News
ENDS Market · FDA Guidance · PMTA Process · Vaping Regulation
The U.S. Food and Drug Administration submitted draft guidance for flavored electronic nicotine delivery systems (ENDS) to the White House for review under Executive Order 12866, signaling an imminent clarification of premarket authorization requirements for manufacturers.
This draft guidance, titled “Statement of Policy – Considerations for Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications,” entered the White House’s Office of Information and Regulatory Affairs (OIRA) review on February 18, with a meeting scheduled for March 10. The policy aims to clarify how flavored vapor products undergo evaluation under the FDA’s Premarket Tobacco Product Application (PMTA) process, requiring manufacturers to demonstrate their products are "appropriate for the protection of public health." The guidance will outline specific scientific evidence, consumer behavior data, and risk assessments needed for flavored product applications.
This move addresses the ongoing debate regarding flavors, which attract youth but also aid adult smokers in transitioning from combustible cigarettes. Stakeholders, including industry groups and public health organizations, have an opportunity to engage with OIRA during this review phase.
Upon OIRA's completion, the FDA will publish the guidance for public comment before finalization, providing either new complexities or long-awaited clarity for the industry.
