As our Tobacco + Nicotine team previously reported, FDA’s May 8, 2026 guidance (the 2026 Guidance or the Guidance) on enforcement priorities for certain unauthorized ENDS and nicotine pouch products created a path for products with pending premarket tobacco product applications (PMTAs) to remain on the market. That Guidance is now being challenged in federal court by advocacy organizations, threatening the viability of FDA’s enforcement discretion.
Link to The Lawsuit The Lawsuit
On July 14, 2026, Plaintiffs filed a federal lawsuit in the U.S. District Court for the District of Maryland (Case No. 8:26-cv-02767), challenging the 2026 Guidance. Plaintiffs include anti-tobacco advocacy groups, a pediatrician, and a parent; defendants are FDA, Acting Commissioner Kyle Diamantas, HHS, and Secretary Robert F. Kennedy, Jr., all sued in their official capacities.
Plaintiffs seek rescission of the Guidance and declaratory and injunctive relief, including an order preventing FDA from creating or maintaining a public list of products qualifying for enforcement discretion. Their six counts fall into three main categories.
Link to Statutory Authority Claims Statutory Authority Claims
Plaintiffs argue that the Guidance conflicts with the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by permitting ENDS and nicotine pouches to be marketed without FDA authorization required by 21 U.S.C. § 387j. They also contend FDA has created an alternative regulatory regime beyond its delegated powers and lacks authority to publish a list of unauthorized products that may be marketed free from enforcement.
Link to Administrative Procedure Act (APA) and Reasoned Decision-Making Claims Administrative Procedure Act (APA) and Reasoned Decision-Making Claims
Plaintiffs assert that the Guidance fails the APA’s reasoned decision-making requirement because FDA allegedly offered no meaningful justification for the safe harbor from enforcement, did not explain its treatment of flavors and youth use, and failed to acknowledge its departure from prior guidance and enforcement positions. They also argue the Guidance is a substantive rule that requires notice-and-comment rulemaking.
Link to Public Participation and FDA Guidance Procedure Claims Public Participation and FDA Guidance Procedure Claims
Plaintiffs further allege that the Guidance triggered public-participation requirements under the Food, Drug, and Cosmetics Act (FD&C Act) and FDA’s own Level 1 guidance procedures because it reflects more than a minor policy change and addresses highly controversial issues. In their view, FDA’s stated basis for bypassing prior public comment was legally insufficient.
Link to What Industry Should Watch What Industry Should Watch
Plaintiffs selected a forum with relevant history: the District of Maryland federal court previously vacated FDA’s 2017 guidance extending compliance periods for ENDS and other products and set the September 2020 PMTA deadline. That decision will likely anchor Plaintiffs’ argument against FDA’s exercise of enforcement discretion relating to premarket authorization requirements.
FDA will likely emphasize that the 2026 Guidance is more targeted than FDA’s 2017 guidance because it applies only to products whose PMTAs have cleared acceptance and filing review, excludes products with youth-appealing design elements or significant safety concerns, and disclaims any connection between safe harbor status and ultimate authorization.
For manufacturers seeking placement on FDA’s public list, three near-term questions matter most:
- Will the court issue a preliminary injunction? Plaintiffs seek to block implementation of the Guidance while the case proceeds.
- If vacatur is ordered, what is the remedy? Any remedy could materially affect products currently relying on the Guidance, including the timing and terms of any transition period.
- How will FDA defend the Guidance? Industry should monitor how FDA defends the policy and its current enforcement approach.
Link to Conclusion Conclusion
The 2026 Guidance remains in effect, and manufacturers whose products qualify should continue to assess whether to seek placement on FDA’s public list. At the same time, this litigation is a serious challenge, and stakeholders should monitor developments closely and consult with counsel about litigation-related risks to their commercial plans.
We will continue to track this case and provide updates as it develops. If you have questions about how the 2026 Guidance or the litigation may affect your business, please contact a member of the Troutman Pepper Locke Tobacco + Nicotine team.