FDA Issues Warning Letters to Crack Down on Kratom-Derived Opioid Products

The U.S. Food & Drug Administration (FDA) has issued warning letters to seven companies for illegally marketing products containing 7-hydroxymitragynine, a powerful opioid alkaloid found in kratom. The warnings cite concerns over unapproved and potentially dangerous items like gummies, shots and tablets sold online and in retail stores. The FDA is recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH) products under the Controlled Substances Act (CSA).  

The availability of 7-OH products is a major concern to the FDA, as consumers can easily purchase products with concentrated levels of 7-OH online and in gas stations, corner stores and vape shops. The FDA is particularly concerned with the growing market of 7-OH products that may be especially appealing to children and teenagers, such as fruit-flavored gummies and ice cream cones. These products may not be clearly or accurately labeled as to their 7-OH content and are sometimes disguised or marketed as kratom. The FDA has also published educational materials for consumers to be more informed about these harmful products.