[RELATED PROVISIONS:

SOR/97-12:

66. Packages of drugs that are labelled in accordance with Part C of the Food and Drug Regulations, as those Regulations read on December 31, 1996, are not required to comply with the labelling requirements in these Regulations until January 1, 1999.

SOR/98-423:

10. For the purposes of sections 11 to 13, “Director” has the same meaning as in section A.01.010 of the Food and Drugs Regulations.

11. Despite sections 1 and 7 to 9, if a numbered certificate of registration has been issued in respect of a drug but a drug identification number has not been assigned under section C.01.014.2 of the Food and Drug Regulations, as amended by section 4 of these Regulations, or under section 12 of these Regulations, then section C.01.001A, paragraphs C.01.015(2)(b) and C.01.062(5)(b) and Division 10 and the schedule and the table to Division 10 of Part C of the Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, remain in force in respect of that drug until October 1, 1998, except to the extent that they require information that is not required by those provisions as amended by these Regulations.

12. (1) Despite these Regulations and subject to subsection (3), if the conditions set out in subsection (2) are satisfied, the Director shall, until October 1, 1998, provide to a manufacturer or importer referred to in paragraph (2)( c),

(a) if the information referred to in section C.01.014.3 of the Food and Drug Regulations as amended by section 5 of these Regulations has not been submitted in respect of the drug, the document referred to in subsection C.01.014.2(1) of the Food and Drug Regulations, as amended by section 4 of these Regulations; or

(b) in any other case,

(i) a drug identification number for the drug preceded by the letters “DIN”, or

(ii) where there are two or more brand names for the drug, the drug identification numbers assigned by the Director for the drug, each of which pertains to one of the brand names and is preceded by the letters “DIN”.

(2) The conditions referred to in subsection (1) are:

(a) a numbered certificate of registration has been issued for the drug under subsection C.10.004(1) of the Food and Drug Regulations as it read before the coming into force of these Regulations;

(b) the numbered certificate of registration has not been cancelled under section C.10.008 of the Food and Drug Regulations as it read immediately before the coming into force of these Regulations; and

(c) prior to September 1, 1998, the manufacturer or importer has submitted to the Director

(i) the name of the drug for which a drug identification number is to be issued, and

(ii) the information referred to in subsection C.01.014.1(2) of the Food and Drug Regulations.

(3) If more than one numbered certificate of registration has been issued for a drug on the sole basis of a difference in colour, flavour or fragrance, a single drug identification number shall be assigned in respect of the drug.

13. Despite section 4 of these Regulations and subject to section C.10.005 of the Food and Drug Regulations as that section read immediately before the coming into force of these Regulations, the Director may, until September 30, 1998, issue a numbered certificate of registration, if

(a) the manufacturer expressly requests that a numbered certificate of registration be issued for the drug; and

(b) its application was accepted by the Director for review before the coming into force of these Regulations.

14. Despite section 2, a manufacturer may, until September 30, 2000, label a drug with the label that was in use on September 30, 1998.]

D.01.001. (1) In this Part,

“advertise” means to advertise to the general public; (faire de la publicité)

“brand name” means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

(a) that is assigned to the drug by its manufacturer,

(b) under which the drug is sold or advertised, and

(c) that is used to distinguish the drug; (marque nominative)

“common name” means, with reference to a salt or derivative of a vitamin, the name in English or French by which the salt or derivative is

(a) commonly known, and

(b) designated in scientific or technical journals; (nom usuel)

“prepackaged product” means any food that is contained in a package in the manner in which it is ordinarily sold to, or used or purchased by, a person; (produit préemballé)

“reasonable daily intake”, in respect of a food named in an item in Column I of Schedule K, means the amount of that food set out in Column II of that item; (ration quotidienne normale)

“recommended daily intake” means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in

(a) column II of Table I to Division 1 and column II of Table I to Division 2, for foods intended for persons 2 years of age or older, and

(b) column III of Table I to Division l and column III of Table I to Division 2, for foods intended for infants and children less than 2 years of age; (apport quotidien recommandé)

“testimonial”, with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)

“weighted recommended nutrient intake” means, in respect of a vitamin or mineral nutrient, the amount of the vitamin or mineral nutrient set out in Table II to Division 1 and Table II to Division 2. (apport nutritionnel recommandé pondéré)

(2) For the purposes of this Part, a serving of stated size of a food shall be

(a) based on the food as offered for sale; and

(b) expressed

(i) in grams, if

(A) the net quantity of the food is declared on the label by weight or by count, or

(B) the food is set out in column 1 of item 78, 149 or 150 of Schedule M, and

(ii) in millilitres, if the net quantity of the food is declared on the label by volume, except in the case of a food referred to in clause (i)(B).

(3) A serving of stated size shall be the net quantity of the food in the package if

(a) the quantity of food can reasonably be consumed by one person at a single eating occasion;

(b) the reference amount, as defined in section B.01.001, of the food is less than 100 g or 100 mL and the package contains less than 200% of that amount; or

(c) the reference amount, as defined in section B.01.001, of the food is 100 g or 100 mL or more and the package contains 150% or less of that amount.

SOR/88-559, s. 31; SOR/93-202, s. 31; SOR/96-259, s. 3; SOR/2003-11, s. 27.

D.01.002. (1) In this Division, “vitamin” means any of the following vitamins:

(a) vitamin A;

(b) vitamin D;

(c) vitamin E;

(d) vitamin K;

(e) vitamin C;

(f) thiamin, thiamine or vitamin B1;

(g) riboflavin or vitamin B2;

(h) niacin;

(i) vitamin B6;

(j) folacin or folate;

(k) vitamin B12;

(l) pantothenic acid or pantothenate; and

(m) biotin. (vitamin)

(2) For the purposes of this Division, no expression, other than an expression set out in subsection (1), shall be used to declare the vitamin content of a food.

(3) This Division applies only in respect of foods represented as containing a vitamin for use in human nutrition.

SOR/88-559, s. 32; SOR/2003-11, s. 28.

D.01.003. (1) For the purposes of these Regulations, the vitamin content of a food, other than a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, shall be determined

(a) in the case of vitamin A, in terms of the content of retinol and its derivatives and beta-carotene, expressed as retinol equivalents (RE) on the basis of the following relationships:

(i) 1 RE = 1 microgram retinol, and

(ii) 1 RE = 6 micrograms beta-carotene;

(b) in the case of vitamin D, in terms of the content of cholecalciferol and ergocalciferol, expressed in micrograms;

(c) in the case of vitamin E, in terms of the content of d-alpha-tocopherol and dl-alpha-tocopherol and their derivatives, expressed in milligrams on the basis of the following relationships:

(i) one milligram d-alpha-tocopherol = one milligram vitamin E, and

(ii) one milligram dl-alpha-tocopherol = 0.74 milligram vitamin E;

(d) in the case of vitamin K, in terms of the content of phylloquinone and menaquinones, expressed in micrograms;

(e) in the case of vitamin C, in terms of the content of L-ascorbic acid and L-dehydroascorbic acid and their derivatives, calculated in milligram equivalents of L-ascorbic acid and expressed in milligrams;

(f) in the case of thiamin, thiamine or vitamin B1, and its derivatives, in terms of the content of thiamin, expressed in milligrams;

(g) in the case of riboflavin or vitamin B2 and its derivatives, in terms of the content of riboflavin, expressed in milligrams;

(h) in the case of niacin, in terms of the content of niacin and its derivatives, calculated in milligrams of nicotinic acid, plus the content of tryptophan, calculated in milligrams and divided by 60, with the total expressed as niacin equivalents (NE);

(i) in the case of vitamin B6, in terms of the content of pyridoxine, pyridoxal and pyridoxamine and their derivatives, calculated in milligram equivalents of pyridoxine and expressed in milligrams;

(j) in the case of folacin, in terms of the content of folic acid (pteroylmonoglutamic acid) and related compounds exhibiting the biological activity of folic acid, calculated in microgram equivalents of folic acid and expressed in micrograms;

(k) in the case of vitamin B12, in terms of the content of cyanocobalamin and related compounds exhibiting the biological activity of cyanocobalamin, calculated in microgram equivalents of cyanocobalamin and expressed in micrograms;

(l) in the case of pantothenic acid or pantothenate, in terms of the content of d-pantothenic acid, expressed in milligrams; and

(m) in the case of biotin, in terms of the content of biotin, expressed in milligrams.

(2) For the purpose of paragraph (1)(h), the content of tryptophan may be calculated

(a) where the protein originates from a food that contains protein from more than one source or from a source other than milk, meat, poultry, fish or eggs, as constituting 1.1 per cent of the protein;

(b) where the protein originates from milk, meat, poultry or fish, as constituting 1.3 per cent of the protein; and

(c) where the protein originates from eggs, as constituting 1.5 per cent of the protein.

SOR/88-559, s. 32; SOR/90-830, s. 7.

D.01.004. (1) No person shall, on the label of or in any advertisement for a food, other than a formulated liquid diet, a human milk substitute or a food represented as containing a human milk substitute, make a statement or claim concerning the vitamin content of the food unless

(a) the vitamin is set out in column I of Table I to this Division;

(b) the percentage of the recommended daily intake of the vitamin, per serving of stated size, is 5% or more; and

(c) the vitamin content is declared on the label or in the advertisement as a percentage of the daily value, per serving of stated size.

(2) If a statement or claim described in subsection (1) is made in an advertisement for a food that is not a prepackaged product or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the percentage of the daily value, per serving of stated size, shall,

(a) in the case of an advertisement, other than a radio or television advertisement, be

(i) adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

(ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;

(b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim; or

(c) in the case of a television advertisement, be communicated

(i) in the audio mode, if the statement or claim is made only in the audio portion of the advertisement or in both the audio and visual portions, or

(ii) in the audio or visual mode, if the statement or claim is made only in the visual portion of the advertisement.

(3) The percentage of the daily value, per serving of stated size, that is communicated in the visual mode of a television advertisement in accordance with subparagraph (2)(c)(ii) shall

(a) appear concurrently with and for at least the same amount of time as the statement or claim;

(b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

(c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

(4) Paragraph (1)(b) does not apply in respect of a declaration of the vitamin content in a nutrition facts table.

(5) Paragraph (1)(c) does not apply in respect of a declaration of the biotin content as required by subparagraph B.24.202(a)(v).

SOR/84-300, s. 57(E); SOR/88-559, s. 32; SOR/90-830, s. 8; SOR/96-259, s. 9; SOR/2003-11, s. 29.

D.01.005. [Repealed, SOR/2003-11, s. 29]

D.01.006. No person shall, on the label of or in any advertisement for a food, make any claim concerning the action or effects of a vitamin contained in the food, except to the effect that the vitamin

(a) is a factor in the maintenance of good health; and

(b) is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health and normal growth and development.

SOR/88-559, s. 32.

D.01.007. (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a vitamin, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the vitamin as a component of that ingredient unless

(a) despite subsection B.01.008(6), the vitamin is declared by its common name immediately following the declaration of the ingredient in such a manner as to indicate that it is a component of that ingredient; and

(b) all components of the ingredient are declared.

(2) Paragraph (1)(b) does not apply to flour used as an ingredient in the manufacture of a prepackaged product referred to in subsection (1).

SOR/84-300, s. 59(E); SOR/88-559, s. 32; SOR/2003-11, s. 30.

D.01.008. [Repealed, SOR/88-559, s. 32]

D.01.009. Subject to section D.01.010, no person shall sell a food to which any of the following vitamins have been added unless a reasonable daily intake of that food by a person would result in the daily intake by such person of not less than,

(a) in the case of vitamin A, 1,600 International Units;

(b) in the case of thiamine, 0.6 milligram;

(c) in the case of riboflavin, 1.0 milligram;

(d) in the case of niacin or niacinamide, six milligrams;

(e) in the case of ascorbic acid, 20 milligrams; and

(f) in the case of vitamin D, 300 International Units.

D.01.010. Where a food to which a vitamin has been added is represented as being solely for use in the feeding of children under two years of age, no person shall sell such food unless a reasonable daily intake of that food by a child under two years of age would result in the daily intake by the child of not less than,

(a) in the case of vitamin A, 1,000 International Units;

(b) in the case of thiamine, 0.4 milligram;

(c) in the case of riboflavin, 0.6 milligram;

(d) in the case of niacin or niacinamide, four milligrams;

(e) in the case of pyridoxine, 0.6 milligram;

(f) in the case of ascorbic acid, 20 milligrams;

(g) in the case of vitamin D, 300 International Units; and

(h) in the case of vitamin E, five International Units.

D.01.011. No person shall sell a food to which any of the following vitamins have been added if a reasonable daily intake of that food by a person would result in the daily intake by such person of more than,

(a) in the case of vitamin A, 2,500 International Units;

(b) in the case of thiamine, two milligrams;

(c) in the case of riboflavin, three milligrams;

(d) in the case of niacin or niacinamide, 20 milligrams;

(e) in the case of pyridoxine, 1.5 milligrams;

(f) in the case of ascorbic acid, 60 milligrams;

(g) in the case of vitamin D, 400 International Units; and

(h) in the case of vitamin E, 15 International Units.

D.01.012. No person shall, in advertising a food that is represented as containing a vitamin or on a label of such food,

(a) give any assurance or guarantee of any kind with respect to the result that may be, has been or will be obtained by the addition of the vitamin to a person’s diet; or

(b) refer to, reproduce or quote any testimonial.

D.01.013. [Repealed, SOR/2003-11, s. 31]

TABLE I

RECOMMENDED DAILY INTAKE

 SOR/88-559, s. 33; SOR/96-259, s. 4; SOR/2003-11, ss. 32, 33.

TABLE II

WEIGHTED RECOMMENDED NUTRIENT INTAKE

 SOR/96-259, s. 5.