Recalls relatively infrequent for dietary supplements, says AHPA

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According to a report recently published by the American Herbal Products Association (AHPA; Silver Spring, MD) dietary supplement recalls are relatively infrequent. Analyzing recall data from FDA, AHPA found that of 803 recorded recalls initiated in 2019, 14 involved dietary supplements, or 1.7%. Compare this to 29% for medical devices, 28% for biological products, 18% for drug products, and 20% for conventional foods.

Of the 14 recalls, 6 were classified as class II: “Use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” Five products were class III: “Use of, or exposure to, a violative product is not likely to cause adverse health consequences.” The remaining three were classified as class I: “A reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

There were seven cases in which a drug was masquerading as a dietary supplement, and one in which a drug was masquerading as a conventional food. These were class I recalls, which were classified separately by AHPA.

“These recall data provide additional evidence of the overall safety of the dietary supplement class,” said AHPA chief information analyst Merle Zimmermann, PhD, in the report. “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.”