The FDA’s plan to fast-track nicotine pouches is long overdue. But why aren’t vapes included?

The U.S. Food and Drug Administration (FDA) launched a pilot program to fast-track authorization of nicotine pouches in September, according to Reuters. For public health advocates, this a welcome—if not long overdue—course correction. The agency’s sluggish and expensive approval process has stifled innovation and protected cigarette sales from competition for years while depriving adult smokers of access to safer alternatives.

But if the Trump administration is serious about reducing the harms of smoking and sticking to its campaign promises, this pilot program should be immediately expanded to include other non-combustible nicotine products, like e-cigarettes.

Currently, the expedited review for premarket tobacco applications (PMTAs) appears open only to nicotine pouches made by four companies, three of which are legacy tobacco firms. This comes as a gut-punch to e-cigarette makers, consumers, and advocates who have pleaded for a similar streamlined process for e-cigarettes since the FDA began regulating them in 2016. The agency’s failure to provide one has been catastrophic.

When Congress granted the FDA authority to regulate tobacco in 2009, the requirement to obtain premarket authorization applied only to new tobacco products. Legacy tobacco products—those marketed in the U.S. prior to 2007—were exempt from premarket authorization. This effectively shielded entrenched cigarette brands from newer, safer competitors, leading some to dub the law the “Marlboro Protection Act.”

This scenario became truly perverse in 2016. When the FDA deemed e-cigarettes subject to its oversight, all vaping products on the market were classified as “new” because there were no e-cigarettes on the U.S. market before 2007. Suddenly, every e-cigarette was forced into a prohibitively expensive and opaque PMTA process, while tobacco companies could continue introducing new cigarettes that were merely “substantially similar” to their legacy products. As many experts and some lawmakers warned, it made no sense to hold safer alternatives to a higher standard than the combustible products they were designed to displace. But the FDA ignored these warnings.

The result was a predictable public health disaster. The FDA’s unworkable approval process eliminated nearly every e-cigarette product available in 2016. Today’s e-cig market is a dystopian mix of the few Big Tobacco brands to receive FDA authorization and a flood of unauthorized e-cigarettes that poured into the U.S. market to fill the vacuum created by the FDA. Few of the independent companies that once existed could afford the $20 to $100 million cost of preparing a PMTA, nor wait the years it might take the FDA to make a decision. Those that tried were squeezed out of the market anyway. They could no longer legally compete with the legacy tobacco brands that received FDA authorization early or the unauthorized products still available in a range of flavors.

The story of Juul, once the dominant e-cigarette brand that was seen as an existential threat to cigarette sales, is just one particularly egregious example of how the FDA’s regulatory failure functionally handed the legal e-cigarette market to Big Tobacco.

In 2018, Juul was the undeniable leader in the e-cig market, representing nearly 70 percent of all e-cigarette sales. Its nearest competitor, British American Tobacco’s Vuse, captured just 13 percent. That year, Juul submitted its PMTA to FDA, reportedly spending over $100 million to prepare the 125,000-page document. But, while the FDA was statutorily required to make a decision within 180 days, it took five years. Juul only received authorization for its tobacco and menthol products this past July.

In the interim, Juul faced massive litigation, nearly went bankrupt, and fell behind its competitors. Vuse, which was authorized by the FDA in 2021, is now the market leader among authorized products, with 35% of sales. Juul is a distant third with 19%, earning fewer sales than even GeekVape—an authorized Chinese import. The technology has also advanced, making the now-approved first-generation Juul outdated before it was authorized. The company’s next generation product, which features built-in age-verification technology, has been available in the U.K. since 2022. But at the FDA’s current glacial approval pace, it will take the agency until 2030 to authorize its sale in the U.S., if it ever does.

The rise of nicotine pouches, arguably accelerated by the FDA’s destruction of the e-cigarette market, is a positive development. Like e-cigarettes, they have no combustion and do not even involve inhalation. As such, nicotine pouches are considered among the least-harmful of the safer smoking alternatives. Speeding up access to these products will undoubtedly benefit public health by giving adult smokers more options to reduce smoking-related risks. But pouches will not work for every smoker, especially those accustomed to the hand-to-mouth ritual of smoking. And it remains unclear if pouches are as effective for smoking cessation as e-cigarettes have proven to be.

The new pilot program is a quiet admission that the PMTA process is broken. It is a small step in the right direction. But, to truly fulfill its public health mission, the FDA must expand this accelerated pathway to include e-cigarettes. Doing so would give adult smokers a full range of life-saving options and allow legal U.S. companies to outcompete the growing illicit market. Streamlining the PMTA process for e-cigarettes is not just sound policy, it is a long overdue correction to a harmful regulatory failure.

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