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Chapter 8 - Annexes

Annex 8-1

Schedule 1 (Subsection 1(1)) - Included Natural Health Product Substances

  1. A plant or a animal material, an alga, a bacterium, a fungus or a non-human animal material
  2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation
  3. Any of the following vitamins:
    1. biotin
    2. folate
    3. niacin
    4. pantothenic acid
    5. riboflavin
    6. thiamine
    7. vitamin A
    8. vitamin B6
    9. vitamin B12
    10. vitamin C
    11. vitamin D
    12. vitamin E
  4. An amino acid
  5. An essential fatty acid
  6. A synthetic duplicate of a substance described in any of the items 2 to 5
  7. A mineral
  8. A probiotic

Schedule 2 (Subsection 1(1)) - Excluded Natural Health Product Substances

  1. A substance set out in Schedule C to the Act
  2. A substance set out in Schedule D to the Act, except for the following:
    1. a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and
    2. any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
  3. A substance regulated under the Tobacco Act
  4. A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act
  5. A substance that is administered by puncturing the dermis
  6. An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic

Annex 8-2

Schedule A Diseases from the Food and Drugs Act [Section 3]

  • Acute alcoholism
  • Acute anxiety state
  • Acute infectious respiratory syndromes
  • Acute, inflammatory and debilitating arthritis
  • Acute psychotic conditions
  • Addiction (except nicotine addiction)
  • Appendicitis
  • Arteriosclerosis
  • Asthma
  • Cancer
  • Congestive heart failure
  • Convulsions
  • Dementia
  • Depression
  • Diabetes
  • Gangrene
  • Glaucoma
  • Haematologic bleeding disorders
  • Hepatitis
  • Hypertension
  • Nausea and vomiting of pregnancy
  • Obesity
  • Rheumatic fever
  • Septicemia
  • Sexually transmitted diseases
  • Strangulated hernia
  • Thrombotic and Embolic disorders
  • Thyroid disease
  • Ulcer of the gastro-intestinal tract

Annex 8-3

Reference List for Probiotic Claims

  • ATCC. 2008. American Type Culture Collection [online]. Manassas (VA): The Global Bioresource Center. Available from: www.atcc.org/ [Accessed 28 May 2008].
  • EFSA (European Food Safety Authority). Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal 2007;587:1-16; Appendix A: Scientific report on the assessment of gram-positive non-sporulating bacteria. Available from: http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/
    sc_appendixa_qps_en.pdf?ssbinary=true [Accessed 28 May 2008].
  • Euzéby JP. 2008. List of bacterial names with standing in nomenclature: a folder available on the Internet. Int J Syst Bacteriol 1997;47(2):590-592. Last full update: May 2, 2008. Available from: www.bacterio.cict.fr/ [Accessed 15 May 2008].
  • FAO/ WHO. 2001. Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Report of a Joint FAO/ WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Córdoba, Argentina, October 1-4, 2001. Available from: www.who.int/foodsafety/publications/fs_management/probiotics/en/index.html [Accessed 3 April 2008]
  • FAO/ WHO. 2002. Guidelines for the Evaluation of Probiotics in Food. Report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food. London, Ontario, April 30 - May 1, 2002. Available from: www.who.int/foodsafety/publications/fs_management/probiotics2/en/index.html [Accessed 3 April 2008]
  • FAO/ WHO. 2006. Probiotics in Food: Health and Nutritional Properties and Guidelines for Evaluation. FAO Food and Nutrition Paper 85. Food and Agriculture Organization of the United Nations and World Health Organization, Rome. Available at: ftp://ftp.fao.org/docrep/fao/009/a0512e/a0512e00.pdf [Accessed 3 April 2008]. (This document integrates the 2001 and 2002 FAO/WHO reports listed above).
  • Gill H, Prasad J. Probiotics, immunomodulation, and health benefits. Adv Exp Med Biol 2008;606:423-454.
  • Gilliland SE. 2001. Technological and Commercial Applications of Lactic Acid Bacteria; Health and Nutritional Benefits in Dairy Products [online]. Background paper for the Joint FAO/ WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Rome, Italy. Food and Agriculture Organization of the United Nations (FAO). Available from: ftp://ftp.fao.org/es/esn/food/Gilli.pdf [Accessed 28 May 2008].
  • Hawrelak JA. 2006. Probiotics. In: Textbook of Natural Medicine, 3rd ed., Vol. 1. Pizzorno JE Jr, Murray MT (eds.), pp 1195-1215. St. Louis (MO): Elsevier Ltd.
  • Health Canada. 2009. The Use of Probiotic Microorganisms in Food. Available from: http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/
    legislation/probiotics_guidance-orientation_probiotiques-eng.pdf
  • Lenoir-Wijnkoop I, Sanders ME, Cabana MD, et al. Probiotic and prebiotic influence beyond the intestinal tract. Nutr Rev 2007;65(11):469-489.
  • Picard C, Fioramonti J, François A, et al. Review article: bifidobacteria as probiotic agents - physiological effects and clinical benefits. Aliment Pharmacol Ther 2005;22(6):495-512.
  • Reid G. 2001. Regulatory and clinical aspects of dairy probiotics [online]. Background paper for the Joint FAO/ WHOExpert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria. Rome, Italy. Food and Agriculture Organization of the United Nations (FAO). Available from: ftp://ftp.fao.org/es/esn/food/Reid.pdf [Accessed 28 May 2008].
  • Reid G, Jass J, Sebulsky MT, McCormick JK. Potential uses of probiotics in clinical practice. Clin Microbiol Rev 2003;16(4):658-672.
  • Skerman VBD, McGowan V, Sneath PHA (eds). 1989. Approved Lists of Bacterial Names, Amended Edition [online]. Washington (DC): American Society of Microbiology Press. Available from: www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=bacname [Accessed 28 May 2008].

Annex 8-4

Policy Respecting the Use of Heart Symbols and Heart Health Claims on Food Labels and in Food Advertisements

Background

Historically, representations such as the use of "heart" symbols and statements such as "heart healthy" on food labels or in advertising have been considered likely to offend the Food and Drugs Act because they can be potentially misleading under subsection 5.(1) and/or may represent the product as a preventative for heart disease [3.(1),FDA].

As a result of the work of the Ad Hoc Intersectoral Committee on Health Information Programs Involving the Sale of Foods and on the Use of Nutrition Recommendations in Food Labelling and Advertising, policies were issued on March 1, 1991 under the title "Guidelines for Health Information Programs Involving the Sale of Foods"

One of the policies contained in this document addressed label and advertising claims relating to disease prevention. This policy statement reiterated the government's commitment to upholding section 3 of the Food and Drugs Act, confirmed that the practice of relating a specific food product to disease prevention is prohibited under section 3 of the Act and described several situations in which the food industry could deliver information on disease prevention without offending section 3. The document did not, however, specifically address the issue of the use of "heart" symbols and "heart health" claims in food labelling and advertising.

The following policy is intended to further clarify the position concerning the use of "heart" symbols and "heart health" claims, and complements the more general policies of the aforenoted Ad Hoc Intersectoral Committee on Health Information Programs.

Scope

The policy will apply to the use of "heart" symbols and "heart health" statements or claims on food labels and food advertisements.

Policy

1. Heart Symbols
  1. Representations which state, suggest or imply that a particular food is nutritionally superior to or healthier than other foods are considered misleading, since one's entire food intake, not a single part of it, is the critical variable in determining the nutritional adequacy of the diet and its contribution to reducing risk for chronic disease. Accordingly, the use of heart symbols in food labelling or advertising (including the "hearting" of restaurant menu items), may create an erroneous impression regarding the merit or value of the food by suggesting that consumption of the specific food or menu selection will, by itself, provide health as it relates to the heart and cardiovascular system. As the use of these symbols in this manner is considered to constitute a potential violation of subsection 5.(1) of the Food and Drugs Act, they should not be used.
  2. A heart symbol which appears in the logo/word mark of, or is used in conjunction with, the name of a non-governmental health organization, or a health information program of a health organization, may be acceptable on a food label or in a food advertisement on condition that: (a) no impression is given that the food may help prevent heart disease, and (b) the appearance of the health organization's name or logo itself satisfies the conditions outlined in the "Policy on the Use of Third-Party Endorsements, Logos and Seals of Approval".
  3. No objection will be taken to heart symbols used in a manner traditionally-recognized as indicating affection or endearment, e.g., heart shapes on the label of Valentine candies.
2. "Heart Healthy", "Heart Healthy (Naming the Food)" or "Heart Healthy Choice" Statements or Claims

As in the case of heart symbols, the use of the term "heart healthy" to describe a food or food choice in food labelling and advertising, may create an erroneous impression regarding the merit or value of the food, by suggesting that it will, by itself, provide heart health. As such terms are considered to constitute a potential violation of subsection 5.(1), FDA, they should not be used.

3. "Heart Healthy Eating" or "Heart Healthy Diet"

The use of the terms "heart healthy eating" or "heart healthy diet" on the labels and/or in the advertisements for specific foods (e.g., "choose X-brand margarine for your heart healthy diet") may give an erroneous impression about the merit or value of the subject food(s). Objection is taken to the use of these terms in association with individual foods for the following reasons:

  1. the consumer may incorrectly conclude that the food itself is "good for the heart" or that it has particular usefulness in providing heart health;
  2. health authorities agree that a single pattern of healthy eating should be recommended to the public to meet the needs for essential nutrients while minimizing risk for chronic disease. The term "heart healthy diet" suggests and promotes the concept of disease- or organ-specific patterns of eating; this is considered confusing and potentially misleading to the public;
  3. a healthy diet may help reduce the risk of cardiovascular disease, but it is only one factor in the multiple etiology of the disease. Promotion of a "heart healthy" diet to the exclusion of other lifestyle factors in the labelling and advertising of a food, may give an erroneous impression of the impact of both the diet and that food on heart health.
4. Misleading Words or Phrases Employing the Term "Heart"
  1. Objection is taken to the use of terms employing the word "heart", such as "heart beat", "whole hearted" and "heart smart" to describe individual foods, menu selections or patterns of eating, where the use of such terms or phrases suggests or implies that the food or diet is "heart healthy".
  2. Terms employing the word "heart" may be acceptable as part of the name of an information program of a health organization provided the program is identified as such, e.g., "the Heart Smart program is a public education program of the Heart and Stroke Foundation of Canada".

Implementation

Steps should be taken by food manufacturers, importers and marketers to ensure the correction of domestic and imported product labels, advertisements and menus now bearing heart symbols and heart health statements or claims in contravention of this policy.

In this regard, the removal or correction (i.e., over-stickering) of existing heart symbols as per item #1 and label or menu claims as per items #2, 3 and 4 will be expected within six months from the date of this policy or at the time of next label or menu printing, whichever occurs first. The subject symbols and claims should not be used on new labels, menus or advertisements produced subsequent to the date of this policy.

In the case of the " Heart Smart" Restaurant Program of the Heart and Stroke Foundation of Canada, a new program is currently being introduced which is in keeping with this policy. Restaurants are being informed of the changes by the provincial Heart and Stroke Foundations, and no additional corrective action is required at this time.

Food Directorate
Health Protection Branch
Health Canada
Food Division

Consumer Products Branch
Consumer and Corporate Affairs Canada*
October 9, 1992

* Consumer and Corporate Affairs ceased to exist as of June 25, 1993. Its responsibilities respecting food labelling and advertising were transferred to Agriculture and Agri-Food Canada and later, on April 1, 1997, to the Canadian Food Inspection Agency. The former Food Division is now known as the Bureau of Food Safety and Consumer Protection, CFIA.

Annex 8-5

Eating well with Canada's Food Guide

Canada's Food Guide

Canada's Food Guide - Daily Servings

Annex 8-6

References

The following historical policy documents are the basis of the information provided in this chapter.

  • Guide for Food Manufacturers and Advertisers. Consumer Products Branch, Consumer and Corporate Affairs Canada, Revised Edition, 1988.
  • Guidelines on Nutrition Labelling. Food Directorate, Health Protection Branch, Health and Welfare Canada, November 1989.
  • Canada's Guidelines for Healthy Eating in Nutrition Recommendations ... A Call for Action. Health and Welfare Canada, 1989.
  • Guidelines for Health Information Programs Involving the Sale of Foods. Food Directorate, Health Canada, March 1995.
  • General Principles for Labelling and Advertising Claims that Relate to the Nutrition Recommendations and Canada's Food Guide to Healthy Eating (GP). Food Directorate, Health Canada, revised December 1993; and Guidelines on the Application of the General Principles. Food Division, Consumer and Corporate Affairs Canada, April 1993.
  • Policy - Advertising Claims Relating to Nutrition Recommendations made by Organizations which do not Control Food Packaging or Labelling (OWLs). Food Division, Agriculture and Agri-Food Canada, December 1995.
  • Policy - Educational Material versus Advertising Material. Food Division, Consumer and Corporate Affairs Canada, March 1991.
  • Policy on the Use of Third-Party Endorsements, Logos, and Seals of Approval. Food Division, Consumer and Corporate Affairs Canada, March 1991.
  • Policy Respecting the Use of Heart Symbols and Heart Health Claims on Food Labels and in Food Advertisements. Food Division, Consumer and Corporate Affairs Canada, October 1992.
  • Nutrition Recommendations for Canadians in Nutrition Recommendations, The Report of the Scientific Review Committee (SRC Report). Canadian Government Publishing Centre, Public Works and Government Services Canada, Ottawa, 1990.
  • IL 793 - Guidelines for Foods Represented for Use in Achieving and Maintaining Healthy Body Weights. Food Directorate, Health Canada, April 1991.
  • Health Canada. 2009. The Use of Probiotic Microorganisms in Food.
  • Health Canada. 2010. Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats.
  • Health Canada. 2009. Guidance Document for Preparing a Submission for Food Health Claims.
Date Modified: 2010-10-20

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