A mysterious, popular ‘supplement’ has been linked to salmonella — and the FDA has issued its first mandatory recall

source
Psychonaught/Wikimedia Commons

  • Kratom is an opioid derived from a plant native to Southeast Asia. It can be consumed in pills, powder, or tea.
  • On Tuesday, the US Food and Drug Administration issued its first mandatory recall after a Las Vegas company’s powdered kratom products were found to be contaminated with salmonella.
  • The recall came on the heels of the Centers for Disease Control and Prevention issuing their third warning in a month that the drug, often called an “herbal supplement,” had been linked to salmonella, bringing the number of people sickened from contaminated kratom products to 87.

The Food and Drug Administration calls it a dangerous opioid, but kratom advocates call their pill of choice a life-saving supplement. Either way, it has been linked to a growing salmonella outbreak and, most recently, has spurred the FDA to issue its first mandatory recall.

Kratom is a psychoactive drug derived from the leaves of Mitragyna speciosa, a plant in the coffee family that is native to Southeast Asia. Research suggests the drug taps into some of the same brain receptors as opioids, spurring the FDA to classify it as one in February.

On Tuesday, the FDA ordered the Las Vegas-based company Triangle Pharmaceuticals LLC to pull all of its kratom-containing products. In a statement, FDA Commissioner Scott Gottlieb said the company failed to cooperate with the agency’s request for the products to be voluntarily removed from store shelves.

The agency’s first recall of this kind comes on the heels of a growing number of reports from the Centers for Disease Control and Prevention linking several kratom pills and powders to salmonella, an outbreak that has officially sickened 87 Americans. Salmonella is a bacterial infection caused by exposure to contaminated food or water that typically causes diarrhea and abdominal pain lasting up to a week.

‘Imminent health risk’

As with any unregulated supplement, kratom may be dangerous and even deadly because there’s no way to verify what pills labeled “kratom” actually contain.

Nevertheless, some marketers tout kratom as capable of boosting strength, delivering feelings of euphoria, relieving pain, and improving focus. Untainted kratom is also sometimes hailed as a way to treat opioid addiction, which some addiction experts have said is not entirely unreasonable given its opioid-like qualities.

But unlike most opioids, which either are illegal or must be prescribed by a doctor, kratom is widely available online. It was even sold for a time out of an Arizona vending machine. That has led to a growing concern among several regulatory agencies including the FDA and the CDC.

In his statement, Gottlieb said the decision to issue a mandatory recall was “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.”

Kratom is increasingly raising eyebrows

Because kratom is classified as a supplement and does not have FDA approval, it remains largely unregulated. That means it is almost impossible to verify what is actually inside any kratom pills, powders, or teas.

In general, if the FDA becomes aware of a safety issue, it relies on a voluntary recall to contain the problem. But according to the statement, Triangle Pharmaceuticals did not comply with a voluntary request by the agency on Friday to pull several its products, which were found to have been contaminated with salmonella.

After the company failed to comply with the request, the FDA ordered the firm on Saturday to stop distributing the products, but Triangle did not respond. It was then that the FDA issued its mandatory recall.

“The action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen,” Gottlieb said in his statement. “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.”

Kratom is banned in Australia, Malaysia, Myanmar, Thailand, and several US states (Alabama, Arkansas, Indiana, Tennessee, and Wisconsin). Across the US, several reports of deaths and addiction led the Drug Enforcement Administration to place kratom on its list of “drugs and chemicals of concern.” The DEA proposed a ban on kratom in 2016 but backtracked under pressure from some members of Congress and outcry from kratom advocates who said it could help treat opioid addiction.

“I want to be clear on one fact: There are currently no FDA-approved therapeutic uses of kratom,” Gottlieb said back in November.