By Pat Anson, Editor
The U.S. Food and Drug Administration has issued a mandatory recall for kratom capsules made by a Las Vegas company after several of its products were found to be contaminated with salmonella bacteria.
The FDA said it ordered the recall after Triangle Pharmanaturals failed to cooperate with the agency’s request to conduct a voluntary recall.
The FDA is advising consumers to discard kratom products made by Triangle, which include 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. The products are sold in 300 capsule plastic bottles.
It’s possible other brands may be included in the recall because Triangle manufactures and packages kratom products for other companies.
“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,” said FDA Commissioner Scott Gottlieb, MD, in a statement.
“We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. 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.”
The FDA said Triangle did not cooperate with its investigation or order a voluntary recall after six samples of its kratom products tested positive for salmonella. “FDA investigators were denied access to the company’s records relating to potentially affected products and Triangle employees refused attempts to discuss the agency’s findings,” the FDA said.
The company did not immediately respond to a request for comment.
At least 87 people have been sickened in 35 states by a salmonella outbreak linked to kratom – an herbal supplement used by millions of Americans to treat chronic pain, depression, anxiety and addiction. At least one other kratom distributor – PDX Aromatics of Portland, Oregon – agreed to voluntarily recall its products after several were found contaminated with salmonella.
Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in hospitalization or even death.
Kratom is usually sold in powder, capsules or leaves. The Centers for Disease Control and Prevention has not been able to trace the salmonella outbreak to a single brand or source, so it is recommending that people not consume “any brand of kratom in any form.”
The FDA has also warned against consuming kratom, claiming it has opioid-like qualities and could lead to addiction. In recent months, the FDA has released a public health advisory warning that kratom should not be marketed as a treatment for any medical condition. The agency also released a computer analysis that found kratom contains over two dozen opioid-like substances.
Under the Food Safety Modernization Act, the FDA has broad authority to order the recall of food products when the agency determines that there is a reasonable probability the food is adulterated or could have serious health consequences.