Food Supplements: moving from the ‘Wild West’ towards quality and compliance
Structure/function claims: a non-compliance hotspot
In the US, both conventional foods and dietary supplements commonly feature structure/function claims on their labels which describe the role of a dietary ingredient in affecting the normal structure or function of the human body. For example, a label might state “Calcium builds strong bones” [16]. These claims are exempt from the strict requirements of health claims and do not require pre- market review or approval [16], although manufacturers must be able to verify that the claim is truthful and is not misleading. In addition, the manufacturer must notify the FDA no later than 30 days after the product is introduced to the market, and include a disclaimer that the FDA has not evaluated the claim. However, one study on Ayurvedic herbal supplement blends in the US market revealed significant non- compliance with these regulations, especially with structure/function claims. It found that legally required disclaimers were often absent, and that claims lacked scientific support: for example, statements like “Cinnamon helps maintain healthy blood sugar/sugar metabolism” were non-compliant as they did not align with the scientific consensus [17]. In the EU, manufacturers and importers can promote nutrition and health benefits, provided they are scientifically substantiated and comply with labelling, presentation, and advertising regulations outlined in Regulation (EC) No 1924/2006. This regulation establishes stringent conditions for making nutrition claims, such as the provision of supporting scientific evidence and adherence to specific labelling guidelines. Additionally, the Register of Nutrition and Health Claims provides a comprehensive list of permitted claims and their definitions - offering clarity to manufacturers, as well as additional protection for consumers against unsubstantiated statements.
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