FDA Forces Recall Of Kratom Products Amid Salmonella Outbreak Fears

By Victoria Kim 04/05/18

In an unprecedented move, the federal agency issued a mandatory recall of kratom products from one Las Vegas company. 

herbal supplements

A few months after the CDC issued a public health advisory warning Americans about potentially tainted kratom, the Food and Drug Administration (FDA) has ordered a mandatory recall of kratom products manufactured and processed by one Las Vegas company.

In February, the Centers for Disease Control and Prevention (CDC) began investigating a multi-state outbreak of salmonella that sickened 28 and hospitalized 11.

“In the current salmonellosis outbreak associated with kratom products, unusually high rates of individuals have been hospitalized for their illness,” said the FDA in a recent statement.

The agency discovered that six samples of kratom products manufactured or handled by Triangle Pharmanaturals tested positive for salmonella. But despite making repeated attempts to request that the company voluntarily recall its kratom products, the FDA said that the company did not cooperate.

As FDA Commissioner Scott Gottlieb explained, the agency made a decision to “pursue all avenues of enforcement under our authority” in light of 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.”

Among the kratom products recalled are Raw Form Organics Maeng Da Kratom Emerald Green, Ivory White, and Ruby Red.

Gottlieb emphasized that the agency’s action had only to do with the risk of salmonella contamination, rather than the FDA’s own skepticism about the safety of the herbal supplement that its advocates say offers pain relief, among other benefits.

The FDA has said that it is “especially concerned” about people who use kratom to treat opioid withdrawal in a February statement that compared certain kratom compounds with opioids. This incited outrage among advocates of kratom (including people in recovery) and drug policy reform alike.

The American Kratom Association accused the FDA of presenting “discredited, incomplete, and mischaracterized scientific claims” about kratom, and demanded that the agency “rescind” its statement.

“We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately,” said Gottlieb in the latest statement. “But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen.”

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Victoria is interested in anything that has to do with how mind-altering substances impact society. Find Victoria on LinkedIn or Tumblr