Food and Drug Regulations (C.R.C., c. 870)

B.24.304. The label of a food represented for use in a very low energy diet shall carry the following information:

• (a) a statement of the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ) per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (b) a statement of the content in the food of protein, fat, carbohydrate and, where present, fibre expressed in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (c) a statement of the content in the food of all those vitamins and mineral nutrients that are listed in the table to subsection B.24.303(1) expressed in milligrams, in the case of vitamin A expressed in retinol equivalents (RE), per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (d) a statement of the content in the food of any other nutritive substance added to the food in an amount described in paragraph B.24.303(1)(c), expressed in milligrams or in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

• (e) the statement “USE ONLY UNDER MEDICAL SUPERVISION” prominently displayed on the principal display panel;

• (f) directions for use of the food, including

  • (i) a statement of the rationale for the use of the food,

  • (ii) criteria to be used for the selection of the persons to whom the food may be prescribed,

  • (iii) instructions for consultation with and evaluation of the patient and patient follow-up, and

  • (iv) a statement concerning adequate precautions and contra-indications;

• (g) directions for the preparation of the food, and storage instructions for the food before and after the container has been opened; and

• (h) the expiration date of the food.

• B.24.305. (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell the food or advertise the food for sale.

• (2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a low energy diet, the following information:

  • (a) the name under which the food is to be sold or advertised for sale;

  • (b) the name and address of the principal place of business of the manufacturer;

  • (c) the name and address of each establishment in which the food is manufactured;

  • (d) a list of the ingredients of the food, stated quantitatively;

  • (e) the specifications for nutrient, microbiological and physical quality for each ingredient and for the food;

  • (f) details of quality control procedures respecting the testing of the ingredients and of the food;

  • (g) details of the manufacturing process and quality control procedures used throughout the process;

  • (h) the results of tests carried out to determine the expiration date of the food;

  • (i) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;

  • (j) a description of the type of packaging to be used;

  • (k) directions for use;

  • (l) the written text of all labels, including package inserts, to be used in connection with the food; and

  • (m) the name and title of the person who signed the notification and the date of signature.

• (3) Notwithstanding subsection (1), a person may sell or advertise for sale a food represented for use in a very low energy diet, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).