SCOTUS Weighs FDA Block on Flavored Vapes
According to the article, a unanimous Supreme Court recently backed the Food and Drug Administration's (FDA’s) refusal to authorize the sale of kid-friendly flavored e-cigarettes and vapes, including the flavors "Killer Kustard Blueberry," "Rainbow Road," and "Pineapple Express."
Note: In addition to the video, please see the following article included at the above-referenced internet address:
“Supreme Court Upholds FDA Block of Flavored Vapes”
Justice Samuel Alito, in his opinion for the court, rejected the manufacturers' claims that the agency had acted arbitrarily and capriciously in violation of federal law by changing the requirements for product approval in the middle of the process.
"In the end, we cannot say that the FDA improperly changed its position with respect to scientific evidence, comparative efficacy, or device type," Alito wrote. He returned the case to a lower court for further review.
The ruling effectively holds the line on the government's decision to severely limit the number of flavored tobacco products legally available in the U.S. market out of concerns over the impact on children.
Kid-friendly flavors, such as fruit, candy, mint, menthol and desserts -- which are largely not approved by the FDA and are currently sold on store shelves illegally -- have been fueling an explosion in retail sales of e-cigarettes.
Youth Vaping Is Declining
While vaping among youth is declining, more than 1.6 million children use the products, according to the Centers for Disease Control and Prevention. Nearly 90 percent of them consume illicit flavored brands.
"Today's ruling is a major victory for the health of America's kids and efforts to protect them from the flavored e-cigarettes that have fueled a youth nicotine addiction crisis," said Yolanda Richardson, president of the Campaign for Tobacco-Free Kids, an advocacy group. She noted the FDA has denied over 26 million flavored e-cigarette product applications so far.
"While the FDA has authorized the sale of only 34 e-cigarette products, manufacturers continue to flood the market with thousands of illegal, unauthorized products," Richardson said in a statement.
"To end this crisis, the FDA must deny marketing applications for flavored e-cigarettes and step up enforcement efforts to clear the market of illegal products. Today's ruling should spur the FDA to act quickly to do so."
The Manufacturers’ Response
An attorney for the companies -- White Lion Investments LLC, operating at Triton Distribution, and Vapetasia LLC -- said in a statement they view flavored vapes as a safe and valuable alternative for smokers trying to quit.
"We are obviously disappointed in the outcome. Triton and Vapetasia continue to believe in the great harm reduction potential of their products for cigarette smokers. We look forward to further proceedings before the Fifth Circuit on the prejudicial error issue that the Supreme Court remanded," said Eric Heyer, the Thompson-Hine partner who argued the case.
Since 2009, federal law requires sellers of new nicotine products to provide regulators with scientific evidence to show that the products would promote public health, but the statute does not spell out specifically what evidence is necessary and sufficient. The FDA's guidance on how to meet that requirement was at the center of the case.
While the first Trump administration had taken a hard line against the marketing and sale sweet and candy flavored vapes, President Donald Trump said during the campaign that he wants to "save" flavored vapes. It's not clear how the FDA, newly under his control, may modify regulations around flavored vapes or alter the approval process.
The Option of Reapplying for FDA Approval
Despite their loss in the case, vape manufacturers can reapply for approval with the FDA in a new application and attempt to show how benefits of the product to public health would outweigh the dangers to teens.
"In light of the statutory text and the well-documented and serious risks flavored e-cigarette products pose to youth, it should have come as no surprise that applicants would need to submit rigorous scientific evidence showing that the benefits of their products would outweigh those risks," Justice Sonia Sotomayor concluded in a short concurring opinion in the case.
Discussion Questions
1. As indicated in the article, in his opinion for the U.S. Supreme Court, Justice Samuel Alito rejected the manufacturers' claims that the FDA had acted arbitrarily and capriciously in violation of federal law by changing the requirements for product approval in the middle of the process. Define “arbitrary and capricious.” What might justify changing the requirements for product approval in the middle of the process?
The term “arbitrary and capricious” refers to actions that are unreasonable, lack a rational basis, or are not supported by substantial evidence. In the legal context, it is a standard for judicial review and appeal often seen in administrative law cases such as the subject case.
Any number of developments could justify changing the requirements for product approval in the middle of the process, particularly scientific evidence regarding the addictive nature of nicotine, and the psychological appeal of certain flavors of e-cigarettes and vaping products to children.
2. Since 2009, federal law requires sellers of new nicotine products to provide regulators with scientific evidence to show that the products would promote public health, but the statute does not spell out specifically what evidence is necessary and sufficient. How could the sellers of nicotine products possibly provide evidence to show that their products would promote public health?
In your author’s opinion, the “path is narrow” for the sellers of new nicotine products to establish that their products will promote public health. The strongest argument for manufacturers of e-cigarettes and vaping products is that they provide a safer alternative for smokers trying to quit.
In your author’s opinion, each new nicotine product should be evaluated on its own merit, rather than comparing the relative safety (in terms of public health) of the new product versus an existing one. At the risk of presenting a less-than-perfect analogy, consider two methods of imposing the death penalty: (1) lethal injection and (2) firing squad. Although a legal injection may involve less “bodily harm” to the defendant than a firing squad, the result is still the same: death. Neither method of execution promotes the “public health” of death row inmates.
3. As indicated in the article, candidate Donald Trump said during the 2024 presidential campaign that he wanted to "save" flavored vapes. What reason(s) might justify “saving” such products?
The two obvious reasons that come to mind are (1) consumer demand and (2) the economic benefits associated with manufacturing e-cigarettes and vaping products (e.g., job creation).
Of course, with the government effectively acting as an intermediary in this case, the question is whether the costs associated with e-cigarettes and vaping products (particularly, those that appeal to children) outweigh the benefits. The U.S. Supreme Court has answered that question with a unanimous opinion, a seemingly “Herculean feat” considering the current reality of a politically charged and divided Court.
