The FDA’s Long-Overdue JUUL Authorization Exposes a Deeper Regulatory Failure

On July 17, the U.S. Food and Drug Administration (FDA) issued marketing orders for four JUUL e-cigarette products – an authorization long overdue. This decision came after the agency initially denied JUUL’s applications in June 2022, only to rescind that denial a month later, citing the need for additional scientific review. While adult tobacco consumers and harm reduction advocates may see this as a win, it is yet another example of the FDA’s failure to effectively regulate a robust tobacco harm reduction marketplace in the United States.

It took five years for the FDA to issue marketing orders for JUUL, despite the 2009 Family Smoking Prevention and Tobacco Control Act requiring the agency to make determinations on applications within 180 days. To date, the FDA has consistently failed to meet this statutory requirement.

More concerning is that the FDA’s approach to regulation increasingly reflects an ideological tobacco control agenda, rather than a science-based public health mission. The agency appears to have strayed from its regulatory role and entered the realm of prohibitionist policymaking.

In 2022, when initially denying JUUL’s application, the FDA claimed the company had not provided sufficient evidence on the toxicological profile of its products to demonstrate they were “appropriate for the protection of public health.” The very next day, the U.S. Court of Appeals for the D.C. Circuit issued an administrative stay of the denial. On July 5, 2022, the FDA followed suit, issuing its own administrative stay and placing the applications back under scientific review in June 2024. It took another full year – nearly double the legally allowed time – for the agency to finally issue its authorization.

With the latest JUUL order, only 39 e-cigarette products are currently authorized for sale in the U.S. – and all come in either menthol or tobacco flavor. Since 2021, the FDA has denied millions of applications, including those from small business owners, covering a wide array of products from disposables to bottled e-liquids.

The agency continues to justify its denials by citing the potential appeal of flavored products to youth. In one such denial, then-Acting FDA Commissioner Janet Woodcock stated that flavored tobacco products are “very appealing to young people,” and therefore youth use is a critical factor in marketing decisions. This rhetorical alignment with anti-tobacco advocacy groups reveals the agency's prioritization of youth prevention over the health and choices of millions of adults.

But the FDA’s narrow focus ignores critical data. As of 2024, youth e-cigarette use is at a 10-year low. At the same time, e-cigarette sales have surged, and adult smoking rates are at their lowest levels in recorded history. In 2023, only 5.6 percent of U.S. adults aged 18 to 24 were currently smoking – compared to 30.6 percent in 2007, the year e-cigarettes were introduced to the U.S. market. This marks an 81.8 percent decline in smoking among young adults.

That decline corresponds with increased vaping. In 2023, 30.4 percent of adults aged 18 to 24 were using e-cigarettes. And contrary to common media narratives, vaping is not limited to young people. More than two-thirds of vapers in 2023 were 25 or older, with nearly half (49.2 percent) between the ages of 25 and 44. In some states, such as Hawaii, adult vaping even surpassed smoking – 10.1 percent versus 9 percent, respectively. These shifts represent meaningful public health progress and long-term reductions in smoking-related disease.

Yet despite these gains, misinformation about nicotine continues to confuse both the public and the medical community. This confusion, combined with the FDA’s sluggish and overly restrictive regulatory framework, leaves many adults and healthcare professionals in the dark about the role of nicotine and the harm reduction potential of non-combustible products.

A 2021 Rutgers University study found that the majority of U.S. healthcare providers mistakenly believe nicotine is responsible for the diseases and deaths caused by smoking. Similarly, an international survey of nearly 15,000 physicians across 11 countries found that two-thirds believed nicotine causes cancer, and three-fourths thought it causes chronic obstructive pulmonary disease (COPD). Another 2021 analysis of over 9,000 U.S. adults found that misperceptions about nicotine were common and correlated with lower cessation success, reduced likelihood of switching to less harmful products, and underutilization of nicotine replacement therapies.

While the JUUL authorization is a step forward, it comes far too late and highlights the broader dysfunction at the FDA. The agency must accelerate its review process and authorize more products – particularly those that appeal to adults and provide effective alternatives to combustible tobacco. It is possible to balance concerns about youth access while ensuring that the 30 million adults who still smoke have access to safer options.

The time has come for the FDA to move beyond its political posturing and fulfill its public health mission. That means approving more than just 39 e-cigarette products and embracing the full spectrum of tobacco harm reduction tools – from heated tobacco to oral nicotine pouches. Anything less is a dereliction of duty – and a disservice to millions of Americans trying to live longer, healthier lives.

Nothing in this is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.