The FDA Just Used a First-of-Its Kind Power Move to Force a Kratom Recall

April 3, 2018, 7:44 PM UTC

The Food and Drug Administration (FDA) continued to step up its aggressive stance against kratom on Tuesday, employing—for the first time—a relatively new power to order mandatory recalls.

The FDA kratom recall is aimed at a company called Triangle Pharmanaturals LLC after some products from the company were found to contain salmonella, according to the agency. Those include: 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. Triangle was reportedly asked on multiple occasions to issue a voluntary recall but did not do so. Kratom is an increasingly popular herbal supplement that’s used by some as a non-opioid alternative for pain management, although there aren’t many clinical studies validating its safety and efficacy up to the FDA’s standards.

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“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 in a statement. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately.”

What’s striking about the FDA’s move is that the mandatory kratom recall order is based on a power the agency gained under the FDA Food Safety Modernization Act, a major piece of reform legislation signed by former President Barack Obama in 2011. That law gives the FDA authority to order mandatory food recalls—for instance, when voluntary recalls aren’t issued. Since non-prescription supplements typically fall under the food (rather than the drug) category, the FDA decided to flex that muscle in the instance of Triangle Pharmanaturals.

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Kratom use has been on the rise in the U.S. But the herb’s supposed benefits are unproven.Joe Raedle Getty Images
Joe Raedle Getty Images

“This is the third time the FDA has started the process of using its mandatory recall authority, but the first time the agency has gotten to the step of ordering a mandatory recall because a company has opted not to voluntarily recall after the FDA’s notification of an opportunity to initiate a voluntary recall,” explained the agency in its statement.

But this is far from the first time the FDA has taken direct aim at kratom under Gottlieb’s tenure. The agency warned last fall that there’s little evidence to support kratom’s use as a “natural” pain relief alternative, and in February, it issued a public health advisory saying that kratom compounds—ostensibly meant to replace addictive opioid products—are actually opioid products themselves.

Advocates for kratom tend to argue that the FDA is protecting big pharmaceutical interests—or at the very least isn’t keeping an open mind—by cracking down on the product.

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