This time it's the FDA
Nov 15 2017, 12:42pm
The Food and Drug Administration on Tuesday issued a public health advisory about what it calls the “deadly risks associated with kratom,” a plant that many users have turned to for relief from chronic pain, anxiety, depression, and PTSD. Others have claimed it helped wean them off opioids by offering the same effect but without getting addicted. The advisory warns people not to use products containing the plant or it psychoactive compounds, citing "concerning reports" about it. In a statement, FDA Commissioner Scott Gottlieb called the “increasing use” of kratom as an opioid alternative “extremely concerning,” and says the agency is aware of reports of 36 deaths related to the use of kratom-containing products and reports of kratom being laced with opioids.
The FDA’s statement will ring familiar to anyone who’s followed the kratom story. In late 2016, the Drug Enforcement Agency announced a plan to temporarily place kratom on the list of Schedule I drugs. Those are substances, such as heroin, LSD, MDMA, and, yes, marijuana, that the agency considers unsafe, with a high potential for abuse and no accepted medical use. After thousands of public comments denouncing the potential kratom ban, the DEA backed down in October 2016, deferring to the FDA.
Now the FDA has begun to signal how it will treat kratom. Tuesday’s statement compares the plant to opioids, saying it has similar risks for addiction, abuse, and even death. It’s hard to say how the agency has reached that conclusion, given that in the same statement it notes that kratom hasn’t been through a formal evaluative process. (Last year, the DEA refused to release the data it used to conclude kratom should be temporarily banned.) The FDA also takes issue with this unapproved product being marketed as a treatment or cure for serious conditions and called for more research.
Andrew Kruegel, a Columbia University pharmacologist who’s studied kratom, previously told Tonic that chemicals in the plant affect the same brain receptors as opioids such as morphine and heroin. Those drugs have a potentially lethal side effect: slowed breathing known as respiratory depression, even to the point that users stop breathing and die. For many users, kratom offers potent pain relief without that risk. As for the risk of addiction and abuse, Kruegel said there’s no scientific consensus—and that making kratom a Schedule I drug would inhibit research, making the question that much harder to answer. He’s also skeptical about the deaths the FDA has attributed to “the use of kratom-containing products,” telling HuffPost that there’s simply not enough proven science to say for sure.
Susan Ash, who was formerly addicted to opioids and founded the American Kratom Association, a nonprofit advocacy group, told Tonic via email that kratom is saving lives. “Not only has kratom been used thousands of years around the world safely,” she says, “I️ have personally witnessed thousands of people kick their opiate addictions thanks to this plant, without any dangerous side effects or dependency issues.”
Meanwhile, in addition to its public health advisory, Gottlieb said in a speech that the FDA would work with the DEA to decide how kratom should be evaluated and scheduled. (Kruegel said earlier this year: "I don't think the kratom plant itself is ever going to become an FDA-approved medication," given the difficulty in standardizing its chemical composition—a problem similar to what we see with marijuana). In remarks to the agency’s Office of Criminal Investigations made yesterday, Gottlieb lumped kratom in with illegal opioids, vowing to do more to stop mail shipments of both at the border. The public health advisory notes that the FDA has already “exercised jurisdiction over kratom as an unapproved drug” and detained hundreds of shipments of kratom at international mail facilities.
The FDA and Gottlieb acknowledge the potential good kratom may do. “While we remain open to the potential medicinal uses of kratom,” its statement reads, “those uses must be backed by sound-science and weighed appropriately against the potential for abuse.” But that research will be much harder to do if kratom is placed on Schedule I—and if kratom is continually tied to the opioid epidemic.