In early December, the Supreme Court heard oral argument in Food and Drug Administration v. Wages and White Lion Investments, a challenge to the FDA's denial of marketing approval for flavored vaping products. The specific question before the Court is whether the U.S. Court of Appeals for the Fifth Circuit correctly concluded that the FDA's denial of specific vaping product applications was arbitrary and capricious. Among other things, the FDA is accused of a bait-and-switch in evaluating vaping product applications, applying different standards to product applications than it had said it would apply.
A particular sticking point is that the FDA appears to have adopted a more stringent standard for non-tobacco-flavored vaping products without having done so officially, as through a rulemaking, or otherwise giving manufacturers notice of the policy. Indeed, it appears that the FDA has adopted a de facto ban on non-tobacco and non-menthol-flavored vaping products* by requiring such products to meet a higher threshold for approval--a threshold that no such products have been able to meet. So vaping companies can only make their products taste like cigarettes, but not anything else.
[*Note: All vaping products are flavored. What are generally referred to as "flavored" vaping products are those with non-tobacco flavors, whether menthol or something else (e.g. vanilla, coffee, fruit, etc.).]
To date the FDA has only approved a few dozen of the over one million vaping product applications it has received. If this trend continues, the FDA regulatory process is likely to cartelize the industry, and may jeopardize the public health benefits of vaping products.
As the FDA acknowledges, vaping products are far-less-dangerous than cigarettes and can help some smokers quit. Adding non-tobacco flavors is one way to make vaping products more appealing than cigarettes, including to current or would-be smokers. Yet the FDA has been reluctant to acknowledge this potential benefit of non-tobacco-flavored vaping products.
There is a growing body of empirical evidence that restricting or banning alternative flavors both reduces vaping and increases smoking. Given that smoking is vastly more dangerous than vaping (to users and bystanders both), this is a real public health concern.
The most recent study to document this substitution effect, and finding that removing alternative flavors from the market can increase smoking, comes from a just-published paper in JAMA Health Forum: "Flavored E-Cigarette Sales Restrictions and Young Adult Tobacco Use," by Abigail S. Friedman, Michael F. Pesko, and Travis R. Whitacre. Consistent with prior research, the paper finds that "restricting flavored ENDS sales is associated with reduced vaping but increased cigarette smoking among young adults, potentially offsetting these policies' public health benefits."
From the paper:
This study found that ENDS flavor restrictions were associated with decreases in vaping but marked increases in cigarette smoking among 18- to 29-year-old individuals compared with the trends expected without restrictions. Comparing effect estimates for restrictions outside Maryland suggests that, in the most conservative case, state restrictions on flavored ENDS sales yield 3.1 to 4.4 additional daily smokers for every 5 fewer daily vapers (unweighted, 2.2 ppt ÷ −3.6 ppt = 0.61; 0.61 × 5 = 3.1; weighted: 3.0 ÷ −3.4 = 0.88; 0.88 × 5 = 4.4). While these point estimates may seem small at first glance, they represent a 22% to 30% increase in daily smoking and a 76% to 80% reduction in daily vaping compared with young adults' rates in 2018, 1 year before the first state-level restriction on flavored ENDS sales went into effect.
These findings concur with a growing body of evidence that ENDS and cigarettes are economic substitutes among youth, implying that policies that make ENDS more expensive (taxes) or less appealing (flavor restrictions) are likely to increase use of more dangerous combustible cigarettes in this age group. These findings reinforce the need to consider young adults as a high-priority group when developing tobacco and nicotine policies.
Although our findings will disappoint advocates of aggressive ENDS flavor restrictions, the findings regarding Maryland's policy suggest an alternative. Specifically, Maryland's restriction on nonmenthol flavors in disposable and cartridge products was associated with reductions in both vaping and smoking. Because that policy exempts the open-system ENDS used more by adults than youth, it may offer a better target for interventions to reduce youth use without impeding adult smokers' substitution away from combustible cigarettes. Or perhaps exempting menthol ENDS dampened cross-product substitution, so that those who vaped flavors and did not want to quit were nudged toward vaping menthol instead of smoking cigarettes.
Until mid-2024, the US Food and Drug Administration had not authorized marketing for any nontobacco flavored ENDS, a track record that shifted in June of 2024 with the approval of 4 menthol ENDS submitted by NJOY (Altria Group; Scottsdale, Arizona). Although flavored ENDS remain widely accessible, it is unclear whether this pattern of marketing authorizations is paving a path toward policy outcomes more similar to those estimated by this analysis for Maryland vs other states' flavor restrictions. Future research should further investigate the potential of ENDS flavor restrictions that exempt open-system devices and/or menthol to reduce young adult vaping without increasing cigarette smoking.
If anything, the authors of this study go easy on the FDA, as the agency has largely ignored this growing body of evidence in developing its approach to vaping regulation. Rather than promulgate vaping product standards, based upon a comprehensive assessment of the available empirical research on how the mix of available vaping products (including flavors) influences smoking rates and otherwise impacts public health, the FDA has engaged in case-by-case evaluation of individual vaping product applications using a standard that few products can meet. This has allowed the FDA broad latitude to deny the vast majority of applications on the grounds that individual applicants cannot show how approval of their specific product is consistent with public health while ignoring the fact that denial of all non-tobacco-flavored products could actually produce some of the public health harms--more young smokers--that the FDA says it wants to avoid.
While the FDA claims it wants to reduce the harm of smoking, there are reasons to suspect FDA regulation has done the opposite. The FDA's regulatory regime is driving less dangerous products from the market and barring manufacturers from informing consumers that their products are less dangerous than cigarettes and are often more effective at helping smokers quit than FDA-approved nicotine replacement therapies. The FDA is also not doing much to educate consumers (including smokers) about the relative risks of nicotine products. Indeed, since the FDA asserted regulatory authority over vaping products, public (mis)understanding of the relative risks posed by different sorts of nicotine products has gotten worse.
The question before the Supreme Court is ultimately about how federal courts should review agency action, not whether the FDA has adopted the best vaping product policy. But how the Supreme Court decides this case will have broad implications for vaping policy and public health.
For more on the Wages & White Lion case and the FDA's regulation of vaping products, I discussed these issues and more in a recent episode of TechFreedom's Tech Policy podcast with Corbin Barthold and Ari Cohn.
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