Washington, D.C.—Dietary supplement recalls are relatively infrequent, according to recent FDA data.
A statement from the American Herbal Products Association (AHPA) notes that out of 803 recorded recalls initiated in 2019, 14 of them, or 1.7%, involved dietary supplements, and only three were Class I recalls, the most serious recall class. 29% of the recalls were for medical devices, 28% for biological products, 18% for drug products, and 20% were for conventional foods.
Related: FDA Releases Draft Guidance for Voluntary Recall Process
Highlights from the AHPA Supplement Congress
Among the dietary supplements recalled between January 1, 2019, and June 26, 2019, four cases were due to risk of microbial contamination, three cases were for mislabeling, and two cases were for the presence of unlabeled allergens. During the same time period, 162 food products were recalled; 73 cases were for undeclared allergens or the presence of sulfur or sulfites, 41 cases were related to microbial contamination, 26 cases were for manufacturing errors usually involving foreign material in the product, and 11 recalls were based on mislabeling.
AHPA chief information analyst Merle Zimmermann, Ph.D., said in the release: “These recall data provide additional evidence of the overall safety of the dietary supplement class. 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.”