Canada: Canadian and U.S. Regulation of Functional Food Claims

In today's health-conscious marketplace, functional food labelling has grown into a multibillion dollar industry. This method of advertising focuses on the specific health-enhancing characteristics of a food product beyond basic nutritional functions.


Canada currently lacks a comprehensive statutory framework to deal specifically with this type of food advertising. At present, foods carrying these health claims fall under one of two regulatory frameworks depending on whether they are characterized as natural health products (NHPs), governed by the Natural Health Product Regulations, or food, governed by the Food and Drug Regulations.

A product that is classified as food would be governed by general regulations that define permissible and non-permissible functional claims. The Canadian Food Inspection Agency's Guide to Food Labelling and Advertising states that claims must be clear, must be supported by acceptable scientific evidence and should include the specified ingredients in amounts equal to at least the established recommended nutrient intake. Nutritional claims are acceptable. This type of functional food claim specifies the type or quantity of a particular nutrient within the product and advertises the nutrient's well-established role in the maintenance or support of specific bodily functions. These claims may state only the food's effects on the normal functioning of the human body – for example, "Contains 100 percent of an individual's daily vitamin C intake" or "Calcium aids in the formation and maintenance of bones and teeth." A limited number of "risk-reduction" claims that describe a link between a food or food constituent and the reduction of risk of a particular disease are permissible if the wording is exactly as set out in the Food and Drug Regulations.

Although Canada has yet to see a high-profile legal action for deceptive functional food claims, the increase in U.S. lawsuits in this particular field suggests that functional food claims are quickly becoming controversial (see below). Recent Health Canada publications that assist in classifying functional foods1 and guiding health claims on probiotic foods2 suggest that Canadian functional food manufacturers might soon experience warnings similar to those seen in the United States if labelling guidelines are violated. As the Canadian food industry produces increasing quantities of products with functional health claims, it is imperative that food manufacturers and distributors become aware of the labelling limitations imposed on functional food products.

United States

In recent years, the U.S. Food and Drug Administration (FDA) has initiated enforcement practices against companies that use functional food claims to overstate the benefits of their food products. One way that the FDA deals with functional food claims is by prohibiting manufacturers from infusing otherwise unhealthy products with vitamins and other nutrients in order to claim that the product is healthy.

In December 2008, the FDA took issue with The Coca Cola Company's claim that Diet Coke Plus contained a variety of vitamins and minerals. The FDA warned Coca Cola that this labelling violated U.S. policy against marketing soda and other snack foods as nutritious. Earlier this year, the FDA sent a warning letter to the makers of Canada Dry Sparkling Green Tea Ginger Ale stating that it "does not consider it appropriate to fortify snack foods such as carbonated beverages." The makers of Lipton Green Tea also received a warning that the product's labelling is misleading because it suggests that Lipton tea is designed to treat or prevent disease. These FDA warning letters represent a recent wave of enforcement against deceptive functional food claims in the United States. Although not legally binding, these letters are significant because the FDA can commence legal action against companies that ignore the warnings.

In addition to receiving FDA warnings, U.S. functional food producers have recently been faced with lawsuits over health claims carried on their products. In early 2010, the U.S. Federal Court ordered Dannon, the makers of Activia and DanActive yogurt, to pay consumers $45 million in damages under the terms of a class action settlement. The action was based on false claims that the product was "clinically" and "scientifically" proven to regulate digestion and boost immune systems. The court-approved agreement called for Dannon to replace the word "immunity" in its health claims with the phrase "helps strengthen your body's defenses" or "helps support the immune system."3

A lawsuit against Coca Cola's functional food product "vitaminwater" has attracted much attention. In July 2010, a U.S. District Court judge ruled that the lawsuit filed against Coca Cola by the Center for Science in the Public Interest (CSPI) could proceed. The CSPI is claiming that the vitaminwater products make unwarranted health claims and deceive consumers by placing vitamin health claims on a high fructose product that contains 33 grams of sugar per bottle. In fact, the U.S. District Court held that the "potential for confusion is heightened by the presence of other statements in vitaminwater's labeling, such as the description of the product as a 'vitamin enhanced water beverage' and the phrases 'vitamins + water = all you need' and 'vitamins+water = what's in your hand' which have the potential to reinforce a consumer's mistaken belief that the product is comprised of only vitamins and water."4

Whether such lawsuits and enforcement action have a major influence on marketing initiatives within the functional food industry remains to be seen. Given the current climate, we recommend that manufacturers carefully review their product labels and be aware of the potential risks in aggressive advertising claims.


1 Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats, 2009.

2 The Use of Probiotic Microorganisms in Food, April 2009.

3 Gemelas v. The Dannon Company Inc., United States District Court, Northern District of Ohio, Eastern Division, January 20, 2010 [Settlement Agreement].

4 Ackerman v. The Coca-Cola Company and Energy Brands Inc. (d.b.a Glaceau), United States District Court, Eastern District of New York, July 21, 2010

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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