Additional Coverage:
- FDA asks Justice Department to classify gas station products with opioid-like effects as illicit substances (nbcnews.com)
FDA Seeks to Outlaw Potent Opioid-Like Substance 7-OH
The Food and Drug Administration (FDA) is taking aim at 7-hydroxymitragynine, or 7-OH, a powerful substance found in readily available products like tablets, gummies, and drinks. On Tuesday, the agency recommended to the Justice Department that 7-OH be classified as an illegal substance, citing serious health risks and a high potential for abuse.
This move comes amid rising concerns about overdoses, poisonings, and emergency room visits linked to 7-OH. The compound, often marketed as a relaxation aid, pain reliever, and mood enhancer, is significantly more potent than morphine, according to studies. The FDA warns that 7-OH can cause a range of adverse effects, from heart and liver damage to seizures, digestive problems, and even death.
“We’re seeing a disturbing increase in incidents related to 7-OH products,” stated Jim O’Neill, deputy secretary of the U.S. Department of Health and Human Services. He stressed the danger of these products being sold without appropriate warnings or quality control, calling the situation a “recipe for public health disaster.”
7-OH is a concentrated, synthetic version of a compound found naturally in kratom, an herbal extract derived from a tropical tree. While kratom itself contains only trace amounts of 7-OH, products marketed as “7-OH” often contain dangerously high levels. Sometimes, these products are deceptively labeled as kratom.
The FDA’s recommendation will now be reviewed by the Drug Enforcement Administration (DEA), which has the authority to classify drugs. The FDA is pushing for a Schedule I classification for 7-OH, the same category as heroin and ecstasy, reserved for substances with no accepted medical use and a high potential for abuse.
This isn’t the first time the DEA has considered regulating substances found in kratom. In 2016, a similar effort was abandoned after significant public outcry from kratom advocates. The DEA has assured the public there will be an opportunity for comment before any final decision is made.
Health and Human Services Secretary Robert F. Kennedy Jr. voiced his concern about the accessibility of 7-OH products, particularly near schools and in low-income neighborhoods. He criticized the industry’s marketing tactics, describing brightly colored, candy-flavored 7-OH products as a “sinister industry” targeting children.
The FDA has already issued warnings to several companies illegally marketing 7-OH products. The agency emphasizes that 7-OH cannot legally be added to food or supplements due to insufficient safety data.
While kratom proponents argue its usefulness for pain management and helping people overcome opioid addiction, the FDA remains focused on the dangers of concentrated 7-OH. FDA Commissioner Martin Makary stated, “We are going after the killer first.” The debate over the safety and regulation of these substances is likely to continue as the DEA considers the FDA’s recommendation.