According to a report from Reuters on July 2, the United States Supreme Court has agreed to hear arguments from the Food and Drug Administration (FDA) regarding its decision to deny two companies' applications to sell flavored e-cigarette products. The FDA believes that these products pose health risks to young consumers.
The Supreme Court will hear this case in the next term, which begins in October of this year. Prior to this, a lower court ruled that the FDA did not follow the proper legal procedures required by federal law when rejecting applications for nicotine-containing products to be marketed.
In 2020, e-cigarette liquid manufacturers Triton Distribution and Vapetasia LLC submitted product applications to the FDA for flavors such as sour grape, powdered lemonade, and caramel pudding. Some of the products included in the applications are "Jimmy The Juice Man Strawberry Astronaut" and "Suicide Bunny Bunny Season".
According to a rule that went into effect in 2016, the FDA now considers e-cigarettes to be tobacco products and, like traditional cigarettes, they must undergo review by the agency under the 2009 Tobacco Control Act. The rule requires manufacturers to seek approval in order to continue selling their products.
Although the FDA has claimed that it has not fully banned flavored e-cigarette products, companies seeking approval must meet strict legal standards because these products pose a "known and significant" risk to young people. In order to obtain approval from regulatory authorities, companies must prove that their marketing activities are "appropriate to protect public health".
According to court records, the FDA has rejected applications from these two companies as well as over one million other products. To date, the FDA has only approved 27 e-cigarette products, all of which are tobacco or mint flavored.
In 2021, Triton and Vapetasia appealed the FDA's rejection of their applications to the United States Fifth Circuit Court of Appeals in New Orleans.
In January of this year, a panel of 10 judges from the Fifth Circuit Court of Appeals ruled 10-6 that the FDA violated the federal Administrative Procedure Act by not considering a company's plan to prevent minors from accessing and using their products when rejecting an application. The decision was written by Judge Andrew Oldham, appointed by former Republican President Donald Trump. Oldham pointed out that the FDA initially requested detailed plans from e-cigarette companies on how they would prevent youth from misusing their products, but ultimately denied the applications without reviewing these plans.
Oldham stated that this did not fulfill the institution's obligation to be "open and straightforward," meaning they failed to communicate with the company in a direct and honest manner.
Triton's lawyer, Eric Heyer, stated that the company "looks forward to the Supreme Court reviewing the FDA's sudden implementation of new study requirements after the fact, as well as instances where the agency did not follow its own application guidelines."
The ruling of the Fifth Circuit Court of Appeals is at odds with the conclusions of other federal appellate courts on the issue, prompting the FDA to appeal to the Supreme Court.
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