FDA battles vaping industry at the Supreme Court

The U.S. Supreme Court takes up the issue of vaping and e-cigarette regulation on Monday.

If you don’t know much about vaping, be assured that teenagers do. For the uninitiated, vaping is the inhaling of an aerosol mist from an electronic cigarette or other similar device, which heats up a liquid containing nicotine to create a vapor that looks like smoke. It’s an alternative that helps some smokers get off more damaging tobacco cigarettes, but it’s also a product that has become increasingly popular with middle- and high-school kids.

William Schultz, who served for five years as the FDA’s deputy commissioner for policy in the 1990s, says that the arrival of e-cigarettes has transformed a major public health victory into a major threat.

“When the FDA started regulating cigarettes in the 1990s, a third of kids smoked cigarettes,” he observes, whereas “now it’s 2%.”

That’s the good news. The bad news is that “in the meantime, e-cigarettes have filled the vacuum,” he says.

Indeed, according to national surveys conducted by the FDA and the Centers for Disease Control and Prevention, the percentage of high school kids who reported daily vaping of e-cigarettes jumped from 9.7% in 2014 to 30% in 2023.

That jump is important because under a 2009 federal law, the FDA is charged with curbing the use of tobacco and nicotine products used by minors to prevent them from becoming addicted. Among the regulated products are e-cigarettes, which first entered the U.S. market in 2006.

How the FDA regulates e-cigarettes

Monday’s case is about how the FDA went about doing that.

“There’s a concern that the FDA has kind of been operating in an ad hoc, unfair manner in the way it’s been evaluating all these applications for what are literally millions of vaping products,” says law professor Jonathan Adler, who has written extensively about this subject.

Basically, the FDA has made it increasingly difficult for vaping producers to sell their products using flavors that appeal to kids. Flavors like “pink lemonade,” “rainbow road” “jimmy the juice-man peachy strawberry,” and “suicide bunny mother’s milk and cookies.”

To date, only 27 companies, most of them small, have been approved to sell their vaping products, and the vaping industry has gone to court to challenge FDA decisions not to allow millions of products on to the market –- products that the agency deems to be “gateway devices,” aimed at minors to introduce them to nicotine addiction.

Lower court action

Seven appeals courts have, for the most part, approved the FDA’s decisions and two have at least partially rejected those decisions. But one appeals court, the ultra-conservative Fifth Circuit Court of Appeals, rejected virtually every aspect of the FDA’s decision-making process, eviscerating the agency’s conduct as a “surprise switcheroo” in which companies were told that the FDA required certain studies, including marketing studies, but then changed its mind.

The Fifth Circuit decision “threatened to allow all vaping product manufacturers to put their products on the market and keep their products on the market,” says Adler.

What’s more, he says, the decision had an additional and “aggressive” feature that “threatened to make this decision the de facto rule for the country as a whole, one that would require the FDA to completely remake it’s regulatory regime.”

So, while the Biden administration had not appealed other adverse lower court rulings, it challenged this one full bore. And because even the FDA concedes that its regulatory guidance has evolved, it faces the charge that its conduct has been well short of ideal.

The agency has not been clear about what the vaping companies must show to get the go-ahead for flavored e-cigarettes, says Adler, a law professor at Case Western Reserve University. He notes that the FDA “initially asked companies what they would do to prevent the marketing of their products to children,” but the agency later decided “it didn’t think any restrictions on marketing would do enough so it stopped looking at those.”

Basically, the companies claim that because the specific demands of the agency have been a moving target, the rules are arbitrary and capricious in violation of federal administrative law.

Former FDA deputy commissioner Schultz has a different take. He notes that just as the agency in the past had to gain experience with earlier products and devices that it was charged with regulating, it has had a similar task in dealing with the explosion of vaping devices over just the last few years.

Indeed, the FDA stopped looking at the marketing of vaping products to children because the agency concluded that there was no way to allow flavored e-cigarettes without harming large numbers of children. To date, the only flavored e-cigarettes the agency has approved for sale are those that are tobacco and menthol flavored. The FDA said essentially that those flavors are more likely to get adults off regular and far more dangerous cigarettes and less likely to attract underage users.

The Supreme Court could rule in many different ways in the case, with experts saying the ultimate decision could be a narrow one. Keep in mind, though, that the conservative Supreme Court supermajority has not hesitated to redraw the regulatory map, and if it does so in this case, it could well open the floodgates to flavored e-cigarettes that greatly increase the number of kids vaping their way through middle and high school.