This week, British American Tobacco (BAT) announced it has “paused a pilot plan to launch an unlicensed disposable vape in the U.S.” The decision marks a reversal for the tobacco giant, which had planned to introduce a product still awaiting a marketing order from the U.S. Food and Drug Administration (FDA) – despite submitting a premarket tobacco application (PMTA) the agency has yet to act on, along with millions of others.

BAT’s decision reportedly comes in response to the FDA’s purported fast-tracking of PMTAs for certain nicotine pouch products. But more broadly, it reflects a shifting tobacco landscape – and how federal overreach continues to stifle adult access to safer alternatives to cigarettes while crushing small businesses and innovation.

In August, BAT announced plans for a pilot launch of its Vuse One disposable vape, which uses synthetic nicotine and has a pending PMTA before the FDA. Sales were expected to begin in the fall. Now, the launch has been scrapped.

The original plan was bold. Over the past several years, BAT – like other major manufacturers – has poured millions, if not billions, of dollars into curbing the rise of unauthorized disposable vapes flooding the U.S. market. The company has supported legislation at the state and local levels directing state taxpayer-funded agencies to enforce FDA regulations. These manufacturers have also worked with federal agencies, including U.S. Customs and Border Protection, to block illegal imports and has engaged in numerous lawsuits arguing such products violate federal law.

Despite these efforts, BAT still had 50 vapor PMTAs pending before the FDA as of July 2024. The Tobacco Control Act requires the agency to rule on PMTAs within 180 days – a deadline the FDA has blown past for virtually every application.

But the burden of this dysfunction isn’t limited to Big Tobacco. Thousands of small businesses have been shuttered by an agency behaving more like an arm of tobacco control activism than a neutral regulator. Worse, in repeatedly denying marketing orders for products demonstrably safer than cigarettes, the FDA is helping to prop up cigarette sales and hinder the goal of a smoke-free America.

Back in 2017, then–FDA Commissioner Scott Gottlieb emphasized that tobacco and nicotine products exist on a continuum of risk. This concept is hardly new: for more than half a century, scientists and public health experts have understood what famed researcher Michael Russell once wrote – “people smoke for the nicotine, but they die from the tar.”

Nicotine itself, while addictive, is not the primary cause of smoking-related disease. Its stimulant effects are comparable to caffeine. It’s the smoke – the combustion – that kills. Cigarettes contain around 600 ingredients that, when burned, produce more than 7,000 chemicals, including 69 known carcinogens.

By contrast, products that eliminate or reduce combustion – like e-cigarettes and smokeless tobacco – dramatically lower health risks. The FDA itself has acknowledged that “non-combusted tobacco products generally have lower health risks than cigarettes and other combustible tobacco products.”

Yet despite recognizing this continuum of risk, the agency’s actions tell a different story. Since 2017, the FDA has issued only 73 PMTA marketing orders for all tobacco products it deemed “appropriate for the protection of public health.” During the same period, it issued 1,269 substantial equivalence (SE) orders – including 414 for combustible cigarettes. Of the 73 PMTA authorizations, only 39 were for e-cigarette products.

Put simply, for every one e-cigarette authorized, the FDA has cleared more than 10 cigarettes for sale.

It’s no wonder, then, that an enormous unregulated market has emerged. As of early 2025, unauthorized vapes in the U.S. were valued at over $2.4 billion, accounting for roughly one-third of retail e-cigarette sales.

There are, however, reasons for cautious optimism. At a recent regulatory conference, Brett Koplow, the acting director of the FDA’s Center for Tobacco Products, reportedly spoke in favor of promoting tobacco harm reduction to reduce cigarette smoking. The data back him up: in the U.S., rising adult vaping rates have corresponded with sharp declines in smoking. Among adults aged 18–24, just 5.6% currently smoke – while that same group makes up the largest share of vapers.

E-cigarettes first entered the U.S. in 2007 – two years before the FDA gained authority to regulate tobacco products. Nearly two decades later, it’s long past time to reform an agency that too often acts as an obstacle to innovation and public health.

If the FDA truly cares about reducing smoking, it should start by authorizing more products on the low end of the risk continuum – and stop protecting the deadliest one of all.

Lindsey Stroud is founder and president of Tobacco Harm Reduction 101, a 501(c)(3) nonprofit organization dedicated to research, education and advocacy for safer alternatives to smoking.