The Food and Drug Administration is ordering a mandatory recall of kratom from Triangle Pharmanaturals LLC after the company failed to voluntarily remove its products.
The FDA put out the order after finding the products were infected with salmonella. This is the third time FDA has issued a mandatory recall but the first that comes as a result of a company refusing to follow a voluntary request.
“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,” Scott Gottlieb, FDA commissioner, said in a statement.
Triangle Pharmanaturals did not immediately respond to a request for comment.
Kratom is an herbal supplement that can be smoked, sipped in tea, or taken as tablets. People who take it have said that it helps relieve chronic pain and depression, and it can work as a replacement for opioids. Some people take it for its stimulating effects.
The FDA, along with the Centers for Disease Control and Prevention, has been examining kratom after 87 people were sickened by salmonella. Not all of them admitted to taking kratom and no one has died from the infection, but 27 people were hospitalized.
But the FDA noted that Triangle Pharmanaturals’ products weren’t linked with the outbreak and said it was continuing its investigation.
FDA had requested a voluntary recall March 30, giving Triangle Pharmanatural 24 hours to quit selling its products and to notify consumers. FDA said the company did not comply with the request and so on March 31 the FDA order the company to stop selling its products and allowed for an informal hearing. After the company failed to respond, the FDA issued its mandatory recall.
The FDA has the power to order such recalls through the Food Safety Modernization Act after determining there is a “reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.”
The FDA advised consumers to throw away products containing the names Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red, but said that it’s possible they sell products also known by other names.
CDC officials have recommended that people “not consume any brand of kratom in any form because the source of salmonella contamination has not been identified.”
Kratom is legal in the U.S. and has not been scheduled as a drug by the Drug Enforcement Administration.
The FDA has advocated for people not to take kratom at all, and has published studies detailing deaths associated with its use. Supporters of keeping the drug legal for research purposes note that the death certificates often mention the possible involvement other drugs.
“We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately,” Gottlieb said. “But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. 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.”
