Labelling Requirements for Foods for Special Dietary Use

This page is part of the Guidance Document Repository (GDR).

Looking for related documents?
Search for related documents in the Guidance Document Repository

Table of Contents

Overview

This section provides information on the labelling requirements for food for special dietary use subject to the Food and Drugs Act (FDA), the Food and Drug Regulations (FDR), the Consumer Packaging and Labelling Act (CPLA) and Consumer Packaging and Labelling Regulations (CPLR). In addition, provincial regulations may also have labelling requirements for food for special dietary use that apply to products sold in that province.

The requirements detailed in the following sections are specific to foods for special dietary use (definition). They are in addition to the core labelling, claims and statements, and food-specific labelling requirement pages of the Industry Labelling Tool that apply to all prepackaged foods.

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), FDR].

Expiration Date

The expiration date must be present on the label of;

  • a formulated liquid diet product [B.24.103, FDR],
  • a meal replacement product [B.24.202, FDR],
  • a foods represented for use in very low energy diet [B.24.304, FDR] and
  • a nutritional supplement [B.24.202, FDR].

For information on this subject, refer to Date Markings.

Nutrition Labelling - Foods for Special Dietary Use

Formulated liquid diets (definition), meal replacements (definition), nutritional supplements (definition) and foods represented for use in a very low energy diet (definition) have detailed and explicit nutrition and other labelling requirements set out in Division 24 of the Food and Drug Regulations (FDR). Therefore, they are prohibited from using the Nutrition Facts table heading (i.e. "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) & (5), FDR].

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 the Association of Official Analytical Chemists (AOAC) methodsFootnote 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, five sample units are to be drawn at random and analysed as a composite or separately and the results averaged. The size of a sample unit will vary depending upon the nutrient analysed, 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:

  • the mean or the composite of the five samples is less than the declared value where the declaration is at the minimum; or,
  • the mean or the composite of the five samples is less than 90 percent of the declared value where the declaration is above the minimum; or,
  • any one of the five samples is less than 30 percent of the declared value.

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

  • the mean or composite of the five samples is greater than the declared value where the declaration is at the maximum; or,
  • the mean or the composite or the five simples is greater than 110 percent of the declared value where the declaration is below the maximum; or,
  • any one of the five samples is greater than 170 percent of the declared value.

However, while sodium is considered an added nutrient in foods for special dietary use, there is no Regulation that stipulates a minimum or maximum value for sodium in these foods. For a lot to be deemed compliant, 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.

Foods for Special Dietary Use Rounding Rules

  • Calories are to be rounded to the nearest whole number. Kilojoules (kJ) should be rounded to the nearest 10 kJ for energy values of 10 kJ or more, and to the nearest kJ for energy values below 10 kJ.
  • Protein and amino acids are to be rounded to the nearest whole gram for amounts of 10 g or more and to the nearest tenth of a gram for amounts less than 10 g. If no protein is present, its absence is to be indicated by a zero.
  • Fat and fatty acids are to be rounded to the nearest whole number for quantities of 10 g or more, and to the nearest tenth of a gram for quantities less than 10 g. Cholesterol should be rounded to the nearest milligram (i.e., 0.4 mg cholesterol would be declared as 0 mg, 0.6 mg cholesterol would be declared as 1 mg). If no fat or fat components are present, their absence should be indicated by a zero.
  • Carbohydrates and sweeteners are to be rounded to the nearest whole number for quantities of 10 g or more, and to the nearest tenth of a gram for quantities less than 10 g. If no carbohydrate is present, its absence should be indicated by a zero.
  • Sodium and potassium are to be rounded to the nearest whole number.

Formulated Liquid Diets

A formulated liquid diets (definition) 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, 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:

  • the content of protein or protein equivalent, fat, linoleic acid, available carbohydrate and, where present, crude fibre, in grams;
  • the energy value in Calories;
  • the amount of vitamins and mineral nutrients listed in the table to section B.24.102 of the FDR in International Units or milligrams;
  • the amount of vitamins or mineral nutrients not listed in the table to section B.24.102 of the FDR in milligrams. [B.24.103, FDR].

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.24.102, FDR].

Meal Replacements

It is prohibited to sell or advertise a meal replacements (definition) unless, when in a ready-to-serve form or when prepared according to the directions of 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:

  • a minimum food energy value of 225 Calories per serving,
  • a specified amount and quality of protein,
  • a maximum amount of energy derived from fat (35 percent) and
  • a specified amount of various vitamins and mineral nutrients.

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 of use. [B.24.202, 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 the direction of use:

  • the content of protein, fat, linoleic acid, n-3 linolenic acid, saturated fatty acid and carbohydrate, in grams;
  • the energy value in Calories and kilojoules;
  • the amount of vitamins and mineral nutrients listed in B.24.202 (a)(iii), (iv) & (v) of the FDR in their specified measurements. [B.24.202, FDR].

When Used in a Weight Reduction Diet

Addition 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. For complete composition requirements, refer to B.24.200 of the FDR. [B.24.200, FDR].

Meal replacements sold or advertised as a replacement for all daily meals 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, 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

As there is no reference amount for meal replacements, the criteria for making nutrient content claims and health claims on these foods can be based on the serving size of the product only.

Nutritional Supplements

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

  • When a nutritional supplement contains less than 225 Calories per serving, requirements include a minimum food energy content of 150 Calories per serving, a specified amount and quality of protein and a specified amount of various vitamins and mineral nutrients.
  • When a nutritional supplement provides 225 or more Calories, requirements include a specified amount and quality of protein, a maximum amount of fat, and a specified amount of various vitamins and mineral nutrients.

For complete compositional requirements, refer to B.24.201 of the FDR. [B.24.201, 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 of use. [B.24.202, 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 the direction of use:

  • the content of protein, fat, linoleic acid, n-3 linolenic acid, saturated fatty acid and carbohydrate, in grams;
  • the energy value in Calories and kilojoules;
  • the amount of vitamins and mineral nutrients listed in B.24.202 (a)(iii), (iv) & (v) of the FDR in their specified measurements. [B.24.202, FDR].

Voluntary Claims and Statements - Nutritional Supplements

As there is no reference amount for nutritional supplements, the criteria for making nutrient content claims and health claims on these foods can be based on the serving size of the product only.

Foods Represented for Use in Very Low Energy Diets

The sale and advertising of foods represented for use in very low energy diet (definition) is strictly controlled by the Food and Drug Regulations. 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 & B.24.302, FDR]. Compositional and labelling requirements are also strictly governed by regulation [B.24.303 & 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 type of foods. Enquiries should be directed to:

Assistant Deputy Minister
Health Products and Food Branch
Health Canada
1st Floor, Health Protection Building
Tunney's Pasture, A.L. 0701A1
Ottawa, Ontario
K1A 0L2

Statement – Under Medical Supervision

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

  • the content of protein, fat, carbohydrate and, where present, fibre, in grams;
  • the energy value in Calories and kilojoules;
  • the amount of vitamins and mineral nutrients listed in the table to section B.24.303(1) of the FDR, in milligrams;
  • in the case of vitamin A, in retinol equivalents (RE);
  • the amount of any nutritive substance added to the food listed in the table to section B.24.303(1)(c), in milligrams or grams. [B.24.304, FDR].

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, 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:

  • A statement of the rationale for the use of the food;
  • Criteria to be used for the selection of the persons to whom the food may be prescribed;
  • Instructions for consultation with and evaluation of the patient and patient follow-up; and
  • A statement concerning adequate precautions and contra-indications. [B.24.304, FDR].

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, FDR].

Prepackaged Meal for Use in Weight-Reduction Diet

A prepackaged meal (definition) that is sold or advertised for use in a weight reduction diet is not exempt from declaring a Nutrition Facts table, it must be declared as per the Nutrition Labelling requirements set out by the Food and Drug Regulations. 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 & B.24.203, FDR]. This statement must also be included in all advertisements for the product. [B.24.205, 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 seven-day menu, in which the prepackaged meal is used. This menu plan must meet the following criteria:

  • each daily meal contains, at a minimum, one serving of each food group from Canada's Food Guide (see Health Canada's webpage on Eating Well with Canada's Food Guide);
  • it must result in a daily energy intake of at least 1200 Calories (5040 kJ);
  • the maximum amount of energy from fat must not be more than 30 percent, of which no more than 10 percent may be from saturated fat;
  • the mean daily intake of each nutrient listed in column I of the table following section B.24.204 of the FDR must not be less than the amount shown in column II, in the case of a menu recommended for men, or in column III, in the case of a menu recommended for women; and
  • the menu does not include any reference to vitamin or mineral supplements. [B.24.202 - B.24.204, FDR].

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, except that the sample seven-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 Food and Drugs Act, 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 vs. 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:

  • free of energy;
  • low in energy;
  • reduced in energy;
  • lower in energy; or
  • free of sugars. [B.01.507 & B.24.003, FDR].

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:

  • free of sodium or salt;
  • low in sodium or salt;
  • reduced in sodium or salt; or
  • lower in sodium or salt. [B.01.508 & B.24.003, FDR].

Texture Modified Diets

Texture modified foods (i.e. minced or pureed) for people with difficulty swallowing (i.e. dysphagia) meet the definition of a Food for Special Dietary Use in Division 24 of the Food and Drug Regulations.

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 (i.e., 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 vs. 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 Food and Drugs Act, "a drug includes any substance or mixture of substances manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
  2. restoring, correcting, or modifying organic functions in human beings or animals; or
  3. disinfection in premises in which food is manufactured, prepared or kept."

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 (e.g. for big muscles, for quick weight loss) are not permitted.

Common food violations include:
  1. the use of non-permitted ingredients;
  2. non-permitted addition of vitamins and minerals;
  3. non-permitted representation of food products for weight loss (B.24.003 of the Food and Drug Regulations (FDR));
  4. non-permitted claims including performance-enhancement claims and / or metabolic claims that fall into the meaning of parts (a) or (b) of the definition of a drug (see above), and claims that may be considered misleading to the consumer.

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, FDR].

Nutritional Supplement

A food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients. [B.01.001, 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

  • (a) 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
  • (b) vegetables, fruit or grain products. [B.01.001, 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: