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

Placement

• B.29.022 (1) The supplemented food caution identifier must be displayed

  • (a) in the case of a supplemented food with a principal display panel whose height is less than its width, on the right half of the principal display panel; and

  • (b) in the case of any other supplemented food, on the upper half of the principal display panel.

• (2) The supplemented food caution identifier must be surrounded by a buffer that

  • (a) has a width that is equal to or greater than that set out in column 4 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications, and

  • (b) does not contain any text or other graphic material.

• (3) If a supplemented food is cylindrical in shape, the outer edge of the buffer must be a minimum distance of 10% of the width of the principal display surface from the edge of the left or right side of that surface.

• (4) If it is impossible to comply with both paragraph (1)(a) and subsection (3), the supplemented food caution identifier may be displayed partially in the left half of the principal display panel but only to the extent necessary to comply with that subsection.

Orientation

B.29.023 The supplemented food caution identifier must be oriented in the same manner as most of the other information that appears on the principal display panel unless the panel is displayed in the vertical plane and most of the other information is not displayed parallel with the base of the package, in which case the identifier must be oriented in such a manner that the words appearing in it are parallel with the base.

Prohibitions

B.29.024 It is prohibited to label a prepackaged product with a supplemented food caution identifier or sell a product that is so labelled, unless a list of cautionary statements is shown on the label.

• B.29.025 (1) It is prohibited to label a prepackaged product with any representation, including a word, phrase, illustration, sign, mark, symbol or design, that is likely to be mistaken for a supplemented food caution identifier, or sell a prepackaged product that is so labelled.

• (2) For the purposes of subsection (1), a representation does not include a nutrition symbol.

Representations

• B.29.026 (1) Despite anything in these Regulations, it is prohibited, on the label of or in any advertisement for a supplemented food, to make a statement or claim to the effect that a supplemental ingredient that is a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health, if the supplemental ingredient is one for which a cautionary statement set out in the list of cautionary statements is applicable.

• (2) However, the label of or advertisement for a supplemented food may carry such a statement or claim if it is accompanied by a statement or claim about the specific action or effect of the supplemental ingredient in maintaining the functions of the body necessary to the maintenance of good health.

• (3) If the label of or any advertisement for the supplemented food carries a statement or claim referred to in subsection (1), that statement or claim and the statement or claim referred to in subsection (2) must,

  • (a) if made on the label of or in an advertisement, other than a radio or television advertisement, for the supplemented food,

    • (i) be adjacent to one another without any intervening printed, written or graphic material, and

    • (ii) be shown in letters of the same size and prominence;

  • (b) if made in a radio advertisement or in the audio portion of a television advertisement for the supplemented food, immediately follow one another; or

  • (c) if made in the visual portion of a television advertisement for the supplemented food,

    • (i) appear concurrently and for the same amount of time,

    • (ii) be adjacent to one another without any intervening printed, written or graphic material, and

    • (iii) be shown in letters of the same size and prominence.

B.29.027 Despite anything in these Regulations, if a supplemented food is required to show a cautionary statement that is set out in the list of cautionary statements and recommends against consumption by any individual less than 18 years of age that is part of a group identified in the cautionary statement, it is prohibited, on the label of or in any advertisement for the supplemented food, to make a statement or claim to the effect that a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to normal growth and development.

• B.29.028 (1) Despite anything in these Regulations, if the label of a supplemented food is required to carry the statement “high caffeine content” in accordance with column 5 of the List of Permitted Supplemental Ingredients, it is prohibited to make a representation, express or implied, on the label of or in any advertisement for the supplemented food with respect to any vitamin or mineral nutrient contained in the supplemented food.

• (2) Subsection (1) does not apply in respect of a declaration of a vitamin in a list of ingredients or supplemented food facts table, or in respect of a declaration of a mineral nutrient in a list of ingredients, nutrition symbol or supplemented food facts table.

• B.29.029 (1) If a list of cautionary statements is shown on the label of a supplemented food, the representations set out in subsection (2) must meet the following requirements:

  • (a) if the representation is displayed on the principal display panel,

    • (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”, and

    • (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”; and

  • (b) if the representation is displayed on any continuous surface, other than on the principal display panel,

    • (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the cautionary statements, and

    • (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the cautionary statements.

• (2) For the purposes of subsection (1), the representations are the following:

  • (a) a declaration referred to in subsection B.01.301(1) or (2);

  • (b) any representation that expressly or implicitly indicates that the supplemented food or any substance it contains has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004; and

  • (c) any health-related statement, logo, symbol, seal of approval or mark.

• (3) This section does not apply to the brand name or product name of a supplemented food.

Adulteration and Exemptions

B.29.030 A prepackaged product, other than a supplemented food, is adulterated if it contains a supplemented food as an ingredient.

B.29.031 A prepackaged product, other than a supplemented food, is adulterated if a substance listed in column 1 of the List of Permitted Supplemental Ingredients has been added to it other than in accordance with these Regulations.

B.29.032 A supplemented food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — by reason only that a supplemental ingredient has been added to it.

PART CDrugs

DIVISION 1

General

• C.01.001 (1) In this Part

  acetaminophen product

  acetaminophen product has the same meaning as in Division 9; (produit d’acétaminophène)

  adult standard dosage unit

  adult standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour adultes)

  adverse drug reaction

  adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (réaction indésirable à une drogue)

  antibiotic

  antibiotic means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; (antibiotique)

  authorization holder

  authorization holder[Repealed, SOR/2017-259, s. 1]

  brand name

  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)

  case report

  case report means a detailed record of all relevant data associated with the use of a drug in a subject; (fiche d’observation)

  children’s standard dosage unit

  children’s standard dosage unit has, with reference to a drug, the same meaning as in Division 9; (dose normale pour enfants)

  child resistant package

  child resistant package means a package that meets the requirements of subsection (2); (emballage protège-enfants)

  common name

  common name means, with reference to a drug, the name in English or French by which the drug is

  • (a) commonly known, and

  • (b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; (nom usuel)

  COVID-19

  COVID-19 means the coronavirus disease 2019; (COVID-19)

  COVID-19 drug

  COVID-19 drug means a drug, other than a veterinary health product, that is manufactured, sold or represented for use in relation to COVID-19; (drogue contre la COVID-19)

  discontinue

  discontinue means, in respect of the sale of a drug by the manufacturer to whom a document was issued under subsection C.01.014.2(1) that sets out the drug identification number assigned for the drug, to permanently cease the sale of the drug; (cesser)

  expiration date

  expiration date means

  • (a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month:

    • (i) the date up to and including which the drug maintains its labelled potency, purity and physical characteristics, and

    • (ii) the date after which the manufacturer recommends that the drug not be used; and

  • (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month:

    • (i) the retest date, or

    • (ii) the date after which the manufacturer recommends that the active ingredient not be used; (date limite d’utilisation)

  flavour

  flavour means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug solely to produce or mask a particular taste. It does not include an ingredient or combination of ingredients that impart only a sweet taste to the drug; (saveur)

  fragrance

  fragrance means a non-medicinal ingredient or combination of non-medicinal ingredients added to a drug to produce or mask a particular odour; (parfum)

  immediate container

  immediate container means the receptacle that is in direct contact with a drug; (récipient immédiat)

  internal use

  internal use means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; (usage interne)

  ISAD Interim Order

  ISAD Interim Order means the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 made by the Minister on September 16, 2020 and published in Part I of the Canada Gazette on October 3, 2020; (arrêté d’urgence IVPD)

  List A

  List A means the document, entitled List of Certain Antimicrobial Active Pharmaceutical Ingredients, that is published by the Government of Canada on its website, as amended from time to time; (Liste A)

  List B

  List B means the document, entitled List of Certain Veterinary Drugs Which May Be Imported But Not Sold, that is published by the Government of Canada on its website, as amended from time to time; (Liste B)

  List C

  List C means the document, entitled List of Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; (Liste C)

  List D

  List D means the document entitled List of Certain Non-prescription Drugs for Distribution as Samples that is published by the Government of Canada on its website, as amended from time to time; (Liste D)

  non-medicinal ingredient

  non-medicinal ingredient means a substance — other than the pharmacologically active drug — that is added during the manufacturing process and that is present in the finished drug product; (ingrédient non médicinal)

  official drug

  official drug means any drug

  • (a) for which a standard is provided in these Regulations, or

  • (b) for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act; (drogue officielle)

  parenteral use

  parenteral use means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane; (usage parentéral)

  per cent

  per cent means per cent by weight unless otherwise stated; (pour cent)

  pharmaceutical ink

  pharmaceutical ink means a non-medicinal ingredient or combination of non-medicinal ingredients used to imprint the drug with marks or symbols; (encre pharmaceutique)

  pharmacist

  pharmacist means a person who

  • (a) is registered or otherwise entitled under the laws of a province to practise pharmacy, and

  • (b) is practising pharmacy in that province; (pharmacien)

  pharmacy technician

  pharmacy technician means a person who

  • (a) is registered or otherwise entitled under the laws of a province to practise as a pharmacy technician; and

  • (b) is practising as a pharmacy technician in that province; (technicien en pharmacie)

  practitioner

  practitioner means a person who

  • (a) is entitled under the laws of a province to treat patients with a prescription drug, and

  • (b) is practising their profession in that province; (praticien)

  prescription

  prescription means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order; (ordonnance)

  proper name

  proper name means, with reference to a drug, the name in English or French

  • (a) assigned to the drug in section C.01.002,

  • (b) that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part, the name of the dispensing form,

  • (c) specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or

  • (d) assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c); (nom propre)

  salicylate product

  salicylate product has the same meaning as in Division 9; (produit de salicylate)

  serious adverse drug reaction

  serious adverse drug reaction means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; (réaction indésirable grave à une drogue)

  serious unexpected adverse drug reaction

  serious unexpected adverse drug reaction means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug; (réaction indésirable grave et imprévue à une drogue)

  teaspoon

  teaspoon means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; (cuillerée à thé)

  test group

  test group means a group that meets the requirements of subsection (3); (groupe d’essai)

  veterinary health product

  veterinary health product means any of the following drugs that is in dosage form and that is not manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms:

  • (a) a substance set out in Column I of Part 1 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of any substances in which all the medicinal ingredients are substances set out in Column I of Part 1 of that list if that combination is, in respect of each of those substances, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those substances;

  • (b) a homeopathic medicine set out in Column I of Part 2 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of homeopathic medicines set out in Column I of Part 2 of that list if that combination is, in respect of each of those homeopathic medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those homeopathic medicines; and

  • (c) a traditional medicine set out in Column I of Part 3 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of traditional medicines set out in Column I of Part 3 of that list if that combination is, in respect of each of those traditional medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those traditional medicines; (produit de santé animale)

  withdrawal period

  withdrawal period means the length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause risk to human health. (délai d’attente)

• (1.1) For the purposes of the Act, serious adverse drug reaction has the same meaning as in subsection (1).

• (2) A child resistant package is a package that

  • (a) when tested in accordance with an acceptable method,

    • (i) in the case of a test group comprising children, cannot be opened

      • (A) by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and

      • (B) by at least 80 per cent of those children after the demonstration, and

    • (ii) in the case of a test group comprising adults

      • (A) can be opened by at least 90 per cent of those adults, and

      • (B) where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or

  • (b) complies with the requirements of one of the following standards, namely,

    • (i) Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Recloseable Child-Resistant Packages, published January 1990, as amended from time to time,

    • (ii) European Standard EN 28317:1992, entitled Child-resistant packaging — Requirements and testing procedures for reclosable packages, as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and

    • (iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.

• (3) For the purposes of this section, test group means

  • (a) in relation to children, a group of at least 200 children who

    • (i) are healthy and have no obvious physical or mental disability,

    • (ii) are between 42 and 51 months of age, and

    • (iii) represent evenly, within plus or minus 10 per cent, each monthly age between 42 and 51 months calculated to the nearest month; and

  • (b) in relation to adults, a group of at least 100 adults who

    • (i) are healthy and have no obvious physical or mental disability,

    • (ii) are between 18 and 45 years of age, and

    • (iii) represent evenly, within plus or minus 10 per cent, each yearly age between 18 and 45 years calculated to the nearest year.

• (4) For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment.