Despite compelling evidence from numerous consumer surveys and research papers, the U.S. Food and Drug Administration (FDA) remains steadfast in its refusal to authorize the sale of non-tobacco-flavored e-cigarette products. As of April 2024, only 23 products have received approval from the nation’s leading tobacco regulator, all of which are solely available in tobacco flavor.
Nevertheless, sales of unregulated flavored e-cigarette products continue to rise. This growth has coincided with a decrease in cigarette sales among adult smokers, suggesting that adults indeed appreciate flavored options. Furthermore, flavors play a crucial role in facilitating both the transition to a less harmful alternative and the maintenance of a smoke-free lifestyle. It is high time for the nation’s leading health agency to acknowledge the potential of flavored e-cigarettes to significantly reduce smoking rates.
According to annual reports filed with the U.S. Securities and Exchange Commission (SEC), major manufacturers of traditional tobacco products are expressing concern over the expansion of the flavored disposable e-cigarette product category.
In one SEC filing, a manufacturer highlighted a decline of 11.4 percent in combustible volume from 2022 to 2023, attributing this decrease to the ban on flavors in California and the growing popularity of flavored disposable products. Another manufacturer in a separate SEC filing, acknowledged that the “growth of innovative tobacco products … has contributed to reductions in the consumption levels and industry sales of volumes of cigarettes and other tobacco products.” The company observed that the use of flavored disposable products has surged, compromising a significant portion of the e-vapor category, and has encouraged adults to transition and led a “higher-than-expected” decline in domestic cigarette industry volumes.
These declines in combustible cigarettes sales should not only be welcomed by the FDA, but should also provide the necessary data indicating that flavored e-cigarettes are “appropriate for the protection of public health (APPH)” – the criterion the agency relies on when evaluating and tobacco and/or vapor product.
Despite receiving over 25 million premarket tobacco product applications, largely for flavored e-cigarette products designed for non-youth appeal devices, the FDA rejected these applications, claiming insufficient evidence to justify meeting the APPH standard for adult smokers' potential benefits or significant reduction in cigarette use that would outweigh youth risks.
In February 2024, the agency issued denial orders to a large manufacturer for its menthol and flavored e-cigarette products, claiming the application “did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risks to youth.”
Essentially, in its denials, the FDA seems to prioritize preventing youth access over facilitating harm reduction for adult smokers.
There is encouraging news regarding youth vaping, as rates have substantially declined since reaching their peak in 2019. In 2023, only 7.7 percent of U.S. middle and high school students reported current e-cigarette use, translating to less than one in ten youths. However, despite this significant decline and with over 90 percent of youths abstaining from e-cigarettes, the FDA and other public health groups continue to characterize youth vaping as reaching "epidemic" levels, a characterization that is demonstrably inaccurate.
It appears that the FDA's expectation is for youth vaping rates to reach zero, an impractical and unattainable goal, which differs from the standard applied to tobacco product sales.
In 1992, Congress enacted the Synar Amendment to curb tobacco sales to youths, mandating states to reduce tobacco product availability to individuals under 18 through unannounced compliance inspections. To qualify for block grants, states were required to minimize tobacco product sales to minors. Before the amendment, approximately 76 percent of inspections resulted in sales to minors. By 1996, it was mandated that violation rates (sales to minors) should not exceed 20 percent of all checks.
If the 20 percent threshold is deemed acceptable for tobacco products sales to minors, what percentage of youth using such products is considered appropriate for marketing tobacco harm reduction products?
More alarmingly, while the FDA has denied millions of flavored tobacco harm reduction product applications, in 2023, the agency authorized the sale of more than 900 traditional tobacco products, including 662 combustible cigarettes—the most harmful of any tobacco products. The FDA's authorization of combustible cigarettes amid declining sales, largely due to the use of unapproved flavored e-cigarette products, is perplexing.
With declining youth usage and increasing adult adoption of e-cigarettes, many of whom have quit smoking, the FDA must reconsider its previous denial orders. Implementing a more comprehensive post-market surveillance plan for manufacturers could enable the agency to monitor and mitigate youth use while permitting U.S. companies to cater to adult preferences for flavored e-cigarette products.
Lindsey Stroud is a Senior Fellow at the Taxpayers Protection Alliance.
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