Kratom Just Became The FDA’s First Ever Mandatory Recall

  • The FDA has issued a mandatory recall of all kratom products sold by Triangle Pharmanaturals.
  • The supplement has been linked to a dangerous salmonella outbreak affecting at least 87 people, and the company failed to comply with a voluntary recall issued by the FDA.
  • Kratom is a supplement most commonly used to treat pain and to curb opioid addiction.

On Tuesday, the Food and Drug Administration issued a mandatory recall of all products sold by Triangle Pharmanaturals that contain kratom, a supplement primarily used to treat pain and opioid addiction. In February, Kratom was linked to a dangerous salmonella outbreak that affected at least 87 people.

“The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall,” the FDA said in a statement. “This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.”

In its recall, the FDA advised consumers to discard the products from 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 supplement — which is sold online and in stores in pill, powder, and other forms, most commonly to help treat pain and overcome opioid addictions — was first linked to the salmonella outbreak, in late February. At the time, the Centers for Disease Control and Prevention put out a report warning that kratom had been linked to salmonella in 28 people over 20 states.

“At this time, CDC recommends that people not consume kratom in any form because it could be contaminated with salmonella,” the report stated. Salmonella, a bacteria, can cause people to develop diarrhea, fever, and abdominal cramps, the CDC explained.

Several weeks prior to the CDC’s salmonella report, the FDA sent up a warning flag about kratom, saying the supplement affects the brain in the same way as addictive opioids and that it has the “potential for abuse, addiction, and serious health consequences, including death.”

In 2016, the FDA reported that 36 deaths had been associated with kratom use. In February, FDA Commissioner Scott Gottlieb updated that figure to 44.

Though kratom, a plant native to Malaysia, has been used traditionally to treat pain as well as heroin or morphine dependence, the FDA implored people to steer clear of it.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist,” Gottlieb said in February. He added, “As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant — it’s an opioid.”

Triangle Pharmanaturals has since taken down its website and social media pages, but MensHealth.com reached out to the FDA for further comment and will update this story with more information as it becomes available.

via Kratom Just Became The FDA’s First Ever Mandatory Recall

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