80,000 Adverse Events in 17 Years

The position paper highlighted the scale of dietary supplement use in the U.S., noting that 57.6 percent of adults reported using a dietary supplement within the previous 30 days, while as many as 100,000 supplement products are available on the market. Between 2004 and 2021, FDA's Center for Food Safety and Applied Nutrition (CFSAN) received 79,071 reports of adverse events associated with dietary supplements.

Recommendations for Stronger Dietary Supplement Oversight

The organization called on Congress to require all dietary supplements, including products already on the market, to undergo "evidence-based review, registration, and approval" by the U.S. Food and Drug Administration (FDA), as well as to meet quality standards established by the U.S. Pharmacopeia (USP).

ACP also recommended strengthening FDA's postmarket surveillance authority, expanding mandatory recall powers for adulterated or mislabeled products, improving adverse event reporting systems, and providing additional resources for both FDA and the Federal Trade Commission (FTC) to oversee supplement manufacturing, labeling, and marketing.

Beyond regulatory reforms, ACP recommended creating a publicly accessible national database of dietary supplements, integrating supplement interaction alerts into electronic health records, improving clinician and patient education, and increasing funding for research on supplement safety, efficacy, and interactions with prescription drugs.

Postmarket Surveillance is ‘Inadequate to Protect Public Health’

In its conclusion, ACP stated that "the reliance on postmarket surveillance in the regulation of dietary supplements is inadequate to protect public health and safety." The organization added that "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."