In a win for the nation’s youth—and all Americans’ health—the U.S. Supreme Court has ruled (PDF) that the Food and Drug Administration (FDA) did not act in an arbitrary and capricious manner when it told applicants that they could not put certain flavored e-cigarette liquids on the shelf.
The unanimous decision overturned a 5th U.S. Circuit Court of Appeals ruling. Had that appellate-court ruling been allowed to stand, companies could have marketed products that clearly were designed to appeal to children, with names such as “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Pink Lemonade,” “Iced Pineapple Express” and “Killer Kustard Blueberry.”
Justice Samuel A. Alito Jr., who wrote the opinion for the court, said the FDA did not act arbitrarily and capriciously when it denied the companies’ applications for premarket approval of the tobacco products. The companies challenged the agency’s decision arguing that, among other things, that the FDA didn’t give them fair notice about the evidentiary and comparative requirements used during the application stage and that the agency had changed its position on scientific evidence.
The high court remanded the case to the 5th Circuit to review other legal arguments, so this is not the end of the litigation, but it is a favorable step forward. The 5th Circuit’s decision was an outlier among the federal circuits that have considered similar cases.
The Litigation Center of the American Medical Association and State Medical Societies joined 10 other medical, public health and community organizations in filing an amicus brief (PDF) in the case, Food and Drug Administration v. Wages and White Lion Investments LLC, dba Triton Distribution et al. The brief urged the court to conclude that the FDA was correct in how it determined that companies should not be able to market the flavored e-cigarette liquids.
In addition to the AMA Litigation Center, the other organizations joining the brief were: the American Academy of Family Physicians, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, American Thoracic Society, Campaign for Tobacco-Free Kids, Louisiana State Medical Society, Parents Against Vaping E-Cigarettes and Truth Initiative.
Find out more about the cases in which the AMA Litigation Center is providing assistance and learn about the Litigation Center’s case-selection criteria.
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Youth e-cigarette use a concern
In the opinion, Justice Alito noted that “early on, evidence began to mount that young American are particularly drawn to e-cigarette products.” He cited data that showed by the mid-2010s, about 2.4 million high school students and 620,000 middle-school students reported using an e-cigarette at least once in the last 30 days.
“One particular feature of e-cigarette products appears to drive this youth demand: the panoply of e-liquid flavors. One nearly decade-old estimate found that there were 7,700 unique e-liquid flavors, including not only flavors that were familiar to cigarette smokers (tobacco and menthol) but also fruit, candy, and dessert flavors that were appealing to non-smokers,” Justice Alito wrote. “The kaleidoscope of flavor options adds to the allure of e-cigarettes and has thus contributed to the booming demand for such products among young Americans.”
The AMA Litigation Center brief told the court that young people’s e-cigarette use is a public health crisis. More than 2.1 million youth—including 10% of high schoolers—reported using e-cigarettes in 2023. Among the middle and high schoolers who use e-cigarettes, 90% report that they use flavored products, not tobacco-flavored products.
In an AMA Leadership Viewpoints column, President Bruce A. Scott, MD, said that he has seen the devastating damage that cigarettes and e-cigarettes cause. As an ear, nose and throat surgeon in Louisville, Kentucky, for more than three decades he has seen mouth and throat cancers that change lives forever or end them prematurely.
“The AMA and our amicus brief partners believe the FDA acted properly to ban these and other products marketed by the defendants, and did so by following the 2009 law’s directive to remove products that threaten the health and well-being of young people without sufficient countervailing benefit to adult cigarette smokers,” Dr. Scott wrote, referring to a 2009 federal law that gave the FDA authority to regulate tobacco and other products containing nicotine.
“While the FDA has not acted as quickly as it could have to take nicotine-containing products made to taste like candy, fruit or sweet desserts off the market, its market denials for more than a million of these products have helped reduce vaping and other tobacco use by teens to its lowest level in 25 years, according to the CDC,” Dr. Scott explained.
He noted that an estimated 1.63 million U.S. middle school and high school students used e-cigarette products in 2023 and that “this is not the time to retreat from the life-saving FDA actions.”
Where the AMA stands
Since the 1960s, the AMA has fought publicly against tobacco use, as evidence in peer-reviewed medical journals linked cigarettes to lung cancer and heart disease.
AMA policy says that the use of e-cigarettes and vaping is an urgent public health epidemic, and the AMA continues to urge the FDA and other stakeholders to counteract tobacco product marketing and to support bans on sales of the products to people under 21 years of age.
