It’s not often that the Drug Enforcement Administration makes a 90-degree policy reversal.But that’s what happened last fall when the DEA withdrew its previously announced plan to place Kratom into Schedule I of the Controlled Substance Act, one of the first steps toward banning its sale in the U.S.
The FDA yielded to requests from congress people and others representing those who have come to rely on the herb for relief from chronic pain, as an alternative to powerfully addictive opioids.
Weighing benefits and drawbacks
Kratom has been used for centuries in southeast Asian traditional medicine to treat exhaustion, pain and other ills. It is unique in that low doses have a stimulating effect on the nervous system — similar to coffee, a relative of the kratom tree — while higher doses act as a sedative and painkiller.
On the negative side, Kratom has been linked to seizures and respiratory depression, but deaths related to it appear rare. Some deaths in the United States have resulted from Kratom being laced with the prescription pain reliever hydrocodone or morphine.
Kratom is now widely available in the U.S. Powdered forms of the leaf are sold at head shops and gas-station convenience stores and on the Internet. Bars have opened in Colorado, New York, North Carolina and other states where customers drink brewed Kratom, varying in strength, from plastic bottles that resemble those for fruit juice.
Because Kratom is categorized as a botanical dietary supplement, the Food and Drug Administration cannot restrict its sale unless it is proved unsafe or producers claim that it treats a medical condition. But the F.D.A. did ban the import of Kratom into the United States in 2014, which it can do when a substance is strongly suspected to be harmful. That year, marshals seized 25,000 pounds of it from a Los Angeles warehouse.
The DEA has listed Kratom as a “drug of concern” but not a controlled substance, which would require proven health risks and abuse potential. Alabama, Arkansas, Indiana, Tennessee, Vermont and Wyoming have banned it on their own; several other states, including Florida and New Jersey, have shelved similar bills until more is known about Kratom’s health risks. The U.S. Army has forbidden its use by soldiers.
Kratom’s narcotic effects have been known for centuries in its native Thailand, which banned the substance decades ago amid widespread abuse. Nevertheless, Kratom being sold in the United States is still smuggled in from Thailand, as well as several other Southeast Asian countries. Western research to better understand and document Kratom’ effects is in its very early stages.
Some Kratom advocates claim that it helped wean them from stronger and more dangerous opiates. One prominent voice is Susan Ash of Norfolk, Va., who used Kratom while in treatment for dependence on prescription painkillers, and now uses a small amount daily for chronic pain and depression. In 2015, she founded the American Kratom Association, a consumer group of more than 2,000 members that lobbies against state bills to ban the substance.
Kratom is classified as an herbal supplement, which makes the situation even more complicated. Unlike pharmaceutical drugs, there is no clear process to clinically evaluate and bring to market traditional herbal medicines such as Kratom. Since herbal supplements cannot be patented, companies lack incentive to invest in costly clinical trials.
As a result, herbal supplements can often be marketed without complete scientific evidence of their positive and negative effects. They can also be quickly banned, if regulators are concerned about potential negative effects.
A less addictive option
Kratom has proven to be much less addictive than the opiates currently on the market, and — to date — has never led to a reported overdose by itself; any overdose that included Kratom also included multiple other drugs known to be dangerous. Still the DEA has stuck with its cautious approach.
Proponents of Kratom argue that pharmaceutical companies are driving the push to ban Kratom, because Kratom erodes the profits they make on the opiates they produce and market. The government, on the other hand, sees kratom as a possibly dangerous supplement that will most likely never be investigated properly enough to warrant legalization and entry into the market.
In March, the American Kratom Association submitted a petition signed by 26,047 Americans urging President Trump to halt the Drug Enforcement Administration (DEA)/Food and Drug Administration (FDA) push to criminalize the herb.
While the DEA continues to gather public comments, chronic pain sufferers hope the DEA will continue to allow Kratom to be used, for now, until scientists can make a solid empirical case one way or the other.