Editor's note: This article was updated Jan. 31 to reflect comments by FDA.
The U.S. Department of Health and Human Services (HHS) in 2018 rescinded a request for DEA to classify two constituents of the botanical kratom as a Schedule I controlled substance under the Controlled Substances Act (CSA), two lawmakers on Capitol Hill learned. The American Kratom Association (AKA), a consumer-based nonprofit group, on Thursday made public a 2018 letter from HHS to DEA that superseded an earlier recommendation to schedule mitragynine and 7-hydroxymitragynine.
But FDA did not make public HHS’ action, which continued to fuel perception by media, policy makers and the public that DEA was actively considering HHS' previous scheduling recommendation, despite the science not supporting it, according to Mac Haddow, senior fellow on public policy for AKA.
“Public health policy makers, state legislators, county commissioners, city councilmen, law enforcement groups, medical examiners and coroners, researchers and substance addiction specialists have all been misled into supporting an FDA narrative on kratom tied directly to the claims that kratom should be banned and that scheduling was imminent,” Haddow said in a statement.
According to AKA's website, six states have effectively banned kratom: Alabama, Arkansas, Indiana, Rhode Island, Vermont and Wisconsin.
In response to AKA's statements about the 2018 HHS letter, FDA spokesman Michael Felberbaum said, "While the FDA is an agency within HHS, the letter at issue was not the FDA’s to publicly disclose, and any announcement regarding a decision to schedule or not schedule a potential controlled substance is made by the Drug Enforcement Administration (DEA), not the FDA."
The 2018 HHS letter “is welcome news to patients in pain who rely on kratom,” U.S. Rep. Mark Pocan (D-Wis.) said Thursday during a press conference hosted by AKA. “This is a message to states that have wrongly banned kratom, and I look forward to working with HHS and with the kratom community to continue to invest in research on this very important substance.”
While exercising their oversight responsibilities over HHS and FDA, Pocan and Morgan Griffith (R-Va.) discovered that on Aug. 16, 2018, HHS rescinded an earlier request in 2017 to classify kratom as a Schedule I controlled substance, according to AKA. Pocan confirmed the authenticity of the letter from HHS to DEA.
In the 2018 letter to then-DEA Acting Administrator Uttam Dhillon, the then-Assistant Secretary for Health, Dr. Brett Giroir, recommended two constituents of kratom, mitragynine and 7-hydroxmitragynine, not be controlled either temporarily or permanently until such action is supported by scientific research.
“This decision is based on many factors, in part on new data, and in part on the relative lack of evidence, combined with an unknown and potentially substantial risk to public health if these chemicals were scheduled at this time,” Giroir wrote.
Among other observations, he cited a peer-reviewed animal study that suggested mitragynine does not have potential for abuse and actually reduced intake of morphine. Giroir also warned of “a significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components” are scheduled as controlled substances—including the risk of kratom users migrating to such lethal substances as prescription opioids, heroin and fentanyl.
Giroir nonetheless acknowledged “kratom may potentially have harmful effects, especially in specific circumstances and/or when used with potent prescription or illicit drugs.
“Finally, it is entirely possible that new data and evidence could support scheduling of chemicals in kratom at some future time,” Giroir stated. He encouraged FDA to continue to enforce against kratom manufacturers making “unproven claims” and was in favor of making the public aware that “kratom contains molecules that may potentially be dangerous.”
In 2016, in the wake of pressure from Congress and the American public, DEA withdrew its notice of intent to temporarily place the main constituents of kratom into schedule I under the CSA.
FDA, however, remains concerned about kratom.
"Kratom products have been associated with significant potential safety concerns," Felberbaum, the FDA spokesman, said. "While it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties that expose users to the risks of addiction, abuse and dependence."
FDA has not approved a drug derived from or containing kratom, and it "has received concerning reports" about the botanical's safety, he added.
"The FDA is actively evaluating available scientific information on this issue," Felberbaum said. "In addition, FDA has sent numerous letters to firms that have marketed kratom products with unsubstantiated claims that their products can treat opioid withdrawal and addiction and other serious medical conditions."
During the press conference hosted by AKA, Kerry Biggs Malczewski—a 41-year-old resident of South Milwaukee—discussed the benefits of kratom.
A single mom with three kids who also cares for her disabled mother, Malczewski said she suffers from several medical conditions, including anxiety, chronic fatigue, depression and rheumatoid arthritis (RA), among others she identified. She said most prescription drugs caused her undesirable side effects.
Malczewski discovered kratom in 2014 before it was banned in Wisconsin.
“It was almost an instant change in my life,” she said. “I had my life back. My children had their mother back. I was able to return to work full time” and take care of the house.
She added, “I was just a more present person emotionally as well.”
But Malczewski suggested after Wisconsin imposed the ban—according to AKA, the state has classified the primary alkaloids in kratom as Schedule I controlled substances—“I was back to square one.”
While she uses CBD oil, she said she can’t use the substance that really helps her.
“I call kratom a miracle plant,” Malczewski said, “and I hope and pray every day that one day soon I will have the option to use what works for me again.”