The Supreme Court took up an e-cigarette case Tuesday, weighing FDA decisions blocking the marketing of sweet flavored products amid a surge in vaping by young people.
The FDA is appealing a lower court ruling siding with vape companies who argue the FDA unfairly denied more than a million applications to market fruit or candy flavored versions of nicotine-laced liquid that's heated by the e-cigarette to create an inhalable aerosol.
The case comes as the FDA undertakes a sweeping review after years of regulatory delays intended to bring scientific scrutiny to the multibillion-dollar vaping market, which includes thousands of flavored vapes that are technically illegal but are widely available in convenience stores, gas stations, and vape shops. The FDA recently approved its first menthol-flavored electronic cigarettes for adult smokers.
The agency says the sweet flavored e-liquids pose a "serious, well-documented risk" of enticing more young people to pick up a nicotine habit. In 2020, nearly 20% of high school students and almost 5% of middle-school students used e-cigarettes, and almost all of those kids used flavored products, the agency said in court documents.
The agency says companies were blocked because they couldn't show the possible benefits for adult smokers outweighed the risk of underage use. The companies say they had prepared detailed plans to avoid appealing to young people.
The companies scored a victory when the 5th U.S. Circuit Court of Appeals sided with the vaping company Triton Distribution and tossed out orders denying the marketing of e-liquids with names like "Jimmy The Juice Man in Peachy Strawberry."
The 5th Circuit found the agency was unfair because it required the companies, without warning, to present studies showing that flavored products would help with smoking cessation.
The justices are expecting to hear the case in the fall.
Other appeals courts have sided with the FDA, which regulates new tobacco products under a 2009 law aimed at curbing youth tobacco use.
Yolonda Richardson, MPH, president and CEO of the Campaign for Tobacco-Free Kids, called on the high court to overturn the appeals-court order, calling it misguided and saying it would "cause significant harm to public health and especially to the health of our kids," if allowed to stand.
Youth vaping has declined from all-time highs in recent years, but 2.8 million middle and high school students still use it, according to federal survey data.
Vaping companies have long claimed their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease, and heart disease.
The company, Triton, is looking forward to the Supreme Court hearing the case, attorney Eric Heyer said. He said the FDA had imposed "surprise, after-the-fact ... study requirements" and failed to follow its own guidance.