FDA v. Wages and White Lion Investments, L.L.C: Will the FDA Finally Lose Its Authority?

The Supreme Court Case, FDA v. Wages and White Lion Investments, L.L.C, is the most recent development in a long history of conflict between the FDA and e-cigarette industry, with the potential to upend the longstanding authority of the FDA. Since their arrival to the United States in 2003, e-cigarette products have stirred great controversy. While the e-cigarette industry has existed since 1927, with inventor Joseph Robinson designing the first device, ultimately, it was marketing during the 2000s that signalled the most growth.
Vape products were initially proposed as nicotine cessation devices — products designed to help smokers quit. Its popularity continued to expand with the addition of flavors, including candy, mint, and fruit. However, it would be the introduction of these flavors that would inspire criticism as many raised concerns that the available flavors targeted a younger audience over adults. These concerns, coupled with research indicating that vape products shared many of the negative health effects of cigarettes, inspired action among lawmakers and government agencies alike.
Disputes between the FDA and the e-cigarette industry began in 2009, with Import Alert 66-41, which prevented US customs from accepting any e-cigarette shipments. This Import Alert would soon draw the ire of e-cigarette company “Smoking Everywhere,” who would file a federal complaint, hoping to remove the ban. The following conflict between Smoking Everywhere and the FDA would define the regulatory abilities of the FDA still present today. The FDA would respond to the complaint, publishing a memorandum opposing Smoking Everywhere’s petition. The conflict would soon warrant the input of President Obama, who published the “Family Smoking Prevention and Tobacco Control Act,” providing the FDA with regulatory power over the tobacco industry. E-cigarette companies would now have to meet FDA standards before releasing products and flavorings including fruit and mint, could be banned.
Smoking Everywhere would retaliate against the legislation with a lawsuit, prompting the FDA to claim that e-cigarettes, indeed, could be categorized as a drug and device — thus affirming the organization’s right to regulate the aforementioned device. The FDA would continue to publish a controversial press release highlighting the health concerns of e-cigarettes as a result of carcinogenic contaminants such as diethylene glycol. However, the release was flawed, as the FDA withheld information including that e-cigarettes had comparable levels of carcinogens to other nicotine cessation products — substances used to quit nicotine — and that diethylene glycol levels within e-cigarettes were non-toxic.
The lawsuit levied by Smoking Everywhere would eventually be concluded in December of 2010, when the Supreme Court of the United States would determine that the FDA can only regulate e-cigarettes as a tobacco product, unless e-cigarettes are shown to have therapeutic usage. Despite new research gathered by the American Journal of Preventive Medicine, indicating that e-cigarettes had promise to help smokers quit, the FDA released the Food, Drug, and Cosmetics Act which asserted that any product with claims to help smokers quit would be regulated more closely, as a drug or medical device.
Since the 2010s, the FDA has maintained the administrative privileges over the e-cigarette industry granted by the Supreme Court Case, Smoking Everywhere v. FDA. Legislation restricting the purchase and sale of e-cigarette products, particularly flavored ones, has continued. CASAA, the Consumer Advocates for Smoke-free Alternatives Association and other organizations have regularly interacted with the FDA and local legislatures to make e-cigarette products — considered valid nicotine-cessation products — more available to consumers. Despite research affirming the effectiveness of e-cigarettes as nicotine-cessation products, additional research has indicated that while “safer” than cigarettes, e-cigarettes and other vape products do have negative health effects.
The most recent development, Supreme Court Case, FDA v. Wages and White Lion Investments, L.L.C, has the potential to challenge the longstanding authority of the FDA granted by the Family Smoking Prevention and Tobacco Control Act and result of Smoking Everywhere v. FDA. The case was initiated in 2020, when Wages and White Lion Investments — conducting business as Triton Distribution — and company, Vapetasia, applied for the release of e-cigarete flavors, “Suicide Bunny Mother’s Milk and Cookies,” “Killer Kustard Berry,” and “Iced Pineapple Express.” The FDA denied the authorization of the flavors, claiming that the companies had not shown sufficient evidence that the flavors would appeal to an adult consumer demographic. A lawsuit was shortly filed by the involved companies, and after consideration by the U.S. Court of Appeals for the Fifth Circuit, the companies were authorized to sell the products. In response, the FDA retaliated by petitioning to the Supreme Court, which will make its decision by June 2025.
Considering that the Supreme Court Case is contesting marketing oriented towards the youth, a decision in favor of Wages and White Lion Investments, L.L.C could allow for other e-cigarette companies to develop products with similar appeals to a young demographic. Consequently, more products with this kind of marketing could fill the market, potentially increasing the numbers of young people who are vaping. Additionally, the authority of the FDA would likely diminish, allowing companies to put unapproved products on the market, without the same supervision they once faced. In contrast, a decision in favor of the FDA could decrease the number of products seemingly targeted towards the youth. The FDA would be able to maintain or increase its regulatory authority allowing products produced by e-cigarette manufacturers to face scrutiny. In either case, the decision of Supreme Court Case, FDA v. Wages and White Lion Investments, L.L.C will mark a significant shift in the e-cigarette industry.