By Pat Anson, PNN Editor

The Food and Drug Administration has announced a large seizure of kratom from a supplement packaging company in Florida, in what could be an escalation of the agency’s efforts to stop kratom sales in the United States.

Over 37 tons of kratom powder and over 200,000 units of dietary supplements containing kratom were seized earlier this month by U.S. Marshals at an Atofill warehouse in Fort Myers, FL. The company imports kratom from Indonesia and resells it in capsules and powder under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical and El Diablo. The seized products are worth about $1.3 million, according to the FDA.

In April, Atofil and dozens of other kratom exporters and importers were named by the FDA in an updated import alert which gives the agency broad powers to seize shipments of kratom. In a statement on Twitter, acting FDA Commissioner Janet Woodcock, MD, compared kratom to morphine.

“To protect the public health, the FDA will continue to take action against kratom-containing dietary supplements,” Woodocok said. “Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Kratom affects the same opioid brain receptors as morphine & appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence.”

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. A recent study estimated that about two million Americans use kratom to self-treat their chronic pain, anxiety, depression and addiction.

Kratom is sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement. During an FDA inspection of Atofil earlier this year, investigators observed large quantities of kratom powder and capsules labeled as “herbal supplements.” In the eyes of the FDA, that is a violation of federal law that prohibits the sale of adulterated dietary supplements.

The U.S. Department of Justice, working on behalf of the FDA, filed a civil complaint against Atofil in federal court, alleging that kratom is a new dietary ingredient for which there is no adequate information on its potential risk to human health.

Mac Haddow, a lobbyist for the American Kratom Association, told PNN the court action and seizure amounted to “an end-around of the Controlled Substances Act” by the FDA and was “a pretty big expansion of their authority.”

‘Embarrassingly Poor Evidence’

A DEA effort to ban kratom in 2016 failed due to a public outcry. Two years later, the Department of Health and Human Services (HHS) withdrew its request to classify kratom as a Schedule I controlled substance, citing lack of evidence it can be abused or posed a public health threat.

Former FDA Commissioner Scott Gottlieb, MD, who regularly campaigned against kratom while heading the agency, says more action needs to be taken by the Biden administration.

“We were prevented by HHS from moving forward with the scheduling of Kratom, and I’m convinced it’s fueling the opioid addiction crisis. The Biden Administration should follow through on efforts of FDA, NIH, and DEA — and the new ASH should affirm health findings of these agencies,” Gottlieb said on Twitter, referring to Rachel Levine, MD, Asst. Secretary for Health at HHS.

Gottlieb’s tweet brought a rebuke from Brett Giroir, MD, a former four-star admiral in the U.S. Public Health Service and Asst. Secretary for Health in the Trump administration. It was Girior who wrote a 2018 letter to the DEA notifying the agency that HHS was withdrawing its request to schedule kratom.

“FDA doesn't schedule; it only recommends. FDA's recommendation was rejected b/c of embarrassingly poor evidence & data, and a failure to consider overall public health. If #Kratom is fueling opioid addiction, prove it; and then @HHS_ASH should reconsider,” Giroir tweeted.

Gottlieb responded with yet another tweet, claiming that “public health suffered” as a result of Girior’s action.

“It’s true: Brett Giroir unilaterally overruled a considered, multi year, scientific effort by the NIH, FDA, and DEA and a careful analysis in an act I found hasty and ill conceived,” said Gottlieb.

A 2020 study funded by the National Institute on Drug Abuse — which is part of the the NIH — concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.