Vaping

Jacob Sullum | 12.4.2024 5:40 PM

The Food and Drug Administration (FDA) has never approved nicotine vaping products in flavors other than tobacco or menthol and probably never will unless it reconsiders the approach it has taken in recent years. But President-elect Donald Trump brags that he "saved flavored vaping" during his first term and promises he will "save vaping again."

The change in administrations underlines the stakes of FDA v. Wages and White Lion Investments, a case that the U.S. Supreme Court considered this week. Triton Distribution, a Dallas-based e-liquid manufacturer, is challenging the FDA's denial of its applications for "premarket" approval of its products, without which the company will be forced to shut down. If Triton prevails, it can stay in business while it submits new applications, and the FDA in the next administration is apt to be more receptive. That would be good news for adult vapers, including former smokers, who overwhelmingly prefer the flavors that the FDA has deemed an intolerable threat to the youth of America.

Last January, the U.S. Court of Appeals for the 5th Circuit ruled that the FDA had acted "arbitrarily and capriciously," in violation of the Administrative Procedure Act (APA), by changing the criteria for premarket approval after Triton's applications were submitted. The company's main complaint is that the FDA, which initially told applicants that no particular kind of scientific evidence was necessary, later decided that manufacturers had to cite long-term cohort studies or randomized trials indicating that vaping products with supposedly kid-friendly flavors are more effective than tobacco-flavored alternatives in helping smokers quit.

The FDA also changed its position on safeguards against underage access. Although the agency initially said such "marketing plans" were "critical," it explicitly ignored them in rejecting Triton's applications, saying age verification measures are not effective enough to negate the risk that minors might end up consuming the company's products.

Much of the questioning during oral argument focused on the issue of whether the FDA had in fact changed its criteria. Justices sympathetic to the agency suggested that manufacturers had adequate notice of its concerns about flavored vaping products.

The FDA "has been completely upfront about this," Justice Elena Kagan told Eric Heyer, Triton's lawyer. The agency "has tried to document" that "blueberry vapes are very appealing to 16-year-olds, not to 40-year-olds," she said. But as Heyer pointed out, that claim is inconsistent with survey data indicating that adult smokers who switch to vaping commonly favor fruit, dessert, and candy flavors.

Heyer also noted that his client's e-liquids, which are used with refillable vape systems, are not a common choice for teenagers. Deputy Solicitor General Curtis Gannon, representing the FDA, tried to rebut that point. "Seven percent of youth are still using
open tank systems or mod systems, according to survey results from earlier this year," he claimed.

That is not true either. According to the 2024........

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