The US Supreme Court largely sided with the Food and Drug Administration in its rejection of applications to sell flavored vaping products, backing actions the agency took during Joe Biden’s presidency amid uncertainty about the approach it will take under Donald Trump.
The justices unanimously contentions that the FDA violated the law when it turned down applications from two companies seeking to sell vaping liquids in flavors that included “Suicide Bunny Mother’s Milk and Cookies” and “Killer Kustard Blueberry.” The justices returned the legal fight to a federal appeals court to revisit one aspect of the case.
The case tested the FDA’s ability to prohibit tobacco products that could be harmful. The agency has denied millions of applications, many of them for flavored vapes, since Congress enacted a 2009 law that requires companies to get FDA approval before selling new tobacco products.
The impact of the ruling ultimately may be limited given that Trump vowed during his presidential campaign to “save vaping.” His administration so far hasn’t spelled out what that will mean or how it will affect the FDA’s handling of the issue going forward. Trump didn’t take a position in the case, which was argued before he took office.
The New Orleans-based 5th US Circuit Court of Appeals said the FDA engaged in “regulatory switcheroos” by imposing new testing requirements after companies had submitted their paperwork seeking approval.
Writing for the Supreme Court, Justice Samuel Alito rejected that reasoning. He said the FDA’s approach was “sufficiently consistent with its predecisional guidance” regarding the required scientific evidence and other issues.
Alito told the 5th Circuit to revisit the significance of the FDA’s refusal to consider the companies’ marketing plans, an approach the agency took despite its previous description of the subject as “critical” for assessing whether the products would be used by children. The FDA said it didn’t review the plans for the sake of efficiency, given that it had previously found similar company proposals to be inadequate.
Alito told the 5th Circuit to consider whether the FDA’s change in position was a “harmless error.”
The case involved Wages and White Lion Investments LLC, which does business under the name Triton Distribution. The business makes e-liquids for its own brands as well as another company, Vapetasia LLC. The companies said the FDA didn’t provide fair notice that it had changed the requirements for authorization of new flavors.
The 2009 law, known as the Tobacco Control Act, says companies must show that products introduced after Feb. 15, 2007, would be “appropriate for the protection of the public health.”
The case is FDA v. Wages and White Lion, .
Photo: Businessman vaping in New York./Bloomberg
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