By: Alyson L. Wooten, Pharm.D.Kratom, a popular alternative medicine used as a home remedy for opioid addiction, is now classified by the Food and Drug Administration (“FDA”) as an opioid - a step that may lead to the classification of the substance as a restricted drug under the Controlled Substance Act. Kratom lies at the intersection of the debate between natural product and drug of abuse. Thousands of people around the world have taken kratom, which grows naturally in areas of tropical Southeast Asia. The plant is part of the coffee family and is commonly crushed for use as an herbal supplement and traditional remedy for pain relief and as a stimulant. The US Drug Enforcement Administration (“DEA”) sought to ban the substance as a Schedule 1 drug in 2016 but in response to significant public backlash, decided to hold on the classification in order to conduct additional investigation about what to do with the substance.,  However, several US states, including Vermont, Wisconsin, and Indiana, have banned the substance within their borders. FDA has continued to investigate kratom and has found sufficient data to re-classify kratom as an opioid. In FDA’s press release, FDA details the evidence gathered about the compounds in kratom and their activity in binding to receptors, including mu-opioid receptors and receptors associated with seizure activity and respiratory depression. To date, FDA has received 44 reported deaths associated with the use of kratom. Review of these reports and other information gathered has led to FDA’s conclusion that “[t]here is no evidence to indicate that kratom is safe or effective for any medical use.” This language, similar to the description of drugs classified as Schedule 1 under the Controlled Substance Act, may lead to DEA listing kratom as a Schedule 1 drug. Of note, FDA’s press release compared kratom to heroin, a Schedule 1 drug that is derived from the seed pod of opium poppy plants.4 The American Kratom Association, an association seeking to protect access to kratom, has demanded more information about the data unveiled by FDA. Additionally, a group of nine doctors have responded to FDA’s press release by writing a letter to White House Opioid Crisis Team Leader Kellyanne Conway and Acting DEA Administrator Robert Patterson cautioning that a ban on kratom would put current users of kratom for opioid withdrawal at “risk of relapse to opioid use with the potential consequences of overdose death” and that similar consequences would be expected by those “forced to use opioids to manage acute or chronic pain” in the absence of kratom. In short, FDA’s announcement does not appear to have put this issue to rest and it is expected that access to kratom will be of continued debate. Download PDF  https://www.dea.gov/divisions/hq/2016/hq083016.shtml  www.gpo.gov/fdsys/pkg/FR-2016-10-13/pdf/2016-24659.pdf.  https://www.regulations.gov/document?D=DEA-2016-0015-0004  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm  https://www.prnewswire.com/news-releases/the-american-kratom-association-aka-demands-fda-stop-its-disinformation-campaign-against-kratom-300596117.html  https://docs.wixstatic.com/ugd/9ba5da_bc5de76f73b5432dab140ed69a67e596.pdf
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