The Trump administration is recommending that a compound called 7-OH be scheduled as an illicit drug, Food and Drug Administration Commissioner Marty Makary announced Tuesday.
The compound is a by-product of the Kratom plant whose ground leaves are sold as a dietary supplement to boost energy or provide pain relief. FDA officials said 7-OH has a “high risk of addiction” and abuse because of its ability to bind to opioid receptors in the brain.
The compound is found in trace amounts in the kratom plant, and the FDA’s move is aimed at products with concentrated levels of 7-OH.
Makary said the agency is urging the Drug Enforcement Agency to classify 7-OH as a Schedule 1 substance, placing it on list of drugs that include heroin, lysergic acid diethylamide (LSD) and ecstasy.
“We have a history in public health of being asleep at the wheel,” Makary said. “Public health is supposed to prevent disasters, not just clean them up after they’ve killed thousands and thousands of people.”
The American Kratom Association (AKA), a trade group representing the industry, applauded the recommendation to classify 7-OH as a Schedule 1 substance.
“This bold step is a critical milestone in protecting public health and consumer safety from dangerous synthetic products that masquerade as natural kratom,” the AKA said in a statement. A spokesperson for the group said that the FDA’s decision shines a light on a “massive and growing” problem in the kratom marketplace.
Earlier this month, the FDA sent warning letters to seven companies regarding allegations that they are illegally marketing 7-OH products as dietary supplements or as a product that can relieve pain or manage anxiety.
Department of Health and Human Services officials said during a Tuesday press conference that they have seen a “disturbing” rise in reports of poisonings and emergency room visits linked to products containing 7-OH which can be found in tablets, gummies, mixed drinks or shots.
But officials did not point to data on the scale of the rise in adverse health events.
These products are often sold online or in convenience stores, gas stations and vape shops, officials said, with no “quality control, no dosage control and no warnings.”
“This is a recipe for a public health disaster,” said Jim O’Neil, deputy secretary at the Department of Health and Human Services. “Young people, veterans and people who suffer from chronic pain or addiction are being misled into thinking that these are safe alternatives. They’re not.”
Kratom has gained popularity as an alternative pain reliever amid the country’s opioid epidemic with some studies suggesting that up to 15 million Americans have use it to treat chronic pain or opioid withdrawal symptoms. In small doses, Kratom can act as a stimulant but can also cause an “opioid-like” drowsiness and euphoria, experts say.
Concentrated Kratom or highly potent Kratom products can cause harmful side effects like nausea, vomiting and even seizures.
Tuesday’s announcement is the Trump administration’s effort to prevent another “wave of the opioid epidemic” from blindsiding the country, Makaray said.
“There’s a lot we don’t know. This may be the calm before the storm,” he said. “It may be the tip of the iceberg, but let’s be aggressive and proactive.”
The DEA previously announced it would schedule kratom compounds as controlled substances in 2016 but opted not to after receiving intense pushback.
Makary stressed that the Trump administration is targeting synthetic, concentrated kratom when asked by a reporter if officials were prepared to deal with similar pushback again.
