The Food and Drug Administration ordered a mandatory recall of a powdered herbal supplement, kratom, on Tuesday. Dietary supplements are classified as foods under federal law, making the recall the first-ever mandatory recall of a contaminated food. The FDA obtained mandatory recall authority through the Food Safety Modernization Act in 2011.
FDA Commissioner Scott Gottlieb said in a statement, “This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions.”
In 2017, the FDA enforced 3 seizures, 12 injunctions, 15,318 warning letters, 2,945 recall events, 9,199 recalled products, and 5 drug product debarments.
To learn more about how you can prevent a recall, read Top 7 Reasons for Pharmaceutical Recalls & How to Avoid them or connect with our experts.