Written By Julia Schatz, Shelby Morrison and Maximillian Pivetta
Health Canada has implemented sweeping 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.
Inconsistencies and shortcomings in effective labelling of NHPs have been noted as significant drivers of "preventable harms" stemming from the uninformed use of these products. Specifically, an absence of the requirement to implement clear and predictable labelling standards for NHPs rendered the consumer landscape inconsistent, uncertain and, at times, dangerous. The regulatory inconsistencies denied consumers the information necessary to make informed choices about the use of NHPs.
The amendments seek to address the labelling inconsistencies through revising existing standards. In particular, the amendments implement three key changes to the NHPR labelling requirements:
Products Facts Table
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
Labelling of NHPs was previously subject to comparatively lax regulatory standardization, and varied by brand and product. The NHPR amendments set a new labelling standard in the form of a "Product Facts Table." 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. While the previous iteration of the NHPR already required that mandated information be "clearly and prominently displayed" and "readily discernable," these revisions will make it easier for consumers to consistently identify product packaging information by providing producers with unambiguous readability standards. To address the issue of readability, the amendments require that any NHPR-mandated information on the label of an NHP be displayed in:
- a non-decorative sans serif font;
- solid black lettering or a close visual equivalent and against a background that is white or containing not more than 5% colour tint;
- a minimum character size of 5.5 points for non-medicinal ingredients, or 5 points if condensed; and
- a minimum character size of 6 points for medicinal ingredients, or 5.5 points if condensed.
These requirements are subject to certain exceptions. Specifically, labelling exceptions apply to: (i) inner and outer product labels of less than 90 square centimeters, (ii) products meant to be consumed in their entirety over the course of less than one day, (iii) those with no more than three total recommended doses per product package and (iv) certain products with a "localized effect."
The amendments require product labels to include a list of allergens and a warning label if any allergens are present in a product.
Prior versions of the NHPR have not mandated a declaration of allergens present in NHPs. As a consequence, manufacturers have not consistently identified the presence of potentially dangerous allergens in products or have not done so in a manner that adequately draws consumers' attention to their presence in a consistent manner. The amendments have introduced a variety of provisions pertaining to allergens and the manner in which manufacturers must label NHPs with respect to allergens. Specifically, if certain allergens are present in an NHP there must be an allergen warning on the product label as follows:
- "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.
Implications for Manufacturers of NHPs
The NHPR amendments have several implications for manufacturers of NHPs. Manufacturers may be required to overhaul their labelling practices in order to conform to the "Product Facts Table" requirement, the allergen warning requirement and the new regulations surrounding readability. Further, the allergen-specific amendment may also spur certain manufacturers to reevaluate product composition and formulations.
The need to include updated contact information within the "Product Facts Table" will mean that NHP manufacturers may receive a higher volume of correspondence from the consuming public concerning their products.
Bennett Jones has extensive knowledge and experience in the NHPR regulatory space and is well-equipped to help you address any questions or concerns regarding these regulatory changes. If want to learn more about the potential impact of the new amendments to the NHPR, contact one of the authors of this post or a member of the firm's Product Regulation group.