Download Is there such a thing as a North American food label?

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
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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
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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
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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
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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
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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
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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.
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