FDA highlights “relatively infrequent” dietary supplement recalls for 2019

11 Sep 2019 --- Only 2 percent of recalled supplements in 2019 were dietary supplements, according to US Food and Drug Administration (FDA) data. Among the recalls, only three were classified as “Class I,” – the most serious recall class. The news was published in a 2019 American Herbal Products Association (AHPA) report which noted that out of 803 recalls, 14 of them included dietary supplements. Dietary supplements to support health are increasingly popular and the news means that regulations to protect consumers from unwanted side effects appear to be working effectively.

Earlier this year, the FDA sought to significantly “modernize” dietary supplement regulations, in an attempt to root out “bad actors” that distribute and sell dangerous products. Touted to be the most “significant modernizations” in 25 years, the FDA announced steps to ensure that the US regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, developing new enforcement strategies and engaging in a dialogue with dietary supplement stakeholders.

“These recall data provide additional evidence of the overall safety of the dietary supplement class,” says Merle Zimmermann, Ph.D., AHPA Chief Information Analyst. “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.”

Click to EnlargeVarious factors lead to a dietary supplement being recalled - Source: AHPA report The most common reasons for conducting a recall were the risk of microbial contamination or mislabeling, including incorrect amounts of ingredients and omitted excipients or the presence of unlabeled allergens. Of the 803 recalls, 29 percent were recorded for medical devices, 28 percent for biological products, 18 percent for drug products and 20 percent for conventional foods, leaving a comparatively low 1.7 percent regarding dietary supplement products. Recalls could include multiple products, up to 16 percent included three or more products. 

Eleven of the 14 dietary supplement recalls were classified as Class II or III, categories which are unlikely to cause adverse health consequences. The other three recalls belonged to the Class I classification, the most severe recall class. Among the entire 803 recalls submitted for analysis, there were seven cases where the FDA indicated that the recalled products were illegal drugs disguised as dietary supplements and one where the illegal drug was labeled as a conventional food. All of these were categorized as Class I recalls. 

The AHPA archives illegal products on their Keep Supplements Clean website. The move seeks to inform consumers, the dietary supplement industry and other stakeholders of the concerns related to illegal, tainted products with false labels.

Earlier this year the AHPA turned its attention to the burgeoning hemp market. In light of the cannabis strain’s recent declassification as a schedule 1 narcotic, which widened the potential for its use in the food, beverage and supplement industry, the AHPA adopted a new Guidance Policy. The policy is for dietary supplement and food products that contain hemp and hemp-derived cannabidiol (CBD) to help ensure the industry complies with existing regulations.

By Anni Schleicher

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