The Food and Drug Administration falsely blamed kratom for deaths that can instead be linked to other drugs, a suicide, tainted products, or other medical conditions, kratom advocates alleged in a new white paper released Tuesday.
The American Kratom Association accused the Food and Drug Administration of deliberately publishing “junk science” in a report laying out 44 deaths associated with the Southeast Asian tea leaf kratom. The FDA, the paper alleges, is pushing a false narrative in order to have kratom banned in the U.S.
To arrive at its conclusions, the American Kratom Association combed through death certificates and offered a counter-explanation for each. The deaths occurred over the course of nine years. The research suggests that while people may have taken kratom, other factors killed them.
Certain death certificates, for instance, showed that people had been abusing other drugs at the same time or took powdered kratom that contained toxic chemicals. One of the deaths was attributed to falling through a window, another was a homicide in which someone was shot in the chest, and another involved a person suffering a heart problem while swimming. The group also found two instances where deaths were reported twice.
The FDA has been urging consumers to avoid kratom and has called for the Drug Enforcement Administration categorize it as a Schedule 1 drug, which would put it in the same category as marijuana and heroin, and effectively mean that scientists would be unable to study its effects. People who take the drug, which can be sipped in a tea or taken as a pill, say that it has helped them stave off addiction cravings for opioids and has alleviated chronic pain and depression.
The DEA has not said whether it will schedule the drug, nor has it provided a timeline for its decision.
When asked about the report from the American Kratom Association, FDA Commissioner Scott Gottlieb said that the agency had originally concluded that 64 deaths involved kratom but, after looking at the death reports again, concluded that 17 had other causes.
“These deaths are just one measure of kratom’s risk,” he said “They don’t account for the many people who may become initiated on, and addicted to, opioids because of the easy access to kratom.”
Gottleib said the FDA was “deeply concerned about the drug’s risks and its potential for abuse.” Gottlieb said that kratom had opioid-like qualities, a characteristic he said was concerning amid the opioid crisis, which involves other drugs, such as prescription painkillers, heroin, and fentanyl.
Earlier this year, FDA warned consumers not to use kratom at all, and carried out an investigation after dozens of people who had ingested kratom reported they had become ill with salmonella, a type of food poisoning.
FDA Commissioner Scott Gottlieb has said that his agency was concerned about reports that people had been using kratom to wean themselves off opioids, saying “there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist.” He has warned in the past that kratom can cause seizures and liver damage.
In the latest report, American Kratom Association scientists and attorneys are accusing the FDA of misleading the DEA, the Centers for Disease Control and Prevention, and the National Institute on Drug Abuse with “incomplete, inaccurate, extrapolated, and distorted information” on the alleged side effects and deaths associated with kratom in order to bolster the agency’s effort to regulate the drug.
“Not only is the FDA’s effort to frame kratom as a culprit in these otherwise unrelated deaths sloppy and lacking in scientific integrity, but one can only conclude that it has been done deliberately,” said Dave Herman, chairman of the American Kratom Association.
The American Kratom Association is calling on the FDA to withdraw its call to schedule kratom and to review all of its documents. It is asking for the agency to re-evaluate its recommendations about kratom, and to rescind a November 2017 public health advisory warning people of its alleged dangers. It also wants to see the FDA work with other government agencies in developing its studies, and to crack down on companies that are selling adulterated kratom.
This article has been updated to include a response from the FDA.
