Following an increase in the use of natural health products (“NHPs”) among Canadians, Health Canada recently released the “Regulations Amending the Natural Health Products Regulations” (the “Amending Regulations”), which came into force on June 21, 2022. These Amending Regulations introduce amendments to the labelling requirements for NHPs sold in Canada, in order to better align the Canadian rules with other countries like the United States, the European Union and Australia, as well as establishing labelling rules that are more consistent with other products in Canada such as non-prescription drugs and food.
Changes to the labelling requirements
The Amending Regulations will improve labelling requirements for NHPs through enhanced obligations on both content to be included on the labels and format of presentation.
Content requirements
(1) Labelling of allergens, gluten, added sulphites and aspartame. Where food allergens (including nuts, seeds, milk, shellfish etc.) or gluten (including barley, oats, wheat etc.) are included in any amount in a NHP, or the amount of added sulphites exceeds a specific amount, then the sources of these ingredients must now be included on the label under the “Warning” header of the Product Facts Table (“PFT”) (See details regarding PFTs below).[1] For example, if casein is an ingredient in the product, then under the “Warning” section the word “milk” would appear beside allergens as that is the source of the allergen. Additionally, if the product contains aspartame, then this should be disclosed on the label as well.[2] This new requirement is more aligned with what we already see required for labelling of Canadian food products.
(2) Modernized contact information. Updates to the manufacturer or importer’s contact information will be required as well. Under the heading “Questions?” in the PFT, the e-mail address, telephone number or website address of the manufacturer or importer is required.[3] This will replace the requirement to solely include a postal address as the contact information, and should allow consumers to ask product-related questions or report adverse events in a more timely manner.
Formatting specifications
(1) Product Facts Table. A standardized facts table is now required on the label to display certain important information about a product, including medicinal ingredients, uses, warnings, directions for use, recommended storage information and contact information (see Figure 1: Example of a full Product Facts Table with proper formatting [JPG]).[4] This table must be on the outer label of the packaging or, if there is no outer label, on the inner label of the product. The PFT must reflect the product’s terms of market authorization that were approved by Health Canada as part of the licensing of the product, and must not include any marketing terms or promotional vocabulary (e.g. the word “improved”). The table must meet prescribed specifications regarding the font, background and order of contents. These new requirements are also similar to what is required for food products, where important information related to nutrition is required to be presented in a standardized format in order to better assist consumers with finding key information about the products to make informed decisions.
(2) Clear and prominently displayed label text. The text on the label of the NHP must be clearly displayed and accessible for the customers when they buy it and when they use it, on the inner and outer labels. The new requirements specify the type of font (sans serif), the position and style of the headings, the spacing of the words, the contrast between font and background (font must be dark and the background must be light with minimal transparency), and the size of the font (no smaller than between 5.5 and 6 points).[5]
Additional changes to security packaging requirements
The Amending Regulations will only require ingestible products (products that can be inhaled, ingested or inserted into the body), products for ophthalmic use (products relating to the eye), and mouthwashes to require specific security features.[6] This change will reduce the amount of products that require secured packaging, including sunscreen, and takes a similar approach to other countries like the United States.
Flexibilities and exceptions
The Amending Regulations allow for some flexibilities regarding the formatting specifications, particularly when it comes to size of the immediate container of the product. The flexibilities include, among other things, having a partial PFT on the label with a leaflet insert that includes the full table. Also, the use of innovative labels such as peel-backs, accordion labels, and fold-out labels are acceptable given space constraints.
NHPs meeting certain criteria may also be exempt from parts of the Amending Regulations. Exemptions may apply if the products have very small packaging, if it is a product which the entire contents can be used in one day (in accordance with the directions on the label), if the immediate container of the NHPs contains no more than three (3) recommended dosage units or if it is a low risk product.[7]
Transitions periods for existing and new products
The labelling requirements for NHPs that have not yet received a product licence from Health Canada will need to comply with the Amending Regulations within three (3) years from the registration date of the Amending Regulations (i.e. June 21, 2025). If an NHP has already received a product licence in advance of the registration date, it will not be required to comply with the labelling requirements until six (6) years after that date (i.e. June 21, 2028).[8] However, regardless of the transition period, Health Canada encourages the implementation of the improved labelling as early as possible.
Note that changes to the security packaging requirements have already come into force the day the Amending Regulations were registered.
Should you have any questions regarding product labelling for NHPs, please feel free to reach out to any member of Miller Thomson’s Marketing, Advertising and Product Compliance team.
[1] Section 21 of the Regulations Amending the Natural Health Products Regulations, adding Section 93.1(11) into the NHPR.
[2] Section 21 of the Regulations Amending the Natural Health Products Regulations, adding Section 93.1(11) into the NHPR.
[3] Section 21 of the Regulations Amending the Natural Health Products Regulations, adding Section 93.1(18) into the NHPR.
[4] Section 21 of the Regulations Amending the Natural Health Products Regulations, adding Section 93.1(1)(f) into the NHPR.
[5] Section 18(1) of the Regulations Amending the Natural Health Products Regulations, amending section 88 of the NHPR.
[6] Section 23 of the Regulations Amending the Natural Health Products Regulations, replacing the existing 95(1).
[7] Section 21 of the Regulations Amending the Natural Health Products Regulations, now Section 93.5 of the NHPR.
[8] Section 24 of the Regulations Amending the Natural Health Products Regulations.
