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Difference between inner and outer label: Visual aid (outer label)

Guidance document: Labelling of natural health products – Canada.ca

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.
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.
This guidance document applies to NHPs as defined pursuant to subsection 1(1) of the Regulations. It includes:
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.
Available display surface: the total surface area of a package that is physically available for labelling (see Table 1).
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:
Labels and alternatives:
Difference between inner and outer label: Visual aid (outer label)
Difference between inner and outer label: Visual aid (inner label)
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.
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:
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.”
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.
Note: All aspects of the product label must also be compliant with the Food and Drugs Act, including section 9 which states that “[n]o person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”
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.
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.
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.
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:
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.
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:
All content requirements should align with the descriptions outlined in Table 6 (Product Facts Table Content) when a PFT is required.
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:
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. »
Figure 1: Product Facts
Figure 1: Product Facts / Info-produit
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:
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.
Product Facts (continued) /
Info-produit (suite)
or
Drug Facts (continued) /
Info-médicament (suite)
If an ePFT is referenced, the website address should be user-friendly, for example using words rather than a series of numbers or random alphanumeric characters. The website should also be easy for the consumer to enter in a browser, such as by using a vanity URL.
The statement does not need to be repeated under individual headings when content has been moved as long as it has already been indicated at the top of the PFT.
List the medicinal ingredients using the proper name (section 93.1(7) of the Regulations). You can use the common name only if the proper name is the chemical name. For additional guidance on proper names and common names refer to the Natural Health Products Ingredients Database (NHPID), which is updated biweekly.
Note: for minerals, the proper name is the medicinal ingredient, per your terms of market authorization, in each dosage form. The salt form is considered its source material. Confusion around labelling of minerals is a serious safety concern. See Annex B for more information.
Medicinal ingredients must be listed from highest quantity to lowest quantity per dosage unit.
For each medicinal ingredient, you must also include:
source material (including strain designations for live microorganisms) associated with the respective medicinal ingredient (section 93.1(7) (b) of the Regulations);
The description of source material should be shown in parentheses following each medicinal ingredient. For example, “Echinacea angustifolia (Echinacea) (root)” or “Glucosamine sulfate (as potassium chloride from shellfish exoskeleton).”
Note that “source material” is referred to in the NHPID as “source materials” and “source ingredients”. For clarity, “strain” is not always captured by source material in NHPID.
quantity of each ingredient per dosage unit.
For topical products, specify the concentration using w/w or w/v, unless otherwise stated in the product monograph (subparagraph 93.1(7) (a)(ii) of the Regulations);
For extract quantities, you should list the medicinal ingredient, the quantity per dosage unit, the extract ratio and quantity dried equivalent in the format shown in the following examples:
potency of each ingredient (if any) (section 93.1(7) (a)(iii) of the Regulations). You can also include the method of preparation
For homeopathic products…
The following examples for homeopathic products are meant for reference and show the proper name, common name, and source material:
These examples are given to increase clarity in the naming of homeopathic medicinal ingredients. All other labelling requirements for homeopathic medicines are applicable, see section 5.2 Labelling Requirements Specific to Homeopathic Medicines of the Evidence for Homeopathic Medicines guidance document as well as the Annex A to this guidance document.
For homeopathic products, the dosage unit is not applicable. You must however include potency here per section 93.1(7) (a)(iii) of the Regulations). You can also list the product’s concentration (mg/mL).
You may only display authorized recommended “Use(s)” or “Purpose(s)” using the exact wording (also referred to as “indications for use”), as expressed in your terms of market authorization. This is the intended benefit of the product when used according to the recommended conditions of use. You must list at least one of the recommended uses or purposes of the NHP per section 93.1(8) of the Regulations. However, you must not remove warnings that are required per the NHP terms of market authorization, regardless of the uses displayed on the label, unless otherwise authorized through a product license amendment.
Recommended uses or purposes are different than advertising/marketing claims. Advertising/marketing claims, which are non-therapeutic in nature, are only permissible outside of the PFT (for example, “new and improved formulation”).
You cannot have use(s) or purpose(s) that refer to the treatment, mitigation, diagnosis or cure of diseases or health-related conditions listed in Schedule A.1, per section 3 of the Food and Drugs Act; however, in some cases, you can make prevention claims for diseases or health related conditions referred to in Schedule A.1, but this has to have been approved as a part of your product’s terms of market authorization. See sections 103.2 and 103.3 of the Regulations as well as the Guidance Document: Schedule A and Section 3 to the Food and Drugs Act for more information.
For traditional products…
The use or purpose for products approved as traditional products should come after an approved qualifier, such as “Traditionally used…” and reflect the product’s specific culture or healing paradigm (for instance, “Traditionally used in Ayurvedic medicine to stimulate the digestive fire or increase agni.”). For confirmation or additional clarify on recommended or required qualifiers, refer to your terms of market authorization.
If the use or purpose is based on both traditional and scientific evidence, the requirement or recommendation for qualifiers will be dictated by the pathway for approval used when seeking authorization, as outlined in your terms of market authorization.
For products with both non-traditional and traditional use claims, the medicinal ingredient(s) supporting the traditional claim should be included in the recommended use. For example, “passionflower is traditionally used in Herbal Medicine as a sleep aid” or “ashwagandha is traditionally used in Ayurveda as Rasayana (rejuvenative tonic)”.
For homeopathic products…
For products approved as homeopathic products, the qualifier “homeopathic product”, “homeopathic medicine”, “homeopathic remedy”, or “homeopathic preparation” should come before the use or purpose. If a use or purpose is supported only by scientific evidence, it must not include a homeopathic qualifier.
The qualifier should meet the size and contrast requirements outlined in section 5.2 of the Evidence for Homeopathic Medicines guidance document.
You must include warning statements, cautions, contraindications and known adverse reactions as outlined in your product’s terms of market authorization, and should list them in the specific order listed below. The language of the warning statements must match the requirements of your terms of market authorization and should comply with any applicable product monographs. Changes in such language would require an authorization amendment, unless permissible for notification under transitional provisions that have been provided for in the Regulations Amending the Natural Health Products Regulations. In such cases, a notification would suffice. You must not remove warnings that are required per the NHP terms of market authorization, regardless of the uses you choose to display on the label. Any changes to warnings would require an amendment to your authorization.
(As applicable, examples only)
For external use only /
Pour usage externe seulement
For rectal use only /
Pour usage rectal seulement
For vaginal use only /
Pour usage vaginal seulement
(As applicable) Allergen(s), gluten and / or added sulphites /
Allergène(s), gluten et / ou sulfites ajoutés
Asthma alert /
Alerte à l’asthme
Contains aspartame /
Contient de l’aspartame
Pursuant to subsection 1(1), paragraph 91.3 (b) and 91.4 of the Regulations, the food allergen source, gluten source and added sulphites statement must list the source of the food allergen (if applicable), the word “gluten” and the source or sources of gluten (if applicable), and, if the product contains 10 p.p.m. of added sulphites or more, the words “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”. For additional clarity, the source of a food allergen must be displayed by the name listed in subsection 91.2 of the Regulations. For example, if casein is used as an ingredient, the name milk must appear after the heading Allergen, and both must be in bold. If defatted wheat germ protein is used as an ingredient, the name gluten, in bold, must appear after the heading Allergen, followed by the word (wheat) in brackets, also in bold.
Pursuant to subsection 93.1(11) of the Regulations, the statement “Allergen” must be in bold , followed by the food allergen source, gluten source and added sulphites statement, also in bold.
For example, if the product contains milk, wheat, and sulfites, the statement must appear as follows: Allergen: gluten (wheat), milk, sulfites.
For additional information please see Appendix 1 of this guidance document.
Precautionary allergen labelling is not required unless there is a concern that there is a probability of the product containing trace elements of an allergen (e.g. you should include “may contain peanuts” if there is a potential for cross-contamination).
For information on contact or fragrance allergens, refer to the Medicinal Ingredients or Non-Medicinal Ingredients subsections.
The “asthma alert” is required if outlined in your terms of market authorization.
The “Contains aspartame” subheading is required if the product contains aspartame. No additional text related to aspartame is required.
You cannot use any other “contains” statements or “substance-free” statements (for example, dye-free, gluten-free) in the PFT per subsection 93.1 (1) of the Regulations. If true and verifiable, this information can appear elsewhere on the label.
List all warnings for persons with pre-existing conditions or for persons experiencing particular symptoms as outlined in your terms of market authorization (subsection 93.1(10) of the Regulations).
List all interaction warnings, including with other NHP, drugs, or food, as outlined in your terms of market authorization (subsection 93.1(10) of the Regulations).
Statements about use or avoidance during pregnancy and while breastfeeding should be included here, as outlined in your terms of market authorization (subsection 93.1(10) of the Regulations).
Acceptable alternatives for “health care practitioner” are: health care provider, health care professional, doctor, physician, or dentist (where appropriate).
Acceptable alternatives for « praticien de soins de santé » in French are: fournisseur de soins de santé, professionnel de la santé, docteur, médecin, or dentiste (where appropriate).
List the notable side effects that the consumer may experience, as outlined in your terms of market authorization (subsection 93.1(10) of the Regulations).
List substances (for example, alcohol, sedatives) or activities (for example, operating machinery, driving a car) that consumers should avoid while using the product, as outlined in your terms of market authorization (subsection 93.1(10) of the Regulations).
List any signs of toxicity or other adverse reactions that would require someone to stop using the product immediately, if applicable and as outlined in the terms of market authorization (subsection 93.1(10) of the Regulations).
Acceptable alternatives for “health care practitioner” are: health care provider, health care professional, doctor, physician, or dentist (where appropriate) / and fournisseur de soins de santé, professionnel de la santé, docteur, médecin, or dentiste in French (where appropriate).
Include other required warnings, as outlined in your terms of market authorization, that have not been captured under the warnings subheadings (subsection 93.1(10) of the Regulations).
State that additional information is available on other parts of the label and package insert, if applicable.
You must include directions for use, including dose instructions (number and frequency of dosage units) and duration, if applicable (subsection 93.1(14) of the Regulations). You should also include route of administration. All information must mirror the information set out in your terms of market authorization.
Dose instructions for specific sub-populations must reflect the terms of market authorization. For example, “Adults (18 years and older) and adolescents (12 to 17 years): Take 1 tablet 3 times per day. Children (6 to 11 years of age): Take 1 tablet once per day.”
If the terms of market authorization has dosing specific to multiple sub-populations, you may choose to market the product to only one sub-population. In this case, dosage information would apply only to that sub-population. For example: “Children (6 to 11 years of age): Take 1 tablet once per day.”
Any storage statements required by the terms of market authorization must be indicated on the label per subsection 93.1(15) of the Regulations. If applicable, recommended storage conditions should be listed using one of the following statements:
You must include information about how long the product is good for and how it should be stored after opening, potency, or reconstitution (for example, “Refrigerate after opening” or “Should be used within 24 hours after diluting”), when applicable.
General precautionary statements, if applicable. Should also be included in this section (for example “Avoid direct light” or “Store in a dry place”).
Include a qualitative list of non-medicinal ingredients by common name (subsection 93.1(17) of the Regulations). Pursuant to subsection 87(3), non-medicinal ingredients can be listed using the International Nomenclature of Cosmetics Ingredients (INCI), regardless of the terms of market authorization. Abbreviations of Latin binomial names may also be used where appropriate.
Non-medicinal ingredients can be listed in alphabetical or by quantity order.
Non-medicinal ingredients that are food allergens, sources of gluten or added sulphites must be displayed in this section, as for any other added non-medicinal ingredient, even if they are listed in the Warnings section (see 7.d.2 above).
If the non-medicinal ingredient is a food allergen, it is recommended that you display the source of food allergen in brackets in bold (e.g. casein (milk)) after the allergenic ingredient, if applicable.
If the non-medicinal ingredient is a source of gluten, it is recommended that you display the word “gluten” in brackets in bold (e.g. wheat (gluten)) if applicable.
If the non-medicinal ingredient is an added sulphites, as defined in the Regulations, then you must use the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents”; or individually by the applicable name set out in the definition added sulphites in subsection 1(1) of the Regulations, except that the name “sodium dithionite”, “sulphur dioxide” or “sulphurous acid” must be followed, in parentheses, by the name “sulfites”, “sulfiting agents”, “sulphites” or “sulphiting agents” (paragraph 91.4 (a) of the Regulations).
For all products, if you move non-medicinal ingredients, including allergenic ingredients, from the physical label to a leaflet, package insert or website, you must clearly direct consumers on the physical label to the location of the displaced information through a statement under the Product Facts title (subsection 93.3(4) of the Regulations).
If your product contains fragrance allergens, such as the ones identified for disclosure in Annex III of the European Commission’s Cosmetic Products Regulation, they must, as for any other non-medicinal ingredient, be listed in the “Non-medicinal ingredient” section by common name of each fragrance, or International Nomenclature of Cosmetics Ingredients (INCI) where appropriate, and not simply by the term “parfum” or “fragrance”. You may group these ingredients together under the term “parfum”, but must thereafter list which fragrances are used. For example, you may list them as Non-medicinal ingredients[…] parfum (cinnamyl alcohol, citral, hydroxycitronellal).
Pursuant to subsection 93.1(17) of the Regulations, any proprietary blends that are used must list their ingredients and not simply be denoted by the term “proprietary blend”.
Information about preservatives required by regulation should appear here (for example, mercurial). This includes the quantity of mercury contained in the product if it contains mercury or its salts or derivatives as a non-medicinal ingredient.
Sugar-based ingredients should be grouped together in brackets after the name “sugar(s)” in descending order by weight. This will help consumers identify all of the sources of sugar added to a NHP and is a similar approach to what is required on food labels.
Provide the contact information of the product licence holder, or a proxy to whom these activities have been contractually designated, where consumers may obtain answers to questions, report problems, or report adverse events associated with the product (subsection 93.1(18) of the Regulations).
The contact information provided must include the full numeric representation of a telephone number, an email address, or a website address (i.e. URL) for the contact per subsection 93.1(18) of the Regulations. You may also include a mailing address in addition to this contact information, or any other information that enables communication with a contact person in Canada, but this is optional.
This section may also include a symbol of a telephone or telephone receiver (( or )), however the symbol cannot replace the heading “Questions?”.
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.
Two or more panels of the label can be used (one English panel and one French panel) to display the PFT.
Per paragraph 93.2 (f) of the Regulations, the information shown under each heading must be in regular type. As such, do not use:
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).
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.
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”.
Rules (to separate headings, including the “Product Facts” table heading):
Hairlines (to separate subheadings within the “Warning(s)” section):
The distance between rules or hairlines and type should be consistent.
Figure 2. Unilingual PFT
Figure 2. Format of PFT
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.
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:
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.
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:
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.
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.
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.
Note: Using an ePFT does not replace the use of a PFT on the physical product label.
The following flexibilities (see Table 8) may be applied as necessary, as outlined in sections 93.3 and 93.6 of the Regulations:
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.
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).
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).
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.
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.
Figure 3. Flexibilities available for the PFT (all products)
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).
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.
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.
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.
Figure 4. Flexibilities available for the PFT (if using a single principal display panel) (all products)
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.
Legend:
X = Element must appear in this specific location
O = Element must appear in at least one of the marked locations
* = Conditional on the use of a single Principal Display Panel (PDP)
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:
You can also use the following subheadings in the “Medicinal ingredients” section:
Figure 5. Labelling of products with four or more medicinal ingredients
Figure 5. Labelling of products with four or more medicinal ingredients
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.
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):
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.
This section outlines the labelling requirements for:
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:
As outlined in section 93.6(2) of the Regulations, the outermost label must show:
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:
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:
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:
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):
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.
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.
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:
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.
For questions about NHP labelling, contact Health Canada’s Natural and Non-prescription Health Products Directorate at nnhpd.consultation-dpsnso@hc-sc.gc.ca.
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.
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.
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”.
Statement of Risk Information
See section 2.3 of the Evidence for Homeopathic Medicines guidance document for additional information on risk statement requirements.
“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).
“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).
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):
The format requirements for the statement can be found below:
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:
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.
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:
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.”
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:
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:
There are no flexibilities or exemptions for nosode-specific labelling.
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:
Examples of recommended label formats for the principal display panel of mineral supplements: Calcium 500mg
Examples of recommended label formats for the principal display panel of mineral supplements: Calcium Carbonate 1250mg
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”.
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:
Gluten means:
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.

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