Wallace Taylor C, Koturbash Igor
Think Healthy Group, LLC, Washington, USA.
School of Medicine and Health Sciences, George Washington University, Washington, USA.
J Diet Suppl. 2025;22(1):1-8. doi: 10.1080/19390211.2024.2419434. Epub 2024 Oct 25.
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organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as 'outdated' regulation of dietary supplements.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.
1994年的《膳食补充剂健康与教育法》(DSHEA)规定了美国食品药品监督管理局(FDA)对膳食补充剂产品进行监管的法定权力,将其作为食品的一个类别。在我们庆祝DSHEA颁布30周年之际,反思其对公众健康的意义、对不断演变和扩展的产品类别的影响、当前的监管框架以及确保市场强大且监管良好的现代化监督的潜在机会非常重要。据估计,四分之三的美国消费者报告使用过膳食补充剂,自DSHEA通过以来,该产品市场大幅增长,从1994年的约4000种产品增长到如今的80000多种。这种增长代表了目前价值600亿美元的国内膳食补充剂市场和2000亿美元的国际市场。科学家、公共卫生官员、医疗保健提供者、患者、消费者权益倡导组织以及美国食品药品监督管理局都呼吁对被描述为“过时”的膳食补充剂监管进行改革。该领域发表的科学证据增长速度甚至更快。《膳食补充剂杂志》的这一特刊收录了由院士、法律学者、美国政府机构代表和行业科学家撰写的一系列文章,这些文章批判性地审视了DSHEA和国内卫生政策在特定方面取得的成功、面临的挑战以及改进的机会。这篇社论提供了美国DSHEA后膳食补充剂监管的历史背景和里程碑,并概述了特刊中包含的研究。朝着更透明、更安全的市场迈进需要可靠的供应链、更高的质量标准遵守度、更多的标签要求以及加强上市后监督。本特刊旨在促进对膳食补充剂监管及其未来方向的更广泛理解。