American Shaman: FDA seizure is ‘fearmongering’ and a ‘rush to judgment’
Federal authorities moved too fast — and without evidence — when they seized roughly $1 million worth of products containing 7-hydroxymitragynine, or 7-OH, from a Northland manufacturing operation tied to CBD American Shaman, the company behind the products argued in a court filing last week.
In a 20-page motion to dismiss filed Thursday in U.S. District Court in Kansas City, Shaman Botanicals, the manufacturing arm of American Shaman founder Vince Sanders, asked a judge to throw out the federal government’s civil forfeiture case, calling it “a rush to judgment” driven by fear rather than facts.
“FDA calls 7-OH products ‘novel potent opioid products’ and engages in fearmongering about a new epidemic following in the footsteps of heroin and fentanyl,” the filing states. “But 7-OH is not a controlled substance like heroin and fentanyl, and the government’s safety concern is unsupported.”
Neither Sanders nor his attorneys — Stephen Moore, Sean Cooper, and Jennifer Cacchio — responded to requests for comment.
A highly concentrated form of kratom made into pills and shots, 7-OH has been determined by researchers to be as much as 13 times more potent than morphine. The opioid is sold unregulated in gas stations and vape shops across the country. It has drawn public health scrutiny and was examined in a three-part series by The Star earlier this year.
In November, the FDA seized and detained thousands of 7-OH products from over 30 brands at Shaman Botanicals’ Riverside and North Kansas City facilities. It also seized products from another local company called Relax Relief Rejuvenate Trading, LLC, which sells 7-OH under the brand named EDP.
The seized items are under a detention order, which bars them from being moved, sold or distributed while the Justice Department pursues forfeiture under the federal Food, Drug and Cosmetic Act.
The FDA has said products containing 7-OH pose serious safety risks. In press releases and a June warning letter to Shaman Botanicals, the agency noted that the compound is prohibited in dietary supplements and conventional foods and expressed concerns about abuse and overdose. The FDA has also asked the Drug Enforcement Administration to classify 7-OH as a controlled substance.
The DEA is reviewing the recommendation but has not yet acted. In the meantime, 7-OH continues to be sold, even amid growing state and local government movements to ban it.
Shaman Botanicals’ response
In a press release issued Monday, Shaman Botanicals said it “would not normally comment on pending litigation, but the narrative so far concerning 7-OH has been one-sided and materially incomplete” and that it is “eager to confront FDA’s claims and defend its products.”
Shaman Botanicals disputes nearly every aspect of the FDA’s safety and legal framing in its motion to dismiss the case.
The motion leans heavily on the company’s August response to the FDA’s warning letter, which included analyses from six scientific and medical experts. Those experts reviewed animal studies, lab data and human surveillance databases and concluded there was “no evidence of serious harm, widespread morbidity, or mortality attributable to 7-OH.”
“The totality of the available scientific evidence… does not support FDA’s conclusion that 7-OH presents a significant or unreasonable risk of illness or injury,” the response said.
The filing also accuses the FDA of sidestepping normal administrative practice. After Shaman Botanicals submitted its warning letter response and invited further scientific dialogue, the company says, the agency never replied. Instead, it moved directly to detain inventory and file a forfeiture case.
Shaman Botanicals’ attorneys also point to a 2018 decision under the first Trump administration, when the Department of Health and Human Services rejected an effort to classify kratom as a Schedule I substance, citing the risk of “immediate adverse public health consequences” if access were cut off. The FDA’s current enforcement posture, Shaman Botanicals argues, contradicts that earlier conclusion without offering new evidence.
“In a departure from its past approach, the government now singles out 7-OH as a supposedly dangerous constituent of kratom (while leveling no criticism against kratom generally or its other constituents),” the filing states. “As a practical matter, though, it is impossible to completely divorce kratom products generally from Shaman Botanicals’ 7-OH products specifically, which are naturally derived from the kratom plant and have a safety profile the same as — or better than — other constituents of kratom.”
The motion also argues prosecutors failed to adequately allege that the seized products moved through interstate commerce — a requirement for federal jurisdiction — and failed to plausibly show that the products were adulterated under federal law.
For products sold as dietary supplements, the government claims 7-OH is a “new dietary ingredient” lacking sufficient safety data. Shaman Botanicals counters that 7-OH has been present in kratom products since at least the 1980s and therefore cannot qualify as “new” under the statute.
Shaman Botanicals is asking the court to dismiss the complaint, order the return of the seized 7-OH products, and “affirm that the FDA cannot proceed with enforcement actions unsupported by fact, science and law,” according to the release.
The Justice Department has until Dec. 26 to respond to Shaman’s motion.
