Natural Health Products Regulations (SOR/2003-196)

89 [Repealed, SOR/2022-146, s. 19]

90 Every lot number required by these Regulations to be shown on a label of a natural health product shall be preceded by one of the following designations:

• (a) “Lot number”;

• (b) “Lot No.”;

• (c) “Lot”; or

• (d) “(L)”.

91 Every product number required by these Regulations to be shown on a label of a natural health product shall

• (a) in the case of a homeopathic medicine, be preceded by the designation “DIN-HM”; and

• (b) in any other case, be preceded by the designation “NPN”.

91.1 The requirement in subsection 93.1(11) and paragraphs 93.4(h) and 93.6(1)(h) to show the food allergen source, gluten source and added sulphites statement on a label of a natural health product does not apply if the food allergen, gluten or added sulphites are present in a natural health product as a result of cross-contamination.

91.2 The source of a food allergen that is required to be shown on a label of a natural health product shall be shown as follows:

• (a) for a food allergen from a food referred to in one of paragraphs (a), (b) and (e) of the definition food allergen in subsection 1(1) or derived from that food, by the name of the food as shown in the applicable paragraph;

• (b) for a food allergen from the food referred to in paragraph (c) of the definition food allergen in subsection 1(1) or derived from that food, by the name “sesame”, “sesame seed” or “sesame seeds”;

• (c) for a food allergen from a food referred to in one of paragraphs (d) and (f) of the definition food allergen in subsection 1(1) or derived from that food, by the name of the food as shown in the applicable paragraph;

• (d) for a food allergen from the food referred to in paragraph (g) of the definition food allergen in subsection 1(1) or derived from that food, by the name “soy”, “soya”, “soybean” or “soybeans”;

• (e) for a food allergen from a food referred to in one of paragraphs (h) to (j) of the definition food allergen in subsection 1(1) or derived from that food, by the common name of the food referred to in item 6, 23 or 24, column 2, of table 1 of the Common Names for Ingredients and Components Document, whichever is applicable; and

• (f) for a food allergen from the food referred to in paragraph (k) of the definition food allergen in subsection 1(1) or derived from that food, by the name “mustard”, “mustard seed” or “mustard seeds”.

91.3 The source of gluten that is required to be shown on a label of a natural health product shall be shown as follows:

• (a) if the source of gluten is shown in the list of non-medicinal ingredients,

  • (i) for gluten from the grain of a cereal referred to in one of subparagraphs (a)(i) to (v) of the definition gluten in subsection 1(1) or derived from that grain, by the name of the cereal as shown in the applicable subparagraph, and

  • (ii) for gluten from the grain of a hybridized strain created from one or more of the cereals referred to in subparagraphs (a)(i) to (v) of the definition gluten in subsection 1(1) or derived from that grain, by the names of the cereals as shown in the applicable subparagraphs; or

• (b) if the source of gluten is shown in a food allergen source, gluten source and added sulphites statement, by the name of the cereal in accordance with subparagraph (a)(i) or (ii), in parentheses, immediately following the word “gluten”.

91.4 The added sulphites that are required to be shown on a label of a natural health product shall be shown as follows:

• (a) if the added sulphites are shown in the list of non-medicinal ingredients,

  • (i) by the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”, or

  • (ii) individually by the applicable name set out in item 21, column 1, of table 2 of the Common Names for Ingredients and Components Document, except that the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid” must be followed, in parentheses, by the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”; or

• (b) if the added sulphites are shown in a food allergen source, gluten source and added sulphites statement, by the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”.

92 No reference, direct or indirect, to the Act, the Food and Drug Regulations or to these Regulations shall be made on any label of or in any advertisement for a natural health product unless the reference is specifically required by law.

93 The following information in respect of a natural health product shall be shown on the principal display panel of the inner label and, if there is an outer label, on the principal display panel of the outer label:

• (a) its brand name;

• (b) its product number;

• (c) its dosage form;

• (d) if it is sterile, the words “sterile” and “stérile”; and

• (e) the net amount in the immediate container in terms of weight, volume or number.

• 93.1 (1) The following information in respect of a natural health product shall be shown on the outer label or, if there is no outer label, on the inner label:

  • (a) if the product is not imported, the name of the product licence holder;

  • (b) if the product is imported, the name of the product licence holder or importer;

  • (c) its recommended route of administration;

  • (d) its lot number;

  • (e) its expiry date; and

  • (f) any of the following:

    • (i) a bilingual table entitled “Product Facts / Info-produit” or “Drug Facts / Info-médicament”,

    • (ii) two tables, one in English entitled “Product Facts” and one in French entitled “Info-produit”, or

    • (iii) two tables, one in English entitled “Drug Facts” and one in French entitled “Info-médicament”.

• (2) Any table that is referred to in paragraph (1)(f) shall be shown on the label vertically or horizontally.

• (3) Despite paragraph (1)(f) and subsection (4), the order of the languages in a bilingual table may be reversed.

• (4) A bilingual table shall contain only the following headings in the following order:

  • (a) “Medicinal ingredients / Ingrédients médicinaux”;

  • (b) “Uses / Usages”;

  • (c) “Warnings / Mises en garde”;

  • (d) “Directions / Mode d’emploi”;

  • (e) “Other information / Autres renseignements”;

  • (f) “Non-medicinal ingredients / Ingrédients non médicinaux”; and

  • (g) “Questions?”.

• (5) A table in English shall contain only the following headings in the following order:

  • (a) “Medicinal ingredients”;

  • (b) “Uses”;

  • (c) “Warnings”;

  • (d) “Directions”;

  • (e) “Other information”;

  • (f) “Non-medicinal ingredients”; and

  • (g) “Questions?”.

• (6) A table in French shall contain only the following headings in the following order:

  • (a) “Ingrédients médicinaux”;

  • (b) “Usages”;

  • (c) “Mises en garde”;

  • (d) “Mode d’emploi”;

  • (e) “Autres renseignements”;

  • (f) “Ingrédients non médicinaux”; and

  • (g) “Questions?”.

• (7) The following information shall be shown under the heading “Medicinal ingredients / Ingrédients médicinaux” or under the headings “Medicinal ingredients” and “Ingrédients médicinaux”:

  • (a) a list of the medicinal ingredients of the natural health product that sets out

    • (i) the proper name of each ingredient or, if the proper name is the chemical name, the common name,

    • (ii) the quantity of each ingredient per dosage unit, and

    • (iii) if applicable, the authorized potency of each ingredient; and

  • (b) a description of the source material of each medicinal ingredient of the natural health product.

• (8) At least one recommended use or purpose of the natural health product shall be shown under the heading “Uses / Usages” or under the headings “Uses” and “Usages”.

• (9) Despite subsections (4), (5), (6) and (8), the recommended use or purpose may be omitted from the table if that information is shown elsewhere on the same label, and, if it is omitted, the heading “Uses / Usages” or the headings “Uses” and “Usages” shall also be omitted.

• (10) The risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with the use of the natural health product, shall be shown under the heading “Warnings / Mises en garde” or under the headings “Warnings” and “Mises en garde” and, subject to subsections (11) and (12), may be shown in bold type.

• (11) If the natural health product contains a food allergen, gluten or added sulphites, the statement “Allergens / Allergènes” or the statements “Allergens” and “Allergènes” shall be shown in bold type under the heading “Warnings / Mises en garde” or under the headings “Warnings” and “Mises en garde”, followed by the food allergen source, gluten source and added sulphites statement, also in bold type.

• (12) If the natural health product contains aspartame, the statement “Contains aspartame / Contient de l’aspartame” or the statements “Contains aspartame” and “Contient de l’aspartame” shall be shown in bold type under the heading “Warnings / Mises en garde” or under the headings “Warnings” and “Mises en garde”.

• (13) Despite subsections (4), (5) and (6), if there is no risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with the use of the natural health product, the heading “Warnings / Mises en garde” or the headings “Warnings” and “Mises en garde” shall be omitted from the table.

• (14) The following information in respect of the natural health product shall be shown under the headings “Directions / Mode d’emploi” or under the headings “Directions” and “Mode d’emploi”:

  • (a) the recommended dose; and

  • (b) the recommended duration of use, if any.

• (15) The recommended storage conditions of the natural health product shall be shown under the heading “Other information / Autres renseignements” or under the headings “Other information” and “Autres renseignements”.

• (16) Despite subsections (4), (5), (6) and (15), the recommended storage conditions may be omitted from the table if they are shown elsewhere on the same label, and, if they are omitted and no information is to be included under the heading “Other information / Autres renseignements” or the headings “Other information” and “Autres renseignements”, the heading or headings shall also be omitted.

• (17) The following information shall be shown under the heading “Non-medicinal ingredients / Ingrédients non médicinaux” or under the headings “Non-medicinal ingredients” and “Ingrédients non médicinaux”:

  • (a) a qualitative list, by common name, of the non-medicinal ingredients of the natural health product; and

  • (b) if the natural health product contains mercury or any salts or derivatives of mercury as a non-medicinal ingredient, a statement that sets out the quantities of those ingredients.

• (18) The telephone number, email address or website address of a contact person who represents the product licence holder of the natural health product shall be shown under the heading “Questions?”.

93.2 The following requirements apply in respect of a table referred to in paragraph 93.1(1)(f):

• (a) the title shall be separated by a solid black line from the other information in the table;

• (b) each heading and the information that is shown under it shall be separated by a solid black line from any subsequent heading;

• (c) the type size of the characters of the title shall be larger than that of each heading;

• (d) the type size of the characters of each heading shall be larger than that of the information that is shown under each heading;

• (e) the title and the headings shall be in bold type;

• (f) the information that is shown under each heading shall be in regular type, except as otherwise provided; and

• (g) the title, the headings and the information that is shown under each heading shall all be shown in the same font type.

• 93.3 (1) If, despite the following measures, the available surface area for a label is insufficient to accommodate all of the information that is required to be shown in a table under section 93.1, the information required to be shown under subsection 93.1(17) shall be shown elsewhere on the same label:

  • (a) the use of a bilingual table;

  • (b) the use of condensed characters of a type size of at least 5 points to show information that is related to non-medicinal ingredients; and

  • (c) the use of condensed characters of a type size of at least 5.5 points to show information that is not related to non-medicinal ingredients.

• (2) If, despite the application of subsection (1), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown in the table, the information required to be shown under subsection 93.1(17) shall be shown

  • (a) in a leaflet that is affixed or attached to the outermost container of the natural health product;

  • (b) in a package insert; or

  • (c) on a website.

• (3) If, despite the application of subsection (2), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown in the table, the information required to be shown under paragraph 93.1(7)(b) shall be shown in the leaflet or package insert, or on the website, that contains the information required to be shown under subsection 93.1(17).

• (4) For the purposes of subsections (1), (2) and (3), the table shall include a statement under the title “Product Facts / Info-produit” or “Product Facts” and “Info-produit” that indicates where the information required to be shown under subsection 93.1(17), and, if applicable, paragraph 93.1(7)(b), can be found.

• (5) The information that is required to be shown in a package insert or on a website shall appear in a table that complies with the requirements of sections 93.1 and 93.2.