In a significant update, the FDA has announced the rescission of the marketing denial orders (MDOs) issued to JUUL Labs, Inc. This development comes after a complex, two-year process involving scientific review, legal battles, and evolving regulatory standards. Here's a detailed look at the journey leading to this decision and what it means for JUUL and the broader e-cigarette industry. 

The Initial Decision: Marketing Denial Orders in 2022 

On June 23, 2022, the FDA issued MDOs to JUUL Labs, Inc. for all its products being marketed in the United States. The agency determined that JUUL's premarket tobacco product applications (PMTAs) lacked sufficient evidence regarding the toxicological profile of their products. Concerns were raised about genotoxicity and potentially harmful chemicals leaching from the e-liquid pods, preventing the FDA from completing a full toxicological review. These issues led to the conclusion that JUUL's products did not meet the public health standard required by law. 

Juul Wins Temporary Stay of FDA Marketing Denial Order 

On June 24, 2022 a federal appeals court granted Juul Labs Inc. an emergency administrative stay of the U.S. Food and Drug Administration's marketing denial order (MDO) of JUUL products, pending further order of the court.  

In a statement following the appeals court action, Gregg Augustine, senior VP, US Commercial JUUL Labs said “As a result of the Court’s action, we will continue to responsibly market our products as we have up to this point pending the Court’s ruling on our forthcoming motion to stay.” 

 “As we previously said, we strongly disagree with the FDA’s decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency. We continue to believe our application provided robust data showing JUUL products meet the statutory standard of being ‘appropriate for the protection of the public health.’ This order allows us to continue engaging with our regulators in pursuit of a science and evidence-based determination for our products.” 

Immediate Reversal: Administrative Stay in July 2022 

Less than two weeks later, on July 5, 2022, the FDA administratively stayed the MDOs. The agency recognized that certain scientific issues warranted additional review. This decision marked the beginning of an extensive re-evaluation process involving toxicology, engineering, social science, and clinical pharmacology disciplines. 

JUUL responded to the FDA decision in a statement posted on their website.” With the administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the Agency’s internal review process. We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health. We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for JUUL products.” 

The Role of Litigation and New Case Law 

During the period of administrative stay, new litigation outcomes from other e-cigarette manufacturers significantly influenced the FDA's approach. These court decisions established new case law, providing a clearer legal framework for the FDA’s reviews. The evolving legal landscape required the FDA to reconsider its initial MDOs in light of new scientific data and judicial precedents. 

Today's Update: Rescission of the MDOs 

Today, the FDA has officially rescinded the MDOs issued to JUUL Labs, Inc. This decision is partly due to new case law and partly because of additional information provided by JUUL. It's important to note that rescission of the MDOs does not equate to an authorization or denial of JUUL's products. Instead, it reverts the applications to pending status, meaning they are back under substantive review by the FDA. 

The rescission indicates that JUUL's applications will be scrutinized once more under the current scientific and regulatory standards. The FDA emphasizes that this action does not alter the legal requirement for all e-cigarette products, including those from JUUL, to have FDA authorization to be marketed legally. 

Looking Ahead: What This Means for the Industry 

As the FDA's review process continues, stakeholders in the e-cigarette market will be watching closely. The outcome of JUUL's PMTAs could set important precedents for other manufacturers and influence the future regulatory landscape for nicotine products. 

The FDA's rescission of the MDOs issued to JUUL Labs, Inc. is a significant milestone in a complex regulatory saga that has spanned two years and involved substantial legal and scientific scrutiny. As JUUL's applications return to pending status, the industry awaits further developments that will shape the future of e-cigarette marketing and public health in the United States.