Why the FDA wants to restrict kratom-related products

The Food and Drug Administration is sounding the alarm on a widely used narcotic and is recommending that steps be taken to restrict its availability. The substance, called 7-hydroxymitragynine or 7-OH, is a synthetic derivative of the kratom leaf, which is commonly used for pain relief. But unlike kratom itself, experts say 7-OH has an opioid-like quality, which makes it addictive and easily abused. That is why the FDA is concerned about its increasing availability nationwide.

'More potent than morphine'

The compound is naturally found in the kratom plant, but "manufacturers have isolated and amplified" it to "make a more potent product," said The New York Times. 7-OH is "not a traditional opioid derived from the poppy plant" but has similar addictive attributes, scientists say, and it "binds to opioid receptors in the brain."

Since the compound has this addictive quality, it is being "increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores," said The Associated Press. It is also widely available in smoke shops. 7-OH's opioid-like effects make it distinct from standard kratom, and companies that sell kratom have been urging a "crackdown on the products containing 7-OH, portraying it as a dangerously concentrated, synthetic form of the original ingredient."

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Kratom itself is "like 'a light beer' in terms of potency," said Chris McCurdy, a professor of medicinal chemistry at the University of Florida, to Axios. But when 7-OH is extracted from kratom, it becomes "closer to Everclear, the grain spirit that can be 95% alcohol by volume" and is "more potent than morphine."

FDA wants 7-OH reclassified

The FDA announced that it is urging the Drug Enforcement Agency to "classify 7-OH as a Schedule 1 substance, placing it on a list of drugs that include heroin, lysergic acid diethylamide (LSD) and ecstasy," said The Hill. This would make the drug harder to obtain at locations like gas stations and convenience stores.

The recommendation "follows a thorough medical and scientific analysis by the FDA and is one of several efforts to address the agency's concerns around the growing availability and use of 7-OH opioid products," the FDA said in a press release. The agency is "specifically targeting 7-OH, a concentrated byproduct of the kratom plant; it is not focused on natural kratom leaf products."

But there has been pushback to this effort. No "evidence was presented at today's press conference. Not a single study. Not one data point specific to 7-OH," said Jeff Smith, national policy director of the Holistic Alternative Recovery Trust trade association, in a statement. The group, which noted that the FDA didn't cite any 7-OH-related deaths, can "only conclude that instead of public health being paramount, other interests may be driving policy decisions."

Companies that sell straight kratom, though, have applauded the step. The FDA's move to reclassify 7-OH is a "critical milestone in protecting public health and consumer safety from dangerous synthetic products that masquerade as natural kratom," the American Kratom Association, a trade group representing kratom manufacturers, said in a statement.

"We do not believe these products should be available over the counter," said Mac Haddow, a spokesman for the American Kratom Association, to The Washington Post about 7-OH. There have been attempts to regulate the substance before, but they were largely unsuccessful. Government officials, said The Hill, are "prepared to deal with similar pushback again."