How are Functional Foods Regulated?
Functional foods are regulated primarily through the frameworks established by food safety and health authorities, such as the Food and Drug Administration (FDA) in the United States and the European Food Safety Authority (EFSA) in the European Union. These organizations ensure that functional foods meet safety, quality, and nutritional criteria before reaching consumers.
In the U.S., functional foods can be classified as conventional foods, medical foods, or dietary supplements. The FDA requires that any health claims made by manufacturers be supported by scientific evidence. Generally, these claims fall into two categories: structure/function claims and health claims. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans. In contrast, health claims link a food or substance to a reduced risk of a disease or health-related condition, requiring more rigorous substantiation.
In Europe, the regulation of functional foods is governed under both general food law and specific regulation for health claims, namely the EU Regulation (EC) No. 1924/2006. Before a health claim can be used, it must be authorized by EFSA based on a scientific assessment. This adds an additional layer of scrutiny to ensure that claimed health benefits are substantiated.
Furthermore, functional food products are also subject to general food safety regulations, ensuring they are safe for consumption and properly labeled. This regulatory framework aims to protect consumers while promoting innovation in the functional food sector.