Supreme Court to Consider Whether FDA Was Too Harsh in Its Flavored E-Cigarette Ruling

The Supreme Court took up the e-cigarette case Tuesday, considering the FDA’s decision to block marketing of sweet-tasting products amid the rise in popularity of vaping among young people.

The FDA is appealing a lower court ruling that agreed with the vaping companies. They argue that the FDA wrongly rejected more than a million applications to market fruit- or candy-flavored nicotine liquids that are heated by an e-cigarette to create an inhalable aerosol.

The case comes as the FDA is conducting a major review after years of regulatory delays to scientifically examine the billion-dollar vaping market, which includes thousands of flavored vaporizers that are technically illegal but are widely available at convenience stores, gas stations and vape shops. The FDA recently approved its first menthol-flavored e-cigarettes for adult smokers.

The agency says sweet flavored e-liquids pose a “serious, well-documented risk” of encouraging more young people to try nicotine. In 2020, nearly 20% of high school students and nearly 5% of high school students used e-cigarettes, and nearly all of those kids used flavored products, the agency said in court papers.

The agency says the companies were blocked because they could not show that the potential benefits to adult smokers outweighed the risks of underage use. The companies say they have made detailed plans to avoid attracting young people.

The companies won a victory when the U.S. 5th Circuit Court of Appeals sided with vaporizer company Triton Distribution and dismissed its injunctions to stop it from marketing e-liquids with names like “Jimmy The Juice Man in Peachy Strawberry.”

The Fifth Circuit found that the agency acted unfairly by requiring companies, without notice, to produce research showing that flavored products help people quit smoking.

The judges expect 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 reducing tobacco use among youth.

Yolonda Richardson, MPH, president and CEO of the Campaign for Tobacco-Free Kids, appealed to the high court to overturn the appeals court decision, calling it flawed and adding that if upheld, “it would cause serious harm to the public health, especially the health of our children.”

In recent years, youth e-cigarette use has fallen from record levels, but 2.8 million high school and middle school students still use them, according to a federal study.

E-cigarette companies have long said their products can help reduce smoking, which causes 480,000 deaths a year in the U.S. from cancer, lung disease and heart disease.

Triton is eagerly awaiting the Supreme Court’s review of the case, attorney Eric Heyer said. He said the FDA imposed “abrupt, after-the-fact … testing requirements” and failed to follow its own guidelines.