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

Regulations are current to 2022-05-02 and last amended on 2022-03-02. Previous Versions

PART BFoods (continued)

DIVISION 24 (continued)

Meal Replacements, Nutritional Supplements, Prepackaged Meals and Foods Sold by Weight Reduction Clinics (continued)

  •  (1) No person shall sell or advertise a nutritional supplement that contains less than 225 kcal or 945 kJ per serving, unless it meets the following requirements:

    • (a) the nutritional supplement contains at least 150 kcal or 630 kJ per serving;

    • (b) not less than 15 per cent and no more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content;

    • (c) the proteins present in the nutritional supplement are

      • (i) of a nutritional quality equivalent to that of casein, or

      • (ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and

    • (d) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section

      • (i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and

      • (ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

  • (2) No person shall sell or advertise a nutritional supplement that provides 225 kcal or 945 kJ, or more, per serving unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk, skim milk, or a combination thereof, it meets the following requirements:

    • (a) the nutritional supplement provides at least 225 kcal or 945 kJ per serving;

    • (b) not more than 35 per cent of the energy available from the nutritional supplement is derived from its fat content;

    • (c) not less than 3.0 per cent of the energy available from the nutritional supplement is derived from linoleic acid in the form of a glyceride and not less than 0.5 per cent of the energy available from the nutritional supplement is derived from n-3 linolenic acid in the form of a glyceride, and the ratio of linoleic acid to n-3 linolenic acid is not less than 4 to 1 and not more than 10 to 1;

    • (d) not less than 15 per cent and not more than 40 per cent of the energy available from the nutritional supplement is derived from its protein content;

    • (e) the proteins present in the nutritional supplement are

      • (i) of a nutritional quality equivalent to that of casein, or

      • (ii) of a nutritional quality and in an amount sufficient to yield a result of not less than 15 per cent when the nutritional quality of those proteins is divided by the nutritional quality of casein and multiplied by the percentage of energy available from the proteins present in the nutritional supplement; and

    • (f) the nutritional supplement contains, per 100 kcal or 420 kJ, each vitamin and mineral nutrient listed in column I of the table to this section

      • (i) subject to subsection (3), in an amount not less than the minimum amount shown for that vitamin or mineral nutrient in column II of the table, and

      • (ii) subject to subsections (4) and (5), in an amount that, including overage, is not more than the maximum amount shown for that vitamin or mineral nutrient in column III of the table.

  • (3) The minimum amount required under subparagraph (1)(d)(i) or (2)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a nutritional supplement that does not contain added selenium, chromium or molybdenum, as the case may be.

  • (4) A vitamin or mineral nutrient that is not an added ingredient in the nutritional supplement shall not be taken into account for the purposes of subparagraphs (1)(d)(ii) and (2)(f)(ii).

  • (5) The maximum amount shown for vitamin C in column III of the table to this section does not include overage.

    TABLE

    Column IColumn IIColumn III
    NutrientsMinimum Amount per Available 100 Kcal or 420 KJMaximum Amount per Available 100 Kcal or 420 KJ
    VITAMINS
    Vitamin A100 RE250 RE
    Vitamin D0.25 µg1 µg
    Vitamin E1.0 mg2.0 mg
    Vitamin C5 mg10 mg
    Thiamine140 µg350 µg
    Riboflavin180 µg360 µg
    Niacin3 NE6 NE
    Vitamin B6180 µg350 µg
    Vitamin B120.1 µg0.3 µg
    Folacin30 µg60 µg
    Pantothenic acid0.6 mg1.2 mg
    Biotin12 µg35 µg
    MINERAL NUTRIENTS
    Calcium100 mg175 mg
    Phosphorus100 mg175 mg
    Iron1.0 mg2.0 mg
    Iodide15 µg45 µg
    Magnesium20 mg40 mg
    Copper0.15 mg0.30 mg
    Zinc1.4 mg2.0 mg
    Potassium175 mg
    Manganese0.45 mg0.90 mg
    Selenium4 µg8 µg
    Chromium4 µg8 µg
    Molybdenum8 µg15 µg
  • SOR/78-698, s. 9
  • SOR/95-474, s. 5

 The label of a meal replacement or nutritional supplement shall

  • (a) show the following information per serving of stated size and per stated quantity of food, when prepared according to the directions for use:

    • (i) the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ),

    • (ii) the protein, fat, linoleic acid, n-3 linolenic acid, saturated fatty acid and carbohydrate contents of the food, expressed in grams,

    • (iii) the vitamin A, vitamin D, vitamin E, vitamin C, thiamin or vitamin B1, riboflavin or vitamin B2, niacin, vitamin B6, vitamin B12, folate and pantothenic acid or pantothenate contents of the food, expressed

      • (A) in the case of a meal replacement, as a percentage of the daily value specified in column 4 of Part 2 of the Table of Daily Values for that vitamin, and

      • (B) in the case of a nutritional supplement, in the applicable unit referred to in subsection D.01.003(1),

    • (iv) the calcium, phosphorus, iron, iodide, magnesium and zinc contents of the food, expressed

      • (A) in the case of a meal replacement, as a percentage of the daily value specified in column 4 of Part 2 of the Table of Daily Values, and

      • (B) in the case of a nutritional supplement, in milligrams for calcium, phosphorus, iron, magnesium and zinc and in micrograms for iodide,

    • (v) the copper, potassium, sodium and manganese contents of the food, expressed in milligrams, and

    • (vi) the biotin, selenium, chromium and molybdenum contents of the food, expressed in micrograms;

  • (b) in the case of a meal replacement or a nutritional supplement to which milk, partially skim milk or skim milk is to be added, 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 will be added according to the directions for use;

  • (c) in the case of a meal replacement that is sold or advertised as a replacement for all daily meals in a weight reduction diet, include directions for use that would result in a daily energy intake of at least 900 kcal or 3 780 kJ;

  • (d) include the expiration date of the meal replacement or nutritional supplement;

  • (e) in the case of a meal replacement for use in a weight reduction diet, carry 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” prominently displayed on the principal display panel; and

  • (f) in the case of a meal replacement for use in a weight reduction diet that is not represented as a replacement for all daily meals in a diet, include the information required under section B.24.204.

  • SOR/78-698, s. 9
  • SOR/88-559, s. 28
  • SOR/95-474, s. 5
  • SOR/2016-305, ss. 59, 75(F)

 The label of a prepackaged meal for use in a weight reduction diet or of a food to be sold in a weight reduction clinic shall

  • (a) [Repealed, SOR/2003-11, s. 24]

  • (b) carry 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” prominently displayed on the principal display panel; and

  • (c) include the information required under section B.24.204.

  • SOR/78-698, s. 9
  • SOR/88-559, s. 29
  • SOR/95-474, s. 5
  • SOR/2003-11, s. 24

 The label of a prepackaged meal, or of a meal replacement other than a meal replacement represented as a replacement for all daily meals in a diet, that is packaged, sold or advertised for use in a weight reduction diet, or of a food to be sold in a weight reduction clinic, shall include, in the directions for use, a sample seven-day menu in which the prepackaged meal, meal replacement or food is used and which meets the following requirements:

  • (a) each daily meal includes a minimum of 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 one food from each of the following groups:

    • (i) milk, milk products or their alternatives,

    • (ii) meat and meat alternatives,

    • (iii) bread and grain products, and

    • (iv) vegetables and fruit;

  • (b) the daily energy intake provided for is not less than 1 200 kcal or 5 040 kJ;

  • (c) not more than 30 per cent of the total daily energy intake of the seven-day menu is derived from its fat content and not more than 10 per cent of the total daily energy intake of the menu is derived from its saturated fatty acid content;

  • (d) the mean daily intake of each nutrient listed in column I of the table to this section is not 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

  • (e) the menu does not include any reference to vitamin or mineral supplements.

    TABLE

    Column IColumn IIColumn III
    NutrientsMean Daily Intake
    MenWomen
    Protein65 g55 g
    VITAMINS
    Vitamin A1000 RE800 RE
    Vitamin D5 µg5 µg
    Vitamin E10 mg7 mg
    Vitamin C40 mg30 mg
    Thiamin1 mg1 mg
    Riboflavin1 mg1 mg
    Niacin14 NE14 NE
    Vitamin B61.5 mg1.5 mg
    Vitamin B121 µg1 µg
    Folacin230 µg200 µg
    Pantothenic Acid5 mg5 mg
    MINERAL NUTRIENTS
    Calcium800 mg800 mg
    Phosphorus1000 mg850 mg
    Iron9 mg13 mg
    Iodide160 µg160 µg
    Magnesium250 mg210 mg
    Copper2 mg2 mg
    Zinc12 mg9 mg
  • SOR/78-698, s. 9
  • SOR/95-474, s. 5
 
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