Plain Language Labelling (PLL) for NHPs
On Wednesday, the Natural Health Products Regulations amendments were published to the Canada Gazette, Part II. Among other things, these amendments make changes to the labelling requirements that govern natural health products (NHP) that are sold in Canada. Health Canada also published a new guidance document to supplement the amended regulations. The new labelling requirements will come into force in three years and product licence holders will have an additional three years from that date to re-label their NHPs in accordance with the new requirements. Below is a breakdown of the new regulations.
Products Facts Table (PFT)
PFT(s) must be included on the outer label of the NHP, or, if there is no outer label, on the inner label. The following headings and subsequent information must be included in the PFT:
- "Medicinal ingredients"
- "Uses"
- "Warnings"
- "Directions"
- "Other information"
- "Non-medicinal ingredients"
- "Questions?"
The PFT must be in both French and English. The label can either include one bilingual table or two tables in each official language. The guidance document also includes formatting and font requirements for the element within the PFT. The use of graphics is prohibited unless they are trademark symbols, recommended by Health Canada or required by regulation.
Exemptions from including PFT(s) on a label are available under certain conditions.
Allergens, Gluten and Sulphite
The amendments will require a disclosure of any food allergens, gluten and/or sulphites contained in the NHP. This is to be disclosed in a statement, which must include all food allergen sources, gluten sources and/or added sulphites. Such a statement is not required if the allergen is present due to cross-contamination. Additionally, if the NHP contains aspartame, it will need to be disclosed on the label as well.
Flexibilities
The regulations and its supplemental guidance document provide for several flexibilities to accommodate different packaging types. For example, an innovative label—such as a peel-back label—can be used as a physical extension of the NHP's label so long as it is used only as a single extension of the principal display panel and is readily accessible to consumers before purchase. Condensed sizing is also permitted for small packages.
The regulations also allow for flexibility with respect to where the PFT(s) and their information can be placed, including on an affixed leaflet, an insert or a website. If the surface area of the label is insufficient to accommodate the entire PFT, a statement can be displayed in its place that directs the consumer to the leaflet, insert or website where the PFT(s) can be found. For example, such statement can read: "For full Products Facts table, including removed information, visit www.insertURL.com."
Formatting
The amendments add formatting requirements for all required information that is displayed on an NHP label. In addition to being clearly and prominently displayed, and readily discernible to the consumer, the required information on the label must also be:
- In 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;
- In characters of a standard sans serif font that is not decorative;
- In characters that are not in contact with each other or with the features of any tables that are required to be shown;
- If they relate to a non-medicinal ingredient, in characters of a type size of at least 5.5 points or, if condensed, of at least 5 points; and
- If they do not relate to a non-medicinal ingredient, in characters of a type size of at least 6 points or, if condensed, at least 5.5 points.
These additional requirements do not apply to:
- The lot number, product number or brand name;
- The statements, information or declarations required to be shown on: (i) the inner label if available surface area is 90 cm2 or less; or (ii) the outer label, if available surface area is 90 cm2 or less.
They also do not apply if:
- The entire quantity of the natural health product is to be used within one day or less in accordance with the directions on the label; or
- The immediate container of the natural health product contains no more than three recommended dosage units.
The Gowling WLG Food and Beverage Group and the Advertising and Product Regulatory Group are here to provide assistance as the NHP industry transitions toward these new regulations – please subscribe to our Food, Natural Health Products & Cosmetics Law newsletter to keep up to date on this and other food regulatory issues.
Should you have any specific questions or would like to discuss the impacts of the amendments further, please contact a member of our Food and Beverage Group or our Advertising and Product Regulatory Group.