FDA Orders Kratom Recall for Salmonella

This story was originally published April 3, 2018. As part of MedPage Today’s year-end review of the year’s news, we are republishing it along with an update on what has happened since with kratom regulation.

WASHINGTON — Kratom products sold by Las Vegas-based Triangle Pharmanaturals must be pulled from the market, the FDA ordered on Monday, after the company allegedly refused multiple requests 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 agency said in announcing the move. The FDA determined that Triangle’s kratom products were among those responsible for a wave of Salmonella infections nationwide.

Kratom is an increasingly popular herbal product, mostly imported from Southeast Asia, with opioid-like psychoactive properties. It is widely promoted for treating pain and symptoms of opioid withdrawal.

The FDA said it had asked Triangle on March 30 to initiate a recall, which the firm ignored. The agency issued another notice to Triangle the following day, ordering the company to stop distributing its kratom products. When that notice also didn’t elicit a response, the agency said, on Monday it followed through with a mandatory recall order.

Other firms have complied with FDA requests to recall their kratom products, the agency said.

As of March 15, according to the CDC, 87 people in 35 states had been diagnosed with Salmonella infections linked to kratom, including 27 who were hospitalized. No deaths have been reported in the outbreak.

The FDA noted that most of the positive Salmonella test results from kratom samples it has analyzed did not involve the same strains isolated in the human cases. But “any positive result for Salmonella poses a threat to consumers,” the agency noted. “The FDA continues to warn consumers not to consume any kratom product. There is no FDA-approved use for kratom and the agency has received concerning reports about the safety of kratom, including deaths associated with its use.”