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

Regulations are current to 2024-03-06 and last amended on 2023-11-24. Previous Versions

PART BFoods (continued)

DIVISION 24 (continued)

Foods for Special Dietary Use (continued)

 [Repealed, SOR/2003-11, s. 22]

 [Repealed, SOR/88-559, s. 6]

  •  (1) Where the manufacturer of a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is requested in writing by the Minister to submit, on or before a specified day, evidence with respect to that product, the manufacturer shall make no further sales of that product after that day unless the manufacturer has submitted the evidence requested.

  • (2) If the Minister determines that the evidence submitted by a manufacturer under subsection (1) is not sufficient, he or she shall so notify the manufacturer in writing.

  • (3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet is not sufficient, the manufacturer shall make no further sales of that product unless the manufacturer submits further evidence and is notified in writing by the Minister that the further evidence is sufficient.

  • (4) A reference in this section to evidence with respect to a formulated liquid diet, a meal replacement or a food represented for use in a very low energy diet means evidence to establish that the food is nutritionally adequate to be used as the sole source of nutrition in meeting the nutritional needs of a person for whom it is intended, when the food is consumed in accordance with the directions for use.

  • SOR/78-698, s. 6
  • SOR/94-35, s. 3
  • SOR/2018-69, ss. 11, 27

 It is prohibited to label, package, sell or advertise a food in a manner likely to create an impression that it is a gluten-free food if the food contains any gluten protein or modified gluten protein, including any gluten protein fraction, referred to in the definition gluten in subsection B.01.010.1(1).

  • SOR/95-444, s. 2
  • SOR/2011-28, s. 6

 [Repealed, SOR/2003-11, s. 23]

Formulated Liquid Diets

 No person shall advertise a formulated liquid diet to the general public.

  • SOR/78-64, s. 7
  • SOR/78-698, s. 7

 No person shall sell a formulated liquid diet unless the food

  • (a) if sold ready to serve, or

  • (b) if not sold ready to serve, when diluted with water, milk, or water and milk,

is a complete substitute for the total diet in meeting the nutritional requirements of a person.

  • SOR/78-64, s. 7
  •  (1) Subject to subsection (4), a formulated liquid diet shall contain, when ready to serve,

    • (a) either

      • (i) not less than 20 grams of protein of nutritional quality equivalent to casein, as determined by official method FO-1, Determination of Protein Rating, October 15, 1981, or

      • (ii) such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein,

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

        • (B) the result obtained by multiplying the fraction by the gram weight of the protein will not be less than 20; and

    • (b) not less than one gram linoleic acid in the form of a glyceride.

  • (2) Notwithstanding sections D.01.009, D.01.011 and D.02.009, a formulated liquid diet shall contain, when ready to serve, the vitamins and minerals named in Column I of the table to this section in amounts,

    • (a) where the recommended intake of the food is 2,500 kilocalories per day or less, not less than the amounts set out in Column II and not more than the amounts, if any, set out in Column III of that table opposite those vitamins and minerals; and

    • (b) where the recommended intake of the food is greater than 2,500 kilocalories per day, not less than the amounts set out in Column IV and not more than the amounts, if any, set out in Column V of the table opposite those vitamins and minerals.

  • (3) The amounts of the nutrients specified in paragraphs (1)(a) and (b) and subsection (2) shall be calculated

    • (a) per 1,000 available kilocalories, where the recommended intake of the food is 2,500 kilocalories per day or less; and

    • (b) per 1,500 available kilocalories, where recommended intake of the food is greater than 2,500 kilocalories per day.

  • (4) Paragraph (1)(a) does not apply to a formulated liquid diet represented as being for a protein restricted diet or a low (named amino acid) diet.

    TABLE

    Column IPer 1,000 available kilocaloriesPer 1,500 available kilocalories
    Column IIColumn IIIColumn IVColumn V
    VitaminsMinimumMaximumMinimumMaximum
    Vitamin A2,000 I.U.5,000 I.U.2,000 I.U.3,000 I.U.
    Vitamin D100 I.U.400 I.U.100 I.U.200 I.U.
    Vitamin E (a-tocopherol)5.0 I.U.5.0 I.U.
    Ascorbic Acid20 mg20 mg
    Thiamine0.5 mg0.6 mg
    Riboflavin0.7 mg0.84 mg
    Niacin6.6 mg7.9 mg
    Vitamin B60.9 mg0.9 mg
    Vitamin B121.5 µg1.5 µg
    Folic Acid100 µg100 µg
    d-pantothenic Acid2.5 mg2.5 mg
    Mineral Nutrients
    Calcium400 mg400 mg
    Phosphorus400 mg400 mg
    Iron8 mg8 mg
    Iodine50 µg50 µg
    Magnesium150 mg150 mg
    Copper1 mg1 mg
    Zinc7 mg7 mg
  • SOR/78-64, s. 7
  • SOR/78-698, s. 8
  • SOR/82-768, s. 75
  • SOR/87-640, s. 9(F)
  • SOR/90-830, s. 6(F)
  • SOR/2022-197, s. 5(E)

 The label of a formulated liquid diet shall carry the following information:

  • (a) a statement that the food is intended to be consumed orally or by tube feeding;

  • (b) a statement of the energy value of the food, expressed in Calories

    • (i) per 100 grams or per 100 millilitres of the food as offered for sale, and

    • (ii) per unit of ready-to-serve food;

  • (c) a statement of the content in the food of protein or protein equivalent, fat, linoleic acid, available carbohydrate and, where present, crude fibre, expressed in grams

    • (i) per 100 grams or per 100 millilitres of the food as offered for sale, and

    • (ii) per unit of ready-to-serve food;

  • (d) a statement of the content of vitamins and mineral nutrients that are listed in the table to section B.24.102, expressed in International Units, milligrams or micrograms

    • (i) per 100 grams or per 100 millilitres of the food as offered for sale, and

    • (ii) per unit of ready-to-serve food;

  • (e) a statement of the content of any vitamin or mineral nutrient that is not listed in the table to section B.24.102, expressed in milligrams or micrograms

    • (i) per 100 grams or per 100 millilitres of the food as offered for sale, and

    • (ii) per unit of ready-to-serve food;

  • (f) complete directions for the preparation and use of the food and for its storage after the container has been opened; and

  • (g) the expiration date of the formulated liquid diet.

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

  •  (1) No person shall sell or advertise a meal replacement unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements:

    • (a) the meal replacement provides a minimum of 225 kcal or 945 kJ per serving;

    • (b) not less than 15 per cent and not more than 40 per cent of the energy available from the meal replacement is derived from its protein content, except that a meal replacement for use in a weight reduction diet shall derive not less than 20 per cent of its available energy from its protein content;

    • (c) subject to subsection (2), not more than 35 per cent of the energy available from the meal replacement is derived from its fat content;

    • (d) not less than 3.0 per cent of the energy available from the meal replacement 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 meal replacement 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;

    • (e) the proteins present in the meal replacement 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, or not less than 20 per cent in the case of a meal replacement for use in a weight reduction diet, 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 meal replacement; and

    • (f) each serving of the meal replacement contains 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 meal replacement that is represented as a replacement for all daily meals unless, when in a ready-to-serve form or when prepared according to directions for use, with water, milk, partially skim milk or skim milk, or a combination thereof, it meets the following requirements:

    • (a) not more than 30 per cent of the energy available from the meal replacement is derived from its fat content; and

    • (b) not more than 10 per cent of the energy available from the meal replacement is derived from its saturated fatty acid content.

  • (3) The minimum amount required under subparagraph (1)(f)(i) for selenium, chromium or molybdenum does not apply in respect of a meal replacement that is not represented as a replacement for all daily meals and 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 meal replacement shall not be taken into account for the purposes of subparagraph (1)(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 ServingMaximum Amount per Serving
    VITAMINS
    Vitamin A250 RE630 RE
    Vitamin D1.25 µg2.50 µg
    Vitamin E2.5 mg5.0 mg
    Vitamin C10 mg20 mg
    Thiamine300 µg750 µg
    Riboflavin400 µg800 µg
    Niacin6 NE12 NE
    Vitamin B6400 µg750 µg
    Vitamin B120.25 µg0.75 µg
    Folacin60 µg120 µg
    Pantothenic acid1.25 mg2.50 mg
    Biotin25 µg75 µg
    MINERAL NUTRIENTS
    Calcium200 mg400 mg
    Phosphorus250 mg500 mg
    Iron2.5 mg5.0 mg
    Iodide40 µg120 µg
    Magnesium60 mg120 mg
    Copper0.5 mg1.0 mg
    Zinc3 mg6 mg
    Potassium375 mg
    Sodium250 mg
    Manganese1 mg2 mg
    Selenium10 µg20 µg
    Chromium10 µg20 µg
    Molybdenum20 µg40 µg
  • SOR/78-698, s. 9
  • SOR/80-13, s. 14
  • SOR/95-474, s. 5
 

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