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4 Bureau of Nutritional Sciences and 5 Bureau of Food Policy Integration, Food Directorate, Health Products and Food Branch, Health Canada, Ottawa, Canada
* To whom correspondence should be addressed. E-mail: mary_labbe{at}hc-sc.gc.ca.
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ABSTRACT |
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 TOP ABSTRACT IntroductionLITERATURE CITED |
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Introduction |
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TOPABSTRACTIntroductionLITERATURE CITED |
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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 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.
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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 risk-reduction 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.
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.
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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 risk-reduction 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 physiological 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.
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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 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) 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 risk-reduction 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 claim-specific 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).
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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 disease-reduction 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 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).
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FOOTNOTES |
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3 Author disclosures: M. R. L'Abbé, L. Dumais, E. Chao, and B. Junkins, no conflicts of interest.
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.
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LITERATURE CITED |
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TOPABSTRACTIntroductionLITERATURE CITED |
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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.
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/fdr-rad/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/food-guide-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/
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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?uri=CELEX: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/proposalp293nutritionhealthandrelatedclaims/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_paper-enonce_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_claims-allegations_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 product-specific 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.
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