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June 30, 2023
A manufacturer of kratom whose products were seized by the federal government has filed a “reply brief” in court in its quest to retrieve its products and dismiss a lawsuit.
In the June 21 filing, Botanic Tonics LLC made its final arguments for why the U.S. District Court for the Northern District of Oklahoma should dismiss the government’s first amended complaint, which seeks to condemn and forfeit the kratom products.
Federal Judge John F. Heil III, who is presiding over the case, is under no deadline to rule, and it could be months before a decision is handed down.
Government attorneys earlier this month objected to Botanic Tonics’ request to dismiss the lawsuit.
In an amended complaint, federal government attorneys in Oklahoma described the kratom products as “adulterated” under U.S. law because “they contain or are a new dietary ingredient [NDI], kratom, for which there is inadequate information to provide reasonable assurance that this ingredient does not present a significant or unreasonable risk of illness of injury.”
While the government alleged the kratom products are adulterated, it failed to allege that a relevant section of federal law in 21 U.S.C. 350(b) doesn’t apply, according to Botanic Tonics’ reply brief.
“That is because a dietary supplement containing a new dietary ingredient is not adulterated if the dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered,” attorneys for Botanic Tonics argued in the reply brief.
“The government’s sole allegation is that there is ‘inadequate information to provide reasonable assurance that this ingredient does not present a significant or unreasonable risk of illness or injury,’ under 21 U.S.C. § 342(f)(1)(B),” the brief added. “However, the alleged lack of information does not matter if the dietary ingredient has been present in the food supply. Accordingly, the government was required to allege that section 350b(a) has not been met, and it failed to do so.”
FDA, with the help of U.S. Marshals, seized articles containing kratom manufactured by Botanic Tonics of Broken Arrow, Oklahoma. According to federal authorities, the seized articles are marketed under the brand name “Feel Free Plant Based Herbal Supplement” and carry an estimated worth of more than $3 million. The seized articles included more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including more than 1,000 kilograms of bulk kratom.
After its products were seized, Botanic Tonics filed a motion to dismiss. The company argued the government’s complaint “fails to even reference, let alone allege non-compliance with, the specific statute addressing whether new dietary ingredients are deemed adulterated.” In a response brief, government lawyers proclaimed the facts alleged in the complaint meet pleading requirements under applicable federal rules.
FDA warns consumers not to use kratom and has expressed concerns that the plant that grows naturally in Indonesia, Malaysia, Papua New Guinea and Thailand affects the same opioid brain receptors as morphine and appears to display properties that expose users to the risks of abuse, addiction and dependence. Advocates of kratom have contended FDA’s concerns are unfounded and ignore the current science on the plant.
Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition
Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a special focus on regulatory issues, including at the Food and Drug Administration.
Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.
Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide, Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.
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