The Justice Department, together with the U.S. Food and Drug Administration (FDA), announced today that recent actions targeting illegal products containing 7-hydroxymitragine, commonly known as 7-OH, resulted in the seizure of approximately 73,000 units of product at three warehouses.

In seizure complaints and accompanying court papers filed in the U.S. District Court for the Western District of Missouri, the government alleged that two firms in the Kansas City area received warnings from FDA that 7-OH products were illegal under the Federal Food, Drug, and Cosmetic Act. According to the seizure complaints, recent FDA inspections showed that the firms continued to distribute unlawful 7-OH products after receiving the warnings.

The seizures were carried out by the U.S. Marshals Service, with support from FDA. The products were seized from facilities operated by Shaman Botanicals LLC and Relax Relief Rejuvenate Trading LLC.

“Products containing 7-OH are illegal under federal law,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division. “We have seen numerous reports of harmful health consequences in consumers, including children, who have taken 7-OH products. Working with our partners at FDA, we will take action against anyone participating in the illegal distribution of these products.”

“The 7-OH products seized are illegal under federal law and pose risks to consumers, including children,” said U.S. Attorney R. Matthew Price for the Western District of Missouri. “We are committed to helping American consumers protect themselves from dangerous chemicals posing as health products. We will continue to work with our law enforcement partners to ensure illegal products never enter the stream of commerce and pursue all possible civil and criminal remedies against those who violate federal laws.”

The FDA has recognized 7-OH products as dangerous and potentially addictive, recommending in July 2025 that a scheduling action be taken to control certain 7-OH products under the Controlled Substances Act. FDA also issued warning letters to multiple firms stating that their 7-OH products appeared to be unlawful.

7-OH products were not marketed in the United States until recent years. Under a bipartisan law passed by Congress in 1994, a dietary supplement may not contain a “New Dietary Ingredient,” meaning a dietary ingredient that was not marketed in the United States prior to October 15, 1994, if there is inadequate information available to provide a reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury. Because there is inadequate information available to provide a reasonable assurance that 7-OH does not present a significant or unreasonable risk of illness or injury, it is illegal to sell dietary supplement products containing it as an ingredient. In each of the seizure actions, the clerk of court issued a warrant authorizing the seizure of specified illegal 7-OH products.

Assistant Director Patrick Runkle, Senior Litigation Counsel David Sullivan, and Senior Trial Attorney James T. Nelson of the Justice Department’s Civil Division’s Enforcement and Affirmative Litigation Branch are handling the cases under the leadership of Sarmad Khojasteh, Acting Deputy Assistant Attorney General for the Civil Division. Assistant U.S. Attorneys Stephanie Bradshaw and Leigh Farmakidis in the Western District of Missouri provided critical support, along with attorneys at the Department of Health and Human Services’ Office of General Counsel and FDA’s Office of the Chief Counsel.

Additional information about the Enforcement and Affirmative Litigation Branch and its enforcement efforts may be found at www.justice.gov.