On June 6, 2024, the U.S. Food & Drug Administration rescinded its Marketing Denial Order for all Juul e-cigarette products. The effect of this action puts Juul’s premarket application back into pending status. According to FDA regulations, tobacco products without an authorization from the FDA cannot be legally marketed in the United States.

While the FDA’s decision to pull back on the MDO may sound like a significant setback, it appears to be an attempt to return to the status quo before June 2022 concerning Juul products. Although manufacturers with pending premarket applications are not allowed to sell their products, we know that many continue to do so at the risk of FDA enforcement. In places where Juul has continued to sell its products, it will likely continue to do so despite the lack of a marketing order -- risking FDA fines, injunctions, and seizures.

Lead-up to the Recission

In June 2022, the FDA issued a marketing denial order for Juul. Public health advocates hailed this decision as it seemed a concrete regulatory action taken after multiple Juul lawsuits were brought because of the health risks Juul products posed, especially to young people. After the FDA issued its MDO, Juul filed a lawsuit to contest the FDA’s decision. Shortly after that filing, the D.C. Circuit entered a temporary stay of the MDO at Juul’s request. Then on July 5, 2022, the FDA entered an administrative stay of its order to give itself time to conduct further scientific reviews unique to the Juul application. At the issuance of the administrative stay, the FDA noted that the MDO order was not rescinded, but that the agency would not enforce against Juul products in the marketplace.

Now almost two years later, instead of presenting additional scientific evidence, the FDA has rescinded the MDO. The FDA claims that part of the reason for the recission is that new case law has developed.

The Future of Regulation of E-Cigarettes

Juul at one point had the largest market share of e-cigarettes in the United States. While that status has been eclipsed, Juul’s fate at the FDA could signal how the agency is recalibrating its approach to regulating e-cigarettes in general.

The FDA notes that the legal landscape has changed regarding how the judiciary is deciding on cases where the industry has challenged FDA MDOs. Although the FDA does not cite specific lawsuits it is concerned about, it is likely that cases like Gripum, Wages and White Lion, and Bidi Vapor, which have not been decided in the FDA’s favor, are influencing the FDA’s decision to reconsider its approach. The opinions expressed in these cases have made it more challenging for the FDA to carry out its regulatory duties and evaluate new information in a timely manner. At the same time, the courts and industry favor a system that does not change and allows them to adhere easily to the guidance that the FDA disseminates.

The rescission is perhaps an opportunity for the FDA to try again at regulating Juul and other e-cigarettes to limit legal challenges or in a way that courts will uphold its regulations.

At this point, on the surface, FDA’s recission of the order looks like a step backwards. Yet, one result of the recission is to make Juul eligible again for enforcement from the FDA. As noted above, during the administrative stay, the FDA stated it would not enforce against Juul. Now, that Juul does not have a marketing order and cannot legally sell its products in the U.S., Juul is once again open to FDA penalties and other enforcement proceedings, including seizure.

While the FDA's decision to rescind Juul’s MDO may appear a setback, it actually repositions Juul back under the scrutiny of the premarket review process. This move underscores the complexities of regulating e-cigarettes in a shifting legal landscape, where recent court decisions have influenced the FDA's strategies. Although Juul and other manufacturers with pending applications are technically barred from selling their products, enforcement has been inconsistent. Now, with Juul's application pending once again, the FDA has the opportunity to enforce its regulations more stringently and potentially reshape its approach to e-cigarette regulation in a manner that better protects public health. It is possible that this period of reassessment and potential enforcement could lead to more robust regulatory actions that withstand judicial challenges and more effectively manage the e-cigarette market.

Esther Agbaje, Lead Senior Staff Attorney
June 10, 2024