The U.S Supreme Court has ruled for the Food and Drug Administration (FDA) on its right to block applications from makers of sweet-flavoured vapes.
The crux of the lengthy legal battle has been whether the FDA failed to correctly consider the requests of two manufacturers – Triton Distribution and Vapetasia – to sell flavoured e-liquids, putting it in violation of federal law.
The FDA was appealing a decision by the U.S Fifth Circuit Court of Appeals that its denial of the applications was “arbitrary and capricious.”
The Supreme Court justices have now unanimously ruled that the FDA did not in fact violate federal law.
Not the final word with Trump in office
However, the decision to throw out the ruling of the federal appeals court is not the final word on the case, and the FDA could be forced to change its approach now that president Donald Trump – who pledged to “save vaping” – has taken office again.
The FDA has rejected applications for more than a million nicotine products designed to taste like fruit, dessert or candy on the basis that their makers failed to show flavoured vapes have a net benefit to public health as required by law.
Triton and Vapetasia argued that the FDA “moved the goalposts” late in the application process by adding a requirement for long-term studies.
They said this “regulatory switcheroos” meant the agency unfairly denied their applications to sell sweet or fruit-flavored e-liquids, which are an important aid in helping adult smokers to quit.
The conservative Fifth Circuit Court of Appeals sided with Triton and Vapetasia, agreeing that the FDA changed its standards with little warning in violation of federal law.
The FDA did not consider Triton’s marketing plan
The U.S Supreme Court heard both sides of the argument in December and seemed mostly sympathetic to the agency’s position, with many of the justices appearing baffled by the suggestion that it had changed its position during the approval process.
While ruling in favour of the FDA on Wednesday, the court noted that the agency had said the company’s marketing plan would be an important factor in evaluating its application, but then ultimately didn’t consider it.
Attorney Eric Heyer, who represented Triton, expressed disappointment with the ruling but said the company believes “in the great harm reduction potential” of the products and plans to continue litigation.
The FDA has to date approved some tobacco-flavoured vapes, and recently allowed its first menthol-flavoured vapes after the company provided data showing the product helps adults quit smoking.
The agency has not yet brought in any changes to its vaping polices in response to Trump’s new tenure as president. But last week, the FDA’s top tobacco regulator Brian King was removed from his post amid sweeping cuts to the federal health workforce that have cleared out many of the nation’s leading health experts.
King oversaw hundreds of warning letters issued to companies that make, sell and distribute flavoured vapes.
