The Supreme Court ruled Wednesday that the Food and Drug Administration lawfully rejected applications from two manufacturers of flavored liquids used in e-cigarettes, The New York Times reported. In its unanimous decision, the Supreme Court rejected a ruling by a lower court that claimed the FDA had acted arbitrarily and capriciously and that the FDA had tried to change the rules in the middle of the application approval process, the newspaper said.
The manufacturers involved, Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC, make e-liquids in flavors including Killer Kustard Blue-berry, Rainbow Road, Iced Blackberry Lemonade and Suicide Bunny Mother’s Milk and Cookies, according to the court opinion.
In 2016, in response to the surging youth demand for flavored products, the FDA deemed e-cigarettes “tobacco products,” the opinion said. The Family Smoking Prevention and Tobacco Control Act requires makers of new tobacco products to receive FDA authorization, which can be done through the premarket tobacco product application (PMTA) process. To comply with the Tobacco Control Act, these newly deemed tobacco products had until Sept. 9, 2020, to submit a PMTA.
More than 18 million PMTAs for vapor products have been denied since the FDA has started reviewing them, and only 34 vapor products had been approved as of August. To get FDA authorization, tobacco manufacturers must demonstrate their products are “appropriate for the protection of the public health,” according to the act.
The FDA rejected Triton Distribution and Vapetasia’s applications for their e-liquids saying the products presented a “known and substantial risk to youth,” The New York Times said.
Then the U.S. Fifth Circuit Court of Appeals, New Orleans, in January 2024, ruled that the FDA should reconsider its decision. The court ruled in an opinion by Judge Andrew Oldham that the FDA “sent manufacturers of flavored e-cigarette products on a wild goose chase” regarding the terms necessary for these manufacturers to get approval only to have their applications denied.
The ruling added that the FDA acted arbitrarily and capriciously in rejecting consideration of marketing plans for both Triton and Vapetasia.
The FDA then filed an appeal in July 2024 with the Supreme Court to reverse the Fifth Circuit Court of Appeals’ decision. The Supreme Court heard oral arguments for the case in December 2024.
In Wednesday’s decision from the Supreme Court, written by Justice Samuel A. Alito Jr., the justices upheld the FDA’s order that prohibited retailers from marketing flavored tobacco products, The New York Times said. The court rejected the claims that the agency unfairly switched its requirements during the application process.
Alito wrote the agency’s details of the applications were “sufficiently consistent” with agency guidance on tobacco regulations, the newspaper said.
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