“Arbitrary and Capricious”: Triton v FDA Explained PT. 1
In January of 2024, the Fifth Circuit Court of Appeals ruled in favor of Wages and White Lion Investments doing business as Triton Distribution (collectively referred to as “Triton”), a company that manufactures nicotine liquids for e-cigarettes and vaporizers. Triton called into question the Marketing Denial Orders (“MDOs”) issued to their products by the United States Food and Drug Administration (“FDA”), stating that the Premarket Tobacco Authorization (“PMTA”) process was both unclear and unfair. The panel of judges voted 10-6 in favor of Triton, and dropped a 52-page decision, famously stating that the FDA had acted “arbitrarily and capriciously” in issuing MDOs.
This decision highlights a long-standing struggle between the vape industry and the FDA, dating as far back as 2009, when the Obama administration signed the Family Smoking Prevention and Tobacco Control Act (“TCA”) into law, giving the FDA the power to regulate the tobacco industry. The TCA also prohibits manufacturers from selling new tobacco products without authorization. Fast forward to 2016, the vapor industry was beginning to boom, seeing millions of responsible adult smokers make the switch to the novel e-cigarette in hopes of reducing the harm done by smoking tobacco. At this time, the FDA deemed e-cigarettes and their necessary components to be “new tobacco products.”
Suddenly, thousands of products on store shelves became subject to the PMTA process, despite having already been sold to a large number of adult consumers. Most vape manufacturers were eager to comply, working diligently to prepare their PMTA paperwork accurately and promptly. This swift action led to the submission of hundreds of thousands of applications in a very short period, overwhelming regulators with too much work and too little time.
In the following years, the FDA issued thousands of MDOs for flavored vaping products. However, according to the January 2024 ruling, the “FDA stated that it did not even read the marketing plans it previously said were critical: ‘For the sake of efficiency, the evaluation of the marketing plans in applications will not occur at this stage of review, and we have not evaluated any marketing plans submitted with these applications.’”
The FDA's broad decisions to deny certain products have effectively banned flavored vaping products without any input from Congress. This situation has primarily favored a few products from Big Tobacco companies, leaving small businesses at a disadvantage. The ongoing Triton v. FDA case, now before the Supreme Court, highlights this issue, and many vape retailers are anxiously watching the outcome.
