Dietary Supplements: International Standards and Trade Agreements (CRS Report for Congress)
| Release Date |
July 15, 2005 |
| Report Number |
98-500 |
| Authors |
Donna V. Porter, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
Summary:
The dietary supplement industry has long been concerned about internationalactivities that could have a potential impact on supplement trade. As originallyproposed, FDA reform legislation contained provisions on mutual agreements andglobal harmonization that would have applied to most products under FDA jurisdiction.However, Congress explicitly exempted supplements from the final provisions of theFood and Drug Administration Modernization Act of 1997 (P.L. 105-115), which meansthat these products are not part of on-going trade discussions. However, the perceptionof supplement proponents at that time was that such harmonization efforts would limitaccess and availability of supplement products and was a harbinger of their reaction toother international supplement agreements ever since. The European Commissionadopted a directive on vitamin and mineral supplements in 2002. Although in April2005, the Advocate General declared it invalid, in July 2005 the European Court judgesruled in favor of upholding the directive. In July 2005, the United Nations' CodexAlimentarius Commission voted to adopt the guidelines on the composition of certainvitamin and mineral supplements. Once adopted, however, Codex guidelines are notbinding on any country, unless the provisions are incorporated into the laws of thatcountry. More recently, questions have been raised about the impact on supplements ofactions by the World Trade Organization (WTO) and implementation of the CentralAmerican Free Trade Agreement (CAFTA).
