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

• B.24.205 (1) No person shall label, package, sell or advertise a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, in a manner likely to create an impression that consumption of a vitamin or mineral supplement must be part of a weight reduction diet.

• (2) No person shall, on a label of or in an advertisement for a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, make any direct or indirect reference to a vitamin or mineral supplement.

• (3) Every person who advertises a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, shall include in the advertisement the 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”.

Foods Represented for Use in Very Low Energy Diets

B.24.300 No person shall advertise to the general public a food represented for use in a very low energy diet.

• B.24.301 (1) No person shall sell, without a written order from a physician, a food represented for use in a very low energy diet.

• (2) Notwithstanding subsection (1), a person may sell, without a written order from a physician, a food represented for use in a very low energy diet to

  • (a) a physician;

  • (b) a wholesale druggist;

  • (c) a pharmacist; or

  • (d) a hospital.

• (3) No person other than a pharmacist shall sell to the general public a food represented for use in a very low energy diet.

B.24.302 A pharmacist shall retain the written order of a physician for a food represented for use in a very low energy diet for at least two years after the date on which the order is filled.

• B.24.303 (1) A food represented for use in a very low energy diet, whether ready to serve or diluted with water according to the manufacturer’s directions, shall provide, per daily allowance recommended by the manufacturer

  • (a) either

    • (i) not less than 60 g of protein of a nutritional quality equivalent to that of casein, or

    • (ii) such an amount and quality of protein that, when the quality of the protein is expressed as a fraction of the quality of casein,

      • (A) the fraction is not less than 85/100, and

      • (B) the product obtained by multiplying the fraction by the gram weight of the protein is not less than 60;

  • (b) each vitamin or mineral nutrient named in column I of an item of the table to this subsection, in an amount not less than the minimum amount per day set out in column II of that item; and

  • (c) any nutritive substance added to the food other than those referred to in paragraph (a) or (b), in an amount that is appropriate for the purpose of the substance in the food as determined from clinical trials.

    	Column I	Column II
    Item	Vitamin or Mineral Nutrient	Minimum amount per day
    1	Thiamine	1.3 mg
    2	Riboflavin	1.6 mg
    3	Niacin	23 mg
    4	Folacin	0.22 mg
    5	Biotin	0.15 mg
    6	Pantothenic acid	7.0 mg
    7	Vitamin B6	1.5 mg
    8	Vitamin B12	0.001 mg
    9	Vitamin A	1000 RE
    10	Vitamin D	0.005 mg
    11	Vitamin E	10 mg
    12	Vitamin C	40 mg
    13	Calcium	800 mg
    14	Phosphorus	1000 mg
    15	Magnesium	250 mg
    16	Iron	13 mg
    17	Iodine	0.16 mg
    18	Zinc	12 mg
    19	Copper	2 mg
    20	Manganese	3.5 mg
    21	Selenium	0.07 mg
    22	Chromium	0.05 mg
    23	Molybdenum	0.1 mg
    24	Sodium	2000 mg
    25	Potassium	3000 mg
    26	Chloride	1500 mg

• (2) Notwithstanding paragraph (1)(a), a food represented for use in a very low energy diet shall be accompanied by directions for use that when followed would result in the daily intake by a person of at least 1.2 g of protein per kilogram target body weight.

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 Minister 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 Minister, 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).

• B.24.306 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Minister in writing of the intention to sell or advertise for sale the food that has undergone the major change.

• (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 very low energy diet that has undergone a major change, 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) a description of the major change;

  • (d) 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;

  • (e) the evidence relied on to establish that the major change has no adverse effect on the food or its use;

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

  • (g) 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 that has undergone a major change, if the Minister, 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).

DIVISION 25

Interpretation

B.25.001 In this Division,

expiration date

expiration date means, in respect of a human milk fortifier or human milk substitute, the date

• (a) after which the manufacturer does not recommend that it be consumed, and

• (b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation)

human milk fortifier

human milk fortifier means a food that

• (a) includes at least one added vitamin, mineral nutrient or amino acid, and

• (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state; (fortifiant pour lait humain)

human milk substitute

human milk substitute means any food that is labelled or advertised

• (a) for use as a partial or total replacement for human milk and as intended for consumption by infants, or

• (b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain)

infant

infant means an individual who is under the age of one year; (bébé)

infant food

infant food means a food that is labelled or advertised for consumption by infants; (aliment pour bébés)

junior (naming a food)

junior (naming a food) means the named food where it contains particles of a size to encourage chewing by infants, but may be readily swallowed by infants without chewing; ((nom d’un aliment) pour enfants en bas âge)

major change

major change means, in respect of a human milk fortifier or human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk fortifier or human milk substitute where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or chemical safety of, the human milk fortifier or human milk substitute; (changement majeur)

new human milk substitute

new human milk substitute means a human milk substitute that is

• (a) manufactured for the first time,

• (b) sold in Canada for the first time, or

• (c) manufactured by a person who manufactures it for the first time; (succédané de lait humain nouveau)

strained (naming a food)

strained (naming a food) means the named food where it is of a generally uniform particle size that does not require and does not encourage chewing by infants before being swallowed. ((nom d’un aliment) en purée ou tamisé)