Supreme Court rules in favor of FDA's marketing denials of flavored e-cigarettes

In early December, the U.S. Supreme Court heard arguments over federal regulation of flavored e-cigarettes in a case between the Food and Drug Administration (FDA) and two vaping companies. The justices were asked to determine whether the agency acted legally when it rejected the companies’ applications to market fruit- and dessert-flavored vaping products. At the hearing, five of the nine justices appeared to agree with the FDA, saying the agency acted legally in refusing to market certain flavored vaping brands. The decision is expected before the end of the Supreme Court’s term in June 2025.

The judges examined whether the agency acted legally when it rejected companies’ applications to market fruity and sweet flavored liquids for their nicotine e-cigarettes. The FDA said the flavors were too appealing to young people and not beneficial enough for current smokers trying to switch to vaping.[1].

A majority of the justices appear to believe that the FDA acted legally

The case involved the FDA’s appeal of a decision by the ultraconservative Fifth Circuit Court of Appeals in New Orleans brought by two vaping companies that alleged the agency had unfairly changed its standards when reviewing vaping companies’ applications. The court upheld the FDA’s conduct, saying the companies had been told the agency was requiring certain studies, but the agency later changed its mind and required more studies.

To date, the FDA has approved only 27 vaping devices for sale in the United States, and all but one were tobacco-flavored. It has denied millions more. Companies seeking FDA approval must meet a number of legal requirements because the products pose a “known and substantial risk to youth,” the FDA said.

At the Supreme Court level, at least two conservative justices appear to believe that the agency acted properly and that the FDA made clear from the outset that it made its decisions based on whether products were attractive to young people. Justice Brett Kavanaugh, whose vote could be decisive in this case, expressed sympathy for the industry, which complains about discretionary government regulation, but suggested that he was not convinced that the FDA acted unreasonably. The Supreme Court's three liberal justices also appear to believe that the FDA was consistent in its approach.  "There's not a lot of mystery about what the FDA was doing. You can disagree with its decisions. But you can't say the FDA didn't tell you everything it thought," Justice Elena Kagan said.

A possible change of situation with the election of Trump

Eric Heyer, an attorney for e-cigarette liquid makers Triton Distribution and Vapetasia, one of the two manufacturers involved in the case, suggested that Trump’s return could lead to a change in the U.S. government’s approach to flavored vaping products. Heyer alluded to Trump’s campaign promise to “save vaping,” though he supported banning flavored vaping products during his first presidential administration.[2].

The Vapor Technology Association said in a recent statement that the incoming administration " can quickly and decisively end all current litigation – and all future litigation that will follow – by implementing a new standard on tobacco and nicotine products.”  

Trump's victory is seen as a victory by the tobacco industry. Reynolds American, a subsidiary of British American Tobacco, was a major donor to the political action committee "Make America Great Again," which is in charge of financing Trump's campaign.[3].

©Tobacco Free Generation

AE

[1] John Kruzel, Andrew Chung, US Supreme Court wrestles with FDA denial of flavored vape products, Reuters, published December 2, 2024, accessed December 9, 2024

[2] Generation without tobacco, Trump, backed by tobacco industry, wants to reverse vaping flavor ban, published September 25, 2024, accessed December 9, 2024

[3] Generation without tobacco, Trump's Chief of Staff Is a Tobacco Industry Lobbyist, published on November 14, 2024, consulted on December 9, 2024