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 DrugRegulations.
Specifically, a "gluten-free" claim attracts a suite of
enhanced requirements set out under Division 24 of the Food and Drug
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
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
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
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
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