Botanical may produce medical benefits previously denied by DEA

The U.S. Drug Enforcement Administration has hit the brakes on banning what only a few months ago the agency was calling an “imminent hazard to public health.”

The choice to further explore mitragyna species, or kratom, before outright banning the substance has led to the discovery of potential medical benefits to the substance that critics have threatened produce “opioid-like effects.”

Deborah Leenhouts of Gorham, who has taken kratom to deal with chronic pain, said she was relieved by the decision to delay the ban.

“I have a little more confidence that they have my best interest in mind,” she said.

Kratom — a tropical plant that grows in Southeast Asia — is available for purchase at smoke shops across the Finger Lakes region and the rest of the nation, as well as through online vendors that distribute natural dietary supplements.

The botanical comes in a variety of forms, including a powder from the ground-up leaves that can be mixed up in a drink, made in a tea or placed in a capsule. Kratom, a family member of the coffee plant, can either stimulate or relax the user depending on the strain of the plant consumed and the dosage ingested.

The American Kratom Association was established in 2014 to educate the public about the herb and to protect its cultivation as the botanical began to become more popular and develop its critics. The group’s website touts kratom as an all-natural substance that has been consumed for hundreds of years to alleviate pain, combat fatigue and help with the effects of depression and anxiety.

However, last September, the U.S. Drug Enforcement Administration was calling kratom an imminent hazard to public safety, despite a lack of information on the substance. The agency proposed designating the chemicals that compose kratom as a Schedule 1 — the most restrictive category of the 1970 Controlled Substance Act. The designation would have clumped kratom with drugs such as heroin and LSD.

The DEA said at the time that kratom is being abused by the public due to its ability to produce opioid-like effects.

“Kratom has a high potential for abuse, has no currently accepted medical use in treatment in the U.S. and has a lack of accepted safety for use under medical supervision,” a DEA release stated.

In addition to the ban, the emergency classification as a Schedule 1 would also throw up road blocks in the research and exploration of kratom, which is largely unexplored within the scientific and medical community.

The AKA led a charge against the DEA’s plans, collecting signatures on a petition calling on then President Barack Obama to halt the agency’s intention to outlaw the botanical. The petition quickly garnered tens of thousands of signatures.

The public outcry caused the DEA to slow down its proposed emergency scheduling. The administration opened up a public comment period with a stated need for additional input from the Food and Drug Administration and the community about the herb.

“During that process, we received a lot of information — probably a record amount of information — so now we are in the process of going through all that information,” said Melvin Patterson, a spokesperson for the DEA.

Patterson added that the administration has received a wealth of conflicting information about kratom regarding its interaction with the chemistry of the brain and the fact that it may offer medical benefits after all.

“There’s doctors that have said that they’ve seen positive results,” Patterson said. “But then there’s doctors that have said that it’s risky as well. We wanted to do further research on it.”

PinneyAssociates, a pharmaceutical and consumer healthcare consulting company, was contracted to review the information about kratom in order to develop a legal framework to assess the abuse potential of kratom. That framework would be used for submission to the FDA, DEA and the National Institute on Drug Abuse to assist in creating informed deliberations regarding potential regulation of the herb.

On Jan. 18, PinneyAssociates put out a press release that included input from Dr. Jack Henningfield, vice president of Research, Health Policy and Abuse Liability at the consulting company, and adjunct professor of Behavioral Biology at Johns Hopkins University School of Medicine.

“It’s important to understand that although kratom has some mild effects similar to opioids, its chemical make-up is different, and it appears overall much safer, with apparently relatively small effects on respiration,” he said. "In fact, kratom's analgesic effects and impact on energy, combined with its favorable safety profile supports continued access by consumers to appropriately regulated kratom products while research on its uses continues."

When Leenhouts found out about the potential ban of kratom, she quickly stocked up on the botanical that she has been taking to alleviate the severe back pain that’s been plaguing her life for years.

The 57-year-old Gorham resident, owner of the New You clothing store on South Main Street in Canandaigua, has dealt with her spine’s degeneration, which caused one of her vertebrae to slip. This led to a blockage of a nerve to her hip that has led to endless discomfort.

Then there was the depression that came with chronic pain.

She was prescribed opioid-based medication by her physician, which led to a physical addiction that required treatment and recovery. Then she discovered kratom.

“It was shocking for me,” Leenhouts said. “I come from a generation where you take a prescription and you do what the doctor says. What was surprising for me was the my primary care physician had never heard of kratom. I told him that he should write it down as something I’m taking, but he said, ‘I trust that you did your research, it’s just an herb.’”

Leenhouts described the DEA's lack of research into the herb before making a push to criminalize the substance “appalling." Leenhouts said she believes the push toward its ban is due to its potential to negatively impact the pharmaceutical industry, as it is an all-natural substance that deals with pain, depression and anxiety.

Patterson noted that there was no clear timeline for what awaits the future of kratom. The DEA must evaluate if it is going to still pursue the emergency scheduling, are going to take the route of normal scheduling, or abandon the concept of scheduling the plant altogether.

“We want to be sure about it,” Patterson said. “This is not something you want to rush. You want to make sure you get it right.”

The substance has been banned in states such as Vermont and Wisconsin. Meanwhile, leadership in Florida and New York are currently drawing up legislation in an attempt to ban the botanical.