The FDA is fighting the industry at the Supreme Court
The FDA hasn’t done enough: a lawsuit against the Biden administration against a high bar for flavors of cigarettes and vaping products
At the Supreme Court on Monday, the government’s lawyer told justices that flavors of cigarettes and vaping products have to meet a high bar in order to appeal to kids. Under the statute, a company must show its product is more likely to get adults off of tobacco cigarettes, and less likely to be used by under-age kids.
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.
Former FDA deputy commissioner Schultz has a different take. In the past the agency has had to learn about older products and devices it was supposed to regulate but in the last few years have had to deal with an explosion of Vaping devices.
The companies claim that the rules are arbitrary and capricious because of the demands of the agency.
While the Biden administration had not appealed other adverse rulings, it challenged this one full bore. Because the FDA acknowledges that its regulatory guidance has evolved, it faces the allegation that it has conducted itself in a way that is short of ideal.
Vaping in the U.S. and Canada: High-Year-Old Trials in the High-Jacobi Court
According to surveys conducted by the FDA and the Center for Disease Control and Prevention, the percentage of high school students who reported daily use of e-cigarettes jumped from 9.7% in 2014 to 30% in 2020.
Vaping can help some adult smokers quit cigarettes, as well as helping middle and high school kids smoke less tobacco products.
In the Supreme Court chamber on Monday, Chief Justice John Roberts asked Deputy Solicitor General Curtis Gannon, the government’s lawyer, whether the government has “an obligation to tell people what they have to do to comply with your regulation.”
The FDA gives fair notice that a business model is risky. It was not enough for the companies to have evidence that met the requirements in the statute.
Gannon noted that Congress was concerned about the fact that most people who become addicted to nicotine start when they are under age, “at a time when the adolescent brain is particularly vulnerable to the effects of nicotine.” Justice Jackson said that it is not a discretionary call of the FDA.
Lawyer Eric Heyer, representing the vaping companies, told the justices that without the approval of more flavors, many small vaping companies will be forced to shut their doors. The FDA tried to document that it’s difficult to appeal to younger people than40), and that it’s hard to find people who want to use the product.
The US government told the Supreme Court on Monday that flavors of cigarettes and vaping products have to meet a high bar in order to appeal to children. The government said the companies must show their product is more likely to get adults off of tobacco cigarettes and less likely to be used by under-age kids.