Editor's note: After this story was published, the DEA withdrew its intent to ban kratom and established a public comment period. More information is available here.
The US Drug Enforcement Administration (DEA) has not taken action to make the herbal supplement kratom as schedule I drug, despite previously announcing its intention to do so by September 30.
The delay comes as some members of Congress, as well as kratom users and researchers, have grown increasingly vociferous over the notion that the DEA would make kratom a schedule I substance, in the same class as heroin and marijuana, without allowing any public input.
In late August, the agency said it would place kratom's active ingredients ― the opioids mitragynine and 7-hydroxymitragynine ― on schedule I within 30 days, but did not invite public comment, as is typically done with federal regulation notices.
The scheduling has not occurred yet but is still on track, DEA spokesman Russ Baer told Medscape Medical News.
"We've consistently said to anyone that has asked that it could be September 30 or sometime thereafter," said Baer. "We're in that 'sometime thereafter' stage."
Baer would not say whether the agency is going to allow any public input. But Susan Ash, founder and director of the American Kratom Association (AKA), told Medscape Medical News that a congressional ally, Rep. Mark Pocan (D-Wisc), has indicated that the DEA will now seek public comment.
The DEA is under pressure from Congress to reconsider making kratom a schedule I substance. Fifty-one members of the House sent letters to the DEA's acting administrator and to the director of the White House Office of Management and Budget on September 26 stating that the action may be illegal and that it could stop much-needed research.
Where's the Proof?
Two separate groups of senators have also urged the agency to put a hold on the scheduling decision.
One letter, issued by Sen. Orrin Hatch (R-UT) and signed by eight other senators, questioned why the DEA considered it an emergency to restrict kratom and asked for evidence that it is a public health threat.
Sen. Hatch has been a frequent advocate for the dietary supplement industry and was the lead developer of the Dietary Supplement Health and Education Act of 1994. That law created the regulatory framework for supplements.
Senators Cory Booker (D-NJ), Ron Wyden (D-Ore), and Kirstin Gillbrand (D-NY), also wrote to the DEA, saying that "an increasing body of research has shown kratom's potential value as a treatment for a number of conditions." They asked the agency to solicit more public input.
Eleven academic researchers, led by Andrew C. Kruegel, PhD, a pharmacologist at Columbia University, wrote to Congress in early September expressing their concern about the DEA action.
Kratom is being studied at Columbia University, Memorial Sloan Kettering Cancer Center, the University of California, San Francisco, and elsewhere, they wrote. The drug may have potential as a painkiller that could be less dangerous than opioids, given the fact that it appears to cause less respiratory depression, they wrote.
Kratom users have made their dissatisfaction known as well. Some 141,000 people signed a petition urging the White House to keep the DEA from scheduling the supplement. "If the DEA gets its way, more people who struggle with addiction will be criminalized," according to a statement by Jag Davies, director of communications strategy at the Drug Policy Alliance, a New York–based nonprofit that is also arguing against scheduling.
Derived from a tree (Mitragyna speciosa korth) grown in Southeast Asia, kratom has become increasingly popular as an alternative to opioids both to treat pain and to ease opioid withdrawal. It is also used recreationally for both its stimulant and its relaxation properties.
The DEA says that kratom has a high potential for abuse, that it has no currently accepted medicinal use, and that there is a lack of evidence of safety when used under medical supervision.
The American Medical Association (AMA) passed a resolution at its annual House of Delegates meeting in June 2016 noting that kratom was being marketed in many cases as a legal high and that its use could lead to addiction. The AMA was directed to "support legislative or regulatory efforts to prohibit the sale or distribution of kratom in the United States which do not inhibit proper scientific research."
Several states, including New York, are considering bans on kratom, and a few states have made the supplement illegal, including Arkansas, Indiana, Tennessee, and Vermont, according to Speciosa.org, a website that appears to be maintained by the Botanical Education Alliance (BEA) and the American Kratom Association.
Those two groups were formed in part to keep kratom legal. The AKA's members include people who have disabilities and others who use kratom, said Ash, the director. The BEA has not responded to requests from Medscape Medical News about its funding. Both the AKA and the BEA are members of the American Herbal Products Association, which describes itself as the "voice of the herbal industry."
Ash said that the AKA does "get donations from some people in the business," adding, "but we are consumers, and do not profit off kratom in any way."
Medscape Medical News © 2016 WebMD, LLC
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Cite this: DEA Delays Kratom Ban - Medscape - Oct 06, 2016.