Natural Health Products Regulations (SOR/2003-196)

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.

Small Package Labelling

• 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:

  • (a) the inner label shall show the following in respect of the natural health product, namely,

    • (i) a brand name,

    • (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,

    • (iii) its recommended dose,

    • (iv) its recommended duration of use, if any,

    • (v) its lot number,

    • (vi) its expiry date,

    • (vii) its product number,

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

    • (ix) the net amount in the immediate container in terms of weight, measure or number,

    • (x) its recommended use or purpose, and

    • (xi) if it does not have an outer label, a statement that refers the purchaser or consumer to the leaflet that is required in accordance with subsection (2); and

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

• (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.

Security Packaging

• 95 (1) Subject to subsection (2), no person shall sell or import one or more of the following natural health products that is packaged unless it is contained in a security package:

  • (a) a mouthwash;

  • (b) a product to be inhaled, ingested or inserted into the body; or

  • (c) a product for ophthalmic use.

• (2) Subsection (1) does not apply to lozenges.

• (3) Subject to subsection (4), a statement or illustration that draws attention to the security feature of the security package referred to in subsection (1) shall be shown

  • (a) on the inner label; and

  • (b) if the security feature is a part of the outer package, on the outer label.

• (4) Subsection (3) does not apply if the security feature of a security package is self-evident and is an integral part of the immediate container.

Pressurized Containers

96 Sections A.01.061 to A.01.063 of the Food and Drug Regulations apply in respect of natural health products.

Cautionary Statements and Child Resistant Packages

97 Subsections C.01.001(2) to (4) and C.01.028(1), paragraphs C.01.028(2)(b) and (c), section C.01.029, subsection C.01.031(1), paragraphs C.01.031.2(1)(a) and (c) to (g), subsection C.01.031.2(2), and paragraphs C.01.031.2(3)(a) and (c) of the Food and Drug Regulations apply in respect of natural health products.

Medicinal Ingredient Representations

98 Section C.01.012 of the Food and Drug Regulations applies in respect of natural health products.

Inspectors

99 Sections A.01.022 to A.01.026 of the Food and Drug Regulations apply in respect of natural health products.

Imported Natural Health Products

100 Sections A.01.040 to A.01.044 of the Food and Drug Regulations apply in respect of natural health products.

Export Certificates

101 Section A.01.045 of the Food and Drug Regulations and Appendix III to those Regulations apply in respect of natural health products.

Sampling of Articles

102 Sections A.01.050 and A.01.051 of the Food and Drug Regulations apply in respect of natural health products.

Tablet Disintegration Times

103 Subsection C.01.015(1) and paragraphs C.01.015(2)(d) to (f) of the Food and Drug Regulations apply in respect of natural health products.

Sale of Natural Health Product for Emergency Treatment

103.1 Section C.08.010 and subsections C.08.011(1) and (3) of the Food and Drug Regulations apply in respect of natural health products with the following modifications:

• (a) a reference to “new drug” is to be read as a reference to “natural health product”;

• (b) the sale of a natural health product can only be authorized for human use;

• (c) in subparagraph C.08.010(1)(b)(i), the reference to “adverse drug reactions” is to be read as a reference to “adverse reactions”;

• (d) paragraph C.08.010(2)(c) is to be read as follows:

  • (c) the Minister has not, in respect of a natural health product, suspended the product licence under subsection 18(1) or section 19 of the Natural Health Products Regulations or cancelled the product licence under paragraph 20(b) of those Regulations;

• (e) in subsection C.08.011(1), the reference to “section C.08.002” is to be read as a reference to “subsection 4(1) of the Natural Health Products Regulations”; and

• (f) in subsection C.08.011(3), the reference to “these Regulations” is to be read as a reference to the Natural Health Products Regulations.

Public or Canadian Armed Forces Health Emergencies

• 103.15 (1) Sections C.11.002 and C.11.003 of the Food and Drug Regulations apply in respect of natural health products for which a product licence has not been issued.

• (2) If the Minister issues an authorization to sell a specified quantity of a natural health product under subsection C.11.003(1) of the Food and Drug Regulations, any quantities of the drug that are sold in accordance with the authorization cease to be considered to be natural health products as of the time of sale.

Exemptions

Advertising

103.2 A natural health product is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act.

Sale

103.3 A natural health product is exempt from subsection 3(2) of the Act with respect to its sale by a person where the natural health product is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act.