Background: Dietary supplements, such as herbals/complementary nutritionals and micronutrients (vitamins/minerals), are commonly used in the U.S., yet national data on adverse effects are limited. Methods: We used a nationally representative stratified probability sample of 63 emergency departments (2004–2013) to describe U.S. emergency department visits for dietary supplement adverse events. Results: Based on 3,667 cases, we estimated that 23,005 (95% confidence interval [CI], 18,611–27,398) emergency department visits, resulting in 2,154 (CI, 1,342–2,967) hospitalizations, were attributed to adverse events from supplements annually. Emergency department visits for supplement adverse events commonly involved young adults aged 20–34 years (28.0%; CI, 25.1%−30.8%) and unsupervised children (21.2%; CI, 18.4%−24.0%). Excluding unsupervised child ingestions, 65.9% (CI, 63.2%−68.5%) of emergency department visits for single-supplement adverse events involved herbals/complementary nutritionals; 31.8% (CI, 29.2%−34.3%) involved micronutrients. Herbal/complementary nutritional products for weight loss (25.5%; CI, 23.1%−27.9%) and increased energy (10.0%; CI, 8.0%−11.9%) were commonly implicated. These weight loss or energy products caused 71.8% (CI, 67.6%−76.1%) of supplement adverse events involving palpitations, chest pain, and/or tachycardia, and 58.0% (CI, 52.2%−63.7%) involved persons aged 20–34 years. Among adults aged ≥65 years, choking or pill-induced dysphagia/globus caused 37.6% (CI, 29.1%−46.2%) of all emergency department visits for supplement adverse events; micronutrients were implicated in 83.1% (CI, 73.3%−92.9%) of these visits. Conclusions: Over 20,000 emergency departments visits in the US annually are attributed to dietary supplement adverse events; these commonly involve cardiovascular manifestations from weight loss or energy products in younger adults, micronutrient ingestions by unsupervised children, and swallowing problems, usually from micronutrients, in older adults.

In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA) as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.

This study characterizes CAERS dietary supplement adverse event data for the 2004-2013 period and estimates a reporting rate of 2% for dietary supplement adverse events based on CAERS data. The findings show that the 2006 Dietary Supplements and Nonprescription Drug Consumer Protection Act had a substantial impact on the reporting of adverse events.

Background:To facilitate ease of swallowing and promote patient adherence, the U.S. Food and Drug Administration (FDA) has provided voluntary guidance for the size of generic drug tablets and capsules (1). This guidance recommends that generic products should not exceed 17 millimeters (mm) in a single dimension. If a branded product already exceeds 17 mm, then the generic product should be no larger. No tablets or capsules should exceed 22 mm. Currently, no similar guidance for dietary supplements exists; however, supplements are implicated in swallowing problems, particularly among adults aged 65 years or older (2).