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

B.24.004 to B.24.014 [Repealed, SOR/2003-11, s. 22]

B.24.015 and B.24.016 [Repealed, SOR/88-559, s. 6]

• B.24.017 (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.

B.24.018 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).

B.24.019 [Repealed, SOR/2003-11, s. 23]

Formulated Liquid Diets

B.24.100 No person shall advertise a formulated liquid diet to the general public.

B.24.101 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.

• B.24.102 (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.

  Column I	Per 1,000 available kilocalories		Per 1,500 available kilocalories
  	Column II	Column III	Column IV	Column V
  Vitamins	Minimum	Maximum	Minimum	Maximum
  Vitamin A	2,000 I.U.	5,000 I.U.	2,000 I.U.	3,000 I.U.
  Vitamin D	100 I.U.	400 I.U.	100 I.U.	200 I.U.
  Vitamin E (a-tocopherol)	5.0 I.U.		5.0 I.U.
  Ascorbic Acid	20 mg		20 mg
  Thiamine	0.5 mg		0.6 mg
  Riboflavin	0.7 mg		0.84 mg
  Niacin	6.6 mg		7.9 mg
  Vitamin B6	0.9 mg		0.9 mg
  Vitamin B12	1.5 µg		1.5 µg
  Folic Acid	100 µg		100 µg
  d-pantothenic Acid	2.5 mg		2.5 mg
  Mineral Nutrients
  Calcium	400 mg		400 mg
  Phosphorus	400 mg		400 mg
  Iron	8 mg		8 mg
  Iodine	50 µg		50 µg
  Magnesium	150 mg		150 mg
  Copper	1 mg		1 mg
  Zinc	7 mg		7 mg

B.24.103 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

• B.24.200 (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.

  Column I	Column II	Column III
  Nutrients	Minimum Amount per Serving	Maximum Amount per Serving
  VITAMINS
  Vitamin A	250 RE	630 RE
  Vitamin D	1.25 µg	2.50 µg
  Vitamin E	2.5 mg	5.0 mg
  Vitamin C	10 mg	20 mg
  Thiamine	300 µg	750 µg
  Riboflavin	400 µg	800 µg
  Niacin	6 NE	12 NE
  Vitamin B6	400 µg	750 µg
  Vitamin B12	0.25 µg	0.75 µg
  Folacin	60 µg	120 µg
  Pantothenic acid	1.25 mg	2.50 mg
  Biotin	25 µg	75 µg
  MINERAL NUTRIENTS
  Calcium	200 mg	400 mg
  Phosphorus	250 mg	500 mg
  Iron	2.5 mg	5.0 mg
  Iodide	40 µg	120 µg
  Magnesium	60 mg	120 mg
  Copper	0.5 mg	1.0 mg
  Zinc	3 mg	6 mg
  Potassium	375 mg
  Sodium	250 mg
  Manganese	1 mg	2 mg
  Selenium	10 µg	20 µg
  Chromium	10 µg	20 µg
  Molybdenum	20 µg	40 µg