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

Regulations are current to 2017-10-13 and last amended on 2017-06-20. Previous Versions

 [Repealed, SOR/2003-11, s. 22]

 [Repealed, SOR/88-559, s. 6]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 Director 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) Where the Director is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he 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 Director 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.

 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 [Repealed, SOR/2003-11, s. 23]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 International Units5,000 International Units2,000 International Units3,000 International Units
    Vitamin D100 International Units400 International Units100 International Units200 International Units
    Vitamin E (a-tocopherol)5.0 International Units5.0 International Units
    Ascorbic Acid20 milligrams20 milligrams
    Thiamine0.5 milligram0.6 milligram
    Riboflavin0.7 milligram0.84 milligram
    Niacin6.6 milligrams7.9 milligrams
    Vitamin B60.9 milligram0.9 milligram
    Vitamin B121.5 micrograms1.5 micrograms
    Folic Acid100 micrograms100 micrograms
    d-pantothenic Acid2.5 milligrams2.5 milligrams
    Mineral Nutrients
    Calcium400 milligrams400 milligrams
    Phosphorus400 milligrams400 milligrams
    Iron8 milligrams8 milligrams
    Iodine50 micrograms50 micrograms
    Magnesium150 milligrams150 milligrams
    Copper1 milligram1 milligram
    Zinc7 milligrams7 milligrams
  • 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).
 
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