Health Canada has implemented amendments to labelling requirements under the Natural Health Products Regulations (NHPR) as a result of challenges identified in recent years surrounding the widespread use of Natural Health Products (NHPs) by Canadians. The amendments imposing revised labelling standards are subject to a three year transition period and will come into force on June 21, 2025. NHPs licensed under the former Regulations, which are labelled in compliance with prior standards before the end of the three-year transition period, will have a further three years from that date to conform to the new requirements.
The amendments introduce a mandatory “Product Facts Table” that provides consumers with data regarding each product’s ingredients, intended use, risks and other important information in a standardized and predictable labelling format. With limited exceptions, this table is now required on the packaging of all NHPs in both English and French. Specifically, it must be included either on the outer label or on the inner label if the product has no outer label.
The Product Facts Table must provide the following information:
- “Medicinal Ingredients”—the product’s medicinal ingredients and the amount of each ingredient present per product dose
- “Uses”—at least one of the product’s recommended uses or purposes
- “Warnings”—all relevant risk information including any warnings, contraindications, interactions and known adverse reactions associated with the NHP’s use, as well as any food allergens, gluten sources, sulphites, or aspartame present in the product, if applicable
- “Directions”—both the recommended dose and use duration of the product
- “Other Information”—the directions for storage of the NHP
- “Non-Medicinal Ingredients”—a non-quantitative list of all non-medicinal ingredients in the product, as well as the product’s mercury content in parts-per-million, if applicable
- “Questions?”—either a telephone number, email address, or website address of a representative of the product license-holder of the NHP
Manufacturers of NHPs are exempted from including a Product Facts Table on their products’ inner or outer label if the available surface area is inadequate. In those cases, they will instead have the option to display the Product Facts Table either on an attached leaflet, a package insert, or on their website.
The amendments also introduce enhanced readability standards for important product information, mandating, amongst other requirements, minimum type size and generic font.
The amendments require product labels to include a list of allergens and a warning label if any allergens are present in a product.
- “Food Allergen”—various nuts, peanuts, seeds, eggs, fish and shellfish products, soy products, dairy products and others
- “Gluten”—a list of gluten sources including barley, oats, rye, wheat, triticale, as well as any form of modified gluten protein derived from those cereals
Such allergens, if present in an NHP in the amount of 10 parts-per-million or more, must be highlighted on the product’s packaging in the “Warnings” section of the “Product Facts Table.”
There are additional provisions for added sulphites and aspartame: added sulphites must also be included under “Allergens,” while the presence of aspartame requires separate attention under “Warnings.” Notably, food allergens, glutens and sulphites present in an NHP due to cross-contamination do not trigger the allergen labelling requirement.
Please refer to below link for detailed guidelines from Health Canada:
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