Company contests FDA’s position in lawsuit that kratom is an NDI – Natural Products INSIDER
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…….
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.”
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 …….