Ohama Hirobumi
The Japanese Institute for Health Foods Standards, 6-26-12 Hongo, Bunkyo-ku, Tokyo, Japan.
Yakugaku Zasshi. 2008 Jun;128(6):839-50. doi: 10.1248/yakushi.128.839.
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.
在美国和欧盟，补充剂作为维持和促进健康以及降低各种疾病风险的物质，其重要性已得到广泛认可。从法律角度来看，美国和欧盟都已建立了规范归类为补充剂产品健康声称的体系。健康声称分为两类，即疾病风险降低声称和结构/功能声称，并且这些声称必须有具体的科学证据予以证实。特别是，为了证实疾病风险降低声称，可靠的人体临床研究，如随机对照干预试验，可作为有力证据被接受。补充剂成分安全性评估是另一个重要问题。安全性主要通过风险分析来评估。然而，风险效益分析的概念正逐渐比以往的风险分析技术变得更为重要。本文将美国和欧盟目前实施的补充剂及健康声称法规与日本目前适用于健康食品的监管体系进行比较讨论。
