The Food and Drug Administration in a criminal case has requested that a judge quash a subpoena seeking information on the botanical kratom (Mitragyna speciosa). FDA argued the subpoena doesn’t comply with federal rules, is burdensome and not relevant to a sentencing proceeding.

The defendant, Sebastian Guthery, who is awaiting sentencing in California Federal District Court, issued the subpoena in hopes of finding evidence to demonstrate kratom is not dangerous and has contested FDA’s challenge to the “subpoena duces tecum.”

FDA in January “posted a ‘grants notice’ soliciting bids for a ‘Human Abuse Study of Botanical Kratom.’ According to the FDA’s regulations, the FDA could not conduct a human abuse study without first determining that kratom is safe for human consumption at some predetermined dose,” lawyers for Guthery and co-defendant Nine2Five LLC wrote in Jan. 22 court papers, opposing FDA’s motion. “And yet, the FDA seeks to deny Guthery access to information it has regarding the safety profile of kratom while another arm of the government is seeking a custodial sentence based on its independently reached conclusion that the kratom is dangerous.”

The subpoena issued in late December requests a mountain of FDA documents, including those FDA reviewed or relied on concerning its position in an import alert that consumption of kratom can lead to a number of adverse health effects, including respiratory depression, delusions and severe withdrawal signs and symptoms. Among other things, the subpoena also seeks documents that FDA relied on to support various statements on its website, including its position that kratom cannot be lawfully marketed as a supplement or added to conventional food.

Expert witnesses on kratom

Amid the subpoena squabbles, an evidentiary hearing is scheduled for Feb. 8. Several experts retained by the U.S. Department of Justice — including Oliver Grundmann, Ph.D., a clinical professor in the Department of Medicinal Chemistry at College of Pharmacy for the University of Florida — are expected to testify over the supposed health risks posed by kratom.

Native to Southeast Asia, kratom is the subject of a growing number of wrongful death lawsuits filed in the U.S.

Grundmann has authored 117 published papers, including 39 papers about kratom, presented lectures on the botanical, and over the last four years, testified or was deposed as an expert on kratom in two court cases, according to DOJ. And he is expected to testify he has been researching the pharmacological effects of kratom since 2016.

The defense has its own experts prepared to offer testimony, including Jack Henningfield, Ph.D., VP of research, health policy and abuse liability with Pinney Associates. In his consulting work there, Henningfield “has contributed to the development of new dietary ingredient notifications for kratom to the FDA,” according to a 148-page disclosure filed in Federal District Court. The disclosure adds Henningfield’s “efforts to develop and implement regulatory frameworks to contribute to the safety of kratom products have been adopted by 11 states and are under consideration by additional states and the U.S. Congress.”

One expert that won’t be testifying on behalf of the U.S. government is the Food and Drug Administration. A judge in December ruled FDA was not part of the prosecution team. That paved the way for the government to offer evidence from its own independent experts regarding the purported health risks of kratom.

Government lawyers last week filed a motion to exclude the testimony of the defendants’ experts, arguing timely disclosures were not made and “the defense has proffered testimony well beyond the expertise of the witnesses.” As of this story’s publication, defense lawyers had not responded to the motion in the U.S. District Court for the Southern District of California.

Criminal indictment, allegations

Guthery and Nine2Five LLC were indicted last year by a grand jury on charges of conspiracy, illegal importation of merchandise, sale of merchandise imported contrary to law, money laundering, aiding and abetting, and criminal forfeiture.

Guthery was the owner of Nine2Five, which the government alleges imported kratom into the U.S. from Indonesia and sold it for human consumption.

“The charges relate to the intentional false declaration of kratom imported from Southeast Asia as fertilizer to avoid seizure by customs officials and to profit from the sale of the substance via websites after it was successfully smuggled into the United States,” according to DOJ’s amended sentencing memorandum.

Guthery could face time behind bars; The government has recommended he be sentenced to no more than 12 months and one day in prison after he reached an agreement to plead guilty to one criminal count. Per DOJ, “Guthery pled guilty to importing kratom by falsely declaring it to be fertilizer.”

Government lawyers, in recent court papers, have described an operation led by Guthery to import kratom for human consumption that intentionally mislabeled products to evade regulatory authorities after FDA issued an import alert for kratom in 2014. In response to the import alert, “Guthery knowingly and intentionally determined that Nine2Five would import the kratom by declaring it as something else besides kratom, including ‘tea leaves’ and ‘kava kava,'" the government alleged in an amended sentencing memorandum.

According to DOJ, Guthery “caused over $17 million to be wired to Indonesia between 2015 and 2018 for the purchase of kratom,” and during “the course of the conspiracy, the IRS identified $67 million in deposits made to the defendant’s accounts from the unlawful importation and sale of kratom.”

Competing narratives

Defense lawyers have painted a different story of Guthery than that portrayed by the government.

‘The government’s efforts to paint Mr. Guthery as someone who is a callous drug lord operating solely out of avarice is unfair, and frankly, not what they agreed to do in the plea agreement,” defense lawyers wrote in a supplemental sentencing memorandum filed in October. “Mr. Guthery repeats his request for a non-custodial sentence with no supervised release so that he may continue being a father and a good citizen.”

Among other arguments, Guthery’s lawyers dispute that kratom caused the death of his girlfriend. She experienced a seizure the morning she died, and paramedics administered a potent sedative (Versed) that is lethal when combined with prescription opioids, the court filing disclosed. Guthery’s girlfriend, his defense attorneys added, had several substances in her body when she died, including kratom, levetiracetam, lorazepam, midazolam, oxycodone and oxymorphone.

“Even if the kratom in her system contributed to her death, it is impossible, even with expert guidance, to determine the significance (if any) it played,” defense lawyers wrote.

Delayed sentencing

Guthery and Nine2Five were scheduled to be sentenced in November.  However, the court ordered an evidentiary hearing on whether kratom posed a danger to consumers, finding that would be an important consideration in sentencing.

DOJ lawyers subsequently revealed the government was unable to obtain information from FDA “either in support of or contrary to the position that kratom poses a danger to U.S. consumers, as ordered by the court.”

FDA’s role in the criminal investigation was limited to performing laboratory analysis of evidence collected by the IRS, and no charges under the Federal Food, Drug & Cosmetic Act were filed in the case, the government noted.

In the Jan. 11 motion to quash the subpoena issued by Guthery, FDA wrote in part, “The United States has made clear that it is no longer relying on anything said by the FDA, either on its website or as part of FDA Import Alert 54-15, to support its claim that kratom is a dangerous substance.”

FDA declined to comment for this article on pending litigation, and DOJ and Guthery’s lawyers had no immediate comment in response to emails from Natural Products Insider.