Health Secretary Robert F. Kennedy Jr. on Tuesday announced a plan to restrict access to a derivative of the kratom plant readily available online and in vape stores and used by millions of Americans to alleviate pain.
In recent years, manufacturers have isolated and amplified a compound in kratom to make a more potent product. Concerns about addiction to 7-OH, or 7-hydroxymitragynine, have mounted because it binds to opioid receptors in the brain.
Dr. Marty Makary, commissioner of the Food and Drug Administration, said his agency would begin the process to officially “schedule” 7-OH, classifying the drug according to its risk for abuse and accepted benefits. The final steps will be handled by the Drug Enforcement Administration.
Though 7-OH is not a traditional opioid derived from the poppy plant, Mr. Kennedy pointed to the opioid epidemic and said the new effort was meant to avert a similar wave of addiction.
The action comes as the F.D.A. has struggled with a growing number of dangerous and even deadly psychoactive products lining gas station and vape shop shelves, from psychedelic candy bars — linked to three deaths last summer — to THC snacks to “gas-station heroin.”
The F.D.A. has been escalating enforcement against companies that make 7-OH products in recent months. The agency sent seven warning letters to manufacturers, a precursor to stricter enforcement action, which can range from fines to product impoundment.
Dr. Makary said at a news briefing on Tuesday that federal health officials were trying to reverse a record of being “asleep at the wheel” in the face of a public health crisis, citing the example of cigarettes.
“Let’s be honest,” he said. “There’s also a lot we don’t know. This may be the calm before the storm. It may be the tip of the iceberg, but let’s be aggressive and proactive.”
People can buy 7-OH online and in smoke shops, where it’s often labeled kratom and 7 or 7-OH. It comes in the form of gummies, chewables, small drinks or tablets that melt in the mouth. Dr. Makary said the agency was issuing a report on 7-OH, a letter to health care providers, and a warning to consumers about the risks associated with 7-OH products.
According to the F.D.A., 7-OH is not lawful in dietary supplements or when added to foods. The agency said there are no approved drugs containing 7-OH nor any regulatory basis for companies to claim that the products relieve pain or anxiety, as some do.
“Consumers who use 7-OH products are exposing themselves to products that have not been proven safe or effective for any use,” according to the F.D.A.
Jeff Smith, national policy director at Holistic Alternative Recovery Trust, which represents 7-OH makers and consumers, said federal officials today did not produce any data to support taking emergency action.
“If 7-OH posed the kind of urgent danger that would justify emergency action, evidence would have been presented,” Mr. Smith said. “It was not.”
The announcement runs counter to a plan unveiled during the Biden administration to lower restrictions on marijuana, a process known as rescheduling.
That effort has hit procedural hurdles, but it was meant to reclassify marijuana from a Schedule I drug, akin to heroin, to Schedule III, given its potential medical benefits.
For 7-OH, federal officials are moving in the opposite direction, taking an unscheduled substance and advising the D.E.A. to place it in Schedule I. Such a process begins with federal health agencies performing an eight-factor analysis of a product’s risk profile and potential for abuse, among other concerns.
Kirsten Elin Smith, a Johns Hopkins University assistant professor who studies kratom, said she was initially very concerned about 7-OH when it began to show up online about two years ago. She said she braced herself for a flood of reports of harm.
Those reports did not come, she said, though perhaps because there are no tests to detect 7-OH in the blood. There are routine tests for another component of kratom, but those did not yield evidence of increasing harm, either, she said.
“If you had asked me a year ago, I would have said this is evil,” Dr. Smith said. “At this point I’m a little more equivocal.”
She said she’s been working to survey several hundred users and conduct in-depth interviews. Some people report benefits, such as improved mood and quality of life. Others tell her that 7-OH is habit-forming.
Though most of the people she has surveyed said the product should not be prohibited, nearly 15 percent said they favored greater restrictions. Dr. Smith said she encountered similar results while studying kratom, which provides a different medley of psychoactive components.
Overall, she said, more research needs to be done.
“Kratom is not a panacea without risk either,” she said. “Both kratom products and 7-OH products have a benefit-risk profile.”
Mac Haddow, a senior fellow on public policy for the American Kratom Association, which represents makers of botanical kratom, said his group has been sounding the alarm about 7-OH since it arrived on the market. Mr. Haddow applauded Tuesday’s announcement.
“You can get addicted to 7-OH in a couple of days, and it’s a horrible situation to get off of it,” he said.
The F.D.A. has encountered a spate of problems with unauthorized products that have popped up in smoke shops and gas stations across the country in recent years.
Last summer, more than 160 people fell ill and three died after eating Diamond Shruumz candy bars, which contained an array of unauthorized ingredients, some of which had psychedelic properties. People who ate the bars reported seizures, loss of consciousness and hallucinations.
The agency has also scrambled to restrict tianeptine products known as “gas-station heroin” after a number of reports of injury, addiction and death.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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