FILE - This Sept. 27, 2017 file photo shows kratom capsules in Albany, N.Y. (AP Photo/Mary Esch, File)
- The FDA said Tuesday it will recommend that the ingredient be banned under federal law.
WASHINGTON (AP) — U.S. health officials are warning Americans about the risks of an opioid-related ingredient increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores, recommending a nationwide ban.
The chemical, known as 7- hydroxymitragynine, is a component of kratom, a plant native to Southeast Asia that has gained popularity in the U.S. as an unapproved treatment for pain, anxiety and drug dependence.
In recent months, dietary supplement companies that sell kratom have been urging the Food and Drug Administration to crack down on the products containing 7-OH, portraying it as a dangerously concentrated, synthetic form of the original ingredient.
The FDA action “is not focused on natural kratom leaf products,” according to a statement Tuesday by the U.S. Department of Health and Human Services.
The agency said it was releasing a report to educate about the risks of “7-OH and its distinction from the kratom plant leaf.” Regulators are also recommending that the ingredient be placed on the federal government’s most restrictive list of illegal drugs, which includes LSD and heroin.
“7-OH is an opioid that can be more potent than morphine,” said FDA Commissioner Marty Makary. “We need regulation and public education to prevent another wave of the opioid epidemic.”
The agency’s recommendation will be reviewed by the Drug Enforcement Administration, which sets federal rules for high-risk drugs including prescription medicines and illicit substances. A federal ban wouldn’t take effect until the agency drafts and finalizes new rules governing the ingredient.
Federal regulators have been scrutinizing kratom for about a decade after reports of addiction, injury and overdose. But users and distributors have long opposed efforts to regulate it, saying kratom could be a safer alternative to opioid painkillers that sparked the ongoing drug addiction epidemic.
Last month, the FDA issued warning letters to seven companies selling drinks, gummies and powders infused with 7-OH. Regulators said the products violated FDA rules because they have not been evaluated for safety and, in some cases, claimed to treat medical conditions, including pain, arthritis and anxiety.
Supplement executives quickly applauded the move.
The FDA “demonstrated the exact kind of data-driven, proactive regulatory excellence needed to safeguard unwitting consumers across the U.S.,” said Ryan Niddel of Diversified Botanics, a Utah-based company that sells kratom supplements.
An industry group, the American Kratom Association, has lobbied Congress for years against restrictions on the plant. Legislation supported by the group would prohibit the FDA from regulating kratom more strictly than food and dietary supplements
Nearly a decade ago, the federal government came close to banning the substance.
In 2016, the DEA announced plans to add kratom to the government’s most restrictive schedule 1, reserved for drugs that have no medial use and a high potential for abuse. But the plan stalled after a flood of public complaints, including a letter signed by more than 60 members of Congress.
The FDA then began studying the ingredient, concluding in 2018 that kratom contains many of the same chemicals as opioids, the addictive class of drugs that includes painkillers like OxyContin as well as heroin and fentanyl.
Since then, FDA regulators have continued to issue warnings about cases of injury, addiction and death with kratom supplements, which are usually sold in capsules or powders.
In recent months, the FDA has also issued warnings on other unapproved drugs sold as supplements or energy drinks, including the antidepressant tianeptine. Sometimes referred to collectively as “gas station heroin,” the drugs have been restricted by several states, but they are not scheduled at the federal level.
