Introduction and Context
Dietary supplements—vitamins, minerals, botanicals, probiotics, amino acids, and other orally consumed products—are part of everyday life for more than half of U.S. adults. Yet for three decades the United States has regulated these products under a food-oriented law, the Dietary Supplement Health and Education Act (DSHEA) of 1994, which does not require routine premarket safety or efficacy review by the U.S. Food and Drug Administration (FDA). In July 2026, the American College of Physicians (ACP) published a position paper calling for substantial modernization of the U.S. regulatory framework to reduce harms, improve product quality, and align policy with contemporary markets and science (Cline et al., Ann Intern Med. 2026). This article summarizes the ACP’s recommendations, explains why change is needed, and highlights implications for clinicians, health systems, and patients.
Why this statement matters now
– The supplement marketplace has exploded: tens of thousands of products, globalized supply chains, and heavy promotion on social media.
– Postmarket-only oversight under DSHEA has repeatedly failed to keep adulterated, mislabeled, or unsafe products off shelves.
– Consumers and many clinicians mistakenly assume FDA premarket review; limited reporting and clinician documentation blunt adverse-event detection.
The ACP argues that the current approach is no longer fit for purpose and sets out concrete, actionable policy and practice recommendations.
