Opinion analysis
By Amy Howe
April 2, 2025
at. 14.46
The judges released two statements on Wednesday. (Amy Howe)
On Wednesday, the Supreme Court largely maintained the food and drug management’s denial of two companies’ applications to sell flavored liquids for use in e-cigarettes. In a unanimous decision, the judges threw a decision from the Conservative US Appeals Court for the 5th Circuit, which claimed that the FDA had incorrectly withdrawn a “legislative switcheroo” when it gave business instructions that they followed, but then ignored these instructions and refused permission while imposing new requirements. In a 46-page decision by Justice Samuel Alito, the court sent the case back to the court of appeal so that it could take another look at one aspect of the dispute-specific whether it made a difference that the FDA had changed its attitude and did not consider marketing plans that companies had submitted as part of their applications.
E-cigarettes, also known as Vapes, are battery-powered devices that heat a liquid which in turn produces an aerosol that the user inhales. E-cigarettes usually contain nicotine, the addictive ingredient released by the combustion of a traditional cigarette, but without some of the other chemicals released when tobacco is burned.
A 2009 law, the Law on Prevention and Tobacco Control of the Family, requires producers to be allowed from the FDA before putting a new tobacco product on the market. The law requires the applicant, among other things, to show that the marketing of the product would be “appropriate for the protection of public health” – a standard that the FDA uses by considering that both the probability that people who are currently using tobacco products will stop and the possibility of people who do not use tobacco products begin to use them.
In 2021, FDA applications from Triton Distribution and Vapetasia refused to sell flavored fluids with names such as “Rainbow Road”, “Crème Brulee” and “Jimmy the Juice Peachy Strawberry” for use in e-cigarettes. Young people are more likely to use e-cigarettes when these kinds of flavored fluids are available, the FDA justified, and it had found no evidence that flavored fluids would benefit adult smokers.
The full US appeal for the 5th circuit deposed the FDA’s denial of the two companies’ applications. The companies had followed specific instructions that the FDA had provided justified the appeal, but then the FDA ignored these instructions and instead introduced – without recognizing it – new requirements.
On Wednesday, the Supreme Court unanimously rejected the 5th circuit decision. Alito explained that the courts under the federal law that govern administrative agencies can only undergo an agency’s actions if they are arbitrary and whimsical – that is, if they lack a rational basis or are unreasonable. Courts emphasized Alito, “must exercise appropriate respect” in such cases and cannot “replace their own judgment with the agency’s.”
At its core, Alito continued that the companies’ argument is boiled down to the idea that “the FDA told them in guidance that it would do one thing and then turned around and did something else as it went through their applications.” But federal administrative law, Alito underlined, allows agencies to change their attitudes as long as they “give a reasoned explanation of the change, show awareness that they are changing position and considering serious addiction interests.”
Alito acknowledged that in the construction of the company’s applications to market their products, the FDA issued “voluminous and discursive documents” that “painting a picture of an agency that felt its way to a final attitude and was unable to say or unwilling to say in clear and specific terms exactly what” the companies “would have to give.” But for three of the issues that companies complain of over-FDA’s alleged lack of givly for the kind of scientific evidence they would have to give, the FDA’s demand is that producers compare the health effects of their non-tobacco-tasted products with the other things horrified by tobacco-flavored products and FDA’s alleged shifts in one to include ex-flavored es-cig. concluded that the FDA’s orders refusing corporate applications were “sufficiently consistent” with the guidance that it had given it had not violated the federal administrative law.
The FDA did not contest the appeal of the appeal that it had changed its attitude towards the importance of submitting marketing plans that outlined a producer’s proposal and limitations to keep e-cigarettes out of the hands of young people. The FDA had told the producers that the submission of such plans would be “critical”, but then did not consider them, the companies complained.
The FDA argued in the Supreme Court that its failure to consider the marketing plans would not have made a difference for these companies because they had later denied applications from other manufacturers with very similar marketing plans that it had undergone. The judges sent the case back to the court of appeal so that it could take another look and decide whether the case should return to the FDA, or instead of whether it should consider the argument itself.
Justice Sonia Sotomayor wrote a brief simultaneous statement to “clarify” that in her view the FDA did not necessarily “feel against a final attitude” as Alito suggested. “Instead,” she said, “the record shows that the agency reasonably gave producers some flexibility in terms of the evidence that would be sufficient to approve their products while chopping (and never suggesting it would be lost from) its statutory duty to approve only the products that would be” appropriate to protect public health. ”” ”
This article was originally published on Howe on the field.
