June 1, 2003
Canadian regulatory reform of functional foods and nutraceuticals is progressing slowly with mixed benefits and regressions for harmonisation with US regulations. Kelley Fitzpatrick, MSc, reviews the situation
Whilst the Canadian health food and supplements industry has been experiencing growth over the last few years, the Canadian food manufacturing industry is lagging behind the US in terms of development and marketing of functional foods. In part this has been attributed to a very restrictive regulatory environment for these products in Canada.1
As discussed in Part 1 of this report, the Food and Drugs Act and Regulations controls the advertising and sale of foods and drugs in Canada. This act does not deal specifically with functional foods and, as a result, these products are considered either foods or drugs, depending on the type and concentration of the active ingredient and whether health claims are made.
When regulated as a food, there are no provisions in the legislation to make claims of a health or therapeutic nature regarding the use, or possible side effects of the product. Any supplement or functional food that carries a health claim, or levels of ingredients not permitted for conventional foods, is currently treated as a drug. This requires a Drug Identification Number (DIN), which is issued by the Therapeutic Products Directorate (TPD) of the Health Protection Branch (HPB) after it reviews the DIN application. This is, in fact, the route that Tropicana chose, with the product carrying a DIN, and providing dosage information on packaging as a 'calcium and vitamin supplement,' otherwise known simply as orange juice in the US.2
In the summer of 1996, the Food Directorate of HPB began deliberations that resulted in a Policy Options paper in which the proposed definition for a nutraceutical was a product that has been isolated or purified from foods and generally sold in medicinal forms not usually associated with food.3
In the same proposal, a functional food was defined as similar in appearance to a conventional food, consumed as part of the usual diet, and having demonstrated physiological benefits and/or an effect of reducing the risk of chronic disease beyond basic nutritional functions. In late 2001, Health Canada announced that a new regulatory definition for functional foods would not be required to permit health claims for foods under the current Canadian Food and Drugs Act. However, 'functional food' is used extensively in Canada to describe foods with health
benefits beyond basic nutrition.
The Food Directorate also recommended allowing foods in Canada to carry structure/function claims and risk-reduction claims, and to continue to regulate therapeutic claims as drugs.3 In 1999, Health Canada took three initiatives.
1. Adoption of certain of the initial 10 diet-based disease risk-reduction claims approved in the US under the NLEA
At the time of the Final Policy paper, 10 generic health claims had been approved in the US under the Nutrition Labeling and Education Act (NLEA). Such claims apply to a food or a group of foods that has compositional characteristic(s) that contribute to a dietary pattern associated with reducing the risk of a disease or health condition. Once the claim is authorised, any food that meets the specified conditions for composition and labelling may carry the claim without further assessment. In 2000, it was announced that five of the NLEA claims were considered valid in a Canadian context; these were:
sodium and hypertension
calcium and osteoporosis
saturated and trans fat and cholesterol and coronary heart disease
fruits and vegetables and cancer
sugar alcohols and dental caries
Each of these health claims required an individual amendment to the Foods and Drug Act. Details of the specific wording of the claims and criteria for the nutrient content of the food and other factors were published in January 2003 in Canada Gazette Part II, "Regulations Amending the Food and Drug Regulations (Nutrition Labeling, Nutrition Claims and Health Claims)" as part of mandatory nutrition labelling regulations.4 Within two years, food labels in Canada will be required to provide more nutrition information.
Health Canada has estimated that these new labelling regulations with five approved claims will result in an estimated $5 billion in health care cost reductions during the next 20 years, specifically in direct and indirect costs associated with three diagnostic categories: cancer, diabetes, and cardiovascular disease and stroke.
For the other five generic US claims considered, Health Canada concluded that issues remained with the following that did not allow for immediate approval:
folate and neural tube defects
fibre-containing grain products, fruits and vegetables and cancer
fruits, vegetables and grain products that contain fibre, particularly soluble fibre, and risk of coronary heart disease
soluble fibre, risk of coronary heart disease
2. Develop standards of evidence and a guidance document on data requirements for supporting the validation of new health claims for foods.
For other health claims, the Health Products and Foods Branch, using an internal working group, and in consultation with an Expert Advisory Panel, has been developing a framework for the standards of scientific evidence required for health claims and a guidance document for industry. In June 2000, Health Canada published a Consultation Document titled, "Standards of Evidence for Evaluating Foods with Health Claims: A Proposed Framework."5
The principles governing the proposed standards have three important elements. The first is product safety, which Health Canada interprets to be reasonable assurance of no adverse health effects. Second is claim validity as determined by demonstration of product efficacy and effectiveness based upon establishing an etiologic link between the desired effect and consumption of the food or bioactive substance, at the recommended level of intake in the target population that will most likely benefit. Thirdly, is quality assurance, meaning that foods bearing health claims should be able to identify, measure and maintain a consistent level of the bioactive substance to ensure efficacy without jeopardising safety.
3. Development of an appropriate regulatory framework to allow product-specific health claims for foods
In October 2001, Health Canada released a proposed approach to regulating product-specific health claims for foods.6 Industry members have expressed the need for a regime that would permit claims based on product-specific evidence without requiring time-consuming claim-specific regulatory amendments. This approach is considered important in facilitating research and development and recognises that food matrices and processing conditions could have an effect on the physiological property of foods. Therefore, an application containing product-specific evidence would be required for a similar claim on another product, unless generally accepted or specific nutritional or food science theory or knowledge would indicate otherwise. A Claim Identification Number (CIN) that would be displayed on product labelling would signify an authorised claim.
Health Canada does not appear to have the labour force or financial resources to review the scientific evidence needed to substantiate the efficacy of other constituents that carry health claims in other countries, such as soy protein and phytosterols for coronary heart disease risk reduction. In regard to the latter, Health Canada advised consumers in mid-October 2001, that Becel pro.activ, which was introduced into the Canadian market earlier in the year by Unilever Canada Ltd, was not in compliance with the Canadian Food and Drugs Act and Regulations. Becel pro.activ is a fat spread manufactured with added plant sterols (phytosterols) for the purpose of reducing blood cholesterol levels. Health Canada also stated that there is evidence to suggest the product is not appropriate for consumption by all Canadians.
Prior to introducing the product, Unilever did not receive the required approval from Health Canada. Many in the industry have suggested that the Unilever case is an example of the inability of Health Canada to recognise the benefits of functional foods and to move toward greater harmonisation with the US. In addition, the government appears to be overlooking the potential labour and cost savings it could realise from a greater acceptance of US data and experience with health claims. Of significance in this debate is the loss of the value-added component that nutraceuticals and functional foods development presents to the struggling agricultural and fishery industries in Canada.
Kelley Fitzpatrick, MSc, is the marketing and research development manager for Richardson Centre for Functional Foods and Nutraceuticals at the University of Manitoba, Manitoba, Canada. [email protected] www.umanitoba.ca/afs/ffnc
1. Hulton, W. Canada stands at regulatory crossroads for nutraceutical products. Nutraceuticals World 1999;2(1):44-6.
2. Singer, Z. Fortified juice must be sold as a drug in Canada. Ottawa Citizen, 1999 Aug 24.
3. Health Canada. Final policy paper on nutraceuticals/functional foods and health claims on foods. 1998. (www.hc-sc.ca/hpb-dgps/therapeut/htmleng/ffn.html).
4. Health Canada. Regulations amending the food and drug regulations (nutrition labeling, nutrition claims and health claims). Canada Gazette Part II 2003 Jan 3. (www.gc.ca/gazette/hompar2-2_e.html).
5. Health Canada. Consultation document: standards of evidence for evaluating foods with health claims: a proposed framework. 2000 Jun. (www.hc-sc.ca/food-aliment/english/subjects/health_claims/standards_of_evidence).
6. Health Canada. Product-specific authorization of health claims for foods: a proposed regulatory framework. 2001b. Oct. (www.hc-sc.ca/food-aliment/english/subjects/health_claims/).
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