The U.S. Food and Drug Administration (FDA) has issued formal warning letters to seven companies for unlawfully marketing products containing concentrated kratom-derived compounds, intensifying the agency’s crackdown on unapproved and potentially dangerous opioid-like supplements.
The FDA’s enforcement action, announced Tuesday, targets the sale and distribution of 7-hydroxymitragynine (7-OH)—a powerful alkaloid found in kratom. The compound is being marketed in the form of tablets, gummies, drink mixes, and shots, all of which the FDA deems illegal for use in food or dietary supplements.
“This action reflects the agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations, and corner stores,” the FDA stated.
While 7-OH may occur naturally in trace amounts within kratom, the FDA emphasized that these firms are selling concentrated versions that pose significant health risks. The companies have been given 15 business days to address the violations or face further regulatory action.
Among those named is Thang Botanicals Inc. (7OHMZ), a California-based firm currently defending a proposed class action in federal court. Plaintiffs allege the company concealed the addictive and opioid-like nature of 7-OH while promoting it as a supplement. The lawsuit points to a podcast where the company’s CFO described 7-OH as a “perfect key” for opioid receptors, with stronger effects than morphine at lower doses.
The FDA’s letter to Thang Botanicals warned that available data raises “serious concerns” regarding consumer safety. Reported adverse effects tied to kratom and its derivatives include liver toxicity, cardiovascular issues, seizures, gastrointestinal problems, respiratory depression, addiction, and even death.
Other companies receiving FDA warning letters include:
