Changes to Canadian Labeling Requirements for Natural Health Products

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Following an increase in the use of natural health products (“NHP) among Canadians, Health Canada recently published the “Regulations Amending the Natural Health Products Regulations” (the “Amending Regulation »), which came into force on June 21, 2022. These amending regulations introduce changes to the labeling requirements for NHPs sold in Canada, to better align Canadian rules with those of other countries such as the United States, European Union and Australia, as well as establishing more consistent labeling rules with other products in Canada, such as non-prescription drugs and foods.*

Changes to labeling requirements

The Amending Regulations will improve the labeling requirements for NHPs through increased obligations regarding both the content to be included on the labels and the presentation format.

Content requirements

(1) Labeling of allergens, gluten, added sulphites and aspartame. When food allergens (including nuts, seeds, milk, shellfish, etc.) or gluten (including barley, oats, wheat, etc.) are included in any amount of an NHP, or the amount of added sulphites exceeds a specific amount, then the sources of those ingredients must now be included on the label under the “Warning” heading of the Product Information Table (PFT) (see PFT details below)[1] . For example, if casein is an ingredient in the product, in the “Warning” section, the word “milk” will appear next to allergens, because that is the source of the allergen. In addition, if the product contains aspartame, this must also be indicated on the label.[2] This new requirement is more in line with what we already see as required for the labeling of Canadian food products.

(2) Updated contact details. Updates to the contact details of the manufacturer or importer will also be required. Under “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 only include a mailing address as contact information and should allow consumers to ask questions about products or report adverse events more quickly.

Formatting specifications

(1) Product Facts Chart. A standardized fact 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 coordinates (see Figure 1)..[4] This table must appear on the outer label of the packaging or, in the absence of an outer label, on the inner label of the product. The PFT must reflect the conditions of market authorization for the product that were approved by Health Canada as part of the product license and must not include marketing terms or promotional vocabulary (e.g. “enhanced” ). The table must meet prescribed specifications for font, background and order of content. These new requirements are also similar to those required for food products, where important nutrition-related information must be presented in a standardized format to better help consumers find key product information to make informed decisions.

Figure 1: Example of a complete product information table with appropriate formatting

(2) Clear and prominent label text. The text on the PSN label must be clearly displayed and accessible to customers when purchasing and using it, on both the interior and exterior labels. The new requirements specify type of font (sans serif), position and style of headings, word spacing, contrast between font and background (font should be dark and background should be light with a minimum transparency), and font size (no smaller than between 5.5 and 6 points).[5]

Additional Changes to Security Packaging Requirements

The amending regulation will require that only ingestible products (products that can be inhaled, ingested or inserted into the body), ophthalmic products (products related to the eyes) and mouthwashes require specific safety features.[6] This change will reduce the amount of products requiring secure packaging, including sunscreen, and takes a similar approach to other countries like the United States.

Flexibilities and exceptions

The Amending Regulations allow for certain flexibilities regarding formatting specifications, particularly with respect to the size of the product’s immediate container. Flexibilities include but are not limited to having a partial PFT on the label with a leaflet that includes the full chart. Additionally, the use of innovative labels such as tear-off labels, accordion labels, and fold-out labels are acceptable given space constraints.

NHPs meeting certain criteria may also be exempt from certain parts of the Amending Regulations. Exemptions may apply if the products have very small packages, if the product is all of the contents can be used in one day (according to the directions on the label), if the immediate container of NHPs does not contain more than three recommended dosage units, or if it is a low-risk product.[7]

Transition periods for existing and new products

Labeling requirements for NHPs that have not yet received a product license from Health Canada will have to comply with the amending Regulations within three years of the date of registration of the amending Regulations (i.e. . on June 21, 2025). If an NHP has already received a product license prior to the registration date, it will not be required to comply with the labeling requirements until six years after that date (i.e. June 21, 2028 ).[8] However, regardless of the transition period, Health Canada encourages the implementation of enhanced labeling as soon as possible.

Please note that the changes to the security packaging requirements already entered into force on the day the Amending Regulations were registered.

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