The U.S. Marshals Service operating under an order from the Food and Drug Administration (FDA) seized approximately 73,000 7-hydroxymitragynine (7-OH) products from three Missouri warehouses. The warehouses are operated by Shaman Botanicals LLC (selling products under the American Shaman brand) and Relax Relief Rejuvenate Trading LLC (selling products under the Relax Relief Rejuvenate brand). American Shaman is considered one of the largest suppliers of 7-OH products in the United States.
The seizures come a week after the Missouri attorney general announced it would be investigating both 7-OH and kratom companies.
The owners of these companies have previously received warning letters from the FDA in June, alleging their products violated the Federal Food, Drug, and Cosmetic Act (FD&C Act).
“Concentrated 7-OH is increasingly recognized as having potential for abuse because of its ability to bind to opioid receptors. It cannot be lawfully added to dietary supplements or conventional foods,” the FDA said in the statement. “These products are considered adulterated because 7-OH does not meet applicable safety standards. Also, the FDA has not approved 7-OH for medical use.”
The FDA considers 7-OH a “new dietary ingredient” (NDI), meaning any ingredient not marketed before 1994. The Dietary Supplements Health and Education (DSHEA) Act of 1994 prohibits supplements from containing an NDI unless information exists to assure it does not present a significant risk of illness or injury. According to the FDA, 7-OH manufacturers have not proven the substance to be adequately safe.
In a July announcement, the FDA recommended 7-OH be classified as a Schedule I controlled substance, explicitly stating it would not target leaf kratom products. However, the FDA also considers that kratom, like 7-OH, is an NDI, and it has previously made large seizures of kratom from distributors.
From the FDA’s website https://www.fda.gov/news-events/public-health-focus/fda-and-kratom:
FDA has concluded from available information, including scientific data, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury and, therefore, dietary supplements that are or contain kratom are adulterated under section 402(f)(1)(B) of the FD&C Act. Further, FDA has determined that kratom, when added to food, is an unsafe food additive within the meaning of section 409; food containing an unsafe food additive, such as kratom, is adulterated under section 402(a)(2)(C)(i). Based on these determinations by FDA, kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods.
Therefore, kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.
The kratom industry and advocates refute this assertion, noting that kratom was marketed in the U.S. prior to 1994 and multiple NDI notifications have been filed by kratom companies with the FDA. The FDA has also been accused of going by outdated and cherry-picked data to determine that kratom is not reasonably safe.
In February 2024, an FDA official announced at the Third International Kratom Symposium at the University of Florida in Orlando that the FDA had been conducting human safety studies into kratom, and found no significant adverse effects. Even in administering a 12-gram dose within five minutes, the only effect was understandable nausea.
Though the FDA still officially considers kratom an unsafe NDI, the ongoing study and the July statement that FDA was not targeting plain leaf kratom seems to indicate that the agency is evolving.