The federal government has spent years restricting access to alternatives to smoking, and the results are predictable: fewer legal options and a thriving unregulated market. The Food and Drug Administration’s (FDA’s) new draft guidance on flavored vapes does little to change that trajectory. If regulators want to know which vaping products help adults quit smoking, they do not need new studies—they need to look at the market.
The FDA’s new draft guidance maintains the agency’s position that fruit and sweet vape flavors increase youth tobacco product use—despite teens not reporting flavors as a major reason for vaping—while attempting to carve out a pathway for flavors it considers less appealing to youth, such as “coffees, teas, and spices.” But there is little to no market for these products, while demand for fruit, sweet, and menthol remains strong. That gap underscores how ineffective this approach is likely to be.
The existing market also exposes the flaw in the FDA’s recommendation that applicants demonstrate the relative appeal of their products. This is a basic function of markets. If the FDA wants to know what flavors adults prefer, it can see what is already being sold: shelves dominated by sweet, fruit, and menthol flavors. If adults preferred coffee, tea, or spices, those flavors would be widely stocked. Attempting to engineer consumer preferences is a losing strategy.
The FDA also recommends that applicants show their flavors provide an added benefit over tobacco-flavored vapes. This requirement is redundant. Evidence already shows that non-tobacco flavors—especially sweet flavors—are more effective at helping adults quit smoking. Again, revealed preference makes this clear: tobacco-flavored vapes occupy a limited share of the market compared to flavored alternatives.
At the same time, the FDA proposes scaling approval standards based on its assessment of youth appeal. Because the agency views fruit and sweet flavors as most attractive to youth—and these are also the flavors adults most prefer—the most effective smoking cessation tools will face the highest regulatory barriers. This comes even as youth nicotine use continues to decline while these products remain widely available without formal approval.
The FDA acknowledges this trend in its own draft, noting that middle and high school vaping fell to 5.9 percent between 2019 and 2024.
The broader problem is that the FDA continues to discount the scientific consensus on vaping. It downplays the role flavored vapes play in helping adults quit smoking and ignores the sustained decline in youth vaping. It also continues to describe vaping as only “potentially less harmful” than smoking. By contrast, Johns Hopkins Medicine acknowledges that vaping is less harmful, and the Royal College of Physicians in London estimates vaping is no more than 5 percent as harmful as smoking.
The path forward is clear: align regulations with evidence and consumer behavior. That means recognizing that flavored vapes—particularly fruit and sweet varieties—are central to smoking cessation, not a problem to be regulated out of existence. Until the FDA accepts that reality, its policies will continue to protect cigarettes from their most effective competition.
Justin Leventhal is a Senior Policy Analyst for the American Consumer Institute, a nonprofit education and research organization that advocates for consumers through evidence-based analysis and data. Follow Justin on X @JustinLeventhal.