Regulatory Issues: Nutrition labeling moves north of the border

On January 1, 2003, Canada published extensive new regulations addressing three concerns: nutrition labeling, health claims, and nutrient content claims. American food manufacturers that market food in Canada will need to bring their labels into compliance with the new requirements, which generally take effect December 12, 2005.Notably, Canada has established mandatory nutrition labeling. We've had this in the U.S. in the form of the nutrition facts panel since 1993, when the U.S. Food and Drug Administration (FDA) implemented the Nutrition Labeling and Education Act (NLEA). Canada now joins the U.S. in a very small fraternity of countries that generally require label to disclose the nutritional content of a given food. In Europe and in many other countries, food labels must bear nutrition labeling only if they bear a nutrition claim, such as fat free or low calorie. Health Canada has not yet issued a summary of the nutrition labeling requirements or other forms of guidance. For now, food manufacturers looking to understand the requirements must resort to the 249 pages of regulatory text published in the Canada Gazette on January 1, along with the existing Food and Drug Regulations that are amended by this text. Basic requirementsIn the area of nutrition labeling, the basic requirement is that all prepackaged foods include on their labels a nutrition facts table that provides the following information: serving size; energy value (calories per serving); fat content (grams per serving and percent daily value per serving); saturated fatty acid content (grams per serving); trans-fatty acid content (grams per serving); the sum of saturated fatty acids and trans-fatty acids (percent daily value per serving); cholesterol content (milligrams per serving and optional additional statement of percent daily value per serving); sodium content (milligrams per serving and percent daily value per serving); carbohydrate content (grams per serving and percent daily value per serving); fiber content (grams per serving and percent daily value per serving); sugar content (grams per serving and percent daily value per serving); protein content (grams per serving); and the content of vitamin A, vitamin C, calcium, and iron (percent daily value per serving). The regulations also provide for the sometimes-voluntary inclusion of additional information in the nutrition facts table. For example, the amount of polyunsaturated fatty acids may be stated in grams per serving. This declaration becomes mandatory if a claim is made regarding the polyunsaturated fat content of the food, either on the label or in advertising. Twenty-one vitamins and minerals are included among the nutrients that may be included somewhat voluntarily in the nutrition facts table. If they are added to the food, they must be declared. If they occur naturally in the food, declaration is voluntary. As with FDA's nutrition labeling regulations, Canada specifies in great detail a standard format that must be followed in preparing the nutrition facts table. There is also a simplified standard format, a bilingual simplified standard format, a bilingual simplified horizontal format. You get the picture. The question on many minds is whether a nutrition facts panel designed to comply with FDA's regulations will be acceptable in Canada. The immediate answer seems to be "not really." There are several minor differences between the Canadian and U.S. requirements. For example, Canada has established "recommended daily intake" values (RDIs) for vitamins and minerals that differ from those included in FDA's regulations. Also, Canada's handling of saturated fat and trans fat differs from FDA's current proposed regulation for transfat labeling. Considering the nature of these differences, though they are minor, it is difficult to conceive of a label that could satisfy both sets of rules simultaneously. But these differences may be ironed out at some point in the future. Nutrient content claimsCanada's new regulations update -- rather than inaugurate -- the criteria for making nutrient content claims such as low fat. Forty-seven nutrient content claims are authorized. The regulations specify the basic conditions that must be satisfied for each specific claim. For example, if a food is claimed to be low in sodium, it must contain less than 140 milligrams of sodium per serving, with certain exceptions. The regulations also establish the exact wording that is acceptable for each claim (e.g., low sodium, low in sodium, little sodium, low salt, etc.) Among Canada's 47 defined nutrient content claims, there are likely to be some minor differences between U.S. and Canadian criteria. Health claimsCanada's new regulations introduce five permitted health claims that may appear on food labels. For the most part, these claims may be characterized as "risk reduction" types. The permitted claims specifically relate to the associations between (1) a diet high in potassium and low in sodium and a reduced risk of high blood pressure; (2) a diet with adequate calcium and vitamin D and a reduced risk of osteoporosis; (3) a diet low in saturated and trans fats and a reduced risk of heart disease; (4) a diet rich in a variety of vegetables and fruit and a reduced risk of some types of cancer. In addition, statements such as "does not promote tooth decay" are permitted on certain sugar-free confectionery items. For the most part, these five claims are a sub-set of the health claims currently authorized by FDA. Canada examined the FDA-approved health claims and decided not to permit all of them, at least not initially. Thus, Canada appears to be taking a more restrictive approach to health claims. FDA's approach has been affected recently by legal challenges under the free speech guarantee of the First Amendment to the U.S. Constitution. Canada's policies regarding health claims on food labels are obviously not affected by the U.S. Constitution and the commercial speech doctrine developed by U.S. courts. Thus, while the U.S. appears to be headed toward more liberal use of health claims on food, Canada may not be joining it anytime soon. One day, the U.S. and Canada may work toward harmonizing their food labeling requirements. A worthwhile objective of such an effort would be to allow food manufacturers in each country to develop a single label that would be legally acceptable throughout the combined territory of the two countries. This objective could be accomplished in more ways than one. The regulatory authorities in both countries could sit down and iron out the minor differences in the nutrition labeling rules. For example, a single set of RDIs for nutrients could be agreed upon. Alternatively, a "mutual recognition agreement" could be reached, whereby each country would agree to permit the marketing of prepackaged food that originates in the other country and is labeled in compliance with the requirements of that country. In any event, U.S. manufacturers planning to market products in Canada will need to provide bilingual French/English labeling, a sensible requirement that certainly won't go away any time soon. If the label is required to disclose high fat content, that might not sound good in either language. DAVID JOY is a partner at the Washington DC law firm of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides, and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's web site at www.khlaw.com.