Guidance document: Labelling of natural health products

This is a guidance document and should be read in conjunction with the Natural Health Products Regulations as well as the proposed regulatory changes to the Natural Health Products Regulations to improve the labelling of natural health products.

Table of contents

• 1.0 Introduction
  • 1.1 Purpose
  • 1.2 Scope
  • 1.3 Definitions
• 2.0 Content
  • 2.1 Information required on the principal display panel of the inner and outer labels
  • 2.2 Information required on the outer label
  • 2.3 Information required on the inner label
  • 2.4 Information required in the Product Facts Table
• 3.0 Format
  • 3.1 Product Facts Table specifications
  • 3.2 Use of graphics
  • 3.3 Packaging
  • 3.4 Innovative labels
• 4.0 Flexibilities
  • 4.1 Labelling of products with four or more medicinal ingredients
• 5.0 Exemptions
  • 5.1 Exemptions from the Product Facts Table and other labelling requirements
  • 5.2 Labelling of exempted products
  • 5.3 Labelling of products in small packages
• 6.0 Coming into force
  • 6.1 Transitional provisions
• 7.0 Contact information
• Annex A: Homeopathic product labelling
• Annex B: Single-entity mineral supplements
• Annex C: Labelling checklist
• Appendix 1: Allergens and aspartame

1.0 Introduction

1.1 Purpose

The purpose of this guidance document is to help you comply with labelling requirements for natural health products (NHPs), as outlined in Part 5 of the Natural Health Products Regulations (the Regulations). It replaces the previous Labelling Guidance Document published in 2006. You should also refer to the Pathway for Licensing Natural Health Products Making Modern Health Claims, Pathway for Licensing Natural Health Products used as Traditional Medicines and Evidence for Homeopathic Medicines guidance documents as applicable, particularly with respect to product health claims.

In conjunction with this guidance document, sponsors may wish to consult the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products, which provides certain best practices for labelling design. Please note that in instances where the two documents contradict, you should always follow the guidance in this document, and must defer to the Regulations.

This guidance document provides information on label design specifications, required sections of the Product Facts Table (PFT), and labelling content to meet your regulatory requirements under the Regulations. NHP licensees looking to have labelling that is compliant with Part 5 of the Regulations should adhere to these principles, the format specifications, and the content requirements defined in the Regulations, as interpreted in this guidance document. This guidance document is supported by recommendations on how a health claim may be presented as described in other NHP guidance documents. Please note that in instances where documents contradict with respect to the new labeling rules set out in the Regulations, you should follow the guidance in this document, and always defer to the Regulations where appropriate.

This guidance document is an administrative instrument. Many of the sections of the guidance document describe requirements in the Regulations, which have the force of law. The guidance document itself does not have force of law, but it is a recommended best practice to assist licensees in meeting their legislative and regulatory obligations. When the guidance document is referring to the requirements of the Regulations, or its interpretation, it will say the step is “required” or that you “must” comply with it, and point to the specific section of the Regulations. When the guidance document refers to a best practice that does not have the force of law, it is either indicated that the step “can” or “should” be done, or that it is “recommended” or “encouraged”. You are encouraged to use all practices outlined in the guidance document, even if they are not required, so that consumers can easily understand the details about the NHP and compare it to other products, allowing them to make informed choices. Other approaches may be acceptable. Prior to the implementation of such an approach, you may wish to contact Health Canada's Natural and Non-prescription Health Products Directorate to discuss such alternatives prior to the implementation of such deviations to avoid non-compliance with the Food and Drugs Act and the Regulations.

Health Canada reserves the right to define requirements not specifically described in this document as part of the product authorization (referred to as the terms of market authorization). Moreover, terms of market authorizations may impose additional labelling requirements. Health Canada is committed to ensuring that requirements are justifiable and that decisions are clearly documented.

1.2 Scope

This guidance document applies to NHPs as defined pursuant to subsection 1(1) of the Regulations. It includes:

• general legibility requirements (for example, contrast and font);
• format requirements, including a standardized PFT to help users find important information and compare similar products;
• information on applying available flexibilities (when applicable); and
• specific labelling instructions for certain classes of products (for example, homeopathic products).

This guidance document does not include information on terms of market authorization application requirements related to NHPs labelling or Health Canada’s review process for labels. For more information on this, please see the Natural Health Products Management of Applications Policy.

1.3 Definitions

Available display surface: the total surface area of a package that is physically available for labelling (see Table 1).

Table 1. Definition of available display surface area

Included	Excluded
total area of package, excluding areas listed in the “excluded” column of this table; bottom of product if it can be labelled (providing that the product will not be damaged or leak if turned upside down).	area destroyed when opened (except single-serve containers); area where a label cannot be physically applied; area where information cannot be legibly set out or easily viewed; Universal Product Code (UPC); innovative labels, leaflets, package inserts, and other extensions of the label, are not included in the calculation of available surface area.

Container: a receptacle, package, wrapper or confining band in which a product is offered for sale but does not include package liners or shipping containers or any outer wrapping or box that is not customarily displayed to the consumer. This is the definition of “container” in the Consumer Packaging and Labelling Act. For clarity, this definition of container includes blister packs, boxes, bottles, covers, sachets, strip packs, tubes, vessels, vials and other similar articles.

Food allergen: any protein from any of the following foods, or any modified protein, including any protein fraction, that is derived from any of the following foods: almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts; peanuts; sesame seeds; wheat or triticale; eggs; milk; soybeans; crustaceans; molluscs; fish; or mustard seeds. This is the definition of “food allergen” pursuant to subsection 1(1) of the Natural Health Products Regulations. Other proteins from other foods may elicit allergic reactions; however only the aforementioned are considered as “food allergens” in this guidance document.

Homeopathic product: a NHP based on homeopathy, denoted by the presence of a DIN-HM instead of an Natural Product Number (NPN) as its product number. Homeopathic products must be manufactured from, or contain as medicinal ingredients, only those substances referenced in a homeopathic monograph in an approved homeopathic pharmacopoeia. They must be prepared in accordance with the methods outlined in an approved homeopathic pharmacopoeia. This is based on the definition of “homeopathic medicine” in the Evidence for Homeopathic Medicines guidance document.

Immediate container: the container that is in direct contact with a NHP. This is the definition of “immediate container” pursuant to subsection 1(1) of the Regulations.

Kit and co-packaged product:

• Co-packaged product: a co-packaged product is when two NHPs are packaged together but are not required to be used together as a unit. A product would constitute a co-packaged product where each item of the co-packaged product has been approved individually.
• Kit: a product would constitute a kit where:
  • the package and the NHP are for use together as a unit;
  • the kit is a single treatment, a single course of treatment or needs to be used in a particular sequence; or
  • a brand name has been identified for the combination of products.

Labels and alternatives:

Text description

This figure provides a visual aid for the difference between the inner and outer label.

There are two images, the first image shows an immediate container (e.g. bottle) which has the inner label affixed to it. The second image shows the outer package (e.g. box) which has the outer label affixed to it. Both images show the “Brand Name” and the natural product number for reference.

• Label: includes any legend, word, or mark attached to, included in, belonging to or accompanying a NHP. This is the definition of “label”, section 2 of the Food and Drugs Act, as interpreted to its application for NHPs.
• Digital label: a label displayed electronically (e.g. a label on a website), compliant with the electronic Product Facts Table requirements set out by Health Canada, that displays all of the information required in a PFT, allowing for the removal of certain information from the physical label. Any information removed from the physical label should be indicated through a statement on the physical label, including what was removed and where it can be found in the digital space.
• Electronic Product Facts Table (ePFT): a PFT, as defined in this guidance document, displayed digitally (e.g. web page of a company’s website). No branding information may be included alongside the ePFT.
• Inner label: the label on or affixed to an immediate container of a NHP. This is the definition of “inner label” pursuant to subsection 1(1) of the Regulations. If the product only has one label, it is considered an “inner label”.
• Innovative label: a label that acts as an extension to a product’s label. Some content, notably the uses and the medicinal ingredients, must be accessible to the consumer at point of purchase and without destroying or compromising the integrity of the label or the package. The innovative label should be physically attached to the label in a manner that does not encourage its separation from the label. Examples of innovative labels include peel-backs, booklet labels, or fold-out labels. As an extension of the label, innovative label format must comply with the font, contrast, and formatting requirements, as outlined in section 88 of the Regulations, as well as this guidance document where applicable.
• Leaflet: a label affixed or attached to the outermost container of a NHP that can easily be removed by the consumer and that contains information that does not fit on the label.
• Outer label: the label on or affixed to the outside of a package, other than the immediate container, of a NHP. This is the definition of “outer label” pursuant to subsection 1(1) of the Regulations. If the product only has one label (i.e., does not have an outer box), it is considered an inner label.
• Package insert: a document inserted in a sleeve (e.g. clear plastic wrapping) on a product’s outer package or immediate container, or contained within a product’s outer package that allows for information to be removed from the outer and/or inner label, as provided for in the Regulations.

Lowest-risk product: a NHP that has a localized or cosmetic-like effect and is either applied on the skin or in the mouth. Lowest-risk products are approved for minor health benefits for issues that would otherwise self-resolve or be self-limited (e.g., not progress), and include mouthwashes; cough drops; lozenges; fluoride toothpastes; products recommended for aromatherapy or organotherapy (topical and oral cavity); and flower essences (topical and oral cavity). However, they do not include nosodes. These products do not rely on systemic absorption or ingestion to achieve their health benefit.

Natural health product: a substance set out in Schedule 1 of the Regulations or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
• restoring or correcting organic functions in humans; or
• modifying organic functions in humans.

However, a NHP does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.

This is the definition of “natural health product” pursuant to subsection 1(1) of the Regulations.

Online Point-of-Sale: any digital platform that sells NHP (e.g. website, application) that should provide the same information that a Canadian needs to make an informed choice as if the product were physically available for selection at said point-of-sale.

Package: includes any thing in which any NHP is wholly or partly contained, placed or packed. This is the definition “package” pursuant to section 2 of the Food and Drugs Act, adapted for a NHP context. Packages are interpreted in this guidance document to be limited to packages that are customarily displayed to the consumer. A store display is not considered a package.

Point: the unit of measurement for type size that is known as a PostScript point and is equal to 0.3527777778 mm. This is the definition of “point” pursuant to subsection 1(1) of the Regulations.

Point-of-selection warning: warning statements needed to make an informed purchasing decision. Please see Table 11 for more information.

Point-of-use warnings: warning statements needed to safely use a product. Please see Table 11 for more information.

Proper name: the vitamin name; the Latin name of the genus for plants, algae, bacteria, fungi, animal material or probiotic; or the chemical name. For a more detailed definition, see section 1(1) of the Regulations.

Principal display panel: the part of the label that is displayed or visible under normal or customary conditions of sale and/or use. This definition is adapted from the Consumer Packaging and Labelling Regulations . Products that only use a single panel as a principal display panel per package (e.g. by using a bilingual principal display panel) are eligible for additional flexibilities.

Small package: a package where the immediate container is not large enough to include an inner label that includes the information and format required by section 93.1 of the Regulations, and can instead can use a leaflet, in the prescribed format, that is affixed or attached to the immediate container. Different than “very small package.”

Traditional product: a NHP based on traditional medicine. Traditional medicine is defined as medicine based on the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. This is based on the definition of “traditional medicine” in the Pathway for Licensing Natural Health Products used as Traditional Medicines.

Very small package: a package for which the available surface area is 90 cm² or less. For additional clarity, both inner labels and outer labels can be considered very small packages. This definition is based on paragraph 88(2) (b) and 93.5 (a) of the Regulations. Different than “small package.”

2.0 Content

You must label and package all NHP in accordance with the Food and Drugs Act, the Regulations, and any other applicable laws, regulations and guidance. Pursuant to section 87 of the Regulations, certain information on the label must be in both English and French.

Advertising of the product in any media (e.g., print, electronic, social, broadcast, etc.), must also be in accordance with the advertising provisions pursuant to section 3 and 9 of the Food and Drugs Act, subject to section 103.2 of the Regulations, and should be in accordance with the applicable Health Canada guidance documents and policies, including the Guidelines for Consumer Advertising of Health Products for Nonprescription Drugs, Natural Health Products, Vaccines and Medical Devices.

Pursuant to Part 5 of the Regulations, product labels (including both inner and outer labels) must have specific information, such as a Natural Product Number and a lot number. The Regulations say where certain information must be located, for example on the principal display panel, per section 93 of Regulations, or in a PFT, per paragraph 93.1 (f) of the Regulations. The Regulations, pursuant to section 88, also say what formatting elements are required by regulation, with many elements being clarified in guidance, including specific font styles, size and contrast. In addition, pursuant to paragraphs 88 (a) and (b) of the Regulations, labels must be legible to consumers under normal conditions of sale or use. There are flexibilities for products that cannot fit all required information while respecting the formatting requirements, both provided for in the Regulations, per subsection 93.3, 93.6(3) and section 94 of the Regulations, which this guide assists in interpreting. There are also risk-based exemptions for some types of products from certain labelling requirements, as established in subsection 88(2) and section 93.5 of the Regulations.

Pursuant to subsections 93.1(4), (5), and (6) of the Regulations, promotional statements that are permitted to be included on NHP labels must be located outside of the PFT. These statements must also be in line with the legislative and regulatory NHP advertising provisions, including those in section 9 of the Food and Drugs Act, and should be aligned with relevant Health Canada or relevant supplemental guidance documents, such as guidance provided by advertising pre-clearance agencies.

2.1 Information required on the principal display panel of the inner and outer labels

You must include the following information on the principal display panel of both the inner and outer labels, if there is an outer label, as outlined in section 93 of the Regulations. If there is only one label, you must put the information on the principal display panel of that label. See section 4.0 (Flexibilities) for more information on other formatting options if the package cannot fit a label with all the required information.

• Brand name
  This is the name used to distinguish or identify the product. You must only use one brand name per product per paragraph 5 (e) of the Regulations, as set out in your product’s terms of market authorization. Note: you may not use a brand name that implies a recommended use that is different than what appears in the approved terms of market authorization for that product. Failing to do so could be considered a violation of section 9 of the Food and Drugs Act.
• Product number
  You will get a product number from Health Canada after Health Canada issues your product’s terms of market authorization. It must be clearly identified on the label by the prefix NPN, or the prefix DIN-HM. Your product number should be displayed horizontally on the label.
• Dosage form
  The dosage form is how the product is applied, ingested or inhaled and includes, for example, “Tablets", “Gels”, etc. When the dosage form appears in the brand name of the product, the dosage form does not have to be repeated (for instance, "Vitamin C Tablets").
• "Sterile" (if applicable)
  Sterile products must be denoted by using the words "sterile" and «stérile».
• Net amount in the immediate container in terms of weight, measure or number
  The net amount is the total number of dosage units or content in the immediate container, by weight, measure or number. When multiple net amounts are used, each should be listed on the label. The net amount must be listed using the standardized or appropriate unit

Table 2. Net Amounts

Net Amount	Definition
Mass	For products that are solids or semi-solids but are not in separate dosage forms (for example, 500 g of powder or 30 g of cream)
Count	When a discrete dosage form is present (for example, 100 capsules)
Volume	For products in liquid form but not in discrete dosage forms (for example, 500 mL of syrup)

A metric symbol used for the abbreviated unit of measure is considered bilingual. Abbreviated symbols should not be followed by a period. If the complete word is being used, it must appear in both English and French. Table 3 provides more details on how to display different units of measure. Other units of measure can be included, however the metric equivalent should be displayed first. The abbreviation “U” for “unit” is not recommended.

Table 3. Units of Measure

Complete Word – English	Complete Word – French	Correct Bilingual Abbreviations
Colony forming units	nombre d'unités formant colonies	CFU / UFC
gram(s)	gramme(s)	g
kilogram(s)	kilogramme(s)	kg
litre(s)	litre(s)	L or l
microgram(s)	microgramme(s)	mcg
milligram(s)	milligramme(s)	mg
millilitre(s)	millilitre(s)	mL

2.2 Information required on the outer label

You must include the following information on the outer label, or if there is no outer label, then on the inner label, as outlined in subsection 93.1 of the Regulations:

• A Product Facts Table (see details below in section 2.4) (if required)
• The name of the licence holder or importer (as applicable). Only one of the two is now required.
• Recommended route of administration (Specifying an oral route of administration is not needed if it is implied by the dosage form)
• Lot number
  One of the following references is recommended to come before the lot number, per section 90 of the Regulations:
  • "Lot number";
  • "Lot No.";
  • "Lot";
  • “LOT”; or
  • "(L)".
• Expiry date
  The expiry, per subsection 1(1) of the Regulations, is the earlier of:
  • the date until which a NHP:
    • maintains its purity and physical characteristics; and
    • its medicinal ingredients maintain their quantity and potency per dosage unit; or
  • the date after which the manufacturer recommends that the NHP should not be used.

The expiry date should come after a term that the general public will clearly understand, for example "Expiration", "Expiry date" or "EXP".

The expiry date should be expressed, at minimum, as a year and month. It is acceptable to use dashes (-), slashes (/), or spaces to separate the year and month. If you choose to also express a day, you should use the last day of the month and use letters for the month to avoid confusion. If you use the complete word for the month, it should appear in English and French. You should use all four numbers for the year to avoid confusion with the month or day. Table 4 shows the recommended expiry date formats. Table 5 shows the bilingual month abbreviations.

Table 5. Acceptable Bilingual Month Abbreviations

Abbreviation	English	French
JA	January	janvier
FE	February	février
MR	March	mars
AL	April	avril
MA	May	mai
JN	June	juin
JL	July	juillet
AU	August	août
SE	September	septembre
OC	October	octobre
NO	November	novembre
DE	December	décembre

2.3 Information required on the inner label

If the NHP has both an inner and outer label, the following information must be on the inner label per section 93.4 of the Regulations:

• The name of the product licence holder or importer (as applicable);
• The contact information of the product licence holder or person who represents the product licence holder or importer (telephone number, email address or website address).
• Medicinal ingredients, quantity of each ingredient per dosage unit, and potency of each ingredient (if applicable). See Annex B for specific labelling recommendations for calcium, iron, magnesium and zinc supplements;
• At least one use or purpose;
• Recommended route of administration (specifying an oral route of administration is not needed, by policy, if it is implied by the dosage form);
• Dose;
• Duration of use, if any;
• Source of food allergens, gluten and source of gluten, and added sulphites, if applicable;
• Contains aspartame disclosure, if applicable;
• Risk information (including those listed in sections 6.d to 6.d.10 in Table 6 and as per the terms of the product’s market authorization);
• Other information (for example, recommended storage conditions);
• Lot number; and
• Expiry date

All content requirements should align with the descriptions outlined in Table 6 (Product Facts Table Content) when a PFT is required.

2.4 Information required in the Product Facts Table

Pursuant to paragraph 93.1(1) (f) of the Regulations, for applicable products, a product’s outermost label must include a PFT, either in the form of:

• A bilingual PFT; or,
• An English PFT AND a French PFT (Tableau Info-produit)

The PFT must be on the outer label or, if there is no outer label, on the inner label, and can be shown horizontally or vertically. Information displayed in the PFT does not have to be repeated elsewhere on the label, unless desired by the licence holder.

The required information, per section 93.1 of the Regulations, is summarized in Table 6 below. The title, headings, and subheadings must appear in the order shown in Table 6. If a heading or subheading is not applicable, it should be excluded from the PFT. Additional subheadings can be included, but must not replace subheadings in Table 6. The information in the PFT must reflect the product’s terms of market authorization and must not include any marketing terms or promotional or marketing wording (for example “improved formulation”, or “recommended by 4 out of 5 experts”) per section 93.1 of the Regulations.

Flexibilities allow for specific information to be moved, in some instances, out of the PFT and to elsewhere on the label, to a leaflet, to an ePFT housed on a website, or to a package insert. A statement, including a URL if using an ePFT, must then be included under the Product Facts title directing consumers to the displaced information, per section 93.3(4) of the Regulations. This statement should be in a font and style consistent with the heading and the language should be precise enough to indicate that information has been removed and clearly indicate where it can be found. This statement does not need to be replicated for every instance that information is removed.

Acceptable statements include:

“For full Product Facts table, including removed information, visit www.websitename.ca" / « Pour le tableau Info-produit complet, incluant les informations déplacées, visitez www.nomdusiteweb.ca » or “Read package insert [or leaflet] for complete warnings before use.” / « Lire la notice [ou le dépliant d'information] pour l’ensemble des avertissements avant l’utilisation. » or “For a full list of non-medicinal ingredients, please see leaflet.” / « Pour une liste complète des ingrédients non-médicinaux, consultez le dépliant en attache. »

Text Equivalent

Figure 1, Examples of acceptable statements for instances where information is removed from the PFT. The text below the heading gives instructions for where consumers can find information removed from the Products Facts table.

For labels that are too small for a PFT, see section 4.1 (Flexibilities) for more details.

Pursuant to subsection 93.5 of the Regulations, the requirement for a PFT does not apply to:

• products with very small packages (defined as 90 cm² of available surface area or less for the label);
• products that contain enough doses for one day’s use or less, as per the directions on the label. This includes samples; sachets; or travel sizes;
• products where the immediate container includes three dosage units or less; or,
• lowest-risk products (see section 1.3 Definitions).

See section 5.0 (Exemptions) for more information.

The following table summarizes the information that must be included in a PFT. For detailed guidance, refer to section 2.4 of this guidance document, or to other sections of this guidance document where applicable.

3.0 Format

Pursuant to section 88 of the Regulations, the information required on the label of a NHP must be clearly and prominently displayed and accessible to the consumer when they buy the product and when they use it. For optimal contrast, all required text must be printed with a single colour that is a visual equivalent to 100% solid black type (100% screen black, dark blue, dark brown, dark green and dark purple are acceptable) on a white or neutral background with a maximum 5% tint of colour.

Text must be in a standard sans serif font of at least 6 points, except for non-medicinal ingredients, which must be at least 5.5 points. If using a condensed font, the 6 points font would appear as 5.5 points, except for non-medicinal ingredients, where the 5.5 points font would appear as 5 points. Secondary information not required by the Regulations, such as copyright protection and product patent, may be any font size. Characters must not come into contact with each other, or with the features of the PFT. It is recommended that headings and subheadings be left justified and in bold.

3.1 Product Facts Table specifications

Table 7. Format of the Standard Product Facts Table

-	Design Element	Format
7.a	Panel	Two or more panels of the label can be used (one English panel and one French panel) to display the PFT. If also using a leaflet, package insert or ePFT, directions on where to find it should be in the same font style as the headings and in 6 point.
7.b	Font Style and Weight	You should use Helvetica Neue 55 Roman and it should be in regular (not bold or italic) font. You should use Helvetica Neue 75 Bold for headings. You should use bold font for the table title “Product Facts” and all headings. Subheadings should be in Helvetica Neue 75 Bold* If Helvetica Neue is not available, the following sans serif fonts should be used: Helvetica, Helvetica LT Standard, Helvetica Neue LT Standard Univers, 55 Roman and 65 Bold Frutiger, 55 Roman and 65 Bold Arial MT Std, Regular and Bold Arial and Arial Bold Benton Sans, Regular and Bold Per paragraph 93.2 (f) of the Regulations, the information shown under each heading must be in regular type. As such, do not use: light style of a font family (for example, Helvetica 45 or 47); or italics (except for Latin terms or where expressly allowed). Characters must not touch each other or the lines of the PFT (paragraph 88 (e) of the Regulations). Character spacing should be standardized to no more than +/-5% of the standard for that font style to ensure the text is easy to read. Where needed, the character width of the type may be reduced horizontally by 10% (in other words, a reduction up to 90% horizontal scale).
7.c	Colour (background and print)	Per paragraph 88(c) of the Regulations, the background colour in the PFT must be white or a uniform neutral background with a maximum 5% tint of colour. This level of tint provides only a slight colour to a background. For optimal contrast, all text and lines should be printed with a single colour that is a visual equivalent of 100% solid black type, such as 100% screen black, dark blue, dark brown, dark green and dark purple.
7.d	Title: Product Facts	Recommended Font:	Helvetica Neue 75 Bold*
		Recommended Font Size:	8 point (should be larger than font size used for Headings)
		Recommended justification:	Left
		Case:	In English: First letter of each word in title is capitalized In French: First letter of the title is capitalized Bilingual headings may be combined with the two headings separated by a slash: “Product Facts” / « Info-produit » or “Drug Facts” / « Info-médicament »
7.e	Title: Product Facts (continued) Drug Facts (continued)	Recommended Font:	“Product Facts” or “Drug Facts”: Helvetica Neue 75 Bold* “(continued)” or « (suite) »: Helvetica Neue 55 Roman*
		Recommended Font Size:	7 point (should be larger than font size used for Headings)
		Recommended justification:	Left
		Case:	In English: First letter of each word is capitalized for “Product Facts” or “Drug Facts”: Lowercase for “(continued)” (not abbreviated) In French: First letter of the title is capitalized for « Info-produit (suite) » or « Info-médicament (suite) » Bilingual headings may be combined with the two headings separated by a slash: “Product Facts (continued)” / « Info-produit (suite) » or “Drug Facts (continued)” / « Info-médicament (suite) »
7.f	Headings (for example, Use(s), Warnings, Directions)	Recommended Font:	Helvetica Neue 75 Bold*
		Recommended Font Size:	7 point (should be smaller than font sized used for PFT title)
		Recommended justification:	Left Bilingual headings may be combined with the two headings separated by a slash (for example, “Warnings” / « Mises en garde »). If the table is too narrow to fit the headings on one line, they can be on separate lines. The combined headings should be left justified.
		Case:	Only the first letter of the first word should be capitalized. For example: “Medicinal ingredients”
7.g	Subheadings (for example, Do not use, Keep out of reach of children)	Recommended font:	Helvetica Neue 75 Bold*
		Recommended Font Size:	6 point
		Recommended justification:	Left Bilingual subheadings may be combined with the two subheadings separated by a slash (for example, “Allergens” / « Allergènes »). If the table is too narrow to fit the subheadings on one line, they can be on separate lines. The combined subheadings should still be left justified.
		Case:	Only the first letter of the first word should be capitalized. For example: “Do not use”
7.h	Text	Recommended font:	Helvetica Neue 55 Roman*
		Recommended font Size:	6 point (or 5.5 condensed)
		Recommended justification:	Left
		Case:	Sentence case
7.i	Bullets	Solid square or solid round bullet points may be used. Bullets with a 3 point font size or bigger are recommended.
7.j	Bulleted content	You can use bullets on the same line as a heading or subheading, except for the “Warnings” heading. Bulleted content can continue to the next line. For sections with multiple bullets, the end of one bullet should be separated from the beginning of the next section by at least one square space the size of the letter "m".
7.k	Box frame, rules and hairlines	Box frame recommendations include: 1.5 point weight key line or box frame to border the table is recommended. The box frame is recommended to be rectangular in most cases, but can follow the shape of differently-shaped packages. Box frames can be adjusted to go around UPCs. Rules (to separate headings, including the “Product Facts” table heading): 1.5 point weight is recommended The rule should extend to touch each side of the box frame Hairlines (to separate subheadings within the “Warning(s)” section): 0.375 point weight is recommended. There should be space the width of 2 characters at 6 point font between the end of each hairline and the box frame The distance between rules or hairlines and type should be consistent.
*If Helvetica Neue is not available, an acceptable font as per “Font Style” (8b) above should be substituted.

Text Equivalent

This image shows two examples of the same Product Facts Table. The headings in the table are, in order: Product Facts, Medicinal ingredients, Uses, Warnings, Directions, Other information, Non-medicinal ingredients and Questions with a question mark. The first example depicts an instance where the Product Facts Table continues onto another panel. After the heading “Warnings” there is a break and a new Product Facts begins with the heading Product Facts (continued) followed by the heading “Directions.”

Each heading or subheading starts on a new line. Headings are separated from each other by a horizontal heavy line, and each subheading in the warnings section is separated from the next by a horizontal hairline.

Under the heading Warnings, there are subheadings: Allergens, Do not use, Ask a doctor or pharmacist before use if you, When using this product, Stop use and ask a doctor if, and Keep out of the reach of children. All headings are bolded and start with a capital letter.

There is mock text after each heading and subheading, in short sentences or bullet points.

3.2 Use of graphics

You must not use graphics in the PFT unless they are trademark symbols (i.e. ® or ™), recommended by Health Canada, or required by the Regulations or the Consumer Chemicals and Containers Regulations, as outlined in section 93 of the Regulations. Examples of acceptable symbols include:

• a red octagon before specific warnings;
• a telephone, a telephone receiver icon, social media icons, or other widely accepted symbols denoting modern contact with the “Questions?” heading;
• graphics linked to an adverse reactions or safety signal assessment; or
• a trademark symbol or registered trademark symbol for trademarked ingredient names.

You cannot use graphics such as pill sizes, food items or depictions of ingredients in the PFT per section 93.1 of the Regulations. You can use these graphics outside the PFT on the same panel of label if space permits.

3.3 Packaging

Kits or co-packaged products require a PFT on the outer label of the kit or co-packaged products per subsection 93.1(1), where applicable. Per section 8 of the Regulations, there must be a separate PFT for each NHP in the kit (in other words, each product with a NPN or DIN-HM). Per paragraph 88 (b) and subsection 93.1(1) of the Regulations, table(s) of the NHP(s) in the kit or co-package must be accessible at the point of sale without breaking the outer package. You should also print the PFT on the package of each NHP, in addition to the outer package of the kit or co-packaged products, whenever possible. The outer label of the kit or co-package must also comply with the requirements for any other types of products included in the kit or co-package (for example, a cosmetic). Refer to the respective regulations of the other product types, such as the Medical Devices Regulations, the Food and Drug Regulations, or the Cosmetic Regulations for label requirements specific to those products.

Security packaging requirements, as outlined in subsection 95(1) of the Regulations, must be followed so customers know the product has not been opened before they buy it. A security package feature can include, for example, seals, transparent wrappers, cotton inserts and lids that are sealed until opened.

Security packaging is only required for NHPs that are intended for human use and are:

• a mouthwash;
• to be inhaled, ingested or inserted into the body; or,
• for ophthalmic use.

For greater clarity, security packaging is not required for topical products, aromatherapy or other products that are diffused into the air, or for lozenges, per subsection 95(2) of the Regulations.

For products with security packaging, pursuant to subsection 95(3) of the Regulations, you must reference the security feature on the label, unless it is evident in the product packaging (subsection 95(4) of the Regulations). If the security feature is part of the outer package, reference to the security feature must be on the outer label per paragraph 95(3) (b) of the Regulations.

Pressurized containers must have hazard symbols and cautionary statements on the principal display panel of the label to ensure consumers are informed of potential safety concerns per section 96 of the Regulations, sections A01.061 to A.01.063 of the Food and Drugs Regulations, and the Consumer Chemicals and Containers Regulations. For additional information, to refer to the Reference Manual for the Consumer Chemicals and Containers Regulations, 2001 of the Hazardous Products Act.

Statement(s) regarding cautionary statements, child-resistant packaging, and safe storage (for example, "Keep out of reach of children") as outlined in section 97 of the Regulations must appear on the label of NHP when required per the product’s terms of market authorization. If this information is included in the PFT, it does not have to be duplicated elsewhere on the package.

3.4 Innovative labels

For the purposes of this guidance document, an innovative label is considered a physical extension of a product’s label. Examples of innovative labels include peel-back, accordion labels, hinge panels, or fold-out labels.

You can use innovative labels to fit required content on the label when there is not enough space on the standard label. An example of required content is the information contained in the PFT. Innovative label formats must comply with applicable regulations and guidance documents, including font, contrast, and formatting requirements as outlined in section 88 of the Regulations.

For the purposes of this guidance document, ePFTs, leaflets or package inserts are not considered innovative labels. They may support labels but cannot be used as an alternative to information required to be presented on the label unless expressly provided for in flexibilities.

General principles:

1. Innovative labels are considered extensions of the label. You can use an innovative label if your product only uses a single panel as a principal display panel (e.g. by using a bilingual principal display panel).
2. Consumers must be able to access the content of the innovative label at the time of product selection, before purchase, and without destroying or compromising the integrity of the label or the package per section 88 of the Regulations.
3. If you use an innovative label, you should ensure that the following information is visible to the consumer at the point of selection without the customer having to manipulate the innovative label:
   • For products with a PFT:
     • the “Product Facts” or “Drug Facts”, title;
     • the “Medicinal ingredients” section;
     • the “Use(s)” section (if the “Use(s)” section has not already been moved to the principal display panel);and,
     • a statement directing the consumer to the continuation of the table on the innovative label.
   • For products without a PFT, you must make sure the following information is visible to the consumer at the point of selection without the customer having to manipulate the label:
     • the list of “Medicinal ingredients” and “Use(s).”

4.0 Flexibilities

Some products and package sizes may not have enough space to include the standard PFT format on the label. Labels may use the series of flexibilities outlined in the Regulations (see Table 8 below) if a standard PFT cannot fit on the label.

Using flexibilities does not change the order of the information in the PFT. This means that some products would have a full table on a label, whereas others may have a partial table on a label and a full table on a package insert and/or an ePFT, depending on the information in question being removed. As outlined in subsection 93.3(5) of the Regulations, leaflets are not required to reproduce a full PFT, unless stated in the conditions set in the Small Package section of this guidance document and section 94 of the Regulations. In all cases, information necessary for the safe selection of the product must appear on the outermost label of the product, per paragraph 88(b) of the Regulations.

When moving information outside the PFT, a statement directing the consumer to the location of the displaced information must appear immediately below the Product Facts title, as outlined in subsections 93.3(4) and 93.6(5) of the Regulations, in a font and style consistent with the label’s headings. For example, “For full Product Facts table, including removed information, visit www.websitename.ca” / « Pour le tableau Info-produit complet, incluant les informations déplacées, visitez www.nomduwebsite.ca » or “Read package insert [or leaflet] for complete warnings before use.” / « Lire la notice [ou le dépliant d’information] pour l’ensemble des avertissements avant l’utilisation » or “For a full list of non-medicinal ingredients, please see leaflet.” / « Pour une liste complète des ingredients non-médicinaux, consultez le dépliant en attache. »

If you are using an ePFT, you should follow the technical standards for the Canadian Drug Facts Table outlined in the Guidance Document: Electronic Canadian Drug Facts Table Technical Standards. If you are using an ePFT, the URL must be included as part of the statement directing consumers to the displaced information under the Product Facts title, as outlined in subsections 93.3(4) and 93.6(5) of the Regulations.

The following flexibilities (see Table 8) may be applied as necessary, as outlined in sections 93.3 and 93.6 of the Regulations:

Table 8. Flexibilities available for the Product Facts Table (all products)

-	Heading / Design element	Flexibility
8.a	Product Facts / Info-produit	If your PFT spans more than one panel, you can remove the “Product Facts (continued)” and « Info-produit (suite) » titles and point the consumer to continued information (for example, by using an arrow).
8.b	Medicinal ingredient(s) (in each dosage unit) / Ingrédient(s) médicinal (médicinaux) (dans chaque unité posologique)	You can move the source information for “Medicinal ingredients” from the label to a leaflet attached to the outermost container of the product, a package insert, or an ePFT (subsection 93.3(3) of the Regulations). Per subsection 93.3(5) of the Regulations, the information required to be shown in a package insert or ePFT must meet the formatting requirements of the PFT (see section 3.0). If the information is being moved to an electronic PFT, the URL must be displayed under the title of the PFT. Note: strain designations for live microorganisms are not recommended to be removed.
8.c	Use(s) / Usage(s)	You can move the content of the “Use(s)” section to the principal display panel (subsection 93.1(9) of the Regulations). “Uses” must mirror the information outlined in your terms of market authorization and cannot be combined with promotional statements. A minimum of one recommended “Use” is required on the label at all times (with the exception of homeopathic products. For more information on homeopathic product labelling, see the Homeopathic Labelling Annex).
8.d	Other information / Autres renseignements	You can place “Other information” content (for example, storage instructions) elsewhere on the label and remove the heading from the Product Facts Table (subsection 93.1(16) of the Regulations).
8.e	Non-medicinal ingredient(s) / Ingrédient(s) non médicinal (médicinaux)	You can remove the “Non-medicinal ingredients” section and place them elsewhere on the label, on a leaflet, package insert, or website (subsections 93.3(1) and (2) of the Regulations).
8.f	Bilingual Product Facts Table	You can use a bilingual PFT instead of separate English and French PFTs (paragraph 93.1(1) (f)(i) of the Regulations).
8.g	Condensed font	You can also reduce the character width horizontally by 10% (in other words, 90% horizontal scale). You can use a condensed font for the “Non-medicinal ingredients” section per paragraph 93.3(1) (c) of the Regulations (i.e. a 5.5 points font condensed, which would appear as a 5 points font). You can also use a 6 points font condensed (which would appear as 5.5 points) for all other required information per paragraph 93.3(1) (c) of the Regulations.
8.h	Headings	For all sections, you can begin the text immediately following the heading.
8.i	Box frame, hairlines, and rules (solid black lines separating headings)	Where multiple panels are sequential, use a single, continuous box frame rather than a frame around each individual panel being used. When applying a continuous box frame, all panels of the PFT should maintain a consistent orientation. Text should not be within 3.175 mm of a fold line. You can reduce the weight of rules to 1.0 point for box frame and rules. Hairlines may be removed from the “Warnings” section and content may begin immediately after the section title. Each section should start on a new line with section titles in bold.

Text Equivalent

Figure 3 shows an example of a Product Facts Table using all the flexibilities available. These flexibilities apply to all products. The headings are presented together with the heading in English followed by a forward slash and the same heading in French. Each heading has mock text in English and then in French, separated by a forward slash.

The headings in the table are, in order: Product Facts / Info Produit, Medicinal ingredient / Ingrédients médicinaux, Warnings / Mises en garde, Directions / Mode d'emploi and Questions with a question mark. All headings are bolded and start with a capital letter. Under the Warnings / Mises en garde heading, there are subheadings and mock text. Under the heading Warnings, there are subheadings, for example, allergens / allergènes and ask a health care practitioner before use if / consulter un practicien de soins de santé si. All headings are bolded and start with a capital letter.

The following flexibilities (see Table 9) can only be accessed if the product only uses a single panel as a principal display panel (e.g. by using a bilingual principal display panel).

Table 9. Flexibilities available for the Product Facts Table (if using a single principal display panel)

-	Heading / Design element	Flexibility
9.a	Font style and weight	Character spacing does not need to follow the +/-5% size limit outlined in Table 7 as long as it is clear and legible.
9.b	Box frame, hairlines, and rules (solid black lines separating headings)	Hairlines and rules may be removed and content may begin immediately after the section title. Each section to start on a new line with section titles in bold. There does not need to be a space the width of 2 characters at 6 point font between the end of each hairline and the box frame. The box frame may be removed if the surrounding label is a different colour than the background of the PFT and creates a natural border.
9.c	Medicinal ingredients / Ingrédients médicinaux	The medicinal ingredients section can continue onto the inside of the innovative label if the “Use(s)” content has been moved to the principal display panel (see 9.a.5 above). If that is the case, a clear indication that the medicinal ingredients section continues onto the inner portion of the innovative label is required. Abbreviations of Latin binomial names may be used where appropriate.
9.d	Non-medicinal ingredient(s) / Ingrédient(s) non médicinal (médicinaux)	Abbreviations of Latin binomial names may be used where appropriate.
9.e	Warnings / Mise(s) en garde	Point-of-selection warnings (see Table 11) are required on the label, without exception. These include warnings related to route of administration, drowsiness or excitability. They may be shown in bold. Point-of-use warnings (see Table 11) may be removed from the PFT and placed on a package insert or a leaflet affixed to the outermost container of the product. Point-of-use warnings must not be moved to an ePFT, except for lowest-risk products, which can move point-of-use warnings to such a space, as long as there is an indication where the complete information can be found. Examples of point-of-use warnings include: “When using this product” / « Lorsque vous utilisez ce produit » and/or “Stop use and ask a health care practitioner if” / « Cessez d’utiliser et consultez un professionnel de la santé si ».

Pursuant to subsection 93.3(5) of the Regulations, products using a package insert and/or a URL directing consumers to an ePFT must display the full PFT on the package insert or Web page, as applicable.

Leaflets are not required to reproduce a full PFT, unless stated in the conditions set in the Small Package section of this guidance document and as outlined in section 94 of the Regulations. In all cases, information necessary for the safe selection of the product must appear on the outermost label of the product, per section 88 of the Regulations. The font size and type, as outlined in section 88 of the Regulations, must be respected and there must be a note under the PFT title directing the consumer to the new location of the displaced information, as outlined in subsections 93.3(4) and 93.6(5) of the Regulations.

For additional clarity, Table 10 outlines which elements should be included on each different type of label.

Text Equivalent

Figure 4 shows an example of a Product Facts Table using the flexibilities available for the table if only a single principal display panel is used. This also applies to all products. The headings are presented together with the heading in English followed by a forward slash and the same heading in French. Each heading has mock text in English and then in French, separated by a forward slash.

The headings in the table are, in order: Product Facts / Info-produit, Medicinal ingredient / Ingrédients médicinaux, Warnings / Mises en garde, Directions / Mode d'emploi and Questions with a question mark. All headings are bolded and start with a capital letter. Under the Warnings / Mises en garde heading, there are subheadings and mock text, for example, allergens / allergènes and ask a health care practitioner before use if / consulter un practicien de soins de santé si.

This table should be read in conjunction with Tables 8, 9 and 10, as well as the section on small labels and exempt packages and products.

Table 11. Warnings needed at point-of-selection and point-of-use

Point-of-selection Point-of-selection warnings are needed to make an informed purchasing decision.	Point-of-use Point-of-use warnings are needed to safely use the product.
For external/rectal/vaginal/ophthalmic use only	-
For use in the nose/eyes/ears only	-
Allergens statement/Asthma alert	-
Flammability warning	-
Choking warning	-
Do not use (if)	-
Do not take other products	-
Ask a health care practitioner before use if	Stop use and ask a health care practitioner if
Ask a health care practitioner if	-
Reye’s Syndrome	-
Keep out of reach of children	-
When using this product (related to drowsiness or excitability or blurred vision)	When using this product (unrelated to drowsiness or excitability or blurred vision)
Other warnings may be needed at point of selection or point of use depending on the nature of the warning, including those identified in Table 7 (7.d to 7.d.10). Please contact Health Canada at the address provided in section 7.0 of this document if further clarification is required.

4.1 Labelling of products with four or more medicinal ingredients

If the product has four or more medicinal ingredients, you can display the “Medicinal ingredients” section within the PFT with the medicinal ingredients, quantity per dosage unit, and potency (if applicable) in one of these ways:

• presented on the same line, separated by bullets; or
• put into columns to show text in both official languages on the same line; or
• left justified text used for one official language and right justified for the second.

You can also use the following subheadings in the “Medicinal ingredients” section:

• vitamins
• probiotics
• minerals
• herbs
• other medicinal ingredients

Text Equivalent

Figure 5 shows two examples of the Product Facts Table for products with four or more medicinal ingredients. The headings are in order: Product Facts /Info-produit, Medicinal ingredient / Ingrédients médicinaux, Warnings / Mises en garde, Directions /Mode d'emploi and Questions with a question mark.

Under the heading Medicinal ingredients/ Ingrédients médicinaux on the left panel, the first table lists the ingredients in bullet form in two columns, and on the second table the ingredients are listed in bullet form continuously. All headings are bolded and start with a capital letter. Under the Warnings / Mises en garde heading, there are subheadings and mock text.

5.0 Exemptions

5.1 Exemptions from the Product Facts Table and other labelling requirements

Products meeting one or more of the following criteria are exempt, per section 93.5 of the Regulations, from the content requirements outlined in sections 2.2 (Information required on the outer label), 2.3 (Information required on the inner label), 2.4 (Information required in the PFT), 3.1 (PFT specifications) and 4.1 (Flexibilities):

• products in very small packages (as defined in section 1.3 of this document);
• products that contain doses for one day’s use or less, as per the directions on the label, including samples, sachets, or travel sizes;
• products for which the immediate container contains no more than three recommended dosage units, such as multiple or single-dose packs, including blisters, strips, push-through cards, ampoules or vials attached by a plastic strip, etc.; and,
• lowest- risk products (as defined in section 1.3 of this document).

For products in very small packages (as defined in section 1.3 of this document), the statements, information and declarations required to be shown on the label of that specific very small package are exempt, per paragraph 88(2) (b) of the Regulations, from the font and contrast requirements outlined in section 3.0 (Formatting).

Products that contain doses for one day’s use or less, as per the directions on the label, including samples, sachets, or travel sizes; and multiple or single-dose packs providing 3 or less doses of product such as blisters, strips, push-through cards, ampoules or vials attached by a plastic strip, are exempt, per subsection 88(3), from the font and contrast requirements outlined in section 3.0 (Formatting).

For lowest-risk products (as defined in section 1.3 of this document), the label content must comply with font and contrast requirements outlined in section 3.0 (Formatting) and section 88 of the Regulations, where applicable.

For information on labelling requirements for these products, see section 5.2 below.

5.2 Labelling of exempted products

This section outlines the labelling requirements for:

• products in very small packages (as defined in section 1.3 of this document);
• products that contain doses for one day’s use or less, as per the directions on the label, including samples, sachets, or travel sizes;
• products for which the immediate container contains no more than three recommended dosage units, such as multiple or single-dose packs, including blisters, strips, push-through cards, ampoules or vials attached by a plastic strip, etc.; and
• lowest-risk products (as defined in section 1.3 of this document).

All content must align with the descriptions outlined in Table 6. As outlined in section 93.6(1) of the Regulations, both the inner and outer labels must show:

• The name of the product licence holder or importer;
• The contact information of the contact person who represents the product licence holder or importer (telephone number, email address or website address (i.e. URL)
• Medicinal ingredients, quantity of each ingredient by dosage unit, and potency of each ingredient (if applicable);
• Use or purpose;
• Recommended route of administration;
• Dose;
• Duration of use;
• The statement “Allergens” / « Allergènes » or the statements “Allergens” and « Allergènes » in bold type, followed by the food allergen source, gluten and gluten source and added sulphites statement, also in bold type, if applicable;
• Contains aspartame if applicable (in bold);
• Other risk information (including those listed in sections 6.d to 6.d.10 in Table 6);
• Other information (for example, recommended storage conditions);
• Lot number; and,
• Expiry date.

As outlined in section 93.6(2) of the Regulations, the outermost label must show:

• Non-medicinal ingredients;
• The quantity of mercury contained in the product if it contains mercury or its salts or derivatives as a non-medicinal ingredient; and,
• A description of the source material of the medicinal ingredients.

Furthermore, these products are not exempted from the requirements set by section 93 of the Regulations regarding mandatory information on the principal display panel. As such, as for any other NHP, an exempted product must show 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:

• its brand name;
• its product number;
• its dosage form;
• if it is sterile, the words “sterile” and « stérile »; and
• the net amount in the immediate container in terms of weight, volume or number.

In addition, except for lowest-risk products, if the information required in this section does not fit on the label, the non-medicinal ingredients as well as the statement setting out the quantity of mercury contained in the product, if applicable, can be moved, per subsection 93.6(3) of the Regulations, from the label to:

• a leaflet attached to the outermost container of the product;
• a package insert; or
• a website.

If there is still not enough space on the label for all the required information, the description of the source material of each medicinal ingredient, per subsection 93.6(4) of the Regulations, can be moved to the same leaflet; package insert; or website.

Although these products are exempted from displaying a PFT and font and contrast requirements (except for lowest-risk products), Health Canada encourages you to include a PFT and encourage the use of appropriate font and contrast recommendations whenever possible.

For lowest-risk products (as defined in section 1.3 of this document), the content outlined in section 5.2 is required in addition to font and contrast requirements outlined in section 3.0 (Formatting).

Regarding flexibilities for lowest-risk products, non-medicinal ingredients and the statement setting out the quantity of mercury contained in the product, if applicable, may also be moved to a leaflet attached to the outermost container, a package insert, or an ePFT if, after using 5.5 points font condensed (which would appear as 5 points) for non-medicinal ingredients and 6 points font condensed (which would appear as 5.5 points) for all other required information, the required information does not fit on the label (subsections 93.6 (3) and (4) of the Regulations).

If there is still not enough space on the label for all the required information, the description of the source material of each medicinal ingredient, per subsection 93.6(4) of the Regulations, can be moved to the same leaflet attached to the outermost container of the product; package insert; or web page.

In any case, if you remove regulatory information per these flexibilities from the physical label and move it to a leaflet, package insert, or website, you must, per subsection 93.6(5) of the Regulations, by using statement that indicates what information has been displaced and where the displaced information can be found. For more information on this statement, refer to section 2.4 or Table 8 of this document.

For lowest-risk products only, point-of-use warnings may also be moved to a leaflet, package insert or ePFT. Pursuant to subsection 93.6(5) of the Regulations, there must be a note directing the consumer to the new location of the displaced information, as outlined in subsections 93.3(4) and 93.6(5) of the Regulations.

For multiple or single dose packs, the required label information should be unaffected by the removal of dosage units. You can do this by printing the required information in a repetitive manner (for instance, blister packages should be printed so that the information can be read for individual units after destruction of part of the package; however, blister packs are not considered inner labels and do not need to meet inner label requirements).

Multiple-dose packs should contain the information outlined below as a minimum requirement:

• the brand name (if no brand name, then proper or common name plus manufacturer's name);
• the potency of the medicinal ingredient except where, in the case of more than one medicinal ingredient, the name used is unique for a particular potency of the medicinal ingredient; and,
• the lot number and expiry date.

5.3 Labelling of products in small packages

If the immediate container and its available display surface is not large enough to
accommodate the labelling requirements outlined in this guidance document the inner label must instead display the following information pursuant to subsection 94(1) of the Regulations (and in alignment with Table 6):

• Brand name;
• Medicinal ingredients;
• Recommended dose;
• Recommended duration of use (if any);
• Lot number;
• Expiry date;
• Product number;
• "Sterile" and « Stérile » if the product is sterile; and,
• Net amount in the immediate container in terms of weight, measure or number; and
• At least one recommended use(s) or purpose(s).

This flexibility does not apply to small packages’ outer labels, if they have an outer label, which must comply with PFT requirements and display a full PFT per paragraph 94(1) (b) of the Regulations.

If the small package does not have an outer label, then the statements, information and declaration as outlined in this guidance document, including the PFT, with the exception of the inner label requirements outlined in this section, can be shown in a leaflet that is attached to the immediate container. The leaflet must comply with font and contrast requirements, as outlined in section 88 of the Regulations. However, if the label would otherwise be required to display a PFT, then a complete PFT must be shown in the leaflet that is affixed or attached to the immediate container, as outlined in subsection 94(2) of the Regulations. The PFT must also comply with the formatting requirements applicable to PFTs. Refer to the section on PFTs and their formatting specifications of this guidance for these requirements.

6.0 Coming into Force

The Regulations Amending the Natural Health Products Regulations came into force on the day on which these Regulations were registered, that is on June 21, 2022. However, for provisions related to the labelling requirements (sections 17 to 22), there is a delayed coming into force date of three years, that is a coming into force date on June 21, 2025. Any natural health product for which a product licence is issued, on or after June 21, 2025, will have to meet the new labelling requirements. Any natural health product for which a product licence is issued before June 21, 2025, will have an additional three-year transition period during which it can be labelled in accordance with the former Regulations (that is, until June 22, 2028). This means that products for which a product licence is issued before June 21, 2025 have until June 22, 2028 before they are required to comply with the new labelling requirements. However, to ensure information is clear, consistent, and legible for consumers, Health Canada encourages the implementation of the improved labelling requirements as early as possible.

6.1 Transitional Provisions

Under paragraph 11(1)(c) of the Natural Health Products Regulations, the deletion or modification of risk information shown on any of a product’s labels, including the deletion or modification of a caution, warning, contra-indication or known adverse reaction associated with its use, requires an application to amend the terms of the market authorization under subsection 11(2) of the Regulations.

However, pursuant to a transitional provision in subsection 24(3) of the Regulations Amending the Natural Health Products Regulations:

• if you hold a product licence under the Regulations that was issued before June 21, 2025, and you are applying to delete or modify risk information such as a caution, warning, contra-indication or known adverse reaction associated with the use of said product during the transition period to comply with the Regulations Amending the Natural Health Products Regulations or to align with changes made to Health Canada's product monographs, you will only be required to submit a notification to the Minister, as outlined in section 12 of the Regulations, instead of an application for amendment, as outlined in section 11 of the Regulations, which would otherwise be required. The notification must include the label text and occur within 60 days after the day on which the change is.

Therefore, you will be able to notify the Minister of such a modification and provide the amended label text from the day when the labelling changes to the Regulations Amending the Natural Health Products Regulations come into force (that is June 21, 2025) and up to the 60th day after the three-year transition period, or August 21, 2028, depending on when the change is made.

For additional clarity, adding or modifying a risk statement to include a food allergen source, gluten source and added sulphites statement, if the ingredient was already listed on your product label, is not considered as a change under paragraph 11(1) (c) nor a change under paragraph 12(2) (f) of the Regulations.

7.0 Contact Information

For questions about NHP labelling, contact Health Canada's Natural and Non-prescription Health Products Directorate at nnhpd.consultation-dpsnso@hc-sc.gc.ca.

Annex A: Homeopathic product labelling

1.0 Scope

This Annex applies to Health Canada-authorized homeopathic products. These products have product numbers with the prefix “DIN-HM”. These labelling requirements are to be applied in addition to the labelling requirements set out in this guidance document (Guidance Document: Labelling of Natural Health Products), the labelling requirements outlined in the Evidence for Homeopathic Medicines guidance document, and in the applicable monographs. Pursuant to section 2 and subsection 86(1) of the Regulations, homeopathic products must meet all applicable requirements in the Regulations.

2.0 Labelling requirements for homeopathic products

2.1 General labelling requirements

This section replaces the information on homeopathic labelling outlined in the 2006 Natural Health Product Labelling Guidance Document. It also replaces changes that were introduced to homeopathic cough, cold and flu products for children 12 years and under in 2015.

Table A.1 outlines labelling requirements for homeopathic products with specific claims and non-specific claims.

Table A.1. Labelling requirements for homeopathic products

-	Homeopathic Products with a Non-Specific Claim	Homeopathic Products with a Specific Claim
Identification of Product Type	One of the following statements is to appear on the label: "Homeopathic Product", "Homeopathic Remedy", “Homeopathic Medicine” or "Homeopathic Preparation" in a minimum font size of 6 on the principal display panel within 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.
Statement of Recommended Use or Purpose	Do not put a recommended use or purpose on the label. If required to use a PFT, the “Uses” section should state "homeopathic medicine", "homeopathic remedy", or "homeopathic preparation".	You must put at least one of the recommended use(s) or purpose(s) on the label in specific, current, unambiguous terms, or, when applicable, in accordance with the monograph.
Statement of Risk Information See section 2.3 of the Evidence for Homeopathic Medicines guidance document for additional information on risk statement requirements.	Label must state: "Consult a health care practitioner/ health care provider/ health care professional/ doctor/ physician if symptoms persist or worsen" AND "Consult a health care practitioner/ health care provider/ health care professional/ doctor/ physician prior to use if you are pregnant or breastfeeding” (unless evidence is provided which specifically supports the safety of the medicinal ingredients in these subpopulations).	Risk information must be consistent with the terms of market authorization. In the absence of other risk statements, the label must include statements to the effect of: "Consult a health care practitioner/ health care provider/ health care professional/ doctor/ physician if symptoms persist or worsen" AND "Consult a health care practitioner/ health care provider/ health care professional/ doctor/ physician prior to use if you are pregnant or breastfeeding" (unless evidence is provided which specifically supports the safety of the medicinal ingredients in these subpopulations).

2.2 Front-of-package statement

All commercially available homeopathic products that do not submit modern scientific evidence to support their health claims as part of their product licence application are required to include one of the following statements on the front of the package (principal display panel):

• For any homeopathic product: “This/These claim(s) is/are based on traditional homeopathic references and not modern scientific evidence.” / « Cette allégation est fondée sur des références homéopathiques traditionnelles et non sur des preuves scientifiques modernes. » or
• For homeopathic products with a non-specific claim: “This product is based on traditional homeopathic references and not modern scientific evidence.” / « Ce produit est fondé sur des références homéopathiques traditionnelles et non sur des preuves scientifiques modernes. »

The format requirements for the statement can be found below:

• Use bold text in a sans serif font with a minimum size of 12 points.
• For optimal contrast, use a single colour that is a visual equivalent of 100% solid black type for the statement text. 100% screen black, dark blue, dark brown, dark green and dark purple are acceptable.
• Use white or a uniform neutral background with a maximum 5% tint of colour for the background of the statement. This level of tint provides only a slight colour to a background.
• If the label surrounding the statement is the same color as the background behind the statement, include a rectangular border around the statement to increase its visibility. The border can be in any colour with sufficient contrast to be visible. The text of the statement must not touch the border. (Note: if the contrast between the colour of the label and the background of the statement creates a natural border, it is not necessary to add an additional border to the statement).

Flexibilities for products in small packages:

Some products and package sizes may not have sufficient space to include the front-of-package statement with the formatting outlined above. These products can access the following graduated flexibilities if the statement does not fit. Use the first flexibility before using the second, use the second before using the third:

1. Use a condensed font and reduce the character width horizontally by up to 10% (in other words, 90% horizontal scale).
2. For products in small packages, you can remove the statement border.
3. For products in packages for which the available surface area for the outer label is 90 cm² or less, if the statement does not fit, the font may be reduced so that the statement is equal to 50% of the font size of the principal or largest brand name on the package to a minimum of 5.5 point font.

For instance, if the principal brand name on the package has a font size of 12 points, then the statement must be a minimum of 6 points. Contrast requirements still apply.

3.0 Additional guidance for specific types of products

3.1 Labelling of nasal, ophthalmic and otic homeopathic products

The labelling of homeopathic products for nasal or ophthalmic use must follow the specifications outlined in the latest edition of Homeopathic Pharmacopeia of the United States or the European Pharmacopoeia.

Homeopathic Pharmacopeia of the United States ophthalmic solution specifications include:

• a label stating the preservatives used, if applicable; and
• for multiple-dose containers, a warning stating that the preparation should not be used more than 30 days after the seal has broken (multiple-dose containers should not exceed 15 mL).

Homeopathic Pharmacopeia of the United States nasal solution specifications include a label stating all preservatives, isotonicity, viscosity and stabilization agents.

Homeopathic otic (ear) drops are to be labelled with a statement to the effect of "Ask a doctor if you have a fever, ear pain, changes in hearing and/or discharge from the ear."

3.2 Labelling specific to nosodes

In addition to the labelling requirements outlined in the rest of this guidance document, nosodes linked to vaccine-preventable infectious disease are to contain the following label statements on the principal display panel in sans serif font with a minimum size of 12 points:

• “This product is neither a vaccine nor an alternative to vaccination.”
• “This product has not been proven to prevent infection. Health Canada does not recommend its use in children and advises that your child receive all routine vaccinations.”

Nosodes linked to infectious diseases are to contain the following label statements on the principal display panel in sans serif font with a minimum size of 12 points:

• “This product has not been proven to prevent infection.”

There are no flexibilities or exemptions for nosode-specific labelling.

Annex B: Single-entity mineral supplements

With regard to single-entity mineral supplements, potencies and content of the active component can differ significantly among various salt forms. The salt form may affect not only the quantity of the element, but also absorption characteristics (for example, for iron and calcium products). When examining a product, consumers and health care professionals may find it difficult to distinguish between the quantity of an active ingredient's salt form and the quantity of the active moiety itself.

Confusion between the active moiety or elemental content, and salt content of the mineral as displayed on the label, has led to medication errors including dosing errors.

For single-entity mineral supplements, the following good labelling practices are recommended to support safe use, with special attention to those containing calcium, iron, magnesium or zinc:

• The principal display panel should identify both the element and the salt with their corresponding quantities to ensure alignment with the range of instructions provided by health care professionals to consumers.
• The quantities on the principal display panel should be located in close proximity to the corresponding name (that is, quantity of salt near salt name, quantity of element near element name). Placing the quantity of the element near the salt name, without clearly identifying it as the quantity of the element should be avoided as it may lead to misinterpretation and dosing errors.
• If space is an issue and the principal display panel cannot accommodate both the salt name/quantity and the element name/quantity, the quantity that appears on the principal display panel must correspond to the description of the ingredient and be placed in close proximity to that name (either the source material or the medicinal ingredient). In other words, if the brand name shown on the principal display panel is the salt name, then the quantity must correspond to that of the salt.
• If the side panel lists both the element and salt, the quantity of both should be specified and clearly associated with the corresponding name, (e.g., Elemental calcium 500 mg (calcium carbonate 1250 mg)). For more details on labelling of specific mineral supplements (calcium, iron, magnesium, and zinc) for the side panel, please refer to Appendix VIII of the Multi-vitamin / mineral supplements monograph or the label text generator in the electronic product licence application.
• These good labelling practices are particularly applicable to single-entity mineral supplements that may be recommended to consumers by health care professionals in conventional practice settings (that is, iron, zinc, magnesium, and calcium with or without vitamin D).
• If the source material is composed of mixed salts or complexes of the same element, the quantity of the salt does not need to be identified.

• 

  

  Text Equivalent

  This figure provides a visual aid for the labelling of single-entity mineral supplements.

  There are two images. The first image shows an immediate container (e.g. bottle) with the inner label affixed to it. On the inner label, the element and its quantity, “Calcium 500 mg”, is shown followed by the salt and its quantity, “calcium carbonate 1250 mg”.

  The second image shows an immediate container (e.g. bottle) with the inner label affixed to it. On the inner label, the salt and its quantity, “Calcium carbonate 1250 mg” is followed by the element and its quantity, “calcium 500 mg”.

Annex C: Labelling checklist

Labelling Requirement	Outer label (NHP with inner/outer)	Inner label (NHP with inner/outer)	Only one label	Exempted product
1.0 Principle display panel:
1.1 Primary Brand Name	X	X	X	X
1.2 Product Number (NPN or DIN-HM pre-fix)	X	X	X	X
1.3 Dosage Form	X	X	X	X
1.4 If the product is sterile, the words "sterile" and « stérile »	X	X	X	X
1.5 Net amount in the immediate container in terms of weight, measure or number	X	X	X	X
2.0 On any panel:
2.1 Name and contact information of the product licence holder or importer	X	X	X	X
2.2 Proper name of each medicinal ingredient, or common name if the proper name is a chemical name	X	X	X	X
2.3 Quantity of each medicinal ingredient per dosage unit (including potency, extract ratio and Quantity Crude Equivalent, if applicable) associated with proper name	X	X	X	X
2.4 Description of source material of each medicinal ingredient	X	-	X	Outermost label
2.5 Recommended use or purpose	X	X	X	X
2.6 Recommended route of administration	X	X	X	X
2.7 Recommended dose (including subpopulation, amount, frequency, and directions of use, if any)	X	X	X	X
2.8 Recommended duration of use, if any	X	X	X	X
2.9 Risk information and warnings	X	X	X	X
2.9.1 Allergen source, gluten and gluten source or added sulphites statement disclosure, if applicable	X	X	X	X
2.10 List by common name, preceded by the heading "non-medicinal ingredients", of all non-medicinal ingredients	X	X	X	Outermost label
2.11 Other information (for example, recommended storage conditions)	X	X	X	X
2.12 Lot number	X	X	X	X
2.13 Expiry date	X	X	X	X
2.14 Security Feature, if applicable.	X	X	X	X
2.15 If product contains mercury or its salts or derivatives as a non-medicinal ingredient, the quantity of mercury in the product	X	-	X	Outermost label
3.0 Cautionary statements and child resistant packages:
3.1 Cautionary Statements and Child Resistant Packages (Section 97)	X	X	X	X

Appendix 1: Allergens and aspartame

This list of food allergens and sources has been included from the Natural Health Products Regulations. It is included in this guidance document for ease of reference, further to requirements for allergen labelling in section 2.4 of this document. If there are any discrepancies between this list and the Natural Health Products Regulations, you must follow the Natural Health Products Regulations.

Food allergen means any protein from any of the following foods, or any modified protein, including any protein fraction, that is or is derived from any of the following foods:

• (a) almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios or walnuts;
• (b) peanuts;
• (c) sesame seeds;
• (d) wheat or triticale;
• (e) eggs;
• (f) milk;
• (g) soybeans;
• (h) crustaceans;
• (i) molluscs;
• (j) fish; or
• (k) mustard seeds

Gluten means:

• any gluten protein from the grain of any of the following cereals or from the grain of a hybridized strain that is created from at least one of the following cereals:
  • (i) barley,
  • (ii) oats,
  • (iii) rye,
  • (iv) triticale,
  • (v) wheat; or
• any modified gluten protein, including any gluten protein fraction, that is derived from the grain of any of the cereals referred to in paragraph (a) or from the grain of a hybridized strain referred to in that paragraph.

Added sulphites means one or more of the food additives that are set out item 21, column 1, of table 2 of the Common Names for Ingredients and Components Document and are present in a NHP as a result of being added to the product.

Additionally, the definition of aspartame, as derived from the Health Canada website, is included for ease of reference.

Aspartame means an artificial sweetener that is a derivative of aspartic acid and phenylalanine.