Language selection

Search

Labelling requirements for foods for special dietary use

On this page

Overview

Foods for special dietary use sold in Canada are subject to the provisions of the Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR), as well as those of the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR).

When sold intraprovincially, foods for special dietary use are subject to the labelling requirements under the FDA and FDR, as well as specific requirements of the SFCA and the SFCR that apply to prepackaged foods sold in Canada, regardless of the level of trade. Provincial regulations may also have labelling requirements that apply when these products are sold within that province.

In general, only the following foods can be represented in a manner likely to create the impression that they are foods for special dietary use, when they meet specific criteria outlined in Division 24 of the FDR [B.24.003(1) and (2), FDR].

The labelling requirements detailed in the following section are specific to foods for special dietary use. Refer to the Industry Labelling Tool for core labelling and voluntary claims and statements requirements that apply to all prepackaged foods.

Expiration date

The expiration date must be present on the label of:

For information on this subject, refer to Date markings.

Nutrition labelling - foods for special dietary use

Formulated liquid diets, meal replacements, nutritional supplements and foods represented for use in a very low energy diet have detailed and explicit nutrition and other labelling requirements set out in Division 24 of the FDR. They are also prohibited from using the Nutrition Facts table heading (that is to say, "Nutrition Facts", "Valeur nutritive" or "Valeurs nutritives"). An appropriate heading for nutrition labelling could be anything reasonable, including "Nutrition Information". However, these foods may voluntarily use the Nutrition Facts table format with respect to order of presentation, naming of nutrients, fonts, layout, etc., provided the applicable requirements of Divisions 24 are met [B.01.401(4) and (5), FDR].

The foods listed above for special dietary use are prohibited from displaying a front-of-package (FOP) nutrition symbol. Foods represented for protein-restricted diets and low (naming the amino acid) diets are also prohibited from carrying the nutrition symbol [B.01.350(15), FDR].

For more information, refer to Are any foods prohibited from displaying the FOP nutrition symbol? in the Front-of-package nutrition symbol labelling guide for industry.

Compliance of nutrient content declarations

As they are prohibited from using the Nutrition Facts table heading, the nutrition labelling compliance test is not used to verify the nutrient content declaration on the labels of these products. Instead, the Canadian Food Inspection Agency (CFIA) uses the procedure outlined below.

Methods of analysis

The nutrient content of products can be measured by using internationally accepted methods of analysis such as methods of the Association of Official Analytical Chemists (AOAC) InternationalFootnote 1 or Health Canada acceptable methods. A list of validated laboratory methods and techniques can be found in Appendix 4 – Laboratory issues of CFIA's nutritional labelling compliance test.

Tolerances

In order to verify the nutrient content of a product, 5 sample units are to be drawn at random and analyzed as a composite or separately and the results averaged. The size of a sample unit will vary depending upon the nutrient analyzed, the methodology used and the food; on average, a 250 g sample is sufficient. The option of testing a composite sample or testing individual samples is provided to address the cost of analysis.

It is the responsibility of industry to determine how best to collect and analyze their products to ensure the accuracy of declared values.

When a claim or regulation stipulates a minimum value, the lot is deemed to be non-compliant if:

When a claim or regulation stipulates a maximum value, the lot is deemed to be non-compliant if:

However, while sodium is considered an added nutrient in foods for special dietary use, there is no Regulation that stipulates a minimum or maximum amount for sodium in these foods, except meal replacements for which a minimum amount is prescribed. For a lot to be deemed compliant when no minimum or maximum amount is prescribed, the reported result must be between 90 to 110 percent of the declared value on the label.

Variance

It is recognized that any declaration of the nutrient content is subject to variance. That is why, when the nutrient content is declared at the stipulated minimum or maximum, that level is established as the tolerance for the product. If the declaration is below the maximum level or above the minimum level, an additional 10 percent tolerance is applied to the declared value.

The amount of vitamin, mineral, protein, carbohydrate, starch, dietary fibre, polyunsaturated fatty acids, monounsaturated fatty acids or potassium, may vary over labelled amounts within good manufacturing practices. The amount of energy, sugars, fat, saturated fatty acids, cholesterol or sodium may vary under labelled amounts within good manufacturing practice.

Reasonable overages of the added vitamins and minerals within good manufacturing practice should be present to ensure that the required level of vitamins and minerals are maintained within the expected shelf life of the food.

Rounding of nutrient values

Manufacturers can use either the rounding rules set out in the tables to sections B.01.401 and B.01.402 of the FDR (see Rounding rules) or the Foods for special dietary use rounding rules below, but should consistently use one system or the other for the entire nutrient content declaration.

In the case of meal replacements and nutritional supplements, nutrient values, which must be expressed in the units specified in B.24.202, may be rounded according to the rules specified in the tables to B.01.401 and B.01.402.

These same rounding rules may not however be applied to formulated liquid diets and to foods for use in very low energy diets, since the units in which some nutrient values must be expressed for these types of foods, as specified in B.24.103 and B.24.304, differ from those in the tables to B.01.401 and B.01.402. The Foods for special dietary use rounding rules below would therefore need to be applied.

Foods for special dietary use rounding rules

Formulated liquid diets

A formulated liquid diet is required to be a complete substitute for the total diet in meeting the nutritional requirements of a person [B.24.101, FDR]. Therefore, formulated liquid diets have detailed and explicit compositional requirements and labelling requirements [B.24.102, B.24.103, FDR]. Formulated liquid diets cannot be advertised to the general public and are not to be confused with infant formula [B.24.100, FDR].

Statement

All formulated liquid diet products must have a statement on their label indicating that the food is to be consumed orally or by tube feeding [B.24.103(a), FDR].

Nutrient content declaration - formulated liquid diets

The label of formulated liquid diets must have a statement indicating per 100 grams or 100 milliliters of the food as offered for sale and per unit of ready-to-serve food:

Directions for preparation, use and storage

Complete directions for the preparation and use of the food and for its storage after the container has been opened must be present on the label of formulated liquid diets [B.24.103(f), FDR].

Meal replacements

It is prohibited to sell or advertise a meal replacement unless, when in a ready-to-serve form or when prepared according to the directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the requirements for a meal replacement as set out in B.24.200, FDR. These include:

Nutrient content statement - meal replacements

Meal replacements to which milk, partially skim milk or skim milk is to be added, must carry a statement that the nutrient content of the food has been determined taking into consideration the milk, partially skim milk or skim milk that is to be added according to the directions for use [B.24.202(b), FDR].

Nutrient content declaration - meal replacements

The label of meal replacements must have a statement indicating per serving of stated size and per stated quantity of food, when prepared according to the directions for use:

When used in a weight reduction diet

Additional labelling requirements must be met when a meal replacement is sold or advertised for use in a weight reduction diet.

Refer to Required weight reduction statement and Direction for use - prepackaged meal for use in weight-reduction diet as the same requirements apply.

When used as a replacement for all daily meals

When a meal replacement is represented as a replacement for all daily meals, the maximum amount of energy from fat is reduced to 30 percent, of which no more than 10 percent may be from saturated fat [B.24.200(2), FDR]. For complete compositional requirements, refer to B.24.200 of the FDR.

Meal replacements sold or advertised as a replacement for all daily meals in a weight reduction diet must also provide on the label directions for use that would result in a daily energy intake of at least 900 Calories (3780 kJ) [B.24.202(c), FDR].

Instant breakfast

Instant breakfast may not be promoted as a replacement for other meals, such as lunch or dinner, nor as snacks, nor as a part of a diet plan. Requirements for "instant breakfast", a breakfast replacement, are set out in section B.01.053 of the FDR.

Voluntary claims and statements - meal replacements

The criteria for making nutrient content claims and health claims on these foods is based on the serving of stated size for meal replacements when in the ready-to-consume form, or on the stated quantity of food when prepared according to directions for use, if the meal replacement requires preparation [item X.1 in the Table of Reference Amounts for Food].

Nutritional supplements

The compositional requirements for a nutritional supplement are set out in B.24.201 of the FDR. Requirements differ depending on the Calories per serving provided by the nutritional supplement.

For complete compositional requirements, refer to B.24.201 of the FDR.

Nutrient content statement - nutritional supplements

Nutritional supplements to which milk, partially skim milk or skim milk is to be added, must carry a statement that the nutrient content of the food has been determined taking into consideration the milk, partially skim milk or skim milk that is to be added according to the directions for use [B.24.202(b), FDR].

Nutrient content declaration - nutritional supplements

The label of nutritional supplements must have a statement indicating per serving of stated size and per stated quantity of food, when prepared according to the directions for:

Voluntary claims and statements - nutritional supplements

The criteria for making nutrient content claims and health claims on these foods is based on the serving of stated size for nutritional supplements when in the ready-to-consume form, or on the stated quantity of food when prepared according to directions for use, if the nutritional supplement requires preparation [item X.1 in the Table of Reference Amounts for Food].

Foods represented for use in very low energy diets

The sale and advertising of foods represented for use in very low energy diet is strictly controlled by the FDR. These foods are not permitted to be advertised to the general public [B.24.300, FDR]. Only a pharmacist is permitted to sell these foods to the general public and only with a written order from a physician [B.24.301 and B.24.302, FDR]. Compositional and labelling requirements are also strictly governed by regulation [B.24.303 and B.24.304, FDR]. As Health Canada must be advised prior to the sale or advertising these products, readers are advised to contact Health Canada prior to manufacturing, labelling or importing these types of food. Enquiries should be directed to:

Submission Management and Information Unit
Food Directorate, Health Products and Food Branch, Health Canada
251 Sir Frederick Banting Driveway
Postal Locator: 2202E
Ottawa, Ontario K1A 0K9
Phone: 613-960-0552
Fax: 613-946-4590
Email address: smiu-ugdi@hc-sc.gc.ca

Statement – under medical supervision

All foods represented for use in very low energy diets must prominently display on the principal display panel the following statement: "use only under medical supervision" [B.24.304(e), FDR].

Nutrient content declaration - foods represented for use in very low energy diets

The label of foods represented for use in very low energy diets must have a statement indicating per 100 grams or 100 millilitres of the food as offered for sale and per unit of ready-to-serve food:

Directions for preparation and storage

Complete directions for the preparation and storage of the food before and after the container has been opened must be present on the label of food represented for use in very low energy diets [B.24.304(g), FDR].

Direction for use - foods represented for use in very low energy diets

The label of a food represented for use in very low energy diets must have directions for use that include the following information:

Voluntary claims and statements - foods represented for use in very low energy diets

It is prohibited to have a disease risk reduction claim on foods represented for use in very low energy diets [B.01.601(1)(c), FDR].

Prepackaged meal for use in weight-reduction diet

A prepackaged meal that is sold or advertised for use in a weight reduction diet is not exempt from declaring a Nutrition Facts table, which must be declared as per the Nutrition labelling requirements set out by the FDR. Prepackaged meals for use in a weight reduction diet must also meet the following labelling requirements.

Required weight reduction statement

All prepackaged meals sold or advertised for use in a weight reduction diet must prominently display on the principal display panel the following statement: "useful in weight reduction only as part of an energy-reduced diet / utile pour perdre du poids seulement dans le cadre d'un régime à teneur réduite en énergie" [B.24.202(e) and B.24.203, FDR]. This statement must also be included in all advertisements for the product [B.24.205(3), FDR].

Direction for use - prepackaged meal for use in weight-reduction diet

The label of these products must have, in the directions for use, a sample 7-day menu in which the prepackaged meal is used. This menu plan must meet the following criteria:

Note: It is not permitted create the impression that the consumption of a vitamin or a mineral supplement must be part of the diet, nor is it permitted to make any reference to a vitamin or mineral supplement on the product [B.24.205, FDR].

Foods sold by weight reduction clinics

Weight-loss clinics are permitted to represent and sell food to their clients as part of a weight-reduction diet supervised by the clinic.

The labelling requirements for foods sold by weight reduction clinics are identical to those which apply to Prepackaged meal for use in weight reduction diet outlined above. The sample 7-day menu in the directions for use must specifically show the food sold by the weight-reduction clinic being used.

Gluten-free foods

For information on gluten-free foods, see Gluten-free claims.

Weight reduction diets

As obesity is included in Schedule A of the FDA, foods may not be advertised as a treatment, preventative or cure for this condition.

The following foods may be represented for use in weight reduction diets if they meet the requirements set out in Division 24 of the FDR:

Testimonials claiming rapid weight loss, which is considered hazardous to health, and testimonials for weight reduction by people who were obese, are unacceptable.

It is important to note that foods represented for use in a weight-reduction diet differ from foods represented for use in achieving and maintaining a healthy body weight. See Weight loss claims versus weight maintenance claims for more information.

Energy-reduced diets

Foods may be represented for use in an energy-reduced diet if they meet the requirements of one of the following nutrient content claims:

Foods that meet the criteria for and carry one of the claims above may also be represented as "diet" or "dietetic" [B.24.003(4), FDR].

Sodium-restricted diets

Foods may be represented as for use in a sodium-restricted diet if they meet the requirements of one of the following sodium (salt) claims:

However, a representation that a food is for use in a sodium-restricted diet is prohibited on the principal display panel (PDP), when the food carries a nutrition symbol for "high in sodium" [B.01.508(2), FDR].

Refer to Are health-related representations permitted on the principal display panel (PDP) when a food also carries the FOP nutrition symbol (the symbol)? in the Front-of-package nutrition symbol labelling guide for industry.

Texture modified diets

Texture modified foods (that is to say, minced or pureed) for people with difficulty swallowing (meaning, dysphagia) meet the definition of a food for special dietary use in Division 24 of the FDR.

However, section B.24.003 identifies which foods may be represented as a food for special dietary use and texture modified foods for people with difficulty swallowing is not included. Therefore, texture modified foods for people with difficulty swallowing must be labelled in the same way as other prepackaged foods (see the core labelling and other requirements pages of the Industry Labelling Tool for more information). The label and advertising of these foods cannot refer to a disease "dysphagia". The recommendation is that the label focus on the physical qualities of the food (for example, fine, coarse or firm texture or easy to swallow).

Other foods for special dietary use

Sports nutrition products

Sports nutrition products include but are not limited to protein and/or carbohydrate-based products, meal replacements and nutritional supplements, beverages, foods that contain natural health products, foods that are labelled or advertised with drug claims, and weight loss products marketed for quick weight loss or muscle definition. These products often have label claims related to increasing endurance, tolerance to fatigue or exercise (reducing exertion), muscle building or other metabolic effects beyond those that can be normally expected from nutrition. These statements may be considered to be claims that bring the product under the definition of a drug. See below. Refer to Foods or natural health products (NHP) and Drugs versus foods for more information on health products and drugs respectively.

Common violations

The status of a product is based on its composition as well as the claims made for it. According to the FDA, "a drug includes any substance or mixture of substances manufactured, sold or represented for use in

A product is classified as a drug if the ingredients present have recognized pharmacological activities or if the above types of claims are made. Drug products in Canada must have a drug identification number issued by Health Canada. Health claims, such as metabolic claims, that is, claims as to what the food will do after it is ingested (such as, for big muscles, for quick weight loss) are not permitted.

Common food violations include:

Definitions

Food for special dietary use
A 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 [B.24.001, FDR]
Formulated liquid diet
A food that:
  • is sold for consumption in liquid form, and
  • is sold or represented as a nutritionally complete diet for oral or tube feeding of a person in whom a physical or physiological condition exists as a result of a disease, disorder or injury [B.24.001, FDR]
Meal replacement
A formulated food that, by itself, can replace one or more daily meals [B.01.001(1), FDR].
Nutritional supplement
A food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients. It does not include a human milk fortifier [B.01.001(1), FDR].
Nutrition symbol
Nutrition symbol means a symbol that is carried on the principal display panel of a prepackaged product under subsection B.01.350(1) [B.01.001(1), FDR]
Prepackaged meal
A prepackaged selection of foods for one individual that requires no preparation other than heating and that contains at least one serving, as described in Canada's Food Guide to Healthy Eating, published in 1992 by the Department of Supply and Services by authority of the Minister of National Health and Welfare, of
  • meat, fish, poultry, legumes, nuts, seeds, eggs or milk or milk products other than butter, cream, sour cream, ice-cream, ice milk and sherbet, and
  • vegetables, fruit or grain products [B.01.001(1), FDR]
Very low energy diet
A diet for weight reduction that provides less than 900 kilocalories per day when followed as directed [B.24.001, FDR].
Date modified: