The FSAI developed the current guidance with input from the Department of Agriculture, Food and the Marine, the National Environmental Health Service, and the Health Service Executive. It serves to help food businesses understand how to use these types of health claims correctly and in compliance with the law.
Now, FBOs can review the draft guidance and submit feedback through the consultation process.
The consultation may lead FSAI to tighten or clarify how food businesses use general, non-specific health claims under The Nutrition and Health Claims Regulation (NHCR), also known as EU Regulation (EC) No 1924/2006. This means the FSAI may define more clearly what wording businesses can and cannot use. It may also set out more explicit rules on when a claim crosses into non-compliant territory, especially where it implies a medical or nutritional benefit without authorization.
The NHCR has a direct influence on day-to-day decisions relating to product development, packaging, advertising, and consumer communications, explained Shauni Fitzgerald, regulatory affairs and research manager at the Ireland-based contract research organization, Atlantia Clinical Trials.
It shapes product positioning and marketing strategies by requiring businesses to ensure that all health and nutrition claims comply with the legal framework.
“The restrictions it places through the use of authorized language only can limit creative flexibility, particularly when trying to communicate benefits in a consumer-friendly way, however, it holds an important place in protecting the EU consumer,” Fitzgerald told NutraIngredients.
She hopes that updated guidance will be “particularly useful for companies when it comes to influencer-created content, which has evolved rapidly, is difficult to control for FBOs, and has probably left regulators scrambling to keep up with monitoring”.
Why does the NHCR need a refresh?
The FSAI consultation focuses on the use of general, non-specific health claims, and in practice, implied health claims and borderline wording remain among the greatest challenges for both food businesses and regulators when interpreting and applying the rules, Fitzgerald noted.
Currently, wellness-related claims are among the most common sources of compliance challenges for food businesses, Fitzgerald explained, with broad or vague statements being particularly problematic as they are difficult to link to specific authorized health claims and often extend beyond the wording and scope of approved claims.
“Businesses often unintentionally stray into regulated territory with terms like ‘boost’, ‘support’ or ‘enhance’, especially when used alongside imagery,” Fitzgerald explained. “This is particularly problematic for influencer marketing, where a lack of knowledge or understanding of the framework by the content creator may result in unintentional claims that place businesses in regulatory hot water.”
‘Quiet but significant shift’ to digital marketing regulation
Fitzgerald explained that the current framework has been in force for almost two decades and continues to reflect its core objective: protecting consumers from misleading information by requiring that health and nutrition claims are truthful, specific, scientifically substantiated, and limited to authorized claims.
However, she noted, the food marketing landscape has changed significantly over the past 20 years. Brands now use a much wider range of channels and techniques to promote products and communicate health benefits, particularly through digital platforms and social media.
“A regulatory framework that was written for labels, leaflets and television advertising will struggle to adapt to the way claims appear today, through influencer marketing content and wellness branding,” Fitzgerald explained.
While the fundamental principles of the Regulation remain relevant, the ways in which businesses present and amplify health and nutrition messages have evolved considerably since the Regulation was adopted.
Vanessa Cruz, food compliance expert at LegaleGo Regulatory, agreed there has been ‘a quiet but significant shift’ in how manufacturers are regulated.
“Increasingly, regulatory problems are not arising from the product itself, but from everything that surrounds it in the digital environment.”
She added: “In today’s marketplace, regulatory exposure no longer begins when a product reaches consumers. It begins the moment a brand goes online.”
She noted content on websites, social media, Amazon, marketplaces, blogs, customer testimonials, consumer generated content, and even via automated translations and QR codes, have all risen into the firing line for regulators.
Looking beyond the consultation, greater clarity on the use of general health messaging in digital environments would be particularly valuable, especially in relation to paid social media marketing, Fitzgerald noted.
As brands increasingly rely on digital channels to communicate with consumers, clearer guidance on how the health claims rules apply in these contexts would help support consistent compliance and reduce uncertainty.
“Right now, food businesses are relying on out-of-date scientific guidance and previously published opinions for unrelated products,” Fitzgerald said. “An update to this guidance in the context of emerging technologies would be welcomed throughout the industry.”
Once the consultation closes, the FSAI is expected to review and assess the feedback received from stakeholders, Fitzgerald explained. Based on this review, the FSAI will consider the issues raised, evaluate whether additional clarification is needed, and issue revised guidance where appropriate.
“My hope would be that this guidance can provide meaningful clarifications that inform regulatory enforcement and industry practice,” Fitzgerald said.
