COMMENTARY: FDA’s failure fuels confusion and overreach on vaping

With only a handful of state legislatures still in regular session and more than a dozen in special sessions, adult vapers and users of other alternatives to combustible cigarettes are enjoying a brief reprieve from new tax hikes and restrictions on tobacco and vapor products.

Despite campaign-trail promises from Donald Trump to protect flavored vapor products, tobacco harm reduction tools remain under increasing threat — this time because of the FDA’s persistent failure to regulate and authorize these products effectively.

Rather than waiting for states to enact patchwork and often prohibitive policies, what’s needed is a straightforward, science-based, top-down regulatory approach — starting with the FDA — to help reduce smoking rates among the 30 million adults still using combustible cigarettes.

The 2025 legislative season has already produced sweeping changes. Indiana lawmakers passed a budget that tripled the state’s cigarette tax and doubled the vape tax to 30 percent. In Illinois, a tax increase on vaping products and nicotine pouches — from 15 percent to 45 percent — took effect July 1. Meanwhile, several states, including Hawaii, Oregon and Washington, debated, but ultimately failed to pass, flavor bans.

Beyond taxes and bans, a new trend has emerged: vape directory bills. These laws empower state tax departments to enforce lists of permitted vapor products, often through inspections and penalties for retailers selling unapproved items. Just two years ago, only a few states, such as Alabama, Iowa and Louisiana, had such directories in place. Between 2024 and 2025, nearly 40 states introduced legislation to enforce federal rules at the state level, and 15 now operate official directories.

State-level regulation isn’t inherently problematic. It becomes a major issue when enforcement hinges on FDA authorizations, particularly given the agency’s inability to process applications in a timely or transparent manner. The FDA’s premarket tobacco product application process has proven to be opaque, slow and biased toward large corporations, sidelining the small U.S. businesses that pioneered the vaping industry and led the charge in reducing cigarette use.

E-cigarettes entered the U.S. market in 2007, and the FDA’s first response was to attempt to regulate them as unapproved medical devices. It wasn’t until 2009, when Congress passed the Family Smoking Prevention and Tobacco Control Act, that the agency gained authority over tobacco products. After years of legal battles, a 2011 court decision affirmed that the FDA could regulate e-cigarettes but only as tobacco products.

In 2016, the FDA issued the “deeming rule,” officially bringing e-cigarettes under its regulatory umbrella and requiring manufacturers to submit applications to sell their products legally.

Here’s where the process broke down: the act defines “new” tobacco products as anything introduced after Feb. 15, 2007, a date that predates the arrival of e-cigarettes. As a result, these products must undergo the burdensome application process, unlike conventional cigarettes, which can use the substantially simpler “substantial equivalence” pathway.

The results are damning. Nearly two decades after e-cigarettes first appeared in the United States, the FDA has authorized only 34 vapor products, all in tobacco or menthol flavors. Only 47 products have completed the federal application process. Meanwhile, 20 million adults, a 68.6 percent increase from 2016, are using e-cigarettes to stay smoke-free.

Flavored vapor products aren’t some nefarious scheme to attract youth. They’re a critical tool for adult smokers trying to quit. A 2018 survey of nearly 70,000 American adult vapers found that 83.3 percent used fruit flavors and 72.3 percent used dessert flavors “at least some of the time.”

The FDA’s dysfunction has not only stalled innovation but has bred confusion. E-cigarettes account for less than 1 percent of all FDA-authorized tobacco products. Thousands of traditional combustible cigarettes have received authorization, while far safer alternatives remain mired in regulatory limbo. When a federal health agency is more likely to approve a Marlboro than a mango-flavored vape, it’s no surprise that lawmakers and the public remain misinformed about nicotine and harm reduction.

Until the FDA streamlines and modernizes its process, states will continue stepping in, with inconsistent and often counterproductive results. The blame starts at the top. If we’re serious about ending the smoking epidemic, then the FDA must stop dragging its feet and start putting public health over bureaucracy.

Lindsey Stroud is the manager of Tobacco Harm Reduction 101. Christian Josi is the founder and managing director of C. Josi &Co., a public affairs consultancy. They wrote this for InsideSources.com.