Recall data from the U.S. Food and Drug Administration (FDA) shows that 14 of 803 (1.7 percent) recorded recalls initiated in 2019 involved dietary supplements, and among these, three were Class I recalls (the most serious recall class), according to an article published in the August 2019 AHPA Report.

“These recall data provide additional evidence of the overall safety of the dietary supplement class,” said AHPA Chief Information Analyst Merle Zimmermann, PhD. “AHPA also regularly reviews other dietary supplement safety resources, including mandatory serious adverse event reports and recorded observations from FDA inspections, and the results suggest that current supplement laws and regulations are working effectively to protect consumer safety and ensure a marketplace of high-quality, safe products.”

FDA is responsible for the safety of most foods, dietary supplements, drugs (both prescription and non-prescription over-the-counter drugs), biologics, medical devices, radiation-emitting products, cosmetics, veterinary products, and tobacco products. These regulatory activities include tracking and reporting on product recalls. Reports documenting these recalls are regularly distributed by FDA and are available to the public through the internet Recall Enterprise System (iRES). AHPA’s analysis is based on iRES data released by the agency through June 26, 2019, which recorded 803 recall events initiated in calendar year 2019.