By Timothy S. Donahue

Top Takeaways:

• Regulatory review: FDA’s draft flavored ENDS premarket guidance is under EO 12866 review at OIRA ahead of formal publication.
• Policy focus: The draft aims to clarify how flavored vaping products should be handled in premarket tobacco product applications.
• Stakeholder engagement: Industry and public health groups can engage with OIRA and HHS/FDA before the guidance is issued.

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration have submitted a draft guidance for the vaping industry on flavored electronic nicotine delivery systems (ENDS) premarket applications for review under Executive Order 12866, signaling forthcoming policy development on how flavored vaping products will be evaluated for market authorization.

The document, titled Statement of Policy – Considerations for Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications; Draft Guidance for Industry, was received by the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) on Feb. 18. The notice appears on the federal regulatory agenda, and an OIRA meeting on the draft is scheduled for March 10.

The draft guidance would articulate FDA’s current thinking on how manufacturers should consider and present information about flavored ENDS products in premarket tobacco product applications (PMTAs).

What EO 12866 regulatory review means

Under Executive Order 12866 — a regulatory planning and review framework issued in 1993 — federal agencies must submit significant proposed regulatory actions to OIRA for interagency review before publication. EO 12866 aims to ensure that proposed regulations are consistent with the President’s priorities, consider costs and benefits, and are based on sound analysis.

OIRA publicly posts a docket of regulatory actions under review and provides opportunities for stakeholder engagement, including voluntary meetings with agency and OIRA officials.

Reginfo.gov lists the flavored ENDS guidance draft as a “notice stage” action under HHS/FDA with Regulatory Identification Number 0910-ZC78, indicating the policy statement is being reviewed but is not yet published for formal public comment. OIRA’s review must conclude before the draft guidance can be released in a Federal Register notice or distributed to industry as a guidance document.

Flavors remain a key focus in U.S. vaping and e-cigarette policy. Federal regulators already require manufacturers to submit PMTAs for all new tobacco products, including ENDS, and the FDA’s existing PMTA guidance outlines the recommended content and procedures for those applications.

The flavor-specific policy statement appears intended to provide additional clarity on how flavored products should be evaluated under the premarket standard, which requires the FDA to determine whether marketing a product is “appropriate for the protection of the public health (APPH).”

Industry and public health observers will be watching to see whether the guidance sets stricter evidence standards for flavored products or clarifies how flavored ENDS applicants can demonstrate that their products will not adversely affect youth use while potentially supporting adult cessation. Previous research has shown that flavored ENDS do appeal to both youth and adult ENDS users, complicating regulatory evaluation.

Update- Two companies have now scheduled (or attended) meetings with OIRA:

• March 2, 2026: Breeze Smoke LLC, represented by Clark Hill Public Strategies (Meeting ID 1324024).
• March 10, 2026: Glas, Inc., represented by Kleinfeld, Kaplan and Becker (Meeting ID 1329273).