On June 21, the U.S. Food and Drug Administration (FDA) announced the agency was authorizing the sale of four menthol-flavored e-cigarette products through the premarket tobacco product application process. This marked a significant shift in the FDA’s regulatory approach to tobacco harm reduction products and was the first time the agency recognized the role that non-tobacco-flavored products can play in reducing harm. While this change is welcome, the FDA still lags behind in approving life-saving tobacco harm reduction products. The authorization orders bring the total number of legal e-cigarette products in the United States to only 27, illustrating how FDA’s tobacco regulatory authority is hampered by politics rather than guided by science.
Congress granted the FDA the authority to regulate tobacco products with the 2009 Family Smoking Prevention and Tobacco Control Act (TCA). This act established the Center for Tobacco Products at the FDA and required new products to seek FDA authorization (notably, the TCA specifies that FDA cannot "approve" tobacco products as this may be misleading) before entering the market.
The TCA essentially hinders the FDA from effectively regulating tobacco harm reduction products, such as e-cigarettes. The application pathways under the TCA do not take reduced harm into account but rather are bound by a specific cutoff date. According to the TCA, any tobacco product that was not on the market by February 15, 2007, is considered new. Manufacturers of products that were available in 2007 can apply using the substantial equivalence pathway, which is less burdensome. In contrast, products introduced after this date must navigate the more challenging premarket tobacco product application pathway.
Since 2013, the FDA has issued authorization orders for more than 16,000 tobacco products—including cigars, cigarettes, e-cigarettes, heated tobacco, hookah tobacco, and smokeless tobacco. As of June 2024, only 49 products have been authorized via the premarket pathway, in stark contrast to over 3,000 products approved via the substantial equivalence pathway. Alarmingly, out of the 16,000 products authorized, only 27 e-cigarette products have FDA authorization to be sold. This is insufficient for the more than 20 million American adults who were vaping in 2022 and the millions more who want to quit smoking combustible cigarettes with e-cigarettes.
Despite widespread misinformation, e-cigarettes and other smoking alternatives are significantly less harmful than combustible cigarettes and are associated with smoking cessation. Even major tobacco companies report declining cigarette sales amid the growing market for flavored disposable e-cigarettes in the U.S.—a trend the FDA has failed to adequately recognize.
While the authorization of menthol-flavored e-cigarettes is a step in the right direction, the agency continues to overlook the role of various other flavors in aiding adults to quit smoking. The argument that cigarettes taste awful and replacing that taste with something enjoyable not only serves as a reward system but also reinforces that cigarettes are undesirable. Youth are not the only demographic that enjoys flavors, and flavors are not the primary reason youth vape. The FDA, relying on national youth survey data, has issued denial orders for tens of millions of flavored e-cigarette products, claiming the risk of youth usage outweighs the benefits for adults switching. Yet, the same survey data reveals that the leading reason kids vape is due to anxiety, depression, and stress, with less than one in ten vaping because of flavors.
The FDA must reconsider the TCA entirely and how new products are brought to market. In 2023, the agency issued zero orders for e-cigarettes, yet authorized the sale of 943 additional tobacco products, including 662 for combustible cigarettes, a stance incongruent with an agency purportedly based on scientific principles.
Moreover, the FDA’s failure to authorize the tens of thousands of e-cigarettes currently on the market contradicts its apparent inability to educate adults about the continuum of harm associated with tobacco products. A growing number of Americans are misinformed about the real risks of nicotine, with many perceiving e-cigarettes as equally or more harmful than cigarettes. Since initially classifying e-cigarettes as a tobacco product, the FDA has authorized the sale of only 27 such products, while issuing more than 2,990 orders for combustible cigarettes. Essentially, for every e-cigarette authorized since 2016, 110 combustible cigarettes have been approved.
Almost 50 years ago, tobacco researcher Michael Russell noted, “People smoke for the nicotine, but they die from the tar.” Nearly half a century later, the FDA continues to promote more tar and restrict access to safer, regulated nicotine products. It is time for Congress to examine reforms to the TCA to ensure it aligns with scientific evidence.
