Labelling Requirements for Foods for Special Dietary Use
Foods Represented for Use in Very Low Energy Diets
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The sale and advertising of foods represented for use in very low energy diet (definition) 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 & 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:
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
Email address: firstname.lastname@example.org
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:
- the energy value in Calories and kilojoules [B.24.304(a), FDR];
- the content of protein, fat, carbohydrate and, where present, fibre, in grams [B.24.304(b), FDR];
- the amount of vitamins and mineral nutrients listed in the table to subsection B.24.303(1) of the FDR, in milligrams [B.24.304(c), FDR];
- in the case of the amount of vitamin A, in retinol equivalents (RE) [B.24.304(c), FDR];
- the content in the food of any nutritive substance added to the food, other than protein and the vitamins and minerals listed in the table to subsection B.24.303(1), in an amount specified in B.24.303(1)(c), in milligrams or grams [B.24.304(d), 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(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:
- 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(f), 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(1)(c), FDR].
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