Opponents of the Food and Drug Administration’s expanding dragnet of the herbal supplement kratom are arguing that the agency is eliminating a vital way to fight the opioid crisis.
Scientists and activists say the agency’s ban on kratom, which is derived from tree leaves native to Southeast Asia, is not scientifically sound and that the agency is taking away a tool that millions of people use to help manage pain and drug withdrawal symptoms.
The FDA says there is no scientific evidence that kratom can help treat opioid withdrawal and that the herb has significant safety issues. FDA Commissioner Scott Gottlieb said in February that 44 deaths have been linked to kratom use, and the agency has recommended that the Drug Enforcement Administration place kratom as a controlled substance in schedule 1, the same category as heroin and marijuana.
Kratom can be taken as a raw powder to mix, a leaf to be brewed, a capsule or an extract.
In the midst of the crackdown, the American Kratom Association, a grassroots group formed in 2014, has been pushing back against the FDA and Drug Enforcement Administration’s targeting.
The group said last month that the problem isn’t kratom itself, but vendors that trump up health claims about the herb or manufacture it irresponsibly.
“Those enemies hand the FDA their daily headlines to smear legitimate kratom vendors, and they hand the FDA the weapons to demonize kratom as an unsafe plant,” David Herman, chairman of the association, wrote on the association’s website May 23.
Grassroots groups are trying to pressure the FDA to end its crackdown on the drug, which the group estimates is used by three to five million people.
“It is not something that we believe should be banned,” said Peter Candland, the association’s executive director. “It should be definitely regulated and keep it safe but keep it legal.”
Congress also has stepped in at times. The DEA tried to schedule kratom as schedule 1 in 2016, but a bipartisan outcry from lawmakers prompted it to halt the effort.
In December, several lawmakers wrote to the FDA to express concern about its public health advisory about kratom. However, no legislation has been introduced this congressional session to protect it from the crackdown.
“The FDA must end its bogus ‘public health warning’ that has already led to several cities banning kratom,” one of the signers, Rep. Jared Polis, D-Colo., said in December. “Patients need and deserve options.”
The association has been working to defeat proposed kratom bans in six states: Mississippi, Kansas, Tennessee, Illinois, West Virginia and Minnesota.
Candland said he hopes to meet with the FDA to determine the proper regulation of kratom.
“As an industry, we are adopting much more stringent guidelines and standards for manufacturers and vendors to adopt,” he said.
The crackdown comes amid a salmonella outbreak that is linked to the product. The Centers for Disease Control and Prevention said last month that the outbreak sickened nearly 200 people.
The FDA says the herb that kratom is made from is unsafe. Gottlieb said in February that patient safety reports and scientific data show that kratom is not just a plant, but also an opioid.
“It’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms,” Gottlieb said.
The agency has 3D computer simulation technology that determines how the chemical compounds of a substance are structured and how they may behave inside the body and affect the brain. The FDA used the simulation to model the compounds found in kratom and concluded “all of the compounds share the most structural similarities with” highly addictive opioids such as oxycodone, Gottlieb said.
The agency also points to kratom’s link in 44 deaths.
But scientists have called the FDA’s logic flawed and have pushed for new studies.
“We believe that the FDA may have based their decision on kratom on very limited evidence,” said Oliver Grundmann, a professor of pharmacology at the University of Florida.
Grundmann was among 44 scientists who wrote to the Trump administration in February concerned about the agency’s decision to recommend scheduling kratom as schedule 1.
He told the Washington Examiner that kratom is different from the highly addictive opioids that the FDA linked it to.
Grundmann said kratom is much safer than the opioids made from oxycodone and hydrocodone, such as Percocet and Oxycontin, which have been leading drivers of the opioid epidemic. Federal data shows that 42,000 people died from an opioid overdose in 2016.
Current research suggests kratom provides some relief in the pain centers of the brain but without the respiratory depression of other opioids, according to the February letter.
The letter also bashed the FDA’s linking of kratom to the deaths.
“Unlike overdose deaths that are rightly attributed to classical opioids, which reliably cause respiratory depression and death at high doses, the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths,” the letter stated.
Candland also objected to the FDA and DEA citing nine deaths linked to kratom in Sweden. He said those deaths were from a combination of kratom and lethal doses of other chemicals.
Grundmann said he understands the Trump administration’s safety concerns, but he thinks the agency could take steps to improve production quality instead of banning the product.
He added the agency also could require kratom producers to label their products correctly and prevent false claims.
“We consider kratom to be a food,” Candland said. He added that in kratom’s “pure form in tea leaves are brewed or chopped up into a powder it should be considered a food and subject to the appropriate regulations.”
But if someone takes ingredients or chemicals to alter kratom, then “we believe it moves more into the dietary product category.”
The FDA’s ability to regulate supplements is limited by federal law. The agency cannot approve a supplement before it goes out but can inspect manufacturing facilities and go after false health claims.
“There are steps to increase safety [and] quality without placing kratom into category 1,” Grundmann said.
But the FDA counters that it conducted a comprehensive scientific review of kratom in addition to an extensive analysis being conducted by the DEA.
The agency told the Washington Examiner that while it is “open to the potential medicinal uses of kratom, those uses must be backed by sound science and weighed appropriately against the potential for abuse.”
“We understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders,” the agency said. “But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. To date, no marketer has sought to properly develop a drug that includes kratom.”