for each product; copies must be maintained in Canada by the importer for subsequentexamination by the inspectors. These records must demonstrate the adequacy, types and correctapplication of processes to ensure product safety.
Good Manufacturing Practices for NHPs make sure proper standards and practices for the testing,manufacture, storage, handling and distribution of natural health products are met. These practices aremeant to ensure safe and high quality products while giving manufacturers, packagers, labellers, importersand distributors the flexibility to implement quality systems appropriate for their product lines andbusinesses. Issues covered include:
product specifications premises equipment personnel sanitation program operations
quality assurance stability records sterile products lot or batch samples recall reporting
http://hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/cons-eng.php#wanhphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/cons-eng.php#wanhphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a21http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a21http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a21http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#slhttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#slhttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a22http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a22http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/gmp-bpf-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a22http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#gmphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#slhttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#a21http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/cons-eng.php#wanhphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.phphttp://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.phphttp://hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.php
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Product licence holders must monitor all adverse reactions related to their product and report seriousadverse reactions to Health Canada. Reporting side effects is important because it helps Health Canadaidentify rare or serious adverse reactions, make changes in product safety information, issue publicwarnings and advisories, and/or remove unsafe products from the Canadian market.
Clinical Trials: A clinical trial is when natural health products are tested using human subjects. Clinicaltrials are intended to:
discover or verify the product's effects ; identify any adverse events that are related to its use; study its absorption, distribution, metabolism and excretion; and test its safety or efficacy.
The Natural Health Products Regulations set out requirements for conducting a clinical trial. Meanwhile,the Natural and Non-prescription Health Products Directorate outlines the range of evidence that can besubmitted in support of the safety and efficacy of a natural health product and the quality of a natural healthproduct, or of a homeopathic medicine. More information on the clinical trial process for natural healthproducts is available in the Clinical Trials for Natural Health Products Guidance Document .
Certification of Natural Products: The NNHPD has a listing for Enzymes, Probiotics, and Oils in the new Abbreviated Labelling Standard (AbLS). Until standardized regulations are in place, Ecocert certification iswidely recognized by Canadian distributors. It is important to note that some essential oils are not permittedin Canada as they are considered unsafe, carcinogenic, or to have the potential to provoke adverse sideeffects. Examples are calamus and sassafras. As well, some essential oils are recommended to be usedonly by a clinically trained aromatherapist (for example: birch oil, sage oil, thuja oil, and wintergreen oil).Others have potentially dangerous effects that make them too risky to experiment with (examples are: bitteralmond, yellow camphor, horseradish, mugwort, mustard, rue, southernwood, tansy, and wormwood).
Relevant Canadian Laws and Regulations
Depending on the product, one or more of the following regulations mustbe adhered to for successful introduction on the Canadian market:
Natural Health Products Regulations; Consumer Packaging and Labelling Act (and Regulations); Competition Act; Trademarks Act; Customs Tariffs Act.
Tariffs
The tariff classification of medicaments including natural health products (Memorandum D10-14-30) isavailable through the Canada Border Services Agency. Tariffs on imports depend on the product and on thesupplying country and its applicable tariff treatment.
Depending on the country of origin, most of the natural health products covered in this report can enter theCanadian market duty free, including ginseng roots, plant-based products and vitamins. However, tariffs doapply to certain fats and oils, up to a high of 6.5% for those derived from marine animals.
Further details are provided in the Handbook on Exporting to Canada 2013.
Clinical TrialsTo import a natural health product
into Canada for the purpose of salein a clinical trial, information aboutthe representative in Canadaresponsible for the sale of the
product must be submitted.
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