GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Food and Drug Regulations — (a)
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 )
Food and Drug Regulations — Food and Drug Regulations
meal replacement [Repealed, SOR/95-474, s. 3]
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
prepackaged meal [Repealed, SOR/95-474, s. 3]
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — Food and Drug Regulations
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 )
Food and Drug Regulations — B.24.003
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in a manner likely to create an impression that it is a food for special dietary use unless the food is (a) to (e) [Repealed, SOR/2003-11, s. 21] (f) a formulated liquid diet that meets the requirements contained in sections B.24.101 and B.24.102; (f.1) a meal replacement for special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. SOR/78-64, s. 2; SOR/78-698, s. 5; SOR/84-334, s. 1; SOR/86-178, s. 8(E); SOR/94-35, s. 2; SOR/95-444, s. 1; SOR/95-474, s. 4; SOR/2003-11, s. 21 SOR/2021-57, s. 11 SOR/2022-168, s. 52
Food and Drug Regulations — B.24.004 to B.24.014
B.24.004 to B.24.014 [Repealed, SOR/2003-11, s. 22]
Food and Drug Regulations — B.24.015 and B.24.016
B.24.015 and B.24.016 [Repealed, SOR/88-559, s. 6]
Food and Drug Regulations — B.24.017
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. SOR/78-698, s. 6; SOR/94-35, s. 3; SOR/2018-69, ss. 11, 27
Food and Drug Regulations — B.24.018
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). SOR/95-444, s. 2; SOR/2011-28, s. 6
Food and Drug Regulations — B.24.100
B.24.100 No person shall advertise a formulated liquid diet to the general public. SOR/78-64, s. 7; SOR/78-698, s. 7
Food and Drug Regulations — B.24.101
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. SOR/78-64, s. 7
Food and Drug Regulations — B.24.102
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. TABLE 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 B 6 0.9 mg 0.9 mg Vitamin B 12 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 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) SOR/2024-244, s. 136
Food and Drug Regulations — B.24.103
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. SOR/78-64, s. 7; SOR/88-559, s. 27 SOR/2022-197, s. 6
Food and Drug Regulations — B.24.201
n III of the table to this section does not include overage. TABLE Column I Column II Column III Nutrients Minimum Amount per Available 100 Kcal or 420 KJ Maximum Amount per Available 100 Kcal or 420 KJ VITAMINS Vitamin A 100 RE 250 RE Vitamin D 0.25 µg 1 µg Vitamin E 1.0 mg 2.0 mg Vitamin C 5 mg 10 mg Thiamine 140 µg 350 µg Riboflavin 180 µg 360 µg Niacin 3 NE 6 NE Vitamin B 6 180 µg 350 µg Vitamin B 12 0.1 µg 0.3 µg Folacin 30 µg 60 µg Pantothenic acid 0.6 mg 1.2 mg Biotin 12 µg 35 µg MINERAL NUTRIENTS Calcium 100 mg 175 mg Phosphorus 100 mg 175 mg Iron 1.0 mg 2.0 mg Iodide 15 µg 45 µg Magnesium 20 mg 40 mg Copper 0.15 mg 0.30 mg Zinc 1.4 mg 2.0 mg Potassium 175 mg Manganese 0.45 mg 0.90 mg Selenium 4 µg 8 µg Chromium 4 µg 8 µg Molybdenum 8 µg 15 µg SOR/78-698, s. 9; SOR/95-474, s. 5
Food and Drug Regulations — B.24.202
B.24.202 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 B 1 , riboflavin or vitamin B 2 , niacin, vitamin B 6 , vitamin B 12 , 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)
Food and Drug Regulations — B.24.203
B.24.203 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
Food and Drug Regulations — B.24.204
B.24.204 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 I Column II Column III Nutrients Mean Daily Intake Men Women Protein 65 g 55 g VITAMINS Vitamin A 1000 RE 800 RE Vitamin D 5 µg 5 µg Vitamin E 10 mg 7 mg Vitamin C 40 mg 30 mg Thiamin 1 mg 1 mg Riboflavin 1 mg 1 mg Niacin 14 NE 14 NE Vitamin B 6 1.5 mg 1.5 mg Vitamin B 12 1 µg 1 µg Folacin 230 µg 200 µg Pantothenic Acid 5 mg 5 mg MINERAL NUTRIENTS Calcium 800 mg 800 mg Phosphorus 1000 mg 850 mg Iron 9 mg 13 mg Iodide 160 µg 160 µg Magnesium 250 mg 210 mg Copper 2 mg 2 mg Zinc 12 mg 9 mg SOR/78-698, s. 9; SOR/95-474, s. 5
Food and Drug Regulations — B.24.205
B.24.205 (1) No person shall label, package, sell or advertise a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, in a manner likely to create an impression that consumption of a vitamin or mineral supplement must be part of a weight reduction diet. (2) No person shall, on a label of or in an advertisement for a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, make any direct or indirect reference to a vitamin or mineral supplement. (3) Every person who advertises a prepackaged meal or meal replacement for use in a weight reduction diet, or a food to be sold in a weight reduction clinic, shall include in the advertisement 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 ”. SOR/78-698, s. 9; SOR/95-474, s. 5
Food and Drug Regulations — B.24.300
B.24.300 No person shall advertise to the general public a food represented for use in a very low energy diet. SOR/94-35, s. 4
Food and Drug Regulations — B.24.301
B.24.301 (1) No person shall sell, without a written order from a physician, a food represented for use in a very low energy diet. (2) Notwithstanding subsection (1), a person may sell, without a written order from a physician, a food represented for use in a very low energy diet to (a) a physician; (b) a wholesale druggist; (c) a pharmacist; or (d) a hospital. (3) No person other than a pharmacist shall sell to the general public a food represented for use in a very low energy diet. SOR/94-35, s. 4
Food and Drug Regulations — B.24.302
B.24.302 A pharmacist shall retain the written order of a physician for a food represented for use in a very low energy diet for at least two years after the date on which the order is filled. SOR/94-35, s. 4
Food and Drug Regulations — B.24.303
B.24.303 (1) A food represented for use in a very low energy diet, whether ready to serve or diluted with water according to the manufacturer’s directions, shall provide, per daily allowance recommended by the manufacturer (a) either (i) not less than 60 g of protein of a nutritional quality equivalent to that of casein, or (ii) such an amount and quality of protein that, when the quality of the protein is expressed as a fraction of the quality of casein, (A) the fraction is not less than 85/100, and (B) the product obtained by multiplying the fraction by the gram weight of the protein is not less than 60; (b) each vitamin or mineral nutrient named in column I of an item of the table to this subsection, in an amount not less than the minimum amount per day set out in column II of that item; and (c) any nutritive substance added to the food other than those referred to in paragraph (a) or (b), in an amount that is appropriate for the purpose of the substance in the food as determined from clinical trials. TABLE Column I Column II Item Vitamin or Mineral Nutrient Minimum amount per day 1 Thiamine 1.3 mg 2 Riboflavin 1.6 mg 3 Niacin 23 mg 4 Folacin 0.22 mg 5 Biotin 0.15 mg 6 Pantothenic acid 7.0 mg 7 Vitamin B 6 1.5 mg 8 Vitamin B 12 0.001 mg 9 Vitamin A 1000 RE 10 Vitamin D 0.005 mg 11 Vitamin E 10 mg 12 Vitamin C 40 mg 13 Calcium 800 mg 14 Phosphorus 1000 mg 15 Magnesium 250 mg 16 Iron 13 mg 17 Iodine 0.16 mg 18 Zinc 12 mg 19 Copper 2 mg 20 Manganese 3.5 mg 21 Selenium 0.07 mg 22 Chromium 0.05 mg 23 Molybdenum 0.1 mg 24 Sodium 2000 mg 25 Potassium 3000 mg 26 Chloride 1500 mg (2) Notwithstanding paragraph (1)(a), a food represented for use in a very low energy diet shall be accompanied by directions for use that when followed would result in the daily intake by a person of at least 1.2 g of protein per kilogram target body weight. SOR/94-35, s. 4
Food and Drug Regulations — B.24.304
B.24.304 The label of a food represented for use in a very low energy diet shall carry the following information: (a) a statement of the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ) per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (b) a statement of the content in the food of protein, fat, carbohydrate and, where present, fibre expressed in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (c) a statement of the content in the food of all those vitamins and mineral nutrients that are listed in the table to subsection B.24.303(1) expressed in milligrams, in the case of vitamin A expressed in retinol equivalents (RE), per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (d) a statement of the content in the food of any other nutritive substance added to the food in an amount described in paragraph B.24.303(1)(c), expressed in milligrams or in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food; (e) the statement “USE ONLY UNDER MEDICAL SUPERVISION” prominently displayed on the principal display panel; (f) directions for use of the food, including (i) a statement of the rationale for the use of the food, (ii) criteria to be used for the selection of the persons to whom the food may be prescribed, (iii) instructions for consultation with and evaluation of the patient and patient follow-up, and (iv) a statement concerning adequate precautions and contra-indications; (g) directions for the preparation of the food, and storage instructions for the food before and after the container has been opened; and (h) the expiration date of the food. SOR/94-35, s. 4