By Pat Anson, Editor
Facing opposition from the public and some members of Congress, the U.S. Drug Enforcement Administration has withdrawn plans to classify two of the active ingredients in kratom as Schedule I controlled substances, a move that would have made the sale and possession of the herb a felony.
“DEA has received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action,” the DEA said in a notice published in the Federal Register.
“DEA is therefore taking the following actions: DEA is withdrawing the August 31, 2016 notice of intent; and soliciting comments from the public regarding the scheduling of mitragynine and 7-hydroxymitragynine under the Controlled Substances Act.”
Mitragynine and 7-hydroxymitragynine are alkaloids in kratom that appear to act on opioid receptors in the brain. They are not approved for any medical use in the United States, even though millions of kratom consumers use the the herb to manage pain, anxiety, depression, addiction and other medical conditions.
The unprecedented decision to withdraw the scheduling of a controlled substance does not end the possibility that kratom will be banned. The DEA said it would re-evaluate its decision after the public comment period ends on December 1, 2016. The agency will also ask the Food and Drug Administration to expedite a full scientific and medical evaluation of kratom.
“DEA will consider all public comments received under the above procedures, as well as FDA’s scientific and medical evaluation and scheduling recommendation for these substances. Once DEA has received and considered all of this information, DEA will decide whether to proceed with permanent scheduling of mitragynine and 7-hydroxymitragynine , or both permanent and temporary scheduling of these substances,” the agency said in its announcement.
If the DEA decides to schedule kratom permanently, the agency said it would publish a new notice in the Federal Register and allow for a second public comment period. Under the original emergency scheduling notice published on August 30, there was no public notice or comment period.
“We moved a mountain and now we’re parting the sea!!! Keep the pressure on; wait for commenting instructions please, we still have A LOT of work ahead of us,” wrote Susan Ash, founder of the American Kratom Association (AKA) in a note to supporters on Facebook.
“I think what this clearly shows is that there is no imminent public health threat or they wouldn’t be adding on a 6 week public comment process and putting it back on the FDA,” Ash told PNN.
She said her organization would resist any effort to classify kratom in a less restrictive category than Schedule I, which is how marijuana, LSD and heroin are classified. At present. there are no federal limits on kratom as a dietary supplement, although it is banned in a handful of states.
"We still believe it should not be scheduled in any way, shape or form. It's been consumed safely here for decades and worldwide for a millennium, so there's really no impetus to make it a controlled substance, period," said Ash.
In its initial attempt to ban kratom -- which comes from the leaves of a tree in Southeast Asia -- the DEA said the herb had “psychoactive effects” and was linked to dozens of overdose deaths.
In reaching that assessment, the agency relied primarily on the research and advice of the FDA and the Centers for Disease Control and Prevention. Critics, however, say much of that research was deeply flawed and unreliable. For example, a recent CDC report claimed kratom was “an emerging public health threat” and cited two published research reports that “associated kratom exposure with psychosis, seizures, and deaths.”
Those two reports, however, make no mention of deaths caused by kratom. The CDC also relied on a newspaper article to help document one kratom-related death, even though it was actually caused by a self-inflicted gunshot wound.
"Nowhere does DEA rely on the scientific, epidemiological, and public health sources that normally undergird the assertion that a substance poses a high potential for abuse, let alone an imminent public health threat,” lawyers for the AKA said in a letter to DEA acting administrator Chuck Rosenberg.
To overturn the ban, the AKA enlisted the help of over 60 members of Congress, who signed letters urging the DEA to delay scheduling kratom and to solicit more public input. Over 142,000 kratom supporters also signed a White House petition asking the Obama administration to postpone the scheduling.
"I think the DEA was pressured so much by Congress, the public and by the media that they realized that they didn't really have the proof and the science to emergency schedule this," Ash said. "It put the DEA in a really difficult position and now the DEA is just trying to admit the fact that they don't have what they need to call this a public health threat."
In a survey of over 6,000 kratom consumers by Pain News Network and the AKA, nine out of ten said kratom was a “very effective” treatment for pain, depression, anxiety, insomnia, opioid addiction and alcoholism. Many also predicted that banning the herb would only lead to more drug abuse, addiction and death.
"The DEA missed the mark here and it would be a gross miscarriage of due process to simply tell millions of American consumers and the legal businesses that serve them that they are now felons,” said Travis Lowin of the Botanical Education Alliance in a statement before the DEA reversed its decision.
“The DEA has a strict set of rules it is supposed to follow for an emergency scheduling of a drug and kratom meets none of those tests. There are reasonable limits on the power of what government can do precisely to avoid situations like this where legal consumer conduct and legitimate free enterprise would otherwise be crushed overnight by indiscriminate use of the power of government."