Is There Such a Thing as a North American Food Label? By Eileen McMahon and Sumeet Dang

F

ood companies based in the United States seeking to market their U.S.-labeled foods in Canada often ask whether they can use U.S. labels for the Canadian

market. The answer is, unfortunately, no. Canada’s labeling

Canada’s Approach Is Prescriptive he development and enforcement of Canadian food labeling laws are federal responsibilities shared between Health Canada, which develops policy and standards, and the Cana-

laws are different from U.S. laws in a few key areas. These

dian Food Inspection Agency (CFIA), which administers and

differences may become greater given that the Food and

enforces the policies and legislation of Health Canada and the

Drug Administration (FDA) has indicated that it expects to

Canadian Food and Drugs Act (the Act) as they relate to food

publish updated requirements for nutrition facts panels in

labeling and safety. he Act prohibits the labeling of any food

1

2011. This article focuses on the differences between these

“in a manner that is false, misleading or deceptive or is likely

two sets of laws, which require different information in

to create an erroneous impression regarding its character,

nutrition facts panels for foods.

value, quantity, composition, merit or safety.” he Food and

Ms. McMahon is the Co-Chair of the Intellectual Property and Food and Drug Regulatory Practices at the law irm Torys LLP, Toronto, Canada.

FDLI

Mr. Dang is a member of the Intellectual Property Practice at the law irm Torys LLP, Toronto, Canada.

September/October 2011

UPDATE

29

Advertising and Promotion Issue

Drug Regulations (the Regulations), as they apply to food, prescribe the labeling of all prepackaged foods, including requirements for nutrient content claims and health claims. A food product that does not meet the requirements of the Regulations violates the Act.

Nutrition Facts Table With certain exceptions,2 any food product that is ofered for sale in Canada as a prepackaged product requires a label that must carry a nutrition facts table. he Regulations prescribe both the core information that the nutrition facts table must contain and the additional information that may be included. he nutrition facts table is also mandatory in the United States for most packaged foods; Figure 1 provides a visual comparison of the nutrition facts tables of the two countries. Important

diference will be discussed in further detail below.

Recommended Daily Values For each food product that requires a nutrition facts table, both the U.S. and Canadian labels must provide the percentage of the recommended daily value of most of the food’s constituent nutrients per a declared serving size. In Canada, the daily values are based, as prescribed in the Regulations, on (i) the reference standards for fat, carbohydrate, iber, sodium, potassium and cholesterol (based on a 2000 calorie reference diet) and (ii) the recommended daily intake for vitamins and minerals. he Canadian and U.S. recommended daily values are identical for fat, cholesterol, carbohydrate, iber (labeled “dietary iber” in the United States), sodium and vitamin C; however, the recommended

daily values are diferent for the remaining three mandatory vitamins and minerals in Canada (namely, vitamin A, calcium and iron), as well as for a number of optional nutrients (such as vitamin B12, folate and ribolavin). As result, the same percentages of the recommended daily value cannot be used in the nutrition facts table for the same food product in both Canada and the United States. he reason for these diferences is that Canada and the United States use different references to determine the daily values for vitamins and minerals. In particular, the Canadian recommended daily values for vitamins and minerals are based on the 1983 Recommended Nutrient Intakes for Canadians, whereas FDA bases these daily values on the Reference Daily Intake, which in turn is based on the highest 1968 Recommended Dietary Allowance for each nutrient.

Percentage Daily Value Protein Figure 1. Comparison of Canadian and U.S. Nutrition Facts Table

Canadian Nutrition Facts Table

30

UPDATE

September/October 2011

U.S. Nutrition Facts Table

A percentage of the recommended daily value for protein is required in the United States only if a claim is made for protein, such as “high in protein,” or if the food is meant for use by children under four years old. In contrast, Canada has no requirement for protein. A food product in Canada with a “high in protein” claim must only abide by the Act’s requirement that a claim must not be made “in a manner that is false, misleading or deceptive.” Both Health Canada and FDA (in the case of children over four years old) consider the percentage of the recommended daily value for protein to be unnecessary information, given that protein intake is not a public health concern. Further, given the complexity and cost in determining this value, Health Canada’s position is that requiring a percentage of the recommended daily value for protein would be a needless burden on manufacturers. www.fdli.org

Advertising and Promotion Issue

Serving Sizes, Servings Per Container and the Use of Non-Metric Units A declaration of servings per container is mandatory in the United States but optional in Canada. If a declaration of servings per container is used in Canada, it must not be made on the basis of “cups” or “tablespoons” because these measurements are not the same in both countries. In contrast, a declaration using nonmetric sizes, such as cups or tablespoons, may be used when providing the serving size (as opposed to the servings per container) in both the United States and Canada, but only if the equivalent metric serving size follows in brackets – for example, “per cup (250 ml).” Somewhat analogous to U.S. regulations that suggest serving sizes for 139 food products, the serving size in Canada may be selected by a food manufacturer from a range of suggested serving sizes provided for 153 diferent product categories in Table 6-3 of CFIA’s Guide to Food Labelling and Advertising (the Guide).3 Health Canada strongly recommends, but does not mandate, that manufacturers provide serving sizes within these ranges. Further, the Act’s prohibition against false, misleading or deceptive claims should also guide a manufacturer when determining the serving size of a food product.4

Saturated Fats and Trans Fats It is mandatory in both countries to provide the saturated and trans fat content in the nutrition facts table; however, the declaration of the percentage of the recommended daily value for saturated and trans fats difers in the two countries. In Canada, the nutrition facts table provides the percentage of the recommended daily value of both the total fat and the sum of “Saturated + trans.” In the United States, by contrast, only the total fat and the saturated fat are FDLI

expressed as a percentage of the recommended daily value. Trans fats are excluded in the United States on the basis of a 2002 Institute of Medicine of the National Academies report5 that did not establish a reference value for trans fats, which is needed to establish a daily value. Canada has taken a diferent approach; Health Canada has established a daily value for the sum of saturated and trans fat at 20 grams (the U.S. daily value for saturated fat alone is 20 grams). As both saturated and trans fats have similar efects on LDL cholesterol and heart disease, Health Canada decided to include trans fats with saturated fats in determining the daily value.

Calories from Fat A declaration of “calories from fat” is mandatory on labels in the United States but optional in Canada. Furthermore, “percent calories from fat” is not a permitted statement in the nutrition facts table in Canada.

Rounding Down In Canada, total fat may be rounded down to zero, and claims of “fat free” or “zero fat” may be made only when the product contains less than 0.5 grams of fat. Claims of “zero saturated fatty acids” may also be made if the food product contains less than 0.2 grams of both saturated and trans fats, which would be rounded to zero as well. Rounding down trans and saturated fats to zero is treated slightly diferently in the United States, where claims can be made that food products are fat free only if they have 0.5 grams or less total fat (as in Canada), but claims of food products being free of saturated fat may only be made for food products with 0.5 grams or less of both saturated and trans fat.

Bilingual he United States has no requirement for nutritional labels to be bilingual, whereas in Canada, the nutrition facts table must be in both English and French, subject to certain exceptions as prescribed in the Regulations.

Health Claims here are a number of important diferences between the two countries’ rules that govern health claims. Although the Canadian Regulations contain no deinition of health claims, these have been classed by the Guide into three main categories: (i) disease risk-reduction and therapeutic claims, (ii) function claims and (iii) general health claims. he Canadian and U.S. regimes with respect to each of these categories are examined below.

Disease Risk Reduction and Therapeutic Claims Disease risk-reduction claims link a food or a constituent of a food to a reduction in the risk of developing a diet-related disease or condition. Only ive particular risk-reduction claims are permitted to be made, as prescribed by the Regulations: • a diet low in sodium and high in potassium, and the reduction of risk of hypertension; • a diet adequate in calcium and vitamin D, and the reduction of risk of osteoporosis; • a diet low in saturated fat and trans fat, and the reduction of risk of heart disease; • a diet rich in vegetables and fruits, and the reduction of risk of some types of cancer and • maximal fermentable carbohydrates in gum, hard candy or breath-freshening products, and the reduced risk of dental caries. September/October 2011

UPDATE

31

Advertising and Promotion Issue

he Regulations also prescribe the exact wording that must be used with respect to these disease risk-reduction claims. hese types of claims are distinct from claims for treatment, prevention or cures for any of the diseases listed in the Regulations, since such claims would qualify as therapeutic claims, which have never been approved in Canada. Any food product with a new disease risk-reduction claim that is not provided by the Regulations requires approval by Health Canada and an amendment to the Regulations. Most recently, health claims for phytosterols and beta-glucan oat iber received Health Canada’s approval with respect to the reduction of cholesterol. Amendments are now planned in order to add phytosterol and beta-glucan oat iber to the existing ive risk-reduction claims in the Regulations. In the meantime, Health Canada has posted on its website the wording that may make up a claim for phytosterols and beta-glucan oat iber.6 he equivalent to risk-reduction claims in the United States are health claims. A health claim must contain the elements of a food and a disease or health-related condition. Like the rules in Canada, health claims are limited to claims about disease risk reduction and cannot be claims about the diagnosis, cure or treatment of disease. Unlike in Canada, however, the U.S. rules are more lexible with respect to breadth of risk-reduction claims that may be made. here are generally two types of health claims in the United States, which must undergo an FDA pre-market review: (i) authorized health claims that are supported by signiicant scientiic agreement among qualiied experts or by an “authoritative statement” and (ii) qualiied health claims that are supported by emerging evidence of a relationship between a food 32

UPDATE

September/October 2011

and reduced risk of a disease. Qualifying language provided by the FDA is included as part of the qualiied health claim to indicate that the evidence supporting the claim is limited. Canada has no equivalent to a qualiied health claim.

Nutritional or Functional Claims Nutritional or functional claims are used to describe the speciic beneicial efects that the consumption of a food or the particular nutrient within a food product has on the maintenance and support of speciic bodily functions. Functional claims may not refer to any disease, disorder or abnormal physical state, or any of their symptoms. he Guide lists three foods that have acceptable function claims (coarse wheat bran, green tea and psyllium). Further, the Guide also provides a list of 23 established nutrient claims, such as iron being a factor in red blood cell formation. A company wishing to make a new function or nutrient claim must have the scientiic evidence to validate the claim before its use on food labels. Companies are encouraged to consult with Health Canada’s Food Directorate for guidance. A pre-market assessment of such function claims is voluntary. A similar regime exists in the United States for “structure/function” claims, which are similar to nutritional or functional claims in Canada in that they bear statements that describe the role of a nutrient or dietary ingredient intended to afect the structure or function in humans; the statements do not bear any disease claims. As is the case with Health Canada, FDA does not require pre-market authorization with respect to structure or function claims for food.

General Health Claims General health claims are broad claims that promote health through healthy

eating or provide dietary guidance, without referring to a speciic or general health efect, disease or health condition. hese claims are governed in much the same way in Canada as they are in the United States. In Canada, no speciic criteria have been included in the regulations for these types of claims. he only requirement, as with the case of all health claims, is that the statement cannot be “false, misleading or deceptive.” Similarly, in the United States, claims that make broad statements regarding the beneit provided by healthy eating must be truthful and not be misleading.

Front of Package Labeling Health claims may be expressed explicitly in a statement or implicitly through “front-of-package” (FOP) slogans, logos or symbols as long as such implicit claims are not false, misleading or deceptive. In both Canada and the United States, the use and variety of FOP claims have increased. here are, however, no speciic regulations governing the use of FOP claims in either country. Health Canada has recognized that FOP claims may draw attention away from less healthy characteristics of a food, and inconsistent FOP claims may also create confusion among consumers. As part of its eforts to modernize its health claim management, Health Canada is reviewing how health claims on prepackaged foods afect consumer choices, particularly with respect to FOP claims. he results will contribute to Health Canada’s current modernization process and form part of its informationgathering eforts with respect to FOP claims and their efect on consumers. FDA has also recognized the issue of FOP labeling and, in 2009, encouraged food companies to review their labeling to ensure they were in compliance with FDA’s requirements. As in Canada, a study on the impact of FOP labeling on www.fdli.org

Advertising and Promotion Issue

consumer choices is being carried out. he results of the study, undertaken by the Centers for Disease Control and Prevention and the Institute of Medicine of the National Academies, and supported by FDA, are planned for release in fall 2011 and will be made available to Health Canada, which will consider the indings in its eforts to develop policy regarding FOP claims.7 By consulting the indings of the same study, Canada and the United States appear to be taking a similar approach to FOP claims. For now, in the absence of any legislation, companies should ensure that all FOP labeling not be false, misleading or deceptive.

FDLI

Conclusion

3.

Although both Canada and the United States require a nutrition facts table, there are a number of important diferences in the content and presentation of the table. In short, there is no such thing (to date) as a North American food label, or at least one that is compliant with all applicable laws. FDLI

4.

1.

2.

“Revising Nutrition Label Regulations: What to Expect” (Panel discussion at the 2011 FDLI Annual Conference, Washington, DC) available at: http:// www.fdli.org/conf/annual/11/agenda.html. Food and Drug Regulations, C.R.C.,c.870, at B.01.401(1), available at: http://laws.justice. gc.ca/eng/regulations/C.R.C.,_c._870/page-27. html#h-20.

5.

6.

7.

Available at: http://www.inspection.gc.ca/english/ fssa/labeti/guide/ch6e.shtml#a6_2. June 22, 2011 phone interview with Health Canada, Food Directorate, Health Products and Food Branch. See Guidance for Industry: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, Health Claims; Small Entity Compliance Guide (August 2003), available at: http://www.fda.gov/ Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053479.htm. Available at: http://www.hc-sc.gc.ca/fn-an/labeletiquet/claims-reclam/assess-evalu/phytosterolseng.php (phytosterols); http://www.hc-sc.gc.ca/ fn-an/label-etiquet/claims-reclam/assess-evalu/ oat-avoine-eng.php (glucan oat iber). Supra note 4.

September/October 2011

UPDATE

33