DSHEA 1994 - Celebrating 30 Years of Dietary Supplement Regulation in the United States.

Abstract

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA's statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.S. consumers report use of dietary supplements, and the product market has grown substantially since the passage of DSHEA, from approximately 4,000 products in 1994 to 80,000+ present day. This growth represents a current $60 billion domestic and $200 billion international market for dietary supplements. Scientists, public health officials, health care providers, patients, consumer advocacy organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as 'outdated' regulation of dietary supplements. Advancing at an even faster rate is published scientific evidence in the space. This special issue of the Journal of Dietary Supplements comprises a collection of articles authored by academicians, legal scholars, representatives of U.S. government agencies, and industry scientists that critically examine the successes, challenges, and opportunities for improving specific aspects of DSHEA and domestic health policy. This editorial provides historical context and milestones of dietary supplement regulation in the U.S. post-DSHEA and offers an overview of the research contained within the special issue. Advancing toward a more transparent and safer marketplace requires trustworthy supply chains, increased adherence to quality standards, additional labeling requirements, and enhancement of post-market surveillance. This special issue seeks to contribute to the broader understanding of dietary supplement regulation and its future direction.