William Bjornsson
Partner
Article
3
This article originally appeared in Food in Canada and is republished with the permission of the publisher.
Functional foods are everywhere, and claims about their health benefits enter the public conversation at unprecedented speed, often from unreliable or unproven sources. As consumers are inundated with health benefits that may be unsupported or misleading, the gap between perception and proof creates regulatory and reputational risk for food companies making, or associated with, health claims for functional ingredients.
Food and beverage companies must navigate this evolving environment and ensure claims are grounded in evidence. Canada’s food regulatory framework is reasonably well suited to manage this risk. It provides safeguards to ensure claims are truthful, while offering the flexibility needed for companies to market substantiated functional or health benefits of food. But it is not as agile as the current market conditions demand.
Canadian food law governs health claims by prohibiting the sale or advertisement of any food in a manner that is false, misleading or deceptive. But not all health claims are treated equally; some require pre-market approval (for example, certain disease reduction claims), while others do not. That said, in cases where pre-market approval is not required, Health Canada will review voluntary submissions from companies seeking to substantiate new health claims for foods. Obtaining this pre-approval can reduce enforcement risk, support more defensible marketing claims, build retailer confidence, and offer greater predictability for companies by ensuring the claims are not misleading in the eyes of the regulator.
Whether formal approval is obtained or not, substantiating health claims takes time. Health Canada’s approval process involves reviewing petitioner-submitted data that may include laboratory specifications, characterization of biomarkers, literature reviews, and clinical data, among other things. Assembling such a dossier is time-consuming and resource intensive. This contributes to the risk that market expectations may evolve faster than new claims can be substantiated, making it challenging for companies attempting to balance risk versus expediency.
However, functional food claims do not have to be novel to be effective. The increased public interest in functional foods has renewed demand for certain established functional foods and ingredients, and what’s old is new again. Protein has become ubiquitous, and dietary staples, such as fibre, have seen a resurgence. From a substantiation perspective, this back-to-basics approach presents a strategic advantage: these functional ingredients are well understood, often with regulator-approved benefits. As a result, reliance on well-established ingredients can reduce challenges associated with substantiating new health claims on foods, but it limits differentiation and innovation.
Building on the use of well-known ingredients, Health Canada introduced the supplemented food regulations, which provide food companies with an additional pathway to market well-recognized functional foods. Supplemented foods are a category of prepackaged foods with recognized functional benefits, containing added vitamins, minerals, amino acids, and other substances. Health Canada recently announced the transition of sports electrolyte products from natural health products (a subset of drugs) to supplemented foods. As a result, electrolyte products with claims related to sports performance, hydration, or electrolyte replenishment can now be sold without pre-market approval, within the food regulatory framework. According to an April 2026 report from Health Canada, the change reflects the way the products are marketed and used.[1] This announcement demonstrates that Canadian regulatory pathways can evolve to accommodate functional ingredients and respond to market realities. While this is a welcome approach, supplemented food claims are still subject to the same evidentiary standards as conventional foods, meaning that claims remain limited.
As the public interest in functional foods grows, claims can circulate faster than facts. Canada’s food framework provides companies with multiple pathways to make substantiated health claims on foods; however, these pathways can be slow, difficult to navigate, and are not always business friendly. Regulators have taken identifiable steps that demonstrate they can be responsive to market conditions, but whether the system can respond at the pace the market now demands is an open question. As a result, the gap between proof and perception may widen, not in the claims themselves, but in the framework meant to govern them.
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