Natural Health Products Regulations (SOR/2003-196)

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?”.