U.S. Marshals have seized around $3 million worth of kratom-containing functional shots and bulk kratom powder from the Oklahoma offices of Botanic Tonics, LLC, the maker of Feel Free Plant Based Herbal Supplement, according to the U.S. Food and Drug Administration (FDA).
Operating at the request of the FDA, Marshals took around 250,000 bottles of Feel Free tonic, 1.5 tanks of liquid product and roughly 1,200 capsules of Feel Free branded supplements – all labeled as containing kratom – as well as “undetermined quantities” of bulk powdered kratom labeled “Green Nano” from Botanic Tonics’ Broken Arrow, Oklahoma offices last week.
In a news roundup Friday, the FDA said that all dietary supplements containing kratom are considered adulterated under the Federal Food, Drug, and Cosmetic Act as there is “inadequate information to provide reasonable assurance that [kratom] does not present a significant or unreasonable risk of illness or injury.” There are currently no FDA-approved uses for kratom, a drug with opioid-like properties, and the agency has warned consumers to avoid it, citing risks of addiction and abuse.
Founded in 2021, Botanic Tonics produces 2 oz. shots and supplements under the Feel Free brand, which are marketed as functional kava products that can provide “a social lift without the booze (or hangover)” and as a “focus enhancement without the crash.” Both products are made with what the company claims is a proprietary blend of kava root extract and kratom leaf, and some older versions of the shots viewable online depict a Supplement Facts label featuring a 2:1 ratio of kratom to kava.
Feel Free is sold online direct-to-consumer and in over 10,000 retail locations, including natural channel chain Erewhon, according to the company’s website. The brand has also partnered with university sports teams and serves as the Official Tonic sponsor for the University of Texas, Florida State University and University of Southern California athletic departments – sponsoring a “Feel Free Moment of the Week” on Instagram for FSU, in one example.
However, the product has been the subject of recent controversy after consumer Romulo Torres filed a class action lawsuit in March against Botanic Tonics and 7-Eleven (which sells Feel Free in its California locations) alleging the products were falsely advertised as a safe alternative to alcohol. The lawsuit alleges that the shots’ kratom content led Torres, an alcoholic in recovery, to become addicted to the product and ultimately leading him to relapse and hospitalization.
Torres is not the only consumer to accuse Feel Free of being habit forming; the class action cites other consumers who said they became addicted to the tonics. An online addiction recovery community hosted on Reddit, r/Quittingfeelfree, has grown to include around 290 members.
According to a complaint filed by the U.S. Department of Justice on April 26, the same day as the civil forfeiture, FDA investigators noted the presence of products labeled as containing kratom during an inspection of the Broken Arrow site last fall. Months after the inspection, the FDA purchased Feel Free supplement capsules in February which were also labeled for kratom. Botanic Tonics is based in Santa Monica, California but manufactures at a facility in Oklahoma.
“Serious safety concerns exist regarding the effect of kratom on multiple organ systems,” the complaint stated. “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.”
In a disclaimer on its website, Botanic Tonics warns that its statements have not been evaluated by the FDA and that its products are not intended to treat illnesses. The disclaimer cautions that Feel Free should only be used “in the recommended quantity and dosage” and is not for use or sale by anyone under the age of 18, or 21 in certain jurisdictions.
This is far from the first time the FDA has requested U.S. Marshals seize products containing kratom. On its website, the agency pointed to civil forfeitures of raw kratom and dietary supplements in 2014, January 2016 and August 2016. In 2019, the FDA sent warning letters to two companies for illegally selling unapproved and misbranded kratom products and in 2021 it requested the seizure of around $1.3 million worth of kratom-containing supplements from a Florida-based company, Atofil, LLC.
In an email to BevNET, Shounak Dharap, an attorney representing Romulo Torres in the class action case against Botanic Tonics, said he views the seizure by the government as “a significant development” that supports Torres’ claims against the company.
“The fact that such a large quantity of kratom was seized from the company and that the government has filed its own complaint in federal court, alleging that there is inadequate information to provide reasonably [sic] assurance that kratom does not present a significant or unreasonable risk of illness or injury, underscores the seriousness of the false advertising and fraudulent omission allegations we’ve made in our class action,” Dharap wrote.
Update 5/4/2023:
In a statement to BevNET, Botanic Tonics said it intends to “vigorously defend” its product in court and “believe this seizure to be completely unwarranted.”
“Botanic Tonics’ Broken Arrow production plant is a US Food and Drug Administration (FDA) registered facility that is Good Manufacturing Practice (GMP) certified by Intertek, a leader in quality and safety assurance,” the company said. “The facility employs more than 100 Oklahomans and continues to grow and develop other dietary supplement products, including those that do not contain kratom. All of our products are produced and manufactured under the appropriate FDA good manufacturing procedures and are fully compliant with the Oklahoma Kratom Consumer Protection Act, which was passed and signed by Governor Stitt in 2021.”
Oklahoma is one of 10 states that have passed legislation explicitly protecting the sale of kratom, but the legality of kratom remains in flux throughout the country as other states have taken measures to ban the substance. Last year the Department of Defense announced it would forbid the use of kratom by active military service numbers.
However, some states that have banned kratom may be softening as both Rhode Island and Wisconsin took action in March to remove certain kratom substances from their scheduled lists.
In a press release this week, the American Kratom Association criticized the FDA’s seizure of Botanic Tonics’ supply, calling it a “pocket ban” and arguing that the “serious safety concerns” put forward by the agency are “directly contradicted by a substantial body of current evidence and data on the safety and addiction profile of kratom.” The group noted that efforts to classify kratom as a Schedule I drug over the past decade have repeatedly failed.
“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,” the group stated.
While Botanic Tonics said it intends to continue to fight for its right to sell supplements and shots containing kratom, the company is also broadening its portfolio beyond the controversial ingredient. Yesterday, Botanic Tonics launched a new Feel Free functional shot containing kava, kola nut, lion’s mane and rhodiola, while its original kava and kratom formula has been rebranded as Feel Free Classic.