Botanic Tonics, LLC, maker of kratom and kava tonic brand Feel Free, is moving to dismiss the FDA’s case against the company after the federal agency seized over 250,000 units of product and raw materials from its Oklahoma manufacturing and distribution facility in April. In its initial action, the FDA cited the company’s improper use of kratom as the reason for the seizure, which it considers to be an addictive drug with no approved uses. However, Botanic Tonics is pushing back on that characterization of kratom, arguing that it is safe to use. While the FDA has defended the seizure by arguing that reports of adverse reactions to kratom increased year-over-year from 2021 to 2022 (131 reports to 209 last year), Botanic Tonics claims that reports are down from 239 in 2018, and noted there have been more “adverse events related to caffeine in the last five years than herbal kratom.” Founded in 2020, Botanic Tonics surpassed $30 million in revenue in 2022, founder JW Ross claime on a March episode of the Beyond A Million podcast. However, the company has faced heightened scrutiny this year; besides the FDA seizure, two consumer class action lawsuits have been filed against the company, in March and May respectively, calling into question the safety of Feel Free and alleging the products are addictive. |