What Went Wrong With the FDA's Vaping Policy?
Congress passed the Family Smoking Prevention and Tobacco Control Act on June 22, 2009, and gave the Food and Drug Administration sweeping authority over tobacco products. Seven years later, in 2016, the agency issued a deeming rule that classified e-cigarettes and vaping liquids as tobacco products subject to premarket review. That decision required every device, flavor, and nicotine strength to win explicit FDA authorization before it could be sold legally. The rule was presented as a careful public health step. For thousands of small businesses, it became a slow-motion execution.
The FDA set a premarket tobacco product application deadline of September 9, 2020. A federal court later ordered the agency to review roughly 6.7 million applications by September 9, 2021. The agency has since issued marketing denial orders for more than one million products, often because manufacturers could not afford studies the FDA never clearly defined. The American Vaping Association has estimated that a single application can cost between $100,000 and $500,000 per stock-keeping unit. Most independent shops do not have that kind of capital.
By 2024 the FDA had authorized only a handful of tobacco-flavored products, such as Vuse Solo and Logic, while denying nearly every flavored application. That pattern told the market the agency was not interested in risk-based regulation. It wanted a flavor ban through paperwork.
Who Pays the Price When Shops Close?
The United States once supported more than ten thousand independent vape shops, according to trade group estimates, and many were opened by former smokers who believed they were helping friends and neighbors in working-class communities quit cigarettes. Each shop employed a handful of workers, paid rent, collected state sales tax, and supported local suppliers. When the FDA removes a flavor from the market, those shops lose inventory they already purchased. When the FDA removes enough flavors, the shop closes.
The damage is not spread evenly. Vape shops cluster in working-class neighborhoods and small towns where smoking rates remain highest. A 2023 Tax Foundation report found that state and local excise taxes on vaping products range from zero in some states to more than ninety percent in others. Heavy taxes on top of federal denials create a one-two punch that drives legal customers toward illicit sellers. The result is predictable. Sales move underground, tax revenue falls, and product safety becomes a guessing game.
Does the Science Support Lower-Risk Alternatives?
The Royal College of Physicians published a landmark report in 2016 estimating that e-cigarettes are likely no more than five percent as harmful as combustible cigarettes. Public Health England, now part of the Office for Health Improvement and Disparities, has maintained that vaping carries a small fraction of the risk of smoking. The American Cancer Society has acknowledged that completely switching from cigarettes to e-cigarettes reduces exposure to toxicants. The National Academies of Sciences, Engineering, and Medicine reached similar conclusions in its 2018 report.
The Centers for Disease Control and Prevention still reports that smoking kills about four hundred eighty thousand Americans each year. The CDC's 2023 National Youth Tobacco Survey found that 2.1 million middle and high school students reported current e-cigarette use, down from peak levels. Youth use deserves serious attention. But a policy that blocks adult smokers from flavored alternatives, while leaving cigarettes on every gas station shelf, is not serious public health policy. It is regulatory theater.
What Should Washington Do Now?
Congress should amend the Tobacco Control Act to create a streamlined, evidence-based pathway for lower-risk nicotine products and require the FDA to publish clear review standards before demanding multimillion-dollar studies. States should tax vaping products at rates that reflect their reduced risk relative to cigarettes, not at punitive levels that match or exceed tobacco taxes. Local governments should stop flavor bans that send adult smokers back to combustibles. Tax revenue from legal sales would rise if lawmakers stopped treating reduced-risk products like contraband.
The FDA should also stop punishing honest businesses for paperwork the agency itself failed to define. It should authorize products that meet reasonable safety standards and let the market compete against cigarettes. The agency could learn from the United Kingdom, where vaping products are regulated as consumer goods and public health agencies actively encourage smokers to switch. Competition works. When smokers have better options, many of them take them.
Entrepreneurs built the vaping industry in small shops across America. They did more to disrupt the cigarette business in a decade than decades of government campaigns. Washington should let them keep competing. Adult smokers deserve choices. Small business owners deserve fair rules. And the FDA should remember that its job is to protect Americans from harm, not to protect the tobacco oligopoly from competition.
