The U.S. Department of Justice, together with the U.S. Food and Drug Administration (FDA), announced the seizure of approximately 73,000 units of illegal products containing 7-hydroxymitragine (7-OH) from three warehouses.

The seized products came from two of the seven firms that received warning letters from FDA in July that 7-OH products were illegal under the Federal Food, Drug, and Cosmetic Act. Both firms, Shaman Botanicals, LLC, and Relax Relief Rejuvenate Trading LLC, were based in the Kansas City area. The seizures were carried out by the U.S. Marshals Service with support from FDA.

“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.”

FDA made a recommendation earlier this year that the DEA should take scheduling action to control 7-OH products under the Controlled Substances Act, and issued a report detailing its medical and scientific analysis of the compound, which it classifies as an opioid. The agency also takes the stance that 7-OH is a new dietary ingredient, and that it hasn’t been presented with information to provide a reasonable assurance that the ingredient doesn’t present a significant or unreasonable risk of illness or injury.

According to America’s Poison Centers, which represents 53 accredited poison control centers in the U.S., there have been 1,690 reports of exposure cases involving kratom from January 1 to July 31, 2025, which already surpassed the total from all of 2024, indicating that 7-OH cases are on the rise. There have also been 165 reports of exposures to 7-OH in particular, and of these, 35% resulted in serious health problems and 67% were treated at a healthcare facility. Symptoms associated with 7-OH included nausea and vomiting, agitation, confusion, sweating, rapid heart rate, high blood pressure, trouble breathing, sleepiness or loss of consciousness, and seizures.  

Implications for the Botanicals Industry

While the question of whether kratom in its natural form as a botanical should be considered a legal dietary supplement ingredient has been divisive among trade associations representing the natural products industry, there’s been unified opposition against products containing 7-OH.

“The Natural Products Association applauds the recent actions by FDA and the U.S. Department of Justice to seize products containing 7-hydroxymitragine, which may be naturally occurring in kratom but is only present in negligible amounts,” Daniel Fabricant, PhD, president and CEO of NPA, told NW. “We concur with FDA’s assessment that 7-OH products are potentially addictive and dangerous, and they are not legitimate dietary supplement products.”

While 7-OH naturally occurs in the kratom (Mitragyna speciosa) plant, it forms less than 2% of the total alkaloid content in kratom leaves, Fabricant noted. Meanwhile, research suggests that 7-OH, in concentrated forms, has the potential for abuse due to its ability to bind to opioid receptors, “and they likely present a significant or unreasonable risk of illness or injury. Simply put, they have no place in an industry that promotes health and wellness.”

FDA’s distinction between the whole kratom leaf and concentrated 7-OH products is therefore important to make, Fabricant said. “Whole leaf kratom, for example, is a botanical that can meet applicable safety standards in the Dietary Supplement Health and Education Act of 1994 (DSHEA). FDA stated in July that its scheduling recommendation is not focused on natural kratom leaf products. The new dietary ingredient notification process in DSHEA provides a pathway to establish the identity and safety of legitimate kratom products, and a growing body of research shows many health benefits associated with kratom.”

In a broader context, the seizures “highlight that FDA has adequate authorities to remove dangerous products from commerce that do not meet safety standards for food or dietary supplements,” Fabricant noted.