FDA Seizes 37 Tons of Kratom in Florida

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.

FDA Updates Import Alert for Kratom

By Pat Anson, PNN Editor

Federal health officials may have dropped plans to schedule kratom as a controlled substance, but that’s not stopping the Food and Drug Administration from updating an import alert that gives the agency broad powers to seize shipments of the herbal supplement.

The alert targets dozens of kratom exporters and importers in the United States, Canada, Indonesia, Malaysia and the Philippines, and allows FDA inspectors to detain “without physical examination” dietary supplements and ingredients that contain kratom.  In an email, an FDA spokesperson told PNN the alert was updated for “minor changes” involved with one firm’s listing  

Kratom is an herbal supplement that comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction.

The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

“Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms,” the alert warns.

The FDA issued its first import alert for kratom in 2012, just as kratom was gaining in popularity in the U.S. Since then, several large shipments of raw kratom or kratom supplements have been seized. One of the largest seizures was in 2018, when 28 tons of kratom were confiscated at a South Carolina warehouse operated by Earth Kratom, a kratom wholesaler and vendor. The kratom was later incinerated.   

Kratom can be 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.

A lobbyist for the American Kratom Association, an association of kratom vendors and consumers, said the updated alert is part of the FDA’s “disinformation campaign” against kratom.

“The FDA routinely uses the import alerts in discussions with various stakeholders to highlight their claims that kratom is not ‘legally marketed’ in the United States, and by adding a recent date by way of an update makes it appear to be a recent action,” said Mac Haddow. “The import alert is an abuse of that authority that is supposed to apply to contaminated and adulterated products.

“In fact, the objections listed in the import alerts issued by the FDA technically only apply to importers who are subsequently making illegal therapeutic claims or as a dietary supplement on marketing materials. A bulk kratom importer is not subject to FDA's authority. Kratom processors who make no claims and sell kratom as a food are not subject to any pre-market approval by the FDA.”

Federal efforts to ban kratom in 2016 failed due to a public outcry. Two years later, federal health officials quietly withdrew their request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. The FDA, however, still maintains “significant potential safety concerns” about kratom. 

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.