The U.S. Supreme Court has agreed to hear the Food and Drug Administration’s defence of its decision to ban flavoured vapes.
The FDA had denied applications from two companies seeking to sell e-liquids in flavours such as sour grape, pink lemonade, and creme brulee. They included names such “Suicide Bunny Bunny Season” and “Jimmy the Juice Man Strawberry Astronaut.”
However, the rejections of these applications, along with over one million other products, was challenged by the companies in the 5th U.S. Circuit Court of Appeals. The appeals court ruled that the FDA’s denial was “arbitrary and capricious” for not considering the companies’ plans to prevent underage access to the vapes.
It also said the FDA engaged in “regulatory switcheroos” by imposing new testing requirements after companies had submitted their paperwork seeking approval.
A major test of the FDA’s powers
Now, the Supreme Court has said it will review the case, marking a major test of the FDA's role in approving new nicotine products.
The decision comes amid conflicting rulings from other federal appellate courts, prompting the justices to find a definitive resolution on the FDA’s regulatory authority over flavoured vaping products.
The agency has consistently rejected applications for flavoured vapes since 2016 when Congress enacted a 2009 law - the Tobacco Control Act - that requires companies to get FDA approval before selling new nicotine products.
Of the million-plus applications it has received, it has approved only around two dozen. These are from companies including Altria Group Inc. and R.J. Reynolds Vapor Co., a subsidiary of British American Tobacco Plc.
The FDA argues that flavoured vapes pose a “known and substantial risk to youth” and that companies must demonstrate that their marketing is “appropriate for the protection of public health.”
Smoking cessation tool
Last week the FDA approved two menthol flavoured vapes for the first time. It said that “after rigorous scientific review,” the agency concluded that the benefit of adult smokers switching to vapes outweighed the risks to young people.
The move supports the vaping industry’s assertion that vapes can drastically reduce the harms of smoking, which kills eight million people a year - including 480,000 in the U.S.
The FDA has declined to comment on the latest review, saying it doesn’t discuss ongoing legal cases. The agency recently said it’s been overwhelmed by lawsuits challenging its denials of some products.
The Supreme Court will hear arguments and decide the case in the next Supreme Court term, which begins in October and ends in June 2025.
