By Pat Anson, Editor
The U.S. Drug Enforcement Administration has announced plans to ban all sales of kratom, a popular herbal supplement increasingly being used as an alternative to opioids for relieving chronic pain.
The DEA filed notice in the federal register that it plans to classify two opioid-like chemicals in kratom as Schedule I drugs under the Controlled Substances Act – the same classification given to heroin, LSD and marijuana. Kratom is currently considered a food supplement, not a drug, but the move would effectively prohibit all sales of kratom, which comes from the leaves of a tree grown in southeast Asia.
The founder of the American Kratom Association told Pain News Network that her organization may go to court to block the DEA from carrying out its plan.
"This honestly was a complete and total shock for those of us involved in this issue," said Susan Ash. "We're weighing all of our options right now and one option of course is to seek a temporary restraining order."
The two main active ingredients in kratom, mitragynine and 7-hydroxymitragynine, act on the same receptors in the brain as opioids do, but are not currently approved as drugs.
The DEA said it needed to classify them temporarily as controlled substances “to avoid an imminent hazard to public safety.”
“Available information indicates that these opioid substances, constituents of the plant kratom, have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision,” the DEA said.
“Consequently, kratom, which contains the main active constituents mitragynine and 7-hydroxymitragynine, is an increasingly popular drug of abuse and readily available on the recreational drug market in the United States. Attempted importations of kratom are routinely misdeclared and falsely labeled. This is similar to other attempts to import controlled substances or substances intended to mimic controlled substances.”
Although the DEA refers to mitragynine and 7-hydroxymitragynine as "opioids," they are actually alkaline compounds that are believed to act on natural opioid receptors in the brain.
"They're not opioids. An opioid is a synthetic version of the poppy plant, so that's just completely wrong," said Ash. "They are novel substances that I really don't think you can define, quite honestly. There's nothing else like them in medicine or nature."
Although illegal in a handful of states, kratom is widely available online and in health stores, where it is sold as dried or crushed leaves, powder, capsules, tablets, liquids and gum. Users tout kratom's pain relieving benefits, and say it also reduces stress, depression and cravings for other drugs. Recent policies that discourage the prescribing of opioid pain medication have increased interest in kratom as an alternative treatment.
Ash is a recovering opioid addict who uses kratom as a deterrent.
"I have no cravings for narcotics. No part of me ever desires to put narcotics back into my body because of kratom. There is no need because it works so well and it eliminates cravings," said Ash, who used the addiction treatment drug Suboxone for about a year while in recovery.
"I went off of Suboxone using kratom. There is no way I would ever put myself back on Suboxone. But where do I go for help with pain now?" she asked.
Ash first had an inkling that the federal government was preparing to take broader action against kratom when the Centers for Disease Control and Prevention issued a report last month claiming that kratom was "an emerging public health threat." The CDC cited kratom-related calls to U.S. poison control centers, which jumped from 26 calls in 2010 to 263 in 2015.
"I'm sorry, but I don't consider 263 calls to poison control an emerging public health threat. I don't think anyone does," said Ash.
Few Kratom Studies
Although kratom has been used medically for hundreds of years, few studies have been done on its safety or to see how it actually works.
“Mitragyna speciose (kratom) has a psychostimulant effect like coca and a depressive effect like opium and cannabis, which seem to be contradictory. It is also reported that it is weaker than morphine, has a milder withdrawal syndrome compared to opioids, and is less harmful than cocaine,” is how one study explained it.
The Food and Drug Administration has been trying unsuccessfully to stop the importation and sale of kratom. Last year the FDA issued an import alert that allows the agency to seize kratom supplements without even physically examining them.
Earlier this month, FDA agents seized more than 100 cases of products labeled as kratom in Grover Beach, California. The products are distributed by Nature Therapeutics Inc. under the name Kratom Therapy. The FDA said the company was illegally selling kratom products as drugs to treat various medical conditions.
“The FDA will continue to take aggressive enforcement action to safeguard the public from harmful drug products illegally marketed as treatments for which they have not been studied or approved,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs.
The DEA says the ban on kratom chemicals would take effect at the end of September. Earlier this month, the agency also said it would not change the classification of marijuana as a Schedule I controlled substance.