American College of Physicians Urges Premarket Approval for Dietary Supplements

What ACP Proposed

In a position paper published in the Annals of Internal Medicine, the American College of Physicians (ACP) called on Congress to modernize the Dietary Supplement Health and Education Act (DSHEA). Among roughly 10 recommendations, ACP urged an evidence-based premarket review and registration process, verification that manufacturers meet U.S. Pharmacopeia quality standards, and stronger postmarket surveillance including mandatory recall authority for FDA.

ACP also proposed a public database of dietary supplements with unique identifiers, standardized global terminology, and integration of supplement data with electronic health records.

Context and Industry Reaction

ACP said the current framework does not evaluate supplements for safety before market entry and cited figures including more than 50% of U.S. adults using supplements and more than 79,000 adverse event reports received by FDA's food center between 2004 and 2021.

Trade groups pushed back: the Council for Responsible Nutrition said it supports mandatory product listing but disagrees with replacing DSHEA with a pharmaceutical-style premarket approval system, and the Natural Products Association called the paper's characterization of the industry overstated.

Alıcı Paketi

The proposal is not law, but it signals pressure for stricter U.S. supplement oversight. Ingredient buyers should watch whether premarket approval or mandatory listing advances, since either would change registration, testing, and document expectations for ingredients such as phosphatidylserine and phospholipids.

Nutranexa does not take a position on the proposal and reports it as industry news.

Kaynaklar

• Modernizing the Regulatory Framework for Dietary Supplements: A Position Paper From the American College of Physicians
• ACP says underregulated dietary supplements endanger public health