The U.S. Supreme Court on Dec. 2 heard the U.S. Food and Drug Administration (FDA) defend its decision to turn down two companies’ request to market flavored vaping products.
The appeal arises out of a court ruling made during the Biden administration, which is now entering its final few weeks in office. President-elect Donald Trump, who will be inaugurated on Jan. 20, 2025, has promised to ease up on regulating the vaping industry, whose market in 2023 was valued at $28 billion.
The case is FDA v. Wages and White Lion Investments. The company does business as Triton Distribution. The other company in the case is Vapetasia.
Vaping supporters say that vapes, which simulate cigarette smoking, assist smokers in quitting smoking cigarettes. However, critics say the products themselves, especially flavored varieties, run the risk of addicting young people to nicotine. The products are also known as e-cigarettes.
On the campaign trail, Trump said, “I’ll save vaping again.”
“I saved flavored vaping in 2019, and it greatly helped people get off smoking,” he wrote on Truth Social on Sept. 20.
Earlier, in 2019, the Trump administration announced plans to ban all flavored vape products. But the next year, the administration instead instituted a partial ban that exempted menthol and tobacco-flavored vaping products.
Triton and Vapetasia had asked in 2020 to market products with names such as “Killer Kustard Blueberry” and “Jimmy The Juice Man Peachy Strawberry.” The government argues that these are aimed at the youth market.
The FDA’s power to regulate vaping products comes from the federal Tobacco Control Act. The FDA made a rule in 2016 that found that e-cigarettes were tobacco products that came under the agency’s authority. The act requires those making e-cigarettes to obtain permission from the agency to offer them for sale to the public.
Benefits Versus Risks
E-cigarette companies also must demonstrate that their products are “appropriate for the protection of the public health.” This means that they must show that any prospective health benefits such as reducing consumption of traditional tobacco products outweigh the risk of allowing the new products to be marketed.
The U.S. Court of Appeals for the Fifth Circuit ruled in January that the FDA’s actions in the case ran afoul of the federal Administrative Procedure Act.
The agency turned down the applications without taking into account the companies’ proposals to discourage the flavored vaping products’ use by underage individuals and had effectively banned the products, the court determined.
The FDA disagrees and is asking the justices to reverse the Fifth Circuit decision.
During the oral argument on Dec. 2, Justice Clarence Thomas told government attorney Curtis Gannon that the guidance the agency gave the companies on complying with regulations was “actually a moving target” and that either the guidance wasn’t clear or the government changed the guidance over time.
Gannon replied, “That is their argument.”
“But I think that the key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to nonsmokers and attracting youth,” Gannon said.
“They knew throughout that FDA was concerned about the fact that flavors are attractive to youth.”
Chief Justice John Roberts asked if the FDA has “an obligation to tell people what they have to do to comply” with their regulations or if “it’s simply an obligation not to mislead”
Gannon replied that the act already provides “the basic calculus that FDA was going to apply” and “we can’t mislead them.”
Gannon also said the “chief risk” regarding flavored products is their “extraordinary popularity” among young people.
Justice Elena Kagan told the companies’ attorney, Eric Heyer, that the agency had been “completely up-front” about the relevant regulations.
“So I guess I’m not really seeing what the surprise is here, or what the change is here,” she said.
“Everybody basically knows that flavors are particularly dangerous in terms of kids starting the use of smoking products.”
Heyer said the FDA treated the companies unfairly.
He said that the agency originally said “no specific studies” were required and then “switched its position on what studies were required and, in so doing, failed to consider applicants’ reliance interests in the original instructions and less drastic alternatives.” The agency also ignored the companies’ marketing plans and the public comment process required by law, he said.
Later in its current session, which began in October, the Supreme Court will hear a case about flavored vaping products in which the government says the manufacturer improperly filed suit in the wrong court to seek a favorable result.
After granting the petition in FDA v. R.J. Reynolds Vapor Co. on Oct. 4, the court scheduled an oral argument in the case for Jan. 21, 2025.
Sam Dorman contributed to this report.
From The Epoch Times