On July 23, 2022, the Food & Drug Administration (FDA) denied Juul’s applications to market its e-cigarettes (devices and pods) in the United States, making their sale or marketing illegal. While long overdue, this denial is a significant step to protect public health because Juul has fueled the youth e-cigarette use epidemic. Juul’s e-cigarettes’ sleek, modern design, combined with a predatory, aggressive marketing campaign that glamorized their use, popularized the e-cigarettes and turned Juul into a billion-dollar company with an unparalleled share of the U.S. e-cigarette market. In fact, Juul’s market share prompted the tobacco industry giant, Altria Group, to buy a 35% stake in Juul for $12.8 billion. FDA’s denial of Juul’s marketing application will go a long way to protect children and young adults from the tobacco industry’s deadly products.
The decision to remove Juul e-cigarettes from the market is long overdue as the FDA has had the authority to regulate e-cigarettes since 2016. When Congress enacted the Family Smoking Prevention & Tobacco Control Act (TCA), it gave the FDA the authority to regulate tobacco products and any other products the FDA deemed to be subject to the TCA. Using that authority, the FDA issued a regulation, known as the “deeming rule,” finding that e-cigarettes fell within the TCA’s definition of “tobacco product.” Thus, Juul is subject to the same rules as other tobacco products, including the FDA’s premarket review. Through premarket review, the FDA assesses new products—including e-cigarettes—and can authorize their marketing only if such marketing would be “appropriate for the protection of public health.”
Although no e-cigarette had received a marketing authorization when the FDA issued the deeming rule, the FDA allowed e-cigarettes to remain on the market but established a staggered deadline for e-cigarette manufacturers to submit premarket review applications and the FDA to act on those applications. The FDA subsequently revised this staggered deadline, effectively allowing certain e-cigarettes to remain on the market indefinitely without marketing authorization. E-cigarette manufacturers and sellers, including Juul, exploited FDA’s lax approach and aggressively marketed their products, leading to millions of children and young adults getting hooked on e-cigarettes. It was not until a group of public health advocates sued the FDA that a court ordered a definitive timeline for when e-cigarettes without FDA authorization had to be removed from the market. Since then, the FDA has reviewed thousands of marketing applications, granting some and denying others. Juul’s marketing denial order is the latest in the series of denials.
The FDA denied Juul’s marketing application because it did not demonstrate that Juul’s e-cigarettes could meet the TCA’s public health standard. In denying Juul’s applications, the FDA noted that “the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” While the FDA’s action is long overdue, it is a move in the right public health direction that will protect millions from the health harms associated with e-cigarettes.
Andrew Twinamatsiko is the associate director of the Health Policy and the Law Initiative at the O’Neill Institute