In early December, the Supreme Court heard oral arguments. Food and Drug Administration (FDA) v. Wages and White Lion InvestmentA challenge to the FDA’s denial of marketing authorization for flavored vaping products. The court’s specific question is whether the U.S. Court of Appeals for the Fifth Circuit correctly concluded that the FDA’s rejection of certain vaping product applications was arbitrary and capricious. Among other things, the FDA has been accused of bait-and-switch, applying a different standard to e-cigarette product applications than it said it would apply when evaluating them.
Particularly troubling is that the FDA appears to have adopted more stringent standards for tobacco-free vaping products without formally enacting regulations or informing manufacturers of their policies. In fact, the FDA appears to have adopted a de facto ban by requiring tobacco and non-menthol flavored vaping products* to meet higher approval standards. This is a standard that the product was unable to meet. . So vaping companies can only make tobacco flavors in their products, 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 approved only a few dozen of the more than a million vaping product applications received. If this trend continues, the FDA regulatory process will likely cartelize the industry and jeopardize the public health benefits of vaping products.
As the FDA acknowledges, vaping products are much less dangerous than cigarettes and may help some smokers quit. Adding non-tobacco flavors is one way to make vaping products more appealing than cigarettes to both current and prospective smokers. However, the FDA has been reluctant to acknowledge these potential benefits of non-tobacco flavored vaping products.
There is growing empirical evidence that restricting or banning alternative flavors reduces vaping and smoking. Smoking increases. Considering that smoking is much more dangerous than vaping (both for the user and bystanders), this is a real public health issue.
The most recent study documenting this substitution effect and found that removing alternative flavors from the market could lead to an increase in smoking. JAMA Health Forum: “Restrictions on the sale of flavored e-cigarettes and youth tobacco use,” By Abigail S. Friedman, Michael F. Pesko, and Travis R. Whitaker. Consistent with previous research, the paper found that “restricting the sale of flavored ENDS is associated with reductions in vaping but also with increases in cigarette smoking among young adults, potentially offsetting the public health benefits of these policies.” Yes.
From the paper:
The study found that ENDS flavor restrictions were associated with reduced vaping but also significantly increased cigarette smoking among individuals ages 18 to 29 compared to the trend expected in the absence of restrictions. Comparing effect estimates to restrictions outside of Maryland, in the most conservative case, state restrictions on the sale of flavored ENDS would add 3.1 to 4.4 additional daily smokers for every five reductions in daily vaping (unweighted, 2.2 ppt ¼ − 3.6 ppt = 0.61; 0.61 × 5). = 3.1; Weighted: 3.0 ¼ −3.4 = 0.88; 0.88 × 5 = 4.4). These point estimates may seem small at first glance, but they show a 22% to 30% increase in daily cigarette smoking and a 76% to 80% decrease in daily vaping among young adults compared to the proportion of young adults in 2018, a year before the first week. indicates. Flavor ENDS sales level restrictions have been implemented.
These findings are consistent with growing evidence that ENDS and cigarettes are economic substitutes among youth, suggesting that policies that make ENDS more expensive (taxes) or less attractive (flavor restrictions) may lead to more risky use of combustible cigarettes in this era. This suggests that there is a possibility of increasing . group. These findings reinforce the need to consider young adults as a priority group when developing tobacco and nicotine policies.
Although our findings will disappoint advocates of aggressive ENDS flavor restrictions, our findings on Maryland’s policy offer an alternative. In particular, Maryland’s restriction of non-menthol flavors in disposable and cartridge products was associated with a decrease in vaping and smoking. Because the policy exempts open-ended ENDS, which are used more frequently by adults than youth, it may provide a better intervention target to reduce youth use without impeding adult smokers’ substitution of combustible cigarettes. Alternatively, exempting menthol could weaken cross-product substitution, causing people who vape flavors and don’t want to quit smoking to vape menthol instead of smoking cigarettes.
The U.S. Food and Drug Administration (FDA) will not approve marketing of any non-tobacco flavored ENDS until mid-2024, with the approval of four menthol ENDS submitted by NJOY (Altria Group, Scottsdale, Arizona) in June 2024. The record has been changed. Flavored ENDS remain widely accessible, but it is unclear whether these marketing approval patterns are paving the way toward policy outcomes more similar to those estimated by this analysis for flavor restrictions in Maryland and other states. Future studies should further explore the potential of ENDS flavor restrictions that exempt open system devices and/or menthol to reduce vaping in young adults without increasing cigarette smoking.
Anyway, the authors of this study are lenient on the FDA. That’s because the FDA largely ignored mounting evidence in developing its approach to regulating vaping. Instead of promulgating vaping product standards, the FDA will: Participated in case-by-case evaluations. Individual vaping product applications using standards that few products can meet. This gives the FDA broad authority to deny the majority of applications on the grounds that individual applicants cannot show how they were approved. their specific products It is consistent with public health while ignoring the fact that it is in denial. All non-tobacco flavored products In fact, it may produce some of the public health harms the FDA says it wants to avoid: more young smokers.
Although the FDA claims it wants to reduce the harms of smoking, there is reason to suspect that its regulations do the opposite. The FDA’s regulatory framework forces less dangerous products off the market and prohibits manufacturers from telling consumers that their products are less dangerous than cigarettes and are more effective in helping smokers quit than FDA-approved nicotine replacement therapies. The FDA also doesn’t do much to educate consumers (including smokers) about the relative risks of nicotine products. In fact, since the FDA asserted its regulatory authority over vaping products, the public’s (mis)understanding of the relative risks posed by different types of nicotine products has worsened.
The question for the Supreme Court is ultimately not whether the FDA has adopted the best vaping product policy, but rather how federal courts should review the agency’s actions. But how the Supreme Court decides this case will have far-reaching implications for e-cigarette policy and public health.
For more information king and white lion I discussed these issues and more as it relates to the FDA’s regulation of vaping products. Latest episode of TechFreedom’s technology policy podcast With Corbin Barthold and Ari Cohn.
