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Natural Health Products Regulations (SOR/2003-196)

Regulations are current to 2022-11-16 and last amended on 2022-06-21. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2022-146, s. 17

      • 17 (1) The portion of subsection 87(1) of the Regulations before paragraph (a) is replaced by the following:

          • 87 (1) If any of the following information is required by these Regulations to be shown on the label of a natural health product, it shall be shown in both English and French:

      • (2) Subsection 87(2) of the Regulations is replaced by the following:

        • (2) Despite subsection (1), if the common name or proper name of a medicinal ingredient or the common name of a non-medicinal ingredient does not have an English or French equivalent and there is an equivalent name in another language, that equivalent name shall be shown.

        • (3) Despite subsections (1) and (2), the common name of a non-medicinal ingredient may be replaced by the International Nomenclature Cosmetic Ingredient name assigned to it in the International Cosmetic Ingredient Dictionary and Handbook, published in Washington, D.C., United States, by the Personal Care Products Council, as amended from time to time.

  • — SOR/2022-146, s. 18

      • 18 (1) Section 88 of the Regulations is amended by striking out “and” at the end of paragraph (a) and by adding the following after paragraph (b):

        • (c) in characters of a single colour of type that is a visual equivalent of 100% solid black type on a white background or a uniform neutral background with maximum 5% tint of colour;

        • (d) in characters of a standard sans serif font that is not decorative;

        • (e) in characters that are not in contact with each other or with the features of any tables that are required to be shown under paragraph 93.1(1)(f);

        • (f) if they relate to a non-medicinal ingredient, in characters of a type size of at least 5.5 points or, if condensed, of at least 5 points; and

        • (g) if they do not relate to a non-medicinal ingredient, in characters of a type size of at least 6 points or, if condensed, at least 5.5 points.

      • (2) Section 88 of the Regulations is renumbered as subsection 88(1) and is amended by adding the following:

        • (2) Paragraphs (1)(c) to (g) do not apply to

          • (a) the lot number, product number or brand name; or

          • (b) the statements, information and declarations required to be shown on

            • (i) the inner label, if the available surface area for the inner label is 90 cm² or less; or

            • (ii) the outer label, if the available surface area for the outer label is 90 cm² or less.

        • (3) Paragraphs (1)(c) to (g) do not apply if

          • (a) the entire quantity of the natural health product is to be used within one day or less in accordance with the directions on the label; or

          • (b) the immediate container of the natural health product contains no more than three recommended dosage units.

  • — SOR/2022-146, s. 19

    • 19 Section 89 of the Regulations is repealed.

  • — SOR/2022-146, s. 20

    • 20 The Regulations are amended by adding the following after section 91:

      • 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”.

  • — SOR/2022-146, s. 21

    • 21 Section 93 of the Regulations is replaced by the following:

      • 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.

      • 93.4 If a natural health product has both an inner and outer label, the following information in respect of the product shall be shown on the inner label:

        • (a) if the product is not imported, the name of the product licence holder and the telephone number, email address or website address of the contact person who represents the product licence holder;

        • (b) if the product is imported, the name of the product licence holder or importer and the telephone number, email address or website address of the contact person who represents the product licence holder or importer;

        • (c) a list of its medicinal ingredients 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;

        • (d) at least one of its recommended uses or purposes;

        • (e) its recommended route of administration;

        • (f) its recommended dose;

        • (g) its recommended duration of use, if any;

        • (h) if it contains a food allergen, gluten or added sulphites, the statement “Allergens / Allergènes” or the statements “Allergens” and “Allergènes” in bold type, followed by the food allergen source, gluten source and added sulphites statement, also in bold type;

        • (i) if it contains aspartame, the statement “Contains aspartame / Contient de l’aspartame” or the statements “Contains aspartame” and “Contient de l’aspartame” in bold type;

        • (j) any other risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with its use;

        • (k) its recommended storage conditions, if any;

        • (l) its lot number; and

        • (m) its expiry date.

      • 93.5 Sections 93.1 to 93.4 do not apply in respect of a natural health product if

        • (a) the available surface area for the outer label — or, if there is no outer label, for the inner label — is 90 cm² or less;

        • (b) the entire quantity of the product is to be used within one day or less in accordance with the directions on the label;

        • (c) the immediate container contains no more than three recommended dosage units; or

        • (d) the product has a localized effect and is

          • (i) recommended to be used in the oral cavity or on the skin,

          • (ii) recommended for aromatherapy,

          • (iii) recommended for organotherapy,

          • (iv) a throat lozenge,

          • (v) a topical nasal decongestant or counterirritant, or

          • (vi) a flower essence.

        • 93.6 (1) If any of the conditions set out in section 93.5 is met, the following information in respect of the natural health product shall be shown on the inner label and, if there is an outer label, on the outer label:

          • (a) if the product is not imported, the name of the product licence holder and the telephone number, email address or website address of a contact person who represents the product licence holder;

          • (b) if the product is imported, the name of the product licence holder or importer and the telephone number, email address or website address of a contact person who represents the product licence holder or importer;

          • (c) a list of its medicinal ingredients 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;

          • (d) at least one of its recommended uses or purposes;

          • (e) its recommended route of administration;

          • (f) its recommended dose;

          • (g) its recommended duration of use, if any;

          • (h) if it contains a food allergen, gluten or added sulphites, the statement “Allergens / Allergènes” or the statements “Allergens” and “Allergènes” in bold type, followed by the food allergen source, gluten source and added sulphites statement, also in bold type;

          • (i) if it contains aspartame, the statement “Contains aspartame / Contient de l’aspartame” or the statements “Contains aspartame” and “Contient de l’aspartame” in bold type;

          • (j) any other risk information, including any cautions, warnings, contra-indications or known adverse reactions associated with its use;

          • (k) its recommended storage conditions, if any;

          • (l) its lot number; and

          • (m) its expiry date.

        • (2) Subject to subsections (3) and (4), if any of the conditions set out in section 93.5 is met, the following information in respect of the natural health product shall be shown on the outer label or, if there is no outer label, on the inner label:

          • (a) a qualitative list, by common name, of the non-medicinal ingredients that it contains;

          • (b) if it contains mercury or any salts or derivatives of mercury as a non-medicinal ingredient, a statement that sets out the quantities of those ingredients; and

          • (c) a description of the source material of each medicinal ingredient that it contains.

        • (3) The information referred to in paragraphs (2)(a) and (b) shall be shown in a leaflet that is affixed or attached to the outermost container of the natural health product, in a package insert or on a website if

          • (a) in the case described in paragraph 93.5(d), the available surface area for the label is insufficient to accommodate the information that is required to be shown under subsections (1) and (2), despite the use of the following:

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

            • (ii) condensed characters of a type size of at least 5.5 points for information that is not related to non-medicinal ingredients; and

          • (b) in all other cases, the available surface area for the label is insufficient to accommodate the information that is required to be shown under subsections (1) and (2).

        • (4) If, despite the application of subsection (3), the available surface area for the label is insufficient to accommodate all of the remaining information that is required to be shown under subsections (1) and (2), the information referred to in paragraph (2)(c) shall be shown in the leaflet or package insert, or on the website, that contains the information referred to in paragraphs (2)(a) and (b).

        • (5) For the purposes of subsections (3) and (4), the label shall include a statement that indicates where the information referred to in paragraphs (2)(a) and (b), and, if applicable, paragraph (2)(c), can be found.

  • — SOR/2022-146, s. 22

      • 22 (1) The portion of subsection 94(1) of the Regulations before paragraph (a) is replaced by the following:

          • 94 (1) If the immediate container of a natural health product is not large enough to accommodate an inner label that complies with the relevant requirements of sections 93 to 93.6, the product shall be labelled as follows:

      • (2) Subparagraph 94(1)(a)(ii) of the Regulations is replaced by the following:

        • (ii) a qualitative list of its medicinal ingredients, by proper name, or by common name if the proper name is the chemical name, in descending order of quantity per dosage unit,

      • (3) Paragraph 94(1)(b) of the Regulations is replaced by the following:

        • (b) the outer label, if any, shall comply with the relevant requirements of sections 93 to 93.6.

      • (4) Subsection 94(2) of the Regulations is replaced by the following:

        • (2) If the natural health product does not have an outer label,

          • (a) the statements, information and declarations that would, but for subsection (1), be required to be shown on the inner label shall be shown in a leaflet that is affixed or attached to the immediate container; and

          • (b) if section 93.1 applies to the product, the tables required under that section, including the information in them, shall be shown in the leaflet in the manner described in that section and in section 93.2.

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