Health Claims on Foods in Canada 1 3

The Journal of Nutrition Evidence for Health Claims on Food: How Much Is Enough? Health Claims on Foods in Canada 1 3 Mary R. L Abbé, 4 * Lydia Dumais, 4 Eunice Chao, 4 and Beth Junkins 5 4 Bureau of Nutritional Sciences and 5 Bureau of Food Policy Integration, Food Directorate, Health Products and Food Branch, Health Canada, Ottawa, Canada Abstract Interest in the health effects of foods by both industry and consumers has put a spotlight on the role of health claims on foods in Canada. The current regulatory framework governing the use of different health claims on foods in Canada is described and compared with international approaches. Similarities were observed in how risk-reduction claims for serious diseases are managed in the United States, European Union and proposed by Food Standards Australia New Zealand, including the need for premarket authorization and the requirement for a high level of certainty based on the totality of evidence in substantiating this type of claim. However, approaches to permitting function claims other than those for the well-established functions of known nutrients are divergent among the jurisdictions compared. Canada also differs from other jurisdictions in not establishing core nutritional criteria for foods carrying disease risk-reduction claims. A brief overview of the status in Canada of a number of disease risk-reduction claims that have been approved in the United States, based on significant scientific agreement under the Nutrition Labeling and Education Act or through authoritative statements under the Food and Drug Administration Modernization Act, is also provided. J. Nutr. 138: 1221S 1227S, 2008. Introduction Interest in the use of health claims on foods by manufacturers has grown in recent years. This interest is driven by a burgeoning market for health-enhancing or functional foods, which, itself, has been fueled by increased media coverage and consumer awareness of a growing body of scientific evidence linking diet to health and disease. Consumers are also increasingly determined to take greater personal responsibility and widen their choice of approaches to optimize their own health. The use of a broader 1 Published in a supplement to The Journal of Nutrition. Presented as part of the Canadian Nutrition Congress held in Winnipeg, Canada, June 18 21, 2007. This conference was supported by Nestlé Nutrition; Canadian Egg Marketing Agency; Danone Institute; Dow AgroSciences Canada; Flax Canada 2015; Martek Biosciences Corporation; The Centrum Foundation; Canadian Grain Commission; Dairy Farmers of Canada; Faculty of Agricultural and Food Sciences, and Faculty of Human Ecology, University of Manitoba; Manitoba Science, Technology, Energy and Mines; Mead Johnson Nutritionals; The Manitoba Co-operator; Alltech Canada; Agri-Food Research and Development Initiative (ARDI); Beef Information Centre; Canola Council of Canada; Cognis; Elanco Animal Health; Grainews; Lipid Nutrition; Manitoba Agriculture, Food and Rural Initiatives; Maple Leaf Animal Nutrition; Monsanto Canada; Pfizer Animal Health; Prairie Hog Country; Pulse Canada; Bruker Optics; Bunge Canada; Canbra Foods; Faculty of Graduate Studies, University of Manitoba; Novus International; and POS Pilot Plant Corp. This publication was supported by Danone Institute International and Agriculture and Agri-Food Canada. Supplement Coordinators for this publication were Peter Jones, University of Manitoba, Winnipeg, Canada and Primal Silva, Agriculture and Agri-Food Canada, Ottawa, Canada. Supplement Coordinator disclosure: P. Jones received travel support and has a consulting agreement from Danone Institute International; P. Silva is employed by the supplement sponsor, Agriculture and Agri-Food Canada. 2 Supported by Health Canada. 3 Author disclosures: M. R. L Abbé, L. Dumais, E. Chao, and B. Junkins, no conflicts of interest. * To whom correspondence should be addressed. E-mail: mary_labbe@ hc-sc.gc.ca. range of health claims in recent years also presents new challenges in the management of these claims. Responding to these market demands and similar developments in other jurisdictions, Health Canada initiated a review of how health claims on foods are managed in Canada. This article describes the Canadian and international regulatory context within which this review was conducted. What are health claims for foods? Definitions. In Canada, the term health claim is not formally defined in food regulations. However, in general, a health claim for food is considered to be any representation in labeling and advertising that states, suggests, or implies that a relation exists between the consumption of foods or food constituents and health (1). Food, as defined in the Food and Drugs Act (the Act) 6 (2), includes any article manufactured, sold, or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever ; and according to the Act, drug includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, (c) disinfection in premises in which food is manufactured, prepared or kept. As discussed later, under the current 6 Abbreviations used: the Act, Food and Drugs Act; CFIA, Canadian Food Inspection Agency; CHD, coronary heart disease; EU, European Union; FDAMA, Food and Drug Administration Modernization Act; FDR, Food and Drug Regulations; FOP, front of package; FSANZ, Food Standards Australia New Zealand; NLEA, Nutrition Labeling and Education Act; SSA, significant scientific agreement. 0022-3166/08 $8.00 ª 2008 American Society for Nutrition. 1221S

regulatory framework, many proposed health claims for foods are of the category that would bring a product within the definition of a drug. Types of health claims. Health claims encompass a range of relations and modes of representation. They can be specific or general in nature (Table 1) and may be stated explicitly with words or implied through slogans, graphics, logos, symbols, or other means such as a name, trademark, seal of approval, or through an association, e.g., a hyperlink to a website. Current regulatory framework in Canada All foods and drugs, including natural health products, sold in Canada, and the claims related to health that appear on packaging or in advertising of these products are regulated under the provisions of the Act (2), the Food and Drug Regulations (FDR) (3), and the Natural Health Products Regulations (4). The Act and these associated regulations have been developed by the Department of Justice Canada with respect to legal content and administered by Health Canada and the Canadian Food Inspection Agency (CFIA). With respect to foods, Health Canada is responsible for the development of policies, regulations, and standards that relate to health and safety, and CFIA is responsible for their compliance and enforcement. The legal status of foods and the way they are regulated can be affected by the use of health claims. As noted above, under the definitions section, and in Table 1, many health representations for foods are of the type that would bring a product within the definition of a drug, as drugs are defined according to their effect and how they are represented for use. Therefore, to permit certain types of health claims on foods, provisions were included in the FDR in December 2002 (5) to exempt food products with these claims, e.g., disease risk-reduction claims, from the regulations governing drugs, as well as Section 3 of the Act, which prohibits the sale and advertisement of any food, drug, cosmetic, or device to the general public as a treatment, preventative, or cure for any of the diseases, disorders, or abnormal physical states referred to in Schedule A. These regulatory changes ensure that food regulations and standards would continue to be applied to food products with health claims. The conditions of use for each approved disease riskreduction claim are listed in a Table following Section B.01. 603 of the FDR. These conditions include prescribed wording for the claim, nutritional and other criteria that must be met for a food product to be eligible to carry the claim, and conditions for the label or advertisement. Health Canada can add new claims and the conditions for their use to the Table through regulatory amendments following a review of the submission. TABLE 1 Types of health claims 1 There are also a number of health claims listed in Table 1 that would not bring a food within the definition of a drug. These include certain types of function claims and general claims about healthy choice. Function claims about the maintenance of body functions that are necessary to the maintenance of good health and normal growth and development are expressly permitted in sections B.01.311(3), D.01.006, and D.02.004 of the FDR (3). These sections of the regulations provide only for statements or claims to the effect that the food s energy value or a nutrient in the food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development. For known nutrients and their well-established functions, examples of acceptable claims are provided in the 2003 Guide to Food Labelling and Advertising maintained by CFIA (6) (Table 2). The generally recognized standard is not officially defined but is based on a well-established prior history of a high level of scientific evidence and broad scientific agreement that the claim is unlikely to be reversed with new data. These claims are referred to as biological role claims in the CFIA guide. For function claims for some key nutrients, the regulations also stipulate that the food must meet specified conditions. For vitamins and minerals, the food must contain at least 5% of the recommended daily intake (defined in Part D of the FDR) in a stated serving; for protein and amino acids, foods must at least represent a source of protein. No other nutritional criteria must be met for foods to carry such biological role or function claims. The word nutrient is not defined in the Act or FDR, but in practice, Health Canada and CFIA generally consider a food substance as a nutrient if the Institute of Medicine of the National Academies, Washington, DC, has recognized it as such and dietary reference values have been established (6). Historically, few other function claims for foods or food constituents have been recognized in Canada. Function claims would be considered drug claims when they fall within the parameters of modifying, correcting, or restoring organic function, e.g., reducing blood cholesterol. As for disease riskreduction claims, regulatory amendments would be required to add them to the list of permitted claims following Section B.01.603 of the FDR. However, function claims that are not deemed to be drug claims are not prohibited if they are truthful and not misleading as set out in Section 5(1) of the Act. A few function claims that are not in Table 2 about maintaining or supporting body functions associated with the maintenance of good health or performance have been reviewed and deemed not misleading. These claims deal with effects for which the nature of the effect and the mode of action are consistent with physi- Specific health claims are claims about the effects of a food, or food constituent, on a specific organ, disease, biomarker, or health condition. There are 2 types of specific health claims: Disease risk-reduction claims: link the consumption of foods or food constituents to a reduced risk of disease in the context of the total diet (considered drug claims under the FDR). Function claims: claims about the maintenance of body functions that are necessary to the maintenance of good health and normal growth and development (e.g., nutrients with well-established functions); claims about maintaining or supporting body functions associated with the maintenance of good health or performance (e.g., for a broader range of substances in foods and to a broader range of physiological functions); and claims about restoring, correcting, or modifying body functions (functions that are considered drug claims under the FDR). General health claims are claims that do not refer to a specific health effect, disease or health condition (e.g., broad ``healthy for you'' or ``healthy choice'' claims that promote choosing a food for overall health, promote healthy eating, or provide dietary guidance). 1 Adapted from Health Canada (1). 1222S Supplement

TABLE 2 Summary of biological role claims for specific nutrients 1,2 Protein Helps build and repair body tissues Helps build antibodies Fat Supplies energy Aids in the absorption of fat-soluble vitamins Docosahexaenoic acid An (n-3) fatty acid, supports the normal development of the brain, eyes, and nerves Carbohydrate Supplies energy Assists in the utilization of fats Vitamin A Aids normal bone and tooth development Aids in the development and maintenance of night vision Aids in maintaining the health of the skin and membranes Vitamin D Factor in the formation and maintenance of bones and teeth Enhances calcium and phosphorus absorption and utilization Vitamin E Protects the fat in body tissues from oxidation Vitamin C Factor in the development and maintenance of bones, cartilage, teeth, and gums Thiamine (vitamin B-1) Releases energy from carbohydrate Aids normal growth Riboflavin (vitamin B-2) Niacin Aids in normal growth and development B-6 Folate Aids in red blood cell formation B-12 Aids in red blood cell formation Pantothenic acid Calcium Aids in the formation and maintenance of bones and teeth Phosphorus Factor in the formation and maintenance of bones and teeth Magnesium Factor in energy metabolism, tissue formation, and bone development Iron Factor in red blood cell formation Zinc Iodine Factor in the normal function of the thyroid gland 1 Reproduced from CFIA (6), Table 8 2. 2 The examples of biological role claims listed in the table have been considered to be acceptable by Health Canada and the CFIA. Other biological role claims for nutrients may also be acceptable and are evaluated on a case-by-case basis. ological effects of, or responses to, foods and diets. Two claims in this category include a claim for a particular sports drink (absorbed up to 30% faster than water) and a claim for coarse wheat bran as an ingredient added to foods providing 7 g of dietary fiber in a reasonable daily intake, promoted for regularity or laxation. To date, very few claims in this category have been proposed by industry and reviewed by Health Canada. There are no specific regulations governing the use of general healthy choice claims on foods. However, like all claims, whether there are specific regulations or not, they are subject to Subsection 5(1) of the Act; i.e., they must not be false, misleading, or deceptive. In addition, there are no standardized nutritional criteria set for foods to be able to carry these types of claims. However, the CFIA and Health Canada have jointly developed guidelines to support the appropriate use of these claims and to limit misleading claims for advertising and educational material, third-party endorsements, logos and seals of approval, and statements related to healthy eating or dietary guidance (6). New guidance has also been published by Health Canada on the principles for using the Eating Well with Canada s Food Guide in advertising and labeling (7). Front-of-package (FOP) claims featuring graphics or icons such as hearts, bones, or check marks and slogans such as healthy choice, nutritionist recommended, or good for you have been used alone or in combination with more formally accepted formats such as disease risk-reduction claims, biological role claims, or nutrient content claims. FOP symbols, graphics, and slogans may also suggest general nutritional or health values without referring to specific health effects. Many of these FOP symbols or graphics can be considered implied health claims, as they may suggest a health benefit without explicitly stating it. Symbols or graphics depicting a heart or bones are examples of implied health claims. In Canada, implied claims are not currently addressed directly in the FDR. An implied claim is open to interpretation by the reader and depends on the context. Therefore, in cases where the regulator has concerns, it can be difficult to establish that an implied claim is misleading. In some jurisdictions, e.g., the European Union (EU), and proposed in Australia/New Zealand, implied claims are prohibited unless accompanied by an approved or authorized claim. International comparison Mechanism for review and approval of health claims. In general, the approaches currently used in Canada to manage disease risk reduction and certain function claims are comparable to the norms applied in the United States (8), the EU (9), and proposed by Food Standards Australia New Zealand (FSANZ) (10) (Table 3), although the legislative frameworks, regulatory environments, and enforcement are different in the different jurisdictions. In Canada, and in all the countries above, preapproval and regulatory authorization are required for the use of disease risk-reduction claims on foods, although Australia/New Zealand is unique in distinguishing between high-level claims for serious (as defined in regulations) and general-level claims for nonserious diseases. Some jurisdictions, for example, the United States, also consider/use scientific reviews from authoritative bodies such as agencies of the U.S. government or the National Academies of Science as the basis for some disease risk-reduction claims. For known nutrients and their well-established functions, Canada uses a published list of acceptable claims (Table 2), but claim-specific regulatory approval is generally not required. Positive listing is a common approach in many jurisdictions, and claim-specific regulatory approval is generally not required, although in the United States there is no specific regulation or other form of positive listing governing the use of function claims for food (Table 3). The authorization of new function claims, i.e., claims other than those for the well-established func- Health claims on foods in Canada 1223S

TABLE 3 Comparison of mechanism for review and approval of health claims in Canada and in selected other countries 1 Claim type Canada United States EU FSANZ (proposed) Disease riskreduction claims Claims for established functions of known nutrients Other function claims General health claims about ``healthy choice'' Approved claims for diseases require claim-specific authorization or amendments to regulations or standards (Canada, U.S. EU); FSANZ proposed that preapproval of general level claims would not be required; FDA can also accept claims based on authoritative statement from government bodies or the National Academy of Sciences. Food bearing the claim must meet specified requirements. Claims are There is no Positive lists Claims that meet permitted by general regulatory provisions without the need for authorization or claim-specific amendments to regulations. Examples of acceptable claims are provided in guidelines. For a health claim that would bring a food within the definition of a drug, a claimspecific regulatory amendment of FDR is required. For a health claim that would not bring a food within the definition of a drug, regulatory amendment of FDR is not required. Guidelines are provided for the 1 Adapted from Health Canada (1). use of claims about ``healthy choice'' that would not be considered misleading. specific regulation or other form of positive listing governing the use of function claims for food. However, they must be truthful and not misleading and be derived from the nutritional value of the product. tions of known nutrients, is the most divergent aspect among jurisdictions (Table 3). Depending on the nature of the claim, the management of these function claims ranges from no explicit regulatory oversight to submission of evidence only on request to voluntary submission of evidence for review for inclusion in a positive list to submission of evidence for authorization of a claim. Standards of evidence for health claims. Substantiation of disease risk-reduction claims in Canada is based on the 2 key principles of 1) the totality of evidence and 2) the requirement for a high or convincing level of evidence. These principles and will be used without the need for community authorization through regulatory amendments (except for claims related to children's development and health). Claims will be included in a Community list of permitted health claims based on generally accepted scientific evidence following consultation with the European Food Safety Authority. the criteria for general level claims and are not on a list of preapproved nutrient function statements do not require premarket review, provided supporting data are available on request. As above As above. For claims that are considered Application for general-level claims (including Claims using descriptors such as ``healthy'' or about a food being useful in maintaining healthy eating practices are prohibited unless provided for in regulation. inclusion in the Community list by submitting a full dossier is required when a claim is based on newly developed scientific knowledge and/or when the protection of verifiable proprietary data is requested. Implied nutrition or health claim may be made only if accompanied by a permitted specific claim. enhanced function claims that refer to risk reduction of nonserious diseases), an approach similar to that for established function claims for known nutrients has been proposed. Proposed that conditions for claims about dietary information be specified in the Food Standards Code. details regarding the preparation of submissions to support health claims are elaborated in the Interim Guidance Document Preparing a Submission for Foods with Health Claims: Incorporating Standards of Evidence for Evaluating Foods with Health Claims (11). First, a structured, comprehensive literature review of the totality of relevant evidence based on human studies of acceptable quality is required. Second, the strength of evidence must be convincing in that it consistently supports a causal relation between the consumption of foods or food constituents and the reduction of a disease risk. This level of supporting evidence is considered to meet the requirement of significant scientific agreement (SSA) in the United States (8) 1224S Supplement

and scientific assessment of the highest possible standard in the EU (12). These principles of substantiation are also proposed by FSANZ in Australia/New Zealand for high-level health claims related to serious diseases (10). Under an interim policy in the United States, disease riskreduction claims that fail to meet evidence requirements for SSA may be made if they carry qualifying language, set out by the FDA in its letters of enforcement discretion (1). The qualifying language is written to reflect the level of scientific evidence for that claim and is termed a qualified claim. However, the United States is alone among regulators in taking this approach to managing disease risk-reduction claims that fail to meet a standard equivalent to SSA. Nutritional criteria for foods carrying health claims. In Canada, criteria for disease risk-reduction claims are set on a claim-by-claim basis. There are currently no common core criteria in Canada to determine which foods are eligible to carry health claims. This is different from the situation in many countries, where a common set of core nutritional criteria are applied to all claims, supplemented with additional claimspecific criteria. For example, in the United States, foods carrying any health claims must meet 3 types of criteria: 1) general nutrient requirements (e.g., for low saturated fat ), 2) minimum level of 1 or more of 6 specified nutrients (e.g., vitamin C), and 3) specific requirements for individual claims. In Canada, the nutritional criteria for a food carrying a claim about saturated and trans fat and the risk of heart disease are similar in principle to the U.S. requirements. However, for a food carrying a claim about calcium, vitamin D, and the risk of osteoporosis, only claim-specific requirements with respect to minimum levels of calcium and vitamin D need to be met. This lack of standardized criteria for different claims or for simplified nutritional or general health messages on the front of food packages can be confusing for consumers. Similarly, the absence of core eligibility criteria for disease risk-reduction and function claims has led to concerns that consumers may be drawn only to the claimed or highlighted product benefit, ignoring other, perhaps less positive aspects. In addition, there are suggestions that consumers view food with claims to be healthier overall than foods with no claims, the halo effect (13 17). Further, if foods carrying health claims also have significant negative attributes that are inconsistent with national dietary guidance, conflict with public health messages can arise. Health Canada is currently consulting whether minimum standards should be applied to foods carrying any type of health claim and whether core eligibility criteria, or a basic nutritional profile, should be applied to foods carrying general or implied health claims as well as to foods carrying function including biological role claims (1). U.S. disease risk-reduction claims and their status in Canada Discussions about health claims in Canada have often focused on the number of disease risk-reduction claims on foods in the United States vs. the number in Canada, although a direct comparison of the number of claims between the 2 countries is challenging because some claims in Canada combine or restrict elements of some claims in the United States (Table 4). In 1999, Health Canada committed to undertaking a review of the 10 U.S. health claims that met the SSA standards and were authorized under the Nutrition Labeling and Education Act (NLEA) at that time. Of these 10 NLEA claims, 5 have been authorized, with some modification of wording, through regulatory amendments (5); 2 have been recommended for approval, with some modification of wording, and have undergone public consultation (18); 2 were found not to be supported by updated science and will not be approved in Canada (5,18); and 1 is the subject of a current review through an industry submission. Updated science does not consistently support a link between the consumption of dietary fiber or cereal grain products and a lower risk of cancer (18). Of the 6 additional SSA and Food and Drug Administration Modernization Act (FDAMA) claims used in the United States since 1999, there has been no interest expressed in Canada for 1 claim concerning fluoridated water and dental carries; 2 other claims are under review through industry submissions; and 3 claims are incorporated into the claims already approved or proposed in Canada. In addition to the health claims based on SSA under NLEA and authoritative statements under FDAMA, the FDA can issue a letter of enforcement discretion for a qualified health claim within 270 d of receipt of a petition, in cases where the strength of evidence falls below the FDA requirements for authorization, i.e., SSA. These health claims must be accompanied by qualifying language, set out by the FDA, to ensure accuracy and nonmisleading presentation of information to consumers, that indicates the nature of the evidence supporting the claim. For example, a qualified health claim and the wording that must be used for tomatoes and prostate cancer are illustrated in the following claim statement: Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim (19). With regard to qualified claims, Canada does not allow claims that do not meet the standard for substantiation. As noted previously, the United States is alone internationally in taking this approach of enforcement discretion. For example, both the recent EU decision (12) for disease risk-reduction claims and the proposed FSANZ approach announced in 2007 to managing risk-reduction claims for serious diseases (10) require that high standards of evidence be met. Canada s position regarding disease risk-reduction claims is consistent with the norms of these jurisdictions. Next steps regarding health claims in Canada The context for the Canadian health claim system has evolved since the publication of the original policy position in 1998 (20) and the 2002 amendments to the FDR (5) permitting diseasereduction health claims, as has the scientific understanding about the relations among foods and food constituents and health. Similarly, there has been significant recent policy development for managing health claims for foods by the EU (12), Australia/New Zealand (10), the United States (21), and the United Kingdom. There is also a growing interest in more efficient and transparent processes for the approval of health claims in Canada. In recognition of many of these factors, Health Canada recently announced a review of its current framework for the management of health claims on foods and released its consultation document (1), which formed the basis of national consultations during the winter of 2007 2008. Broad themes of the review included increasing efficiency and transparency of the health claim approval and regulatory processes; seeking input on the appropriate level of scientific substantiation for different types of health claims; managing products at the food-natural health products interface containing bioactive substances that may present a risk to some segments of the population; types of oversight required for function claims and diverse FOP health-related claims not Health claims on foods in Canada 1225S

TABLE 4 U.S. disease risk-reduction claims and their status in Canada in February 2008 1 U.S. risk-reduction claims 2 Accepted 3 Proposed 4 Submission under review Rejected 3,4 Original 10 health claims based on SSA (Health Canada 1999 commitment) 1. Calcium and osteoporosis Added vitamin D (SSA), proposed inclusion of Vitamin D (Jan 7 2007) 5 2. Sodium and hypertension (SSA) Added potassium 3. Dietary fat and cancer (SSA) Rejected 4. Fiber-containing grain products, fruits and vegetables and cancer (SSA) 5. Fruits, vegetables and cancer (SSA) 6. Dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) (SSA) 7. Fruits, vegetables, grain products that contain fiber, particularly soluble fiber, and CHD (SSA) 8. Soluble fiber from certain foods (oats and psyllium, and recently barley) and risk of CHD (SSA) Accepted fruit and vegetable aspect Accepted Modified to include trans fat but not cholesterol Accept with modification (whole grain); exclude reference to fiber (Dec 2006) 9. Folate and neural tube defect (SSA) Accept (Dec 2006) 10. Dietary sugar alcohol and Accepted dental caries (SSA) Claims since 1999 (SSA and FDAMA decisions) 11. Potassium and blood Combined with 2 pressure and stroke (FDAMA) (2000) 12. Whole grain and heart disease, cancer (FDAMA) (2003) 13. Soy protein and risk of CHD (SSA) (Oct 1999) 14. Plant sterol/stanol esters and risk of CHD (SSA) (2000) 15. Fluoridated water and risk of dental carries (FDAMA) (2006) 16. Saturated fat, cholesterol, trans fat and heart disease (FDAMA) (2006) 17. Substitution of saturated fat with unsaturated fatty acids and risk of heart disease (FDAMA) (2007) Combined with 7 for whole grains and heart disease No interest has been expressed for such a claim in Canada. See 6 above Claim has not been submitted nor reviewed. Yes Yes Yes Grains and cancer rejected Grains and cancer rejected in 4 above 1 Adapted from Health Canada (1). 2 Includes health claims based on significant scientific agreement under NLEA and authoritative statement under FDAMA. Qualified health claims are excluded (22). 3 Data from Health Canada (23). 4 Data from Health Canada (18). 5 Data from FDA (24). specifically regulated at present; exploring the need for core eligibility criteria for all types of health claims; and enhancing informed consumer choice. The review is comprehensive, and the topics examined are complex. It is expected that prioritization of the review themes for multistage policy development will be required. Other articles in this supplement include references (25 34). Literature Cited 1. Health Canada. Managing health claims for foods in Canada: towards a modernized framework, food directorate, health products and food branch. November 2007. [cited Jan 8, 2008]. Available from: http://www.hc-sc.gc. ca/fn-an/consultation/init/man-gest_health_claims-allegations_sante_e.html. 2. Department of Justice Canada. Food and Drugs Act [cited Jan 8, 2008]. Available from: http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/ pdf/legislation/e_a-contnt.pdf. 1226S Supplement

3. Health Canada. Food and Drug Regulations (FDR). [cited Jan 8, 2008]. Available from: http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/fdrrad/index_e.html. 4. Canada Gazette. Natural Health Products Regulations (NHPR). [cited Jan 8, 2008]. Vol. 137, No. 13, June 18, 2003. Available from: http:// canadagazette.gc.ca/partii/2003/20030618/html/sor196-e.html. 5. Canada Gazette. Regulations amending the Food and Drug Regulations (nutrition labelling, nutrient content claims and health claims). [cited Jan 8, 2008]. Vol. 137, No. 1, January 1, 2003. Available from: http:// canadagazette.gc.ca/partii/2003/20030101/html/sor11-e.html. 6. Canadian Food Inspection Agency. Guide to food labelling and advertising. [cited Jan 8, 2008]. 2003. Available from: http://www. inspection.gc.ca/english/fssa/labeti/guide/toce.shtml. 7. Health Canada. General Principles for the Use of Content from Canada s Food Guide Resources in Labelling and Advertising. 2007. [cited Jan 8, 2008]. Available from: http://www.hc-sc.gc.ca/fn-an/foodguide-aliment/gen_prin_e.html. 8. FDA (US Food and Drug Administration). Guidance for industry significant scientific agreement in the review of health claims for conventional foods and dietary supplements. November 2, 1999. Rockville, MD: Center for Food Safety and Applied Nutrition (CFSAN), Office of Special Nutritionals. [cited Jan 8, 2008]. Available from: http://www.cfsan.fda.gov/;dms/ssaguide.html. 9. European Parliament and the Council of the European Union. December 20, 2006. Regulation (EC) No. 1924/2006 on nutrition and health claims made on foods. [cited Jan 8, 2008]. Available from: http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri¼CELEX:32006R1924R(01):EN:NOT. 10. FSANZ (Food Standards Australia New Zealand). Proposal P293 Nutrition, health and related claims. Preliminary final assessment report. April 2007. [cited Jan 8, 2008]. Available from: http://www. foodstandards.gov.au/standardsdevelopment/proposals/proposalp293- nutritionhealthandrelatedclaims/index.cfm. 11. Health Canada. Interim guidance document preparing a submission for foods with health claims: incorporating standards of evidence for evaluating foods with health claims. 2002. Government of Canada: Bureau of Nutritional Sciences Food Directorate Health Products, Food Branch Health Canada. [cited Jan 8, 2008]. Available from: http:// www.hc-sc.gc.ca/fn-an/label-etiquet/nutrition/claims-reclam/abstract_ guidance-orientation_resume_e.html. 12. EFSA (European Food Safety Authority). Opinion of the Panel on dietetic products, nutrition and allergies (NDA) on a request from the Commission related to scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim. 2007. [cited Jan 15, 2008]. Available from: http://www.efsa.europa.eu/efsa/ efsa_locale1178620753812_1178623592448.htm. 13. Ford GT, Hastak M, Mitra A, Ringold DJ. Can consumers interpret nutrition information in the presence of a health claim? A laboratory investigation. J Pub. Policy Marketing. 1996;15:16 27. 14. Murphy D, Hoppock TH, Rusk M. Generic copy test of food health claims in advertising. A joint staff report. The Bureaus of Economics and Consumer Protection, Federal Trade Commission. November 18, 1998. [cited Jan 8, 2008]. Available from: http://www.ftc.gov/os/1998/11/index.shtm 15. Roe B, Levy AS, Derby BM. The impact of health claims on consumer search and product evaluation outcomes: Results from FDA experimental data. J Pub. Policy Marketing. 1999;18:89 105. 16. Health Canada. Canadian consumer perspectives on food fortification. 2004. Available from: http://www.hc-sc.gc.ca/fn-an/nutrition/vitamin/ focus_test_final_exec_summary-resume_exec_final_test_type_e.html. 17. FSANZ (Food Standards Australia New Zealand). Research on consumers perceptions and use of nutrition, health and related claims on packaged foods and associated advertising material. A research report prepared for FSANZ by TSN Consultants. Proposal P293 Nutrition, Health and Related Claims. Draft Assessment Report, Attachment 4. December 2005. 18. Health Canada. Position paper on five U.S. generic health claims considered for use in Canada. 2006. [cited Jan 8, 2008]. Available from: http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/position_paperenonce_position_e.html. 19. FDA Center for Food Safety and Applied Nutrition, Office of Nutritional Products, Labeling, and Dietary Supplements, Qualified Health Claims. Letter regarding tomatoes and prostate cancer (Lycopene Heath Claim Coalition) (Docket No. 2004Q 0201). November 8, 2005. [cited Jan 8, 2008]. Available from: http://www.cfsan.fda.gov/ ;dms/qhclyco2.html. 20. Health Canada. Policy paper: nutraceuticals/functional foods and health claims on foods. Government of Canada: Therapeutic Products Program and the Food Directorate from the Health Protection Branch. November 2, 1998. [cited Jan 8, 2008]. Available from: http://www.hc-sc.gc.ca/fn-an/ label-etiquet/nutrition/claims-reclam/nutra-funct_foods-nutra-fonct_ aliment_e.html. 21. U.S. Food and Drug Administration (FDA). Guidance for industry. Evidence-based review system for the scientific evaluation of health claims. July 2007. [cited Jan 8, 2008]. Available from: http:// www.cfsan.fda.gov/;dms/hclmgui5.html. 22. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Food Labeling Guide Appendix C. [cited Jan 8, 2008]. Available from: http://www.cfsan.fda.gov/;dms/flg-6c.html. September 1994 (Editorial revisions June 1999 and November 2000) and updates. 23. Status of Health Claims in Canada Permitted Health Claims and Proposed Claims. November 2007. [cited Jan 8, 2008] Available from: http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/permitted_claimsallegations_autorisees_e.html. 24. FDA Updates. Health Claim for Calcium and Osteoporosis, January 5, 2007. [cited Jan 8, 2008] Available from: http://www.fda.gov/bbs/ topics/news/2007/new01543.html. 25. Jones PJH, Asp N-G, Silva P. Evidence for health claims on foods: how much is enough? Introduction and general remarks. J Nutr. 2008; 138:1189S 91S. 26. Yamada K, Sato-Mito N, Nagata J, Umegaki K. Health claim evidence requirements in Japan. J Nutr. 2008;138:1192S 8S. 27. Yang Y. Scientific substantiation of functional food health claims in China. J Nutr. 2008;138:1199S 205S. 28. Tapsell LC. Evidence for health claims: A perspective from the Australia New Zealand region. J Nutr. 2008;138:1206S 9S. 29. Asp N-G, Bryngelsson S. Health claims in Europe: New legislation and PASSCLAIM for substantiation. J Nutr. 2008;138:1210S 5S. 30. Hasler CM. Health claims in the United States: An aid to the public or a source of confusion? J Nutr. 2008;138:1216S 20S. 31. Jew S, Vanstone CA, Antoine J-M, Jones PJH. Generic and productspecific health claim processes for functional foods across global jurisdictions. J Nutr. 2008;138:1228S 36S. 32. Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008;138:1237S 43S. 33. Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008;138:1244S 9S. 34. Farnworth ER. The evidence to support health claims for probiotics. J Nutr. 2008;138:1250S 4S. Health claims on foods in Canada 1227S