FDA Recommends Scheduling Kratom Byproduct 7-OH as Controlled Substance

The FDA, under the Trump administration and led by HHS Secretary Robert F. Kennedy Jr. and Commissioner Marty Makary, is recommending that 7-hydroxymitragynine (7-OH), a concentrated byproduct of the kratom plant, be classified as a Schedule 1 controlled substance due to its high potential for abuse and addiction. Unlike natural kratom leaf products, 7-OH binds strongly to opioid receptors and is found in concentrated forms such as gummies and drinks sold at vape shops and convenience stores, often under misleading labels. The FDA and health officials have raised alarms about rising poisonings and emergency room visits linked to 7-OH products, which are more potent than morphine and widely accessible, prompting calls for stricter regulation. Families affected by kratom-related deaths, such as Dana Pope whose son died after using kratom, and addiction specialists support this scheduling action as a crucial step to protect public health and address the opioid crisis. The American Kratom Association also endorsed the FDA's move, emphasizing the need to crack down on dangerous synthetic products falsely marketed as natural kratom. This action follows prior attempts by the DEA to regulate kratom, reflecting growing concern over its health risks despite its availability in most U.S. states.