On Feb. 1, 12 senators across the political spectrum sent a letter to Xavier Becerra, secretary of the U.S. Department of Health and Human Services, railing against the inability of the Food and Drug Administration (FDA) Center for Tobacco Products to stop youth from vaping. While the letter is right about the ineffectiveness of tobacco product regulation, the authors fail to diagnose the root cause of the issue: Tobacco control is not a zero-sum game in the United States, where we have to pick who lives and who dies. There’s more than one tool to help the United States’s 30.8 million adult smokers, while also addressing youth vaping.
The crux of the argument rests on delays by the FDA to regulate e-cigarettes. They argue that “the agency has neglected its duty under the law to regulate e-cigarettes, jeopardizing the health of millions of children.”
They cite the FDA’s missed deadlines reviewing millions of premarket tobacco product applications (PMTAs), which serve as the regulatory pathway for e-cigarettes and other tobacco products. There have even been delays enforcing denials and removing unregulated e-cigarettes from the market.
Delays, delays, delays. While the FDA has rejected millions of products from the market, those products together represent only a fraction of total e-cigarette sales. In fact, the FDA has asked for yet another extension to make decisions on the most popular e-cigarette brands available on store shelves today.
Admittedly, the PMTA process is complex and is inadvertently shutting small vape companies out of the market. A key part of this process requires significant data to indicate whether a product is appropriate for the protection of public health. The process is also expensive, with the FDA estimating an average cost between $200k-500K per application, but the costs are actually much higher.
In a lawsuit against the FDA by two vapor companies that received marketing denials, costs incurred for a handful of the required tests ballooned to over $300,000 for just one e-liquid product. It stands to reason that well-resourced companies have an advantage in the process. The more funding for application preparation, the better the odds of approval.
But the authors of the letter exclude adult smokers, the biggest population with the most to gain from e-cigarettes. Instead, they push the false narrative that youth vaping is still an epidemic. While there was an uptick last year, youth vaping has declined significantly since 2019. And it is illegal to purchase e-cigarettes if you are under 21 years of age. If the FDA isn’t willing to use all its health tools to help adults quit smoking combustible cigarettes and address youth vaping simultaneously, then it isn’t taking either crisis seriously.
In their attempt to protect youth, policymakers have committed a grave offense.
They have positioned tobacco control as zero-sum. In this framework, reducing youth vaping comes at the expense of helping adult smokers kick their combustible cigarette habits. This cognitive dissonance is astounding as policymakers simultaneously push opioid harm reduction efforts while rejecting the same for tobacco.
As a result, the United States is falling behind in the global race to reduce smoking rates. For instance, the United Kingdom’s National Health Service – arguably the gold standard for tobacco control – found that those who used e-cigarettes to quit smoking were “twice as likely to succeed” as those who did not. The evidence is clear that e-cigarettes are more effective than nicotine patches and other FDA-approved therapies to help people to quit smoking.
The FDA has a golden opportunity to establish a forward-looking and transparent strategy, leveraging the latest evidence on e-cigarettes to help eliminate smoking across all population demographics. Tobacco harm reduction should be paired with stronger age enforcement for purchasing tobacco products and youth awareness campaigns based on fact and not fiction.
This is not a compromise. Ending the war on vaping, like ending any war, is a way to save more lives.
Mazen Saleh is the policy director of Integrated Harm Reduction at the R Street Institute.