The Food and Drug Administration had to issue a mandatory recall on kratom herbal supplements from the Raw Form Organics brand on April 3 because of a positive test for salmonella. The FDA advises customers who purchased kratom products manufactured, processed, packaged, or held by Triangle Pharmanaturals LLC to throw away bottles of Raw Form Organics Maeng Da Kratom in Emerald Green, Ivory White, and Ruby Red varieties.
Kratom is derived from a tree native to Southeast Asia. Use of the supplement has increasingly been the subject of controversy due to its reported psychoactive effects.
The FDA issued their first ever mandatory recall after Triangle Pharmanaturals refused to voluntarily recall contaminated products when two samples collected in Oregon tested positive for salmonella. The FDA does not have the authority to issue mandatory recalls for drugs, but gained the authority to do so for tainted food in 2011 under the Food Safety and Modernization Act. Under federal law, dietary supplements are typically considered foods.
“Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority,” FDA Commissioner Scott Gottlieb said in a statement.
An ongoing investigation by the FDA and the Centers for Disease Control and Prevention has linked kratom to at least 87 cases of salmonella across 35 states. CNN reports that the most recent case in the outbreak began February 24 and that 27 people have been hospitalized for salmonella poisoning so far.
The CDC currently recommends that people not consume kratom in any form due to the salmonella concern. Salmonella contamination is a concern with foods ranging from herbs to chicken to shredded coconut, and it’s been a prominent factor in some of the biggest food recalls.