In DOJ lawsuit, company denies kratom is an NDI

Josh Long, Associate editorial director, Natural Products Insider

June 17, 2021

2 Min Read
In DOJ lawsuit, company denies kratom is an NDI

A firm linked to a government seizure of $1.3 million in kratom products denied in federal court that the botanical is a new dietary ingredient (NDI).

The “affirmative defense” raised by MT Brands LLC asserts the “articles” seized were marketed in the U.S. before Oct. 15, 1994.

Dietary ingredients marketed before the above date are not subject to a notification requirement in the law to demonstrate their safety to FDA.

For several years, FDA has raised concerns over kratom, a botanical from Southeast Asia which has long been the subject of an import alert. Although several companies aiming to lawfully market kratom in dietary supplements have submitted to FDA premarket NDI notifications, the agency has essentially rejected all of them, citing safety concerns and other considerations.

In May, U.S. Marshals seized dietary supplements and bulk dietary ingredients containing kratom made by Atofil LLC, of Fort Myers, Florida, over continuing concerns that the products pose risks to public health. Atofil is a subsidiary of Premier Manufacturing Products LLC.

The U.S. Department of Justice (DOJ) alleged Atofil’s articles are “adulterated” because “they contain or are a new dietary ingredient, kratom, for which there is inadequate information to provide reasonable assurance that this ingredient does not present a significant or unreasonable risk of illness or injury.”

Related:FDA seizes kratom supplements

MT Brands, a wholly owned subsidiary of Premier Manufacturing Products, claimed an interest in the products and recently filed an answer to the government’s amended lawsuit for a “forfeiture in rem," which is an action brought in court against property. On its website, MT Brands bills itself as “a trusted global kratom wholesaler” marketing products such as “Bronze Kratom,” “Ghost Ship Kratom” and The Devils Kratom.”

Affirmative defenses to kratom action 

In its answer to the lawsuit, MT Brands raised several affirmative defenses, including the government lacked “probable cause” to bring its condemnation action.

The company further denied the government’s allegations that Atofil’s articles are adulterated. In its second affirmative defense, MT Brands asserted sufficient information exists “to provide reasonable assurance that the defendant articles do not present a significant or unreasonable risk of illness or injury.”

Its third affirmative defense claimed Atofil’s articles are not an NDI. MT Brands raised a fourth affirmative defense that forfeiture of Atofil’s articles function as an “excessive fine,” which the Eight Amendment to the U.S. Constitution prohibits.

MT Brands, who bears the burden of proving its affirmative defenses, is demanding a jury trial in the U.S. Court District for the Middle District of Florida. The lawsuit remains in its early stages: On June 15, the court issued a civil action order to govern the case.

About the Author(s)

Josh Long

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 focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

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 (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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