FDA, US Marshals seize $3 million of kratom from Broken Arrow company

In a case winding its way through federal court, a Broken Arrow manufacturer of dietary supplements is fighting with the federal government over millions of dollars in product that contains kratom, an herbal drug often marketed as effective for easing opioid withdrawals.

Earlier this month, the U.S. Department of Justice announced that the U.S. Marshals Service, acting with investigators from the Food and Drug Administration, seized more than $3 million in kratom from Botanic Tonics LLC.

The products included 250,000 liquid bottles, a tank of liquid product, more than 1,200 cartons of capsules, and more than 1,000 kilograms of bulk powder kratom.

The government said the seized products containing kratom were manufactured by Botanic Tonics and marketed under the brand name "Feel Free Plant Based Herbal Supplement."

In California, a class action lawsuit filed against Botanic Tonics accuses the company of misleading the public by claiming its "Feel Free Wellness Tonic" is a safe and healthy alternative to alcohol.

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Also named in the class action lawsuit is 7-Eleven, which is accused of participating "in a joint venture with Botanic Tonics to increase their profits through the expansion of the market for "Feel Free."

Lawyers for Botanic Tonics and 7-Eleven could not immediately be reached for comment Thursday.

In Broken Arrow, authorities seized Botanic Tonics products after the U.S. attorney's office in the Northern District of Oklahoma filed a civil forfeiture complaint on behalf of the FDA.

The complaint alleges that kratom is a new dietary ingredient with no assurances that the substance isn't a health risk to the public.

The complaint also states that dietary supplements containing kratom are "adulterated" under the Federal Food, Drug, and Cosmetic Act.

"Serious safety concerns exist regarding the effect of kratom on multiple organ systems," the complaint states. "Consumption of kratom can lead to a number of negative health impacts, including respiratory depression, vomiting, nervousness, weight loss, and constipation. Kratom consumption has been linked to neurologic, analgesic and sedative effects, addiction, and liver toxicity."

On Wednesday, lawyers for Botanic Tonics asked a federal judge to dismiss the Oklahoma case.

The lawyers wrote that the government's complaint "fails to even reference, let alone allege noncompliance with, the specific statute addressing whether new dietary ingredients are deemed adulterated. Further, the complaint and its boilerplate language are bereft of facts that support the government's conclusory allegations about the safety of kratom."

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A plant native to Southeast Asia, the leaves of kratom (mitragyna speciosa) contain the psychoactive compounds mitragynine and 7-hydroxymitragynine.

The compounds interact with the brain's opioid receptors, which can mimic the effects of drugs such as hydrocodone, including sedation, euphoria and a decrease in pain, according to the National Institutes of Health's National Institute on Drug Abuse.

For years, the plant, which typically is ingested by eating the leaves or making a tea, has been available over the internet and at tobacco shops.

NIDA reports that Kratom products may contain harmful contaminants, with adverse effects ranging from mild to severe, but "a very small number of deaths have been linked to kratom products compared to deaths from other drugs."

Kratom was a cause of death in 91 overdoses in the United States from July 2016 to December 2017, according to a report released by the U.S. Centers for Disease Control and Prevention.

In seven of the overdoses, kratom was the only substance to test positive in a toxicology report, though the CDC says other substances couldn't be ruled out.

In their motion to dismiss, lawyers for Botanic Tonics wrote that "kratom has been in the food supply for years and is legal in 44 states," including Oklahoma.

"To state the obvious, there are ‘safety concerns’ with many different foods such as sugar, red meat, artificial sweeteners, diet sodas, and high fructose corn syrup, but (the) FDA has not sought to seize those food items, and certainly not on an emergency basis," lawyers for Botanic Tonics wrote.