Legal situations of supplements in the United States and European Union

Abstract

The importance of supplements is well recognized both in the United States (US) and European Union (EU) as substances to maintain and promote health and to reduce the risk of various diseases. From a legal point of view, systems to regulate the health claims of products classified as supplements have been established in both the US and EU. The health claims are divided into two categories, that is, disease risk reduction claims and structure/ function claims, and the claims must be substantiated with concrete scientific evidence. In particular, to substantiate the disease risk reduction claims, reliable human clinical studies, such as randomized controlled interventional trials, are acceptable as strong evidence. Evaluation of the safety of the ingredients for supplements is another important issue. The safety is mainly evaluated by means of risk analysis. However, the concept of risk-benefit analysis is gradually becoming more important than previous risk analysis techniques. The regulations for supplements and health claims currently enforced in both the US and EU are discussed in this article in comparison with the current regulatory systems applied to health foods in Japan. © 2008 The Pharmaceutical Society of Japan.