Week of August 11 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• FDA’s Center for Tobacco Products expected to make more decisions on which vapor products, nicotine pouches are legal to sell - CSP

There are now 39 vapor products and devices that have received an MGO and two flavored (menthol) vapor products to receive authorization. It is also noteworthy because Juul’s original application was denied in 2022. After court action, the FDA was required to re-review the PMTA application. In the coming months, it is expected that the CTP will issue more PMTA decisions on the thousands of remaining vapor and nicotine pouch product applications.

• Evidence, not fear, should guide the FDA’s vaping policies - Reason

In a recent appearance on Politico’s The Conversation podcast, Food and Drug Administration (FDA) Commissioner Marty Makary stressed the importance of building stakeholder consensus and incorporating broad input on policy issues, while grounding decisions in evidence. Yet, in the same discussion, he described a “child vaping epidemic” and signaled plans for increased supply controls.

The policy takeaway is clear: To reduce the spread of illicit products and improve public health outcomes, the FDA should authorize a broader range of regulated, appealing alternatives. When adult smokers have access to legal options that match their preferences, the economic incentives for illicit trade diminish.

Efforts that focus only on cracking down on illegal supply while limiting lawful access will continue to drive consumers toward unregulated products, undermining both safety and public health goals. Makary’s call for collaboration and evidence-based regulation should fully extend to vaping policy, replacing fear-driven narratives with strategies grounded in public health evidence and economic insight.

• TOBACCO—5th Cir.: FDA properly denied Chinese company’s application for vaping products, (Aug 13, 2025) - Vitallaw.com

Concluding that the FDA’s decision in denying an application for new tobacco and nicotine products was reasonably explained, the U.S. Court of Appeals for the Fifth Circuit in New Orleans has denied a petition for review sought by a Chinese manufacturer for an electronic nicotine delivery system and vaping products. The appeals court held that the FDA did not act in an arbitrary and capricious way when the agency reasonably considered the public health risks and benefits in denying the application sought by Shenzhen Youme Information Technology Co., Ltd. for an electronic nicotine delivery system (Shenzhen Youme Information Technology Co., Ltd. v. FDA, No. 24-60060 (5th Cir. July 23, 2025)). - See Additional Analysis Below