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|Letter to Health Canada Director Ronald Burke: Amendments to Food and Drug Regulations concerning nutrition labelling, nutrition claims, and health claims published in the Canada Gazette, Part I on June 16, 2001.
September 14, 2001
Mr. Ronald Burke, Director
Re: Amendments to Food and Drug Regulations concerning nutrition labelling, nutrition claims, and health claims published in the Canada Gazette, Part I on June 16, 2001.
Dear Mr. Burke:
The Centre for Science in the Public Interest(1) congratulates Health Canada and Minister Rock for moving ahead with plans to introduce comprehensive food labelling reforms. We are especially pleased with the decision to mandate that comprehensive nutrition information be reported on most packaged foods in absolute values and as a percentage of the average recommended daily intake, and that this information be displayed on labels in a uniform, easy-to-read format. In addition, we support Health Canadas approach that allows only health and nutrition claims that it explicitly approves to appear on food labels.
Benefits of food label reforms
Preventive health care is a cost-effective approach to enhancing the public health. As Health Canada and Agriculture and Agri-food Canada noted, poor diets are expected to cost the Canadian economy more than $6.3 billion per year(2) and $76 billion during the next two decades.(3) The proposed reforms to food labelling rules are expected to generate $5 billion in net savings over the next two decades as a result of declining premature deaths and disabilities due to coronary heart disease, stroke, cancer, and diabetes. These predicted cost savings contrast very favourably with the comparatively small $263-$357 million in costs to industry for implementing the label reforms.(4)
CSPI has been a strong advocate of mandatory, comprehensive, and easy-to-read nutrition labelling for over four years, and we support, with some modification, the core list of nutrients that Health Canada has proposed to require on nutrition labels for most foods. However, we are concerned about the potential proliferation of poorly controlled health and nutrition claims used for marketing purposes. Such claims may deceive consumers and impair, rather than improve, the quality of Canadians diets. Two of the five proposed health claims could result in misleading food labels that will not only fail to benefit consumer health, but could increase the risk of other diseases and, in so doing, undermine the credibility of the entire food label. Some of the proposed nutrition claims would have the same results. As outlined in the attached appendices, it is critical that several revisions be made to the proposed regulatory amendments to prevent adverse effects on the public health.
The proposed amendments to the Food and Drug Regulations represent an opportunity for fundamental reform of food labels. All reasonable steps should be taken to optimize this opportunity. In particular, the proposed nutrition labelling rules should be extended to encompass all fresh meat and in-store baked goods chief sources of saturated and trans fats, respectively. We also urge Health Canada to require nutrition labelling for all fresh poultry and marine and freshwater animal products (hereinafter seafood). Nutrition information is particularly important as a decision-making tool on these foods because variation in the nutritional composition of meat, poultry and seafood can not be accurately estimated by consumers using visual inspection. For instance, according to the US Department of Agriculture, a 3 oz. serving of trimmed, broiled Top Round Beef Steak has only 1 gram of saturated fat while a 3 oz. serving of trimmed, broiled Shoulder Blade Pork Steak has 4 grams of saturated fat.
There is an opportunity now to fashion new food labelling regulations that will deliver maximum public health benefits to Canadians and be regarded, by public health officials world-wide, as the model to emulate much like the current Canadian tobacco regulations. We urge Health Canada to review its proposal with the objective of advancing the public health to the greatest extent possible.
The proposed regulations could be specifically improved by taking the following measures:
We also encourage you to ensure that Health Canada and the Canadian Food Inspection Agency have the funds necessary to educate the public about the new labels, monitor compliance by manufacturers, and take appropriate enforcement measures when necessary.
If we can be of any assistance to your office in addressing these concerns, please do not hesitate to contact us at (613) 565-2140.
cc. The Honourable Allan Rock, M.P., P.C., Minister of Health
1. EXEMPTIONS FROM NUTRITION LABELLING FOR MEAT, POULTRY AND MARINE AND FRESHWATER ANIMAL PRODUCTS
Exemptions from nutrition labelling for raw, single-ingredient meat, poultry and marine and freshwater animal products (hereinafter seafood) deprive consumers of important nutrition information on products that vary considerably in nutritional content and, in some cases, are a significant source of saturated fat.
Close the loophole for labelling fresh meat, poultry and seafood and extend the grace period for complying with mandatory nutrition labelling rules to three years for these foods by:
(a) Deleting proposed subparagraphs B.01.401(2)(b)(iii) and (iv); and
(b) Inserting the following transitional provision:
34 (4) In applying subsection (2) in respect to a single ingredient meat, meat by-product, poultry meat or meat by-product that is raw and not ground, marine or fresh water animal product, the reference to two years in that subsection shall be read as a reference to three years.
Conferring an outright exemption on fresh, single-ingredient meat, poultry, and seafood from compliance with nutrition information requirements withholds from consumers information that is critical from a public health perspective. Consumers need nutrition information on the labels of all meat, poultry and seafood products to better follow the Canada Food Guide and Health Canadas dietary advice to choose lower fat foods and leaner meat, poultry and seafood. According to the most recent available data, meat, poultry and seafood (including fresh, processed and restaurant food) contribute 23.9% of the saturated fat in the Canadian diet.(8) Nutrition information is particularly important as a decision-making tool on these foods because variation in the nutritional composition of meat, poultry and seafood can not be accurately estimated by consumers using visual inspection. For instance, according to the US Department of Agriculture, a 3 oz. serving of trimmed, broiled Top Round Beef Steak has only 1 gram of saturated fat while a 3 oz. serving of trimmed, broiled Shoulder Blade Pork Steak has 4 grams of saturated fat.
Instead of exempting these foods from nutrition labelling requirements, Health Canada could, if necessary, extend the grace period for complying with mandatory nutrition labelling rules from two to three years for all raw, single-ingredient, fresh meat, poultry, and seafood products. The extended grace period would give the industry additional time to develop a reference table of the nutritional composition of these products. The use of nutrition information in advertisements and industry web-site marketing information suggests much progress has already been made. See, for instance, http://www.beefinfo.org/nutrient.cfm where the Beef Information Centre (a division of the Canadian Cattlemens Association) supplies detailed nutrition composition information for more than 100 cuts of beef.
Canadian consumers support nutrition labelling for these foods. In 1992, 67% of respondents to a public opinion survey expressed interest in seeing more nutrition information on store-wrapped meats.(9) More recently, the report of a series of focus groups conducted for Health Canada observed: Several respondents mentioned disappointment in the fact that there are no labels for fresh foods such as produce and packaged meat.(10)
Health Canadas justification for exempting fresh meat, poultry and seafood products is that there is inadequate, unreliable industry knowledge about the nutritional composition of these products. However, industry-supplied estimates for analysing pre-packaged prepared meats suggest that analysing fresh meats to create a nutrient reference table will not be excessively onerous for industry to develop. According to a Deloitte & Touche survey of Canadian food companies, the average estimated analytical costs for meat, meat products, poultry products, and fish is $1,264 per stock-keeping unit (SKU). This cost is less than the industry average of $1,345 for the 50 product categories surveyed. It is comparable to, or less than, virtually every class of products surveyed with the notable exceptions of fluid milk and frozen fruits and vegetables.(11)
2. EXEMPTION FOR FRESH FRUIT AND VEGETABLES
The proposed exemption for fresh fruits and vegetables deprives consumers of information about the nutritional composition of these foods and would preclude comparison of their nutritional content with that of canned and frozen vegetables.
Delete proposed section B.01.401(2)(b)(ii).
Health Canada proposes that all fresh fruits and vegetables (whether packaged or not) be exempt from nutrition labelling requirements. We see no reason for this arbitrary exemption. The degree of processing should not determine whether nutrition information is provided for consumers. All fruits and vegetables whether fresh, frozen, or canned should be required to provide full nutrition information. Nutrition information for pre-packaged produce can simply be included on the label, as is proposed for all other packaged foods. Nutrition information for unpackaged produce could be provided at the point-of-purchase with shelf markers, bin labels, or posters. This information should be provided in the same standardized format as is proposed for packaged food labels (see, Exemption for Bulk Foods, below).
3. EXEMPTIONS FOR BULK FOODS
Health Canada proposes to exempt foods sold in bulk from nutrition labelling requirements.
(a) Insert the following subsection:
B.01.401(1.1) In applying subsection (1) in respect of a food that is not prepackaged, the reference to label shall be read as a reference to shelf liner, bin label or brochure located at the display case or receptacle, and any reference to label space in these regulations shall be read as a reference to space available at the bin or receptacle from which the food is displayed for sale.
(b) Delete the word prepackaged everywhere is appears in the proposed regulations, except in section B.01.001 (definitions) and subsections B.01.401(1) and B.01.401(1.1).
Nutrition information for unpackaged produce and other foods sold in bulk should be provided at the point-of-purchase with shelf markers, bin labels, or posters. This information should be provided in the same standardized format as is proposed for packaged food labels. There is no evidence in the record that it is overly burdensome for nutrition information to be provided for bulk foods.
4. EXEMPTIONS FOR FOODS PREPARED AT THE RETAIL SITE
Problem: The proposed exemption from nutrition labelling for foods intended to be sold in the establishment where the product is prepared and processed and where the ingredients are mixed and combined would permit many foods with low nutritional merit to escape nutrition labelling requirements.
Add the words when prepared at the request of a consumer immediately before the comma in the proposed exemption for foods processed and prepared on-site at the retail premise in subparagraph B.01.401(2)(b)(vi).
In-store baked goods include many cakes, pies, cookies and muffins that are high in trans and saturated fat, sugars and calories, and low in fibre, vitamins and minerals. The place of production of a food product should not determine whether nutrition information must be provided on the label, and we believe that most grocery stores and bakeries should have little difficulty supplying this information.
We recognize that this exemption was partly intended to give some relief from the nutrition labelling requirements to small bakeries and butcher shops in the absence of a small-business exemption (see below). However, the exemption is over inclusive because it includes large stores that can easily comply with the rule, and is not rationally connected to the goal of relieving smaller stores from burdensome requirements. We believe that this exemption should be limited to customized foods prepared at the request of consumers (such as birthday cakes and made-to-order cheese trays).
5. EXEMPTIONS FOR SMALL BUSINESSES
The proposed exemptions (e.g., for foods prepared on the retail premises) do not adequately relieve small businesses of regulatory burdens. Such exemptions, however, do relieve large companies from the responsibility of providing nutrition information that members of the public clearly need to protect their health.
(a) Reconsider the scope of the authority conferred on the Governor in Council in section 30 of the Food and Drugs Act to ascertain whether it permits exemptions for low-volume foods.
(b) Insert the following provision in paragraph B.01.401(2)(b):
(viii) manufactured in Canada or imported into Canada by the company responsible for the labels, in volumes of less than 10,000 units in the previous calendar year.
(c) Delete proposed subparagraphs B.01.401(2)(b)(iii) and (iv) (which exempt meat, poultry, seafood and foods processed at the retail establishments) and revise subparagraph B01.401(2)(b)(vi) as proposed in Part 4 above.
(d) If necessary, in consultation with the Ministers of Finance and National Customs and Revenues, implement a system of tax credits to alleviate the costs incurred for providing nutrition information by food companies with annual sales of less that $100,000 per stock-keeping-unit.(12)
(e) Only if the measure described in (b) (above) is adopted, delete the transitional provision in 34(3) of the proposed regulations (the extended grace period for small businesses).
Health Canada should consider other approaches instead of the exemptions currently under consideration for addressing the burden that labelling requirements place on small business, and we believe that the agency has authority to do so. Subsection 30(1) of the Act confers broad authority on the Governor in Council to adopt regulations. While that subsection enumerates specific categories of regulation-making authority, the preamble to that list stipulates that the Governor in Councils authority is not limited to those specific categories. Furthermore, even if the enumerated list restricts the Governor in Councils regulation-making power, it does so only in respect to the power to make regulations that provide exemptions from the Act, not from any regulations.
While subsection 30 of the Food and Drugs Act does not specifically authorize the creation of exemptions for manufacturers of a certain size, its plain meaning does appear to contemplate exemptions for low-volume products. For instance, subsection 30(1) of the Act provides in part that:
The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations...
(b) respecting (i) the labelling and packaging and the offering, exposing and advertising for sale of foods, drugs, cosmetics and devices...
Even if subsection 30(1) prohibits the Governor in Council from conferring exemptions from the regulations on small businesses, it does not appear to fetter the Governors discretion to exempt products that are sold in small production runs. Using the size of the production run (rather than the size of the business that imports or manufactures the product) as the basis for the exemption appears to bring this type of regulation squarely within the authority contemplated by subsection 30(1)(j) of the Act.
Indeed, basing exemptions on the volume of the annual production run, rather than on the location of production or the annual sales of the manufacturer/importer, more closely corresponds to the nature of the burden created by the regulatory requirements. The costs per unit of making nutrition labelling changes favour companies that have large-scale production runs. For example, medium-size companies that manufacture hundreds of product lines may incur more costs than small companies that produce only a few products. Finally, costs associated with providing nutrition information also vary by product and package type. Indeed, some small businesses that produce certain products (such as fluid milk) may have little difficulty complying with nutrition labelling requirements.
For these reasons, exemptions for products that are imported or manufactured in Canada (in manufacturing plants or on-site in retail establishments) in volumes of less than, for instance, 10,000 units per year, could be exempted from providing nutrition information on labels. Such a regulation would provide relief to low- volume imports or manufactured foods such as specialty foods, made-to-order foods, and seasonal foods.
6. FOLIC ACID
The failure to require disclosure of the amount of folic acid on labels prevents consumers from selecting foods that may help reduce the risk of neural tube birth defects and possibly help reduce the risk of heart disease.
(a) Set a daily value of 400 micrograms in the Reference Standards table to proposed section B.01.001.1 by adding the following:
(b) Add the following text to the Core Nutrition Information table in proposed section B.01.401 following the information concerning vitamin A, Vitamin C, calcium and iron:
(c) Increase from seven to eight the threshold number of nutrients not present in a food in order for a manufacturer to use the simplified format in proposed section B.01.401(5), and from six to seven in proposed section B.01.403(5).
(d) Revise all of the applicable figures in proposed schedule L accordingly.
Requiring manufacturers to disclose the amount of folic acid will encourage them to fortify foods with this important safeguard against neural tube birth defects. Disclosure will also assist women of child-bearing age to select foods rich in folic acid.
Dietary folacin does not occur naturally in sufficient quantities in most foods to satisfy the 400 microgram recommended daily intake to reduce the risk of neural tube defects such as spina bifida and fetal anencephaly. However, a mandatory requirement for disclosure of folacin content of foods would encourage consumers to choose good sources of folacin or alert them to the low levels of folacin in foods that they may erroneously believe are good sources. It would also act as an effective incentive for food manufacturers to fortify their products with folic acid, thereby increasing its availability in the food supply. Folic acid fortification of commonly consumed foods such as bread, cereals, and pasta would increase folacin intake, which is especially important for women of childbearing age who do not take folic supplements.
Taking a multivitamin with folic acid may be the most convenient and foolproof way to ensure an adequate intake of folacin to reduce these risks. However, for the millions of Canadians who do not take supplements, it is critical that food labels disclose folacin levels.
The effect of a mandatory fortification program for flour and other grains is credited with producing a remarkable 19% decline in the rate of neural tube birth defects in the United States a decline from 37.8 to 30.5 per 100,000 live births.(14) Requiring that folic acid content be disclosed on labels would provide an incentive for manufacturers to fortify foods and, thereby, replicate this impressive public health benefit in Canada. Additional research suggests that folic acid fortification could lower the incidence of cardiovascular disease by as much as 13% in men.(15) However, labelling would only be an effective incentive if folic acid disclosures were required on all labels.
7. ADDED SUGARS
The failure to require the amount per serving of added sugars to be disclosed on the nutrition label foregoes a valuable opportunity to help consumers distinguish nutrient-poor foods from those that are more healthful.
(a) Set a daily value (or recommended maximum daily intake) of 40 grams for added sugars by amending the Reference Standards table in proposed section B.01.001.1 as follows:
(b) Require that the amount of added sugars per serving be listed separately on nutrition labels as a percentage of the recommended maximum by adding the following to the table to proposed section B.01.401:
(c) Increase the threshold number of nutrients not present in a food in order for a manufacturer to use the simplified format to eight (from seven) in proposed section B.01.401(5), and from six to seven in proposed section B.01.403(5).
(d) Revise all of the applicable figures in proposed schedule L accordingly.
We believe that treating all sugars equally on the nutrition label fails to assist consumers in choosing a healthy diet. While naturally occurring sugars are chemically identical to added sugars, treating them the same for labelling would be misleading. Added sugars are found largely in soft drinks, baked goods, candies, and other empty-calorie, nutrient-poor foods that should be consumed in smaller quantities by the average Canadian. By contrast, naturally occurring sugars are found in nutrient-dense fruits and dairy products, foods that appear to lower the risk of major illnesses that threaten Canadians health.(16) Requiring disclosure of added sugars content will help consumers distinguish foods that are high in total sugars (such as nutrient-rich orange and grapefruit juices) from foods that are high in added sugars (such as fruit drinks made with very little real juice).
Foods that are high in added sugars offer no known benefits and, instead, replace foods that are more healthful. Data from the U.S. Department of Agriculture indicate that people who consume diets high in added sugars consume lower levels of protein, fibre, vitamins A, E, C, B-6, B-12, riboflavin, niacin, folacin, calcium, iron, zinc, and magnesium.(17) They also consume fewer servings of grains, fruits, vegetables, meats, and dairy products than people who consume less added sugar. For some people, diets rich in added sugars also contribute to obesity, which increases the risk of diabetes, heart disease, high blood pressure, and other health problems.
The U.S. Department of Agriculture recommends a limit of 40 g of added sugars per day for a 2,000 calorie diet. Accordingly, we recommend that Health Canada adopt this figure as the Canadian Daily Value (DV) so that amounts of added sugars (rather than total sugars) can also be expressed as a %DV, like most other nutrients.
8. HIERARCHY OF LABEL FORMATS
The proposed regulations establish a hierarchy of label formats (i.e., standard, horizontal, abbreviated, reduced font size and linear formats) that manufacturers must use, depending on the available label space on their packages. However, the proposed regulations fail to specify particular qualifying criteria (in square centimetres) for using each label format. This omission undermines the objective of maximizing the readability of labels and creates enforcement problems.
(a) Replace the words
if the available label space of a prepackaged product [cannot accommodate a nutrition facts table in the specified format(s)]with
if the available label space is less than XX/YY/ZZ square centimetres
in each of the following subsections of the proposed regulations(18)
The values for XX, YY, ZZ would be established by Health Canada in the same way that the value in proposed section B.01.458 is prescribed.
(b) The regulations should explicitly prohibit manufacturers from using the abbreviated or linear format merely because they choose to provide nutrition information in the dual format (proposed section B.01.459), provide additional nutrition information (proposed section B.01.461), or use the split unilingual format.
We are concerned that the failure of the proposed regulations to specify eligibility criteria for use of particular format options will undermine the goal of easy-to-read nutrition labels. As a result, manufacturers may be able to fill the available label space with voluntary information separate English & French nutrition panels, dual nutrition information (e.g., reported for the product consumed with and without milk), information about the amounts of 30 non-core nutrients and then make use one of the alternate labelling formats (horizontal, abbreviated, or linear formats) for the required nutrition information.
Under the regulations, as proposed, enforcement officers must exercise considerable discretion in deciding whether the regulations are being violated. We are concerned that the lack of clear rules could lead to abuses by manufacturers. In particular, we recommend that the linear format be prohibited except in very limited circumstances because it is much more difficult to read than the tabular formats. Indeed, the example provided in section 2 of the October 2000 Consultation Document on Label Format (no parallel bilingual examples are provided in proposed Schedule L) indicates that very little space is saved by using the linear format.
We recognize that the horizontal tabular format may be impracticable for some types of packages that have surface areas of less than 260 cm2 surface area where the package is long and very narrow. However, manufacturers should not have the discretion to determine how much space is sufficient to provide nutrition in a tabular format. Manufacturers should only be permitted to use the linear format on packages where the width of the narrower dimension of the broadest package surface is less than 4 cm.
9. LINEAR FORMAT
Nutrition information is very difficult to read when presented in linear or string format.
Add the following subsections to sections B.01.457 and B.01.464:
(3) The names of all nutrients reported in the linear formats described in this section shall be presented in bold face and the amounts of the respective nutrients shall not appear in boldface.
Even the most comprehensive nutrition labelling requirements are worthless if the format for this information is not readable. The proposed format for small packages should be revised to ensure that nutrition information is easier to read and is clearly provided on the label whenever possible.
10. ALTERNATIVE METHODS OF PRESENTATION FOR SMALL PACKAGES
When nutrition information in not displayed on very small packages, consumers are unlikely to request nutrition information by mailing a written request.
Delete the words at least a postal address or from proposed subsection B.01.458(4).
A toll-free number (not only a mailing address) should be required on product labels so that consumers can obtain nutrition information in a simple and timely manner. Requesting nutrition information by mail is a much more cumbersome, time-consuming method of obtaining nutrition information and it is much less likely to be used by consumers.
11. NUTRITION INFORMATION FOR PRODUCTS REQUIRING THAT NUTRITIVE INGREDIENTS BE ADDED BY CONSUMERS
It is misleading to provide nutrition information based on foods as sold when nutritive ingredients (i.e., besides water) must be added to the product by the consumer prior to consumption.
Amend proposed section B.01.405 by replacing the words as offered for sale with as consumed.
For products that require the addition of other ingredients before consumption (such as beverage mixes and cake mixes), nutrition information should be provided for the food as prepared by the consumer. Providing nutrition information for the product as sold should be voluntary. The failure to provide nutrition information as prepared would be very misleading and would make it difficult for consumers to independently determine the actual nutritional composition of the finished product.
12. ACCURACY OF NUTRITION INFORMATION ON LABELS
The absence of stated accuracy requirements for nutrition information will undermine the reliability of the information provided and provide enforcement problems for regulators.
We recommend that Health Canada, in association with the Canadian Food Inspection Agency, issue enforcement standards, including variance thresholds, before the amendments are put forward to the Special Committee of Council.
To ensure the accuracy and reliability of food labels, we recommend that all nutrition information provided on labels vary by no more than 10% from the actual amounts of nutrients found in a sample of the food offered for sale. If variances greater than 10% are permitted, then the publics confidence in, and effective use of, all nutrition labels will be undermined.
13. NUMBER OF SERVINGS PER CONTAINER
Failure to require that the number of servings per container be reported impairs the ability of consumers to estimate serving sizes and plan meals accordingly.
Insert the following provision in the Core Nutrition Information table in proposed section B.01.401:
Manufacturers should be required to report the number of servings per container. This information would assist consumers in determining how large a serving is and in planning meals accordingly. For example, a 240 mL serving size of juice may be easier to visualize if a consumer knows that there are eight such servings in a 1.89 L carton. Disclosing the number of servings per package is also useful in comparing products whose package volume is the same, but whose weight varies significantly.
14. NUTRITION INFORMATION BASED ON DAILY VALUES
Failure to require manufacturers to disclose that nutrition information is based on a 2000-calorie diet will mislead consumers who have very high or very low nutritive intakes or requirements.
Remedial Solution: Insert the following provision in the Core Nutrition Information table in proposed section B.01.401:
All nutrition labels should be required to disclose the fact that the Daily Values are based on a 2,000 calorie diet. If consumers know that the recommended intake levels are set for a specific caloric intake level, they can adjust Daily Values to their own caloric levels.
15. SERVING SIZES
It is not clear from the regulations that the longstanding problems associated with variable serving sizes have been addressed by the reference amounts for 151 categories of foods that are specified in proposed Schedule M.
Edit item 1 in the Core Nutrition Information table in proposed section B.01.401 as follows:
Permissible serving sizes, wherever possible, should not be expressed as ranges. We recognize that some foods of the same type such as cookies or dill pickles vary in size and weight and that serving sizes will necessarily vary from brand to brand. Similarly, foods that are sold as single servings cannot be expected to conform to a prescribed size. However, the serving sizes for pourable or spoonable foods (such as cereal, soups, spreads, ice cream, peanut butter, salad dressings, oils, and beverages) and foods that are intended to be divided into portions that could match a proposed Schedule M reference amount, should not be allowed to vary across brands. For example, currently, the Guide to Food Labelling and Advertising suggests (but does not require) a 35 gram serving size for peanut butter; other suggested serving sizes in the Guide are expressed as ranges. As a result, Kraft Peanut Butter uses a serving size of one tablespoon, while Presidents Choice Peanut Butter uses a serving size of two tablespoons. To compare nutrition information between those two products, consumers have to remember to check the serving size before checking calories or other nutrients. Then, they must double the numbers listed on the Kraft label or halve the numbers listed on the Presidents Choice label.
To rectify this problem, serving sizes should be, wherever possible, based on the Reference Amounts stipulated in Schedule M. Standardization makes it easier for consumers to make nutrient comparisons among foods and ensures that companies do not use an unrealistically small or large serving size to favourably portray the nutritional composition of their products.
1. DISQUALIFYING LEVELS FOR ALL HEALTH CLAIMS
The proposal would allow health claims on foods that are high in saturated fat, trans fat, cholesterol, sodium, or added sugars.
Insert the following provision at the end of proposed section B.01.600:
(3) Any food that contains more than 13.0 g of fat, 4.0 g of saturated/trans fat, 60 mg of cholesterol, 480 mg of sodium, or 8 grams of added sugars per reference amount will not be allowed to carry a statement or claim set out in column 1 of the table to this
CSPI strongly urges Health Canada to adopt a general policy that would prohibit a food label or advertisement from bearing a health claim when the food contains high levels of an unhealthful nutrient. Excessive consumption of unhealthful nutrients is linked to serious public health problems. Intake of these nutrients should not be encouraged by the use of health claims even if the foods have other health benefits.
As Health Canada has acknowledged, there was broad support from health professionals and health and consumer interest groups for general nutritional requirements that foods must first satisfy in order to bear health claims. Indeed, as Health Canadas report on the health claims focus group noted:
Participants were very quick to say that just because a food is low in fat or sodium, it may be high in something else that is not healthy...Participants wondered about the value of promoting the benefits of one element when there may be other harmful elements in the food...Overall these concerns imply that Health Canada should not be in a position to recommend a food that could potentially be bad for consumers, even though it is good in one key element or component. (20) [emphasis added]
We believe that a requirement that a food not exceed established levels of unhealthful nutrients in order to be eligible to make a health claim is the most important of these general requirements.2. MINIMAL NUTRITIONAL REQUIREMENTS
The proposal does not prohibit health claims for foods that have little nutritional value.
(a) Insert the following provision in proposed subsection
(d) the food contains 10 percent more of the recommended levels for vitamin A, vitamin C, iron, calcium, protein, or fibre per reference amount prior to any nutrient addition.
(b) Insert the following provision in the eligibility criteria for the dental carries/sugar alcohol claim in column 2, item 5 of the table to section B.01.600:
Paragraph B.01.600(1)(d) does not apply to this claim.
CSPI urges Health Canada to adopt a general policy that, in most circumstances,(21) all health claims should be restricted to foods that have some minimum nutritional value prior to any fortification. Allowing candy, soft drinks, and other foods with low nutritional value to carry a health claim would undermine the goal of assisting consumers in eating a more healthful diet. While such a requirement would not prohibit any of the five proposed health claims, it should be established as a general precondition to any health claim being approved in the future.
3. IMPLIED CLAIMS
The proposal currently does not define implied health claims such as this cereal is a heart-healthy food. The failure of the proposal to cover implied claims creates an incentive for food companies to make implied claims in order to avoid the requirements for making express claims. Such claims might mimic the appearance of express health claims and mislead consumers into erroneously believing that certain foods provide health benefits when that is not the case.
Insert the following provision at the end of proposed section B.01.600:
(4) (a) All implied health claims that relate to any claim set out in the accompanying table, will be subject to the applicable conditions set out in columns 2 and 3;
It is essential that Health Canada make clear that its rules apply to both express and implied health claims. Otherwise, manufacturers may use implied claims to avoid the requirements established for express claims,(22) and in so doing, deceive consumers concerning the healthfulness of foods.
4. CALCIUM/OSTEOPOROSIS CLAIM
The proposed rule does not limit the saturated fat content of foods making an osteoporosis claim.
Insert the following under column 2 of Item 2 in the table to proposed section B.01.600:
and (g) contains less than 4.0 grams of saturated/trans fat per reference amount.
As we have noted above, it is essential that Health Canada set disqualifying levels for total fat, saturated/trans fat, sodium, cholesterol, and added sugars content that a food must meet before making any health claims. However, if Health Canada chooses not to set general disqualifying levels for all health claims, then it must, at the very least, address the problem posed by the high saturated fat content of many of the foods that could otherwise make a calcium/osteoporosis claim.
The current proposal would allow calcium/osteoporosis claims on high-fat cheeses, pizza, and numerous other foods that are high in saturated fat. In 1995, dairy products were estimated to contribute 33.4% of the saturated fatty acids in the diets of Canadians.(23)
It is highly misleading to allow an approved health claim on a food that helps prevent one disease, but helps promote another. Essentially, Health Canada is leaving the burden on consumers to determine that these foods would help them follow one Nutrition Recommendation but hinder them from following others. Consumer confusion could undermine public confidence in authorized health claims and jeopardize the effectiveness of valid, non-misleading claims.
The report of Health Canadas health claims focus group supports this view: It is useful to note that some felt that foods high in calcium may be high in saturated fat. This did not influence belief in the claim as much as it made participants wonder about the usefulness of this claim to their total health, beyond strong bones. (24)
Without setting a limit for saturated fat content for this health claim, Health Canada is putting the health of adults in jeopardy. For example, postmenopausal women, who are concerned about osteoporosis, also have a high risk of heart disease and are therefore advised by the Nutrition Recommendations for Canadians to limit their saturated fat intake. A calcium/osteoporosis claim for a product that is high in saturated fat will make it harder for these women to follow dietary advice. Similarly, autopsies of young soldiers killed during the Korean and Vietnam Wars indicate that atherosclerosis begins in the second decade of life. Therefore, a calcium/osteoporosis claim on foods that are high in saturated fat could promote atherosclerosis in male teens and young adults, who are at risk for heart disease starting in middle age.
Supermarkets now carry a wide selection of foods that supply more than 200 mg of calcium without supplying high levels of saturated fat. The agency should send a clear, simple message to consumers that these low-fat and fat-free milk, yogurt, cheese, and other products are the type of foods that should be considered by those seeking to increase their intake of calcium.
If Health Canada chooses not to limit the saturated fat content of foods that make osteoporosis claims, then we propose that the regulation permits two separate claims: (1) a claim for products marketed to adults and teenagers that would have a saturated-fat limit and (2) a claim aimed at young children with a disclosure requirement triggered by a saturated fat content level in excess of the limit established for the first type of claim.
5. FRUITS AND VEGETABLES/CANCER CLAIM
The proposed rule does not set a sodium or fat limit for this claim, nor does it require that foods making the claim contain a minimum amount of fruits or vegetables.
Insert the following under column 2 of Item 4:
(b) A serving of the food contains less than 13.0 g of fat, 4.0 g of saturated/trans fat, and 480 mg of sodium per reference amount and at least one serving of fruits or vegetables as defined in the Canada Food Guide.
If Health Canada decides against establishing general disqualifying levels for all health claims, then it must prohibit use of a fruits and vegetables/cancer claim for food products that contain significant amounts of fat and sodium. This proposal does not expressly prohibit claims for foods that are high in unhealthful nutrients such as high-sodium tomato soup or high-fat creamed spinach. Excessive amounts of those nutrients may actually increase the risk of coronary heart disease and certain forms of cancer, respectively, thereby undermining the healthful benefits of the fruits and vegetables. A general set of disqualifying levels of nutrients, such as we have proposed, would clarify what we believe to be the intent if not the effect of Health Canada in drafting the proposed regulations.
Furthermore, the plain meaning of the qualifying conditions for this claim (in item 4 in the table to proposed section B.01.600) authorizes many nutrient poor-foods such as fruit jam, ketchup, relish and pickles to carry the fruits and vegetables cancer claim.(25) Health claims on these foods would undermine the message that consumers need to eat full servings of fruits and vegetables in order to receive the health benefits claimed.
1. IMPLIED CLAIMS
The proposed rule currently does not define implied nutrition claims. Without specifying that these types of claims are also covered by the proposal, food companies have the incentive to skirt the rules requirements by making implied claims, such as those that focus on a particular ingredient (e.g. high in oat bran) instead of a nutrient (e.g. high in fibre).
Insert the following provision:
B.01.505.1 Subject to section B.01.503, no person may, on the label or in any advertisement, use any statement, claim, symbol, or mark that
It is essential that Health Canada ensure that it does not create loopholes in the regulatory system governing nutrition claims. Moreover, food manufacturers need specific guidance as to what label statements will be considered implied nutrition content claims. Without strict regulation of implied claims, companies will be able to circumvent the nutrition claim eligibility criteria by making implied claims that mimic the appearance of express nutrition claims and mislead consumers into erroneously believing that certain foods provide superior health benefits when that is not the case.
2. DISCLOSURE LEVELS
Nutrition claims can help consumers readily identify whether a particular food has desirable amounts of certain nutrients. However, if foods with nutrition claims also contain unhealthful levels of other nutrients, then the public health could be undermined.
Insert the following provision:
B.01.503.1 Notwithstanding section B.01.503, any food label or advertisement bearing a nutrition claim permitted by the table to section B.01.503, which contains more than 13.0 g of fat, 4.0 g of saturated/trans fat, 60 mg of cholesterol, 480 mg of sodium, or 8 grams of added sugars per reference amount, must also include on its label, in close proximity to the claim, a statement disclosing all nutrients exceeding the specified levels that are present in the food as follows: See Nutrition Facts for content (e.g., See nutrition information for fat content).(26)
The chief consideration in developing rules for nutrition claims is to assist the Canadian consumer in choosing a healthy diet consistent with the Guidelines to Healthy Eating... (27) For this reason, it is essential that nutrition claims not be used in ways that promote consumption of unhealthful nutrients and worsen the diets of consumers who select products on the basis of such claims.
In the Status Report, Health Canada recognized the problem of using nutrient claims to selectively promote the presence or absence of a nutrient while remaining silent about unhealthful levels of other nutrients. For instance, foods bearing trans fat free, cholesterol free, or low cholesterol claims are completely disqualified from making these claims unless the foods are also low in saturated and trans fats. Similarly, foods bearing the sugar free claim must also meet the requirements for the energy free claim.
However, the proposed rules do not apply this principle consistently. Under the proposed table of conditions in section B.01.503, consumers may select foods labelled low sodium with a belief that the food is a good choice for reducing high blood pressure (a risk factor for cardiovascular disease) without recognizing that it is also high in saturated fat, which promotes high levels of LDL serum cholesterol (also a risk factor for cardiovascular disease). We believe that this approach undermines public health. Manufacturers should not be able to highlight misleading characterizations of their food products, especially when those statements bear directly on consumers health.
3. USE OF FREE AND LOW CLAIMS
The proposed rules on nutrition claims do not require labels of foods that have not been specially processed or reformulated to qualify for the claim to indicate that they are no different from all other similar foods in the same category in regard to the absence or presence of a highlighted nutrient.
Insert the following words in subsection B.01.505(3) immediately prior to the period:
and shall state the applicable statement/claim from column 4 of the table to section B.01.503 in the following format: (Naming the category of food from Schedule M), a (naming the statement/claim) food. (e.g. Applesauce, a cholesterol free food.)
Health Canada has recognized this problem by proposing to require that manufacturers of foods which have not been so re-formulated be prohibited from associating their brand names with nutrition claims. However, Health Canada must go further to prevent consumers from being misled. The requirement CSPI has proposed will better enable consumers to select a healthful diet.
4. ENERGY (CALORIE) CLAIMS
The proposed rule allows use of the term energy interchangeably with the term calories. The term calories is well understood by most consumers, while the term energy is not. Because use of the term energy is vague and misleading, energy claims will confuse consumers.
Delete the term energy in Items 1-5 in the table to proposed section B.01.503 and replace it with calories.
CSPI urges Health Canada to require that all claims related to high or low caloric content of foods refer only to calories, not energy, in order to avoid consumer confusion. At the same time, we urge Health Canada to prohibit the use of energy claims altogether, because they are misleading.
Currently, many food manufacturers are making energy claims for their products, in particular, so-called sports drinks and energy bars. Their goal is to convince consumers that these products provide increased vitality or endurance when, in fact, these foods do nothing more than supply additional calories, usually in the form of refined sugar, or contain additional ingredients not considered safe for use in food products. To eliminate the misleading impression created by these claims, Health Canada should prohibit all energy claims (low-calorie, reduced-calorie, and calorie-free claims should be permitted).
If Health Canada insists on allowing energy claims, then it should require the word calories to appear in parentheses in close proximity to the word energy when it appears on the nutrition label. When the word energy appears on the front of the package, it should be accompanied by a disclosure, such as contains calories.
5. FAT AND SUGAR CLAIMS
The use of claims free, low, or reduced fat or sugar claims can mislead consumers who reasonably assume that a product making one of these claims is also low in calories, when this is not, in fact, the case.
Require that the statement Not a low-calorie food. accompany all fat, saturated/trans fat, and sugar claims in items 10-20 and 33-37 in the table to proposed section B.01.503, where the food product does not satisfy the conditions of low in energy as defined in Item 2 in the table to proposed section B.01.503.(28)
As noted above, Health Canada must ensure that its proposed nutrition claims rules do not create some deceptive results. Many consumers in the United States where nutrition claims have been regulated, since 1994, in a fashion similar to those proposed by Health Canada apparently assume that fat-free or low in saturated fat foods are also low in calories. The proposed disclosure statement is intended to address this problem by correcting the erroneous impression that all foods that are free of, or low in, fat or saturated/trans fat, or are sugar free or contain no added sugar, are always low in calories.(29)
6. HEALTHY CLAIMS
Use of the claim healthy and other related terms are currently restricted under the Guide to Food Labelling and Advertising.
Insert the following provision:
B.01.503.4 The term healthy, as well as an synonyms and words of similar intent, whether used as part of a brand name or anywhere on a label or advertisement, may be used provided that the food
A specific definition for healthy can be an easy-to-use mechanism to identify foods that contain low amounts of risk-increasing nutrients and at least moderate amounts of some healthful nutrients. In the U.S., the use of healthy claims on food labels has had an important impact on the marketplace. It has created new markets for canned soup, frozen dinners, processed meats, and other foods that have been modified to meet the requirements of this claim. A similar regulation could have the same impact on those markets in Canada.
1. The Centre for Science in the Public Interest (CSPI) is a non-profit health advocacy organization specializing in food safety and nutrition issues with offices in Ottawa and Washington, D.C. CSPIs Ottawa health advocacy office is funded by 120,000 subscribers to the Canadian edition of Nutrition Action Healthletter. CSPI does not accept funding from industry or government.
3. This includes the diet-related costs (expressed in 2000 dollars) anticipated over the period 2002-22 of only four diagnostic categories: cancer, diabetes, heart disease and stoke. See: Agriculture and Agri-food Canada, Costs and Benefits of Nutrition Information (2000) at 4.
4. Id. at 4 and 6. See also The Canada Gazette, Part I, Vol. 135, No. 24 (June 16, 2001) at 2054-5. The Regulatory Impact Analysis Statement that appeared in the June 16, 2001 issue of Canada Gazette, Part I, did not account for other potential benefits. For instance, the $5 billion in net economic benefits (due to increased productivity and declining health care costs) predicted to accrue from implementing the proposed regulations do not include the benefits that could flow from requiring nutrition labels on fresh meat, poultry, seafood, and in-store baked goods.
5. As discussed in Appendix B, if Health Canada decides to allow a health claim on the label of dairy products that are high in saturated fat, it should consider allowing two separate claims, one geared to children, and the other to adults. This approach would address Health Canadas concern that limiting the claim to low-fat products may impair the bone growth of children by indirectly decreasing their fat intake. We propose that high-calcium foods that have more than 2 grams of saturated fat be required to disclose, in close proximity to the claim, the amount of saturated fat in a serving of the food and advise adult consumers to choose foods lower in saturated fat.
6. The conditions for this claim (set out in column 2 of item 4 in the table to proposed section B.01.600) permit it to be used for fruits or vegetables ...with or without seasoning, salt, food additives, or sweetening ingredients defined by the standards in Division 11... of the Food and Drug Regulations. Division 11, however, prescribes compositional standards not only for fruit and vegetable products, but also for condiments such as tomato catsup, fruit jam, marmalade, and fruit jelly. Thus, without the revisions we recommend, it seems clear that such products would be eligible to bear the fruits and vegetables/cancer claim.
7. These are permitted under proposed paragraph B.01.311(2)(b).
8. Linda Robbins and Lina Robichon-Hunt, Making the Best Use of Family Food Expenditure Data, in 11 NIN Rapport, No. 2 at 6 (Spring 1996). The data in this paper are based on 1992 estimates. However, the disappearance rates of meat, poultry and fish remained stable (at about 99.5 KG per capita) in Canada during the period 1990-97, suggesting that the contribution of saturated fat did not change significantly over the period. A small (3.3 KG) decline in red meat consumption over the period was offset by a corresponding increase in the consumption of fish and poultry. See Statistics Canada, Food Consumption in Canada: Part I, 1998 (1999), Cat. No. 32-229 at vii.
9. Debra Reid, Consumer Use and Understanding of Nutrition Information on Food Package Labels, at xv (July 1992).
11. Deloitte & Touche, Nutrition Labelling Study: Analytical Framework for Estimating Costs A Study Prepared for Agriculture and Agri-food Canada, at Table 4.1 (2000). The averages calculated by CSPI are based on raw estimates.
12. A system of tax benefits based on actual costs of label changes is a more precise way than an outright exemption for mitigating the impact on small businesses. If necessary, the Governor-in- Council, in consultation with the Ministers of Finance and of National Customs and Revenue could establish a program of tax relief to defray the costs of providing nutrition information for importing and manufacturing companies that have small annual importing and production runs.
13. Paragraphs 30(1)(b) and (j), Food and Drugs Act, R.S.C. 1985, c. F-27.
14. See MA Honein et al., Impact of folic acid fortification of the US food supply on the occurrence of neural tube defects, 23 JAMA 3022 (2001).
15. See, e.g., JA Tice et al., Cost effectiveness of vitamin therapy to lower plasma homocysteine levels for the prevention of coronary heart disease: effect of gram fortification and beyond, 8 JAMA 936 (2001).
16. Numerous studies suggest that a diet rich in fruits and vegetables is associated with a lower risk of several cancers. Food, Nutrition and the Prevention of Cancer: A Global Perspective, Washington, D.C.: World Cancer Research Fund/American Institute for Cancer Research (1997). Other studies have found lower rates of stroke in people who eat more fruits and vegetables. M. W. Gillman, Protective Effect of Fruits and Vegetables on Development of Stroke in Men, 273 JAMA 1113 (1995). The recent DASH study, which found that a low-fat diet rich in fruits (as well as vegetables, low-fat dairy products, etc.) lowered blood pressure in people with high-normal levels. L. J. Appel, A Clinical Trial of the Effects of Dietary Patterns on Blood Pressure: DASH Collaborative Research Group, 336 New Eng. J. Med. 117 (1997). A large body of research also indicates that adequate calcium intakes can reduce the risk of osteoporosis by increasing peak bone mass or by raising (or maintaining) bone density.
17. Testimony of Rachel Johnson, U.S. Dietary Guidelines Advisory Committee Meeting, Washington, D.C., Mar. 9, 1999, at 364.
18. These changes should also apply to the corresponding sections related to labelling food for children under two.
19. These suggested disclosure levels for individual foods except for the proposed level for added sugars are the ones established by the U.S. Food and Drug Administration (FDA) in its rules regarding health claims, 21 C.F.R. §101.14(a)(4). These levels are based on what FDA called a food composition methodology 58 Fed. Reg. 2478, 2492 (1993). They represent a reasonable starting point for Health Canada, which can adjust the levels based on the most-recent nutritional data and research. Additionally, levels for prepackaged meals and main-dish entrees will also have to be established. Moreover, U.S. regulations do not include a disclosure level for added sugars, however, we urge Health Canada to establish one. Sugar promotes the development of plaque, dental caries, and periodontal disease, and excessive consumption of added sugars leads to obesity and diet-related diseases.
21. This requirement need not apply to the proposed health claim for sugar alcohols and dental carries.
22. Policy statements, such as the one concerning the use of heart symbols on food labels in section VII of the Guide to Food Labelling and Advertising, should be codified and incorporated into the rules concerning the use of health claims in the proposed regulations.
23. Linda Robbins and Lina Robichon-Hunt, Making the Best Use of Family Food Expenditure Data, (Spring 1996) in NIN Rapport Vol. 11, No. 2 at 6. The data in this paper are based on 1992 estimates (the most recent available). However, in the ensuing six years, the slight decrease in per capita disappearance of whole milk was partly offset by increases in the per capita disappearance of cheese and cream. See: Statistics Canada, Food Consumption in Canada: Part I, 1998, (1999) Cat. No. 32-229, at vii. Only one ounce of cheddar cheese has 6 grams of saturated fat, more than a quarter of a days worth for someone who eats 2,000 calories a day. Our Compliments Frozen Deep Dish Sausage and Pepperoni Pizza has 12 grams of saturated fat more than half a days worth.
25. The conditions for this claim (set out in column 2 of item 4 in the table to section B.01.600) permit it to be used for fruits or vegetables . . . with or without seasoning, salt, food additives, or sweetening ingredients defined by the standards in Division 11. . . of the Food and Drug Regulations. Division 11, however, prescribes compositional standards for 46 foods including not only for fruit and vegetable products, but also for fruit/vegetable-based condiments such as tomato catsup, fruit jam, marmalade, and fruit jelly. Thus, without the revisions we recommend, it seems clear that such products would be eligible to bear the fruits and vegetables/cancer claim.
26. All of these suggested disqualifying levels except the one for added sugars are the ones established by the U.S. FDA in its nutrient content claim regulations. See 21 C.F.R. §101.13(h). See supra, Appendix A, for a discussion of added sugars.
27. Health Canada, Status Report on Nutrient Content Claims 1 (2000).
28. As noted above, we urge Health Canada require use of the term calories instead of energy.
29. A similar disclosure statement is required under the U.S. rules for sugar-free claims, and the rationale is the same: the disclosure is necessary to eliminate the misleading impression that a food that is sugar free is also low in calories. See 21 C.F.R. §101.60(c)(1); 56 Fed. Reg. 60421, 60435 (1991). The U.S. has yet to require this disclosure for fat claims.