ACP pushes for stronger safeguards on dietary supplements

Clinical takeaway: Ask patients specifically about dietary supplement use and counsel them that supplements are not reviewed by the FDA for safety or effectiveness before reaching the market. Be alert for potential drug-supplement interactions, particularly in patients taking multiple prescription medications.

More than half of US adults use dietary supplements, and many mistakenly believe these products undergo the same regulatory scrutiny as prescription drugs. A new American College of Physicians (ACP) position paper argues that the current regulatory framework no longer adequately protects patients and should be modernized to address growing safety concerns.

The paper cites the rapid expansion of the supplement market, with as many as 100,000 products now available. Between 2004 and 2021, the FDA received more than 79,000 reports of adverse events related to dietary supplements, and products marketed for muscle building, weight loss, and sexual enhancement have been associated with the highest rates of serious adverse events.

ACP notes that dietary supplements are regulated as foods rather than drugs under the Dietary Supplement Health and Education Act of 1994, meaning manufacturers generally do not have to demonstrate safety or effectiveness before products reach the market. The organization cites concerns about adulterated or mislabeled supplements, unlisted ingredients, excessive dosages, and clinically important interactions with prescription medications.

ACP calls on Congress to require dietary supplements to undergo FDA registration, evidence-based review, and premarket approval while meeting United States Pharmacopeia quality standards. The organization also advocates expanding FDA authority to remove adulterated or mislabeled products more quickly, strengthening postmarket surveillance, and increasing funding for regulatory oversight.

The proposals have practical implications for clinicians. ACP recommends integrating dietary supplement databases into electronic health records with interaction alerts, routinely documenting supplement use alongside prescription medications, and improving clinician and patient education. The organization also urges the FDA to develop a publicly searchable database containing supplement ingredients, available evidence, and known drug interactions.

"The reliance on postmarket surveillance in the regulation of dietary supplements is inadequate to protect public health and safety," the ACP authors concluded. "A robust approach to premarket registration and postmarket surveillance of dietary supplements is needed to prevent the marketing of harmful products and protect the health of the public."

Source: Cline K, et al. (2026 Jul 14) Ann Intern Med. Modernizing the Regulatory Framework for Dietary Supplements: A Position Paper From the American College of Physicians