The Trump administration this week lashed out against users of the drug kratom, which some believe can help combat opioid addiction. The president's appointee to head the U.S. Food and Drug Administration, Scott Gottlieb, said in a statement that the herbal supplement from Southeast Asia can be deadly and that there's no proven use for it as medicine.
"I want to be clear on one fact: There are currently no FDA-approved therapeutic uses of kratom," Gottlieb said. "Moreover, the FDA has evidence to show that there are significant safety issues associated with its use."
Last year, the U.S. Drug Enforcement Administration backed off a plan to enact an emergency ban on kratom after receiving feedback not only from everyday consumers but from 51 members of Congress, who urged the DEA to hold off while the drug's promise for opioid addiction treatment was explored.
Advocates for the drug, which can be found online and is not necessarily illegal to possess, have been waiting for the next move, and some believe Gottlieb's rant is a precursor to a move by the DEA to again attempt to schedule the substance as an outlaw with no legit medical uses.
"We were waiting for something like this," says Jag Davies, director of communications strategy at the Drug Policy Alliance. "Everyone in the kratom world were not sure what was going to happen next. The DEA can still schedule the drug at any time, even though it withdrew its emergency scheduling petition."
In his screed, the FDA chief made it clear that scheduling — basically outlawing the substance — is one way forward. But some argue that scheduling a drug is really just kicking it to the black market, where science, labels and dosage information are scant.
"Before it can be legally marketed for therapeutic uses in the U.S., kratom’s risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with," Gottleib wrote. "Moreover, Congress has also established a specific set of review protocols for scheduling decisions concerning substances like kratom. This is especially relevant given the public’s perception that it can be a safe alternative to prescription opioids."
Overdoses have become the leading cause of accidental deaths in the United States, and opioids, including those prescribed by doctors, have fueled the epidemic. Some prescription opioid addicts turn to street heroin, which can be fatal. Kratom advocates say it can help opioid users deal with withdrawal.
"It's a drug millions report using to cut back or quit the harmful use of opioids," says Davies of the Drug Policy Alliance. "We know it's safer than opioids in a lot of ways. The federal government should be encouraging innovative substitution therapies instead of cracking down on them."
The Trump administration has filled the FDA with former pharmaceutical industry executives, including Gottlieb. And, last month, U.S. Rep Tom Marino withdrew as Trump's nominee for federal drug czar after 60 Minutes reported that he guided legislation through Congress that hamstrung the DEA's ability to track the illegal flow of pharmaceutical opioid pills.
Questions about the administration's motives here are legit, Davies says. He argues that, even before the days of President Trump, the drug-industrial complex has never been motivated to legitimize herbal drugs like kratom, which can be found on trees in Southeast Asia.
"The FDA's definition of an approved medicine is so narrow it doesn't allow for botanicals to be brought to market," he says. "There's no pharmaceutical profit motive to do the research necessary."
Davies suggests that states like California could take the medical marijuana route and legalize kratom without waiting for federal regulation.
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The euphoric drug is especially popular in the Golden State, where herbal and alternative medicine have long found a home. In August the U.S. Attorney's Office in Los Angeles announced it seized more than 100 cases of health products containing the unapproved drug from a company in Grover Beach that was advertising kratom online.
"Kratom has been indicated to have both narcotic and stimulant-like effects, and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones, and jerky limb movements," federal prosecutors said in a statement last year.
Gottlieb argued in his statement that this is what we do know about kratom, and that it should be forbidden.
"The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products," he said. "There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms."