July 24, 2025
We are writing today to share our perspective on a recent and important development in the U.S. FDA regulatory space: the marketing granted orders issued to JUUL Labs for their JUUL System closed-pod electronic nicotine delivery system (ENDS). While JUUL’s history with the agency has been marked by substantial controversy, this milestone represents a strong signal that the U.S. Food and Drug Administration is indeed willing to grant market access to applicants, regardless of past challenges, if they can compellingly demonstrate that their products are appropriate for the protection of public health (APPH).
The FDA’s decision to approve JUUL’s premarket tobacco product applications (PMTAs) reflects a science-based regulatory framework that rewards companies who invest in robust scientific evidence, product stewardship, and thoughtful marketing controls. JUUL’s ability to turn the tide underscores the critical importance of engaging proactively with FDA, responding transparently to regulatory concerns, and committing to long-term compliance and positive public health outcomes.
At Accorto Regulatory Solutions, we view this decision as a tide-turning moment. It reinforces our long-standing counsel to clients: rigorous testing, critical risk-benefit analysis, and strategically aligned marketing practices can yield regulatory success, even for companies that may have once faced skepticism or previous enforcement action.
“The JUUL authorization is a testament to how far a company can go when it takes regulatory obligations seriously and invests in doing things right. This is an encouraging message to all stakeholders working to responsibly innovate in regulated markets.”
– Tom Beaudet, CEO, Accorto Regulatory Solutions
Our team at Accorto stands ready to guide companies through the complex but navigable PMTA process. We bring deep expertise, agency insight, and proven strategies that ensure our clients are not only compliant but well-positioned for long-term market presence.
If your organization is navigating the PMTA process or thinking ahead about long-term compliance strategies, we’d be glad to talk. Our team is here to exchange insights, answer questions, and explore how we can support your mission to bring innovative, responsible, public health–oriented products to market.
