ROANOKE, Va. – The FDA has issued a mandatory recall for all food products containing powdered kratom manufactured, processed, packed or held by Triangle Pharmanaturals after several were found to contain salmonella.
The agency took this action after it says the company failed to cooperate with the FDA’s request to conduct a voluntary recall.
This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are not limited to:
- Raw Form Organics Maeng Da Kratom Emerald Green
- Raw Form Organics Maeng Da Kratom Ivory White
- Raw Form Organics Maeng Da Kratom Ruby Red
The FDA ordered a mandatory recall for kratom products due to risk of salmonella. Our first approach is to encourage voluntary compliance, but if a company doesn't cooperate, the agency will pursue all avenues of enforcement under our current authority https://t.co/uFRhPF5ulr— U.S. FDA (@US_FDA) April 3, 2018
The FDA understands that Triangle Pharmanaturals may manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.
“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, M.D. “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.”
There is strong evidence that kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence, according to the FDA.
The agency also remains concerned about the use of kratom as an alternative to FDA-approved pain medications or to treat opioid withdrawal symptoms, as neither kratom nor its compounds have been proven safe and effective for any use and should not be used to treat any medical conditions.
Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found in Triangle Pharmanaturals’ products are not currently linked to the outbreak.
The illness usually lasts four to seven days, and most people recover without treatment. However, in the current salmonellosis outbreak associated with kratom products, unusually high rates of individuals have been hospitalized for their illness.
If consumers have one or more of these products in their homes, they should discard them immediately.