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

B.23.005 Di(n-octyl)tin maleate polymer shall be the octyltin chemical made from di(n-octyl)tin dichloride and shall have the formula ((C₈H₁₇)₂ SnC₄H₂O₄)n (where n is between 2 and 4 inclusive), and a saponification number of 225 to 255, and shall contain 25.2 to 26.6 per cent of tin.

• B.23.006 (1) (n-octyl)tin S,S′,S″-tris (isooctylmercaptoacetate), being an octyltin chemical having the formula n-C₈H₁₇Sn(SCH₂CO₂C₈H₁₇)₃, shall be made from (n-octyl)tin trichloride and shall contain 13.4 to 14.8 per cent of tin and 10.9 to 11.9 per cent of mercapto sulfur.

• (2) For the purposes of this Division, (n-octyl)tin trichloride shall be the chemical having an organotin composition of not less than 95 per cent (n-octyl)tin trichloride and shall contain not more than

  • (a) five per cent total of di(n-octyl)tin dichloride, tri(n-octyl)tin chloride or the higher (more than eight (8) carbons) alkyltin chlorides or any combination of the foregoing;

  • (b) 0.2 per cent total of alkyltin derivatives; and

  • (c) 0.1 per cent of the lower (less than eight carbons) homologous alkyltin derivatives.

B.23.007 No person shall sell a food in a package that may transfer to the food any amount of vinyl chloride or acrylonitrile, as determined by the corresponding method set out in column 4 of the Table of Chemical, Physical and Nutritional Characteristics of Food.

B.23.008 [Repealed, SOR/2024-244, s. 135]

DIVISION 24

Foods for Special Dietary Use

B.24.001 In this Division,

expiration date

expiration date means, in respect of a formulated liquid diet, a food represented for use in a very low-energy diet, a meal replacement or a nutritional supplement, 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)

food for special dietary use

food for special dietary use means food that has been specially processed or formulated to meet the particular requirements of a person

• (a) in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or

• (b) for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods; (aliment à usage diététique spécial)

formulated liquid diet

formulated liquid diet means a food that

• (a) is sold for consumption in liquid form, and

• (b) is sold or represented as a nutritionally complete diet for oral or tube feeding of a person described in paragraph (a) of the definition “food for special dietary use”; (préparation pour régime liquide)

hospital

hospital means a facility

• (a) that is licensed, approved or designated as a hospital by a province, in accordance with the laws of the province, to provide care or treatment to persons suffering from any form of disease or illness, or

• (b) that is owned or operated by the government of Canada or of a province and that provides health services; (hôpital)

major change

major change means, in respect of a food that is represented for use in a very low energy diet, any change in any of the following, where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, the microbiological or chemical safety of or the safe use of the food:

• (a) an ingredient or the amount of an ingredient in the food,

• (b) the manufacturing process or the packaging of the food, or

• (c) the directions for the preparation and use of the food; (changement majeur)

meal replacement

meal replacement[Repealed, SOR/95-474, s. 3]

pharmacist

pharmacist means a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy under those laws in that province; (pharmacien)

physician

physician means a person who is registered and entitled under the laws of a province to practise medicine and who is practicing medicine under those laws in that province; (médecin)

prepackaged meal

prepackaged meal[Repealed, SOR/95-474, s. 3]

target body weight

target body weight means the anticipated body weight at the end of the weight reduction diet, as determined by the physician before the weight reduction diet begins; (poids corporel cible)

very low energy diet

very low energy diet means a diet for weight reduction that provides less than 900 kilocalories per day when followed as directed. (régime à très faible teneur en énergie)

• B.24.003 (1) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use unless the food is

  • (a) to (e) [Repealed, SOR/2003-11, s. 21]

  • (f) a formulated liquid diet that meets the requirements contained in sections B.24.101 and B.24.102;

  • (f.1) a meal replacement for special dietary use that meets the requirements contained in section B.24.200;

  • (f.2) a nutritional supplement that meets the requirements contained in section B.24.201;

  • (g) a gluten-free food that meets the requirements contained in section B.24.018;

  • (h) represented for protein-restricted diets;

  • (i) represented for low (naming the amino acid) diets; or

  • (j) a food represented for use in a very low energy diet, where the food meets the requirements contained in section B.24.303.

• (1.1) Despite subsection (1), a person may label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use if its label carries a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:

  • (a) “free of energy”, set out in item 1;

  • (b) “low in energy”, set out in item 2;

  • (c) “free of sodium or salt”, set out in item 31;

  • (d) “low in sodium or salt”, set out in item 32; or

  • (e) “free of sugars”, set out in item 37.

• (2) Subsection (1) does not apply to a human milk fortifier or human milk substitute as defined in section B.25.001.

• (3) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is for use in a weight reduction diet unless that food is

  • (a) a meal replacement that meets the compositional requirements contained in section B.24.200;

  • (b) a prepackaged meal;

  • (c) a food sold by a weight reduction clinic to clients of the clinic for use in a weight reduction program supervised by the staff of the clinic; or

  • (d) a food represented for use in a very low-energy diet that meets the compositional requirements contained in section B.24.303.

• (4) Except as otherwise permitted by these Regulations, no person shall label, package, sell or advertise a food as “dietetic” or “diet”, or use those words as part of the brand name of the food, unless its label carries a statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:

  • (a) “free of energy”, set out in item 1;

  • (b) “low in energy”, set out in item 2;

  • (c) “reduced in energy”, set out in item 3;

  • (d) “lower in energy”, set out in item 4; or

  • (e) “free of sugars”, set out in item 37.

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) at least 20 g of protein, the quality of which is not less than that set out in column 3 for that item of the Table of Chemical, Physical and Nutritional Characteristics of Food, as determined by the corresponding method set out in column 4, 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