In recent years, there has been a sudden increase in the popularity of a “gluten-free” diet. Since then, the trend has grown steadily and food products are increasingly being advertised and labelled as “gluten-free”. However, it’s not a free-for-all; Canada has very specific regulatory requirements for advertising claims with regard to food under the Food and Drugs Act and the Food and Drug Regulations. Specifically, a “gluten-free” claim attracts a suite of enhanced requirements set out under Division 24 of the Food and Drug Regulations.

First, to be labelled “gluten-free”, a food product must not contain:

  • any gluten protein from the grain of any of the following cereals or from the grain of a hybridized strain that is created from at least one of the following cereals: barley, oats, rye, triticale, wheat or
  • any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the above cereals or hybridized strain.

Currently, it is Health Canada’s position that, when Good Manufacturing Practices are followed, inadvertent cross-contamination resulting in levels of gluten below 20 ppm is deemed acceptable to meet the above criteria. However, no amount of gluten must have been intentionally added, even if it makes up only a small portion of the final food.

Second, gluten-free foods that meet the above requirements fall under the definition of “foods for special dietary use”. This is defined by the Food and Drug Regulations as food that has been specially processed or formulated to meet the particular requirements of a person

  • in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or
  • for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods.

According to Health Canada, therefore, only foods that have been “specifically processed or formulated” to contain less than 20 ppm of gluten may qualify for a “gluten-free” claim.  In other words, foods that are naturally gluten-free and would not normally contain gluten from cross-contamination do not meet the “specifically processed or formulated” requirement and therefore cannot be marketed as “gluten-free”. This would be the case, for example, where a vegetable juice is manufactured exclusively from vegetables. On the contrary, foods that could be expected to contain gluten, but were (a) specifically processed using additional processing steps that are demonstrated to be effective in removing gluten or (b) specifically formulated to exclude the sources of gluten protein listed above, would be eligible to use a “gluten-free” claim. For example, if the vegetable juice is formulated with additional ingredients that could be expected to contain gluten, such as spice mixtures or seasonings, but was specifically processed or formulated to remove or exclude gluten, then a “gluten-free” claim could be used.

Where a food that does not meet the above requirements is labelled, packaged, sold, or advertised “in a manner likely to create an impression” that it is “gluten-free”, it may be in violation of section B.24.018 of the Food and Drug Regulations.  Further, section 5. (1) of the Food and Drugs Act, which prohibits labelling, packaging, treating, processing, selling or advertising of “any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety”, may also be violated in such circumstances.

Violations are dealt with by the Canadian Food Inspection Agency using “appropriate enforcement action”, which may include the possibility of recall on the basis of a health risk assessment by Health Canada. Therefore, it is extremely important for companies marketing food in this sector to know exactly when a “gluten-free” claim can be made, as mistakes may have costly consequences.