FDA seizes $3 million worth of kratom

FDA, with the help of U.S. Marshals, has seized more than $3 million worth of kratom finished products and bulk herb from a location in Oklahoma.

Hank Schultz, Senior Editor

May 8, 2023

3 Min Read
FDA seizes $3 million worth of kratom

The seizures were made at a business called Botanic Tonics LLC of the Tulsa suburb of Broken Arrow. The seized products include more than 250,000 capsules and more than 1,000 kilograms of bulk kratom.

The products were marketed under the brand name Feel Free Plant Based Herbal Supplement.

FDA's dim view of kratom

In an import alert that has been in effect for many years, FDA has concluded kratom and dietary supplements containing the herb are adulterated “because they contain 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.”

Mitragyna speciosa, commonly known as kratom, is a botanical that grows as a shrub or a small tree.  It is native to Thailand, Malaysia, Indonesia and Papua New Guinea. The botanical has gained a following in recent years for its purported effects on pain management and its claimed ability to help wean people off the use of opioids.

Because kratom works on opioid receptors in a fashion like opioids themselves, the Drug Enforcement Administration (DEA) has maintained the substance presents a risk of addiction. The botanical is not a controlled substance, but DEA lists it as a “Drug and Chemical of Concern.”

“This seizure underscores our commitment to taking aggressive action when companies distribute products that contain dangerous ingredients such as kratom that put consumers at risk,” said Judy McMeekin, PharmD, the FDA’s associate commissioner for regulatory affairs, in a U.S. Department of Justice press release. “We will continue to safeguard consumers against illegally marketed products that do not comply with FDA regulations.”

Trade group pushes back

The American Kratom Association (AKA) claims FDA’s safety concerns are unfounded, and that the agency has overstepped its regulatory authority. When FDA failed to have kratom listed as a controlled substance, then-Assistant Secretary of Health, Dr. Brett Giroir, M.D., said the action would have posed a “significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule I.”

The quote was taken from a letter from the U.S. Department of Health and Human Services (HHS) to DEA in 2018.  AKA made the letter public in 2021.

“The FDA is singling out kratom because they could not convince the DEA or HHS to schedule this botanical supplement and is asserting an excessively broad authority to classify kratom as an unapproved drug or an unregistered new dietary ingredient,” AKA said in an emailed statement.

Botanic Tonics, which lists its headquarters in Santa Monica, Calif., does not currently list a kratom product for sale on its website. Under the same brand name listed in the FDA complaint (Feel Free Plant Based Herbal Supplement) the company now sells a formula that consists of extracts of kava, kola nut, lions mane mushroom, Rhodiola rosea and MCT oil.

The company did not respond to a request for comment in time for publication.

About the Author(s)

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the senior editor of Natural Products Insider since early 2023. He can be reached at [email protected]

Prior to joining the Informa team, he was an editor at NutraIngredients-USA, a William Reed Business Media publication.

His approach to industry journalism was formed via a long career in the daily newspaper field. After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors. The newspaper won two Pulitzer Prizes during his time there.

The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.

Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.

In 2015, Hank was recognized by the American Herbal Products Association with a Special Award for Journalistic Excellence.

When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.

Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.

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