Number: 98-500
Title: Dietary Supplements: International Standards and Trade Agreements
Authors: Donna V. Porter, Domestic Social Policy Division 
Abstract: The dietary supplement industry has long been concerned about international activities that could have a potential impact on supplement trade. As originally proposed, FDA reform legislation contained provisions on mutual agreements and global harmonization that would have applied to most products under FDA jurisdiction. However, Congress explicitly exempted supplements from the final provisions of the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), which means that these products are not part of on-going trade discussions. However, the perception of supplement proponents at that time was that such harmonization efforts would limit access and availability of supplement products and was a harbinger of their reaction to other international supplement agreements ever since. The European Commission adopted a directive on vitamin and mineral supplements in 2002. Although in April 2005, the Advocate General declared it invalid, in July 2005 the European Court judges ruled in favor of upholding the directive. In July 2005, the United Nations' Codex Alimentarius Commission voted to adopt the guidelines on the composition of certain vitamin and mineral supplements. Once adopted, however, Codex guidelines are not binding on any country, unless the provisions are incorporated into the laws of that country. More recently, questions have been raised about the impact on supplements of actions by the World Trade Organization (WTO) and implementation of the Central American Free Trade Agreement (CAFTA).
Pages: 6
Date: July 15, 2005