FDA Recommends Banning Kratom Byproduct 7-OH

Key Facts

How Dangerous Is 7-Oh?

FDA Commissioner Dr. Marty Makary compared the substance to morphine, and researchers agree. “This is a pure opioid agonist that only interacts with opioid receptors in our bodies, making it no different than prescription opioids or illicit opioids like heroin,” Christopher McCurdy, a leading researcher on kratom at the University of Florida College of Pharmacy, told Forbes. McCurdy said he agreed with the FDA’s description of 7-OH as a public health threat, asking “who in their right mind would allow morphine or codeine to be available in the gas station?”

What Prompted This Decision?

“We’ve seen a disturbing rise in overdoses, poisonings, and emergency room visits linked to products containing 7-OH,” Deputy Health and Human Services Commissioner James O’Neill told reporters Tuesday. “These substances are often sold online or at convenience stores with no quality control, no dosage control, and no warnings. This is a recipe for a public health disaster. Young people, veterans, and people who suffer from chronic pain or addiction are being misled into thinking these are safe alternatives. They are not.” However, the FDA also said it was not clear how many people had died from overdoses related to 7-OH, and Makary said the agency needed better statistics to understand exactly how many people have overdosed from 7-OH. “If somebody comes in with 7-OH overdose, I’m not even sure a doctor would know to ask about 7-OH.” Makary said. “I think we’re just starting to understand,” the commissioner said, comparing the moment to when the medical community realized the crisis following the overprescription of opioids like oxycontin.

How Is 7-Oh Related To Kratom?

7-OH occurs naturally in kratom in small amounts, the FDA said in its report. However, McCurdy said researchers have not been able to identify how the plant manufactures 7-OH, suggesting its presence in products is due to synthetic manipulation. The FDA also warned that some 7-OH products are “often falsely marketed” as natural kratom. “I’ve been surprised going to these vape stores at what I’m seeing,” Makary said. “I’ve been surprised at the candies, and gummies, and drinks, and ice cream cones.”

Will The Fda Examine Natural Kratom Plant Products As Well?

Tuesday’s report is “not focused on natural kratom leaf products,” the FDA said. Over 100 people have died while using the substance, a Tampa Bay Times investigation found, however many were using it alongside other drugs like fentanyl or prescription drugs used to treat anxiety and depression. “There should be better regulation on these products yet they should remain available to consumers,” McCurdy said of kratom. “We’re not targeting the kratom leaf or ground up kratom, we are targeting the concentrated synthetic byproduct,” Makary said. When reporters asked if the administration had any plans to regulate natural kratom as well, the commissioner said that some doctors had “concerns” about the plant, but the FDA would “prioritize” working on 7-OH first. “We’re going after the killer first, which is this synthetic concentrated kratom, and then we can look into that other question. But we think it’s night and day in terms of the public health risk.”