Groups Sue FDA Over Enforcement Policy for Unauthorized Vapes and Pouches

On July 14, 2026, a coalition of pediatricians, public health organizations, and parents filed a federal lawsuit in the U.S. District Court for the District of Maryland challenging an FDA “enforcement priorities” guidance issued May 8, 2026 for certain new tobacco products marketed without premarket authorization.

What changed in FDA’s May 8 guidance

FDA’s guidance, titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization,” lays out when the agency says it does not intend to prioritize enforcement against some unauthorized electronic nicotine delivery systems (ENDS, often described as “vapes”) and oral nicotine pouch products.

According to FDA, the “does not intend to prioritize” posture applies when, for the relevant product category, the manufacturer has a pending application that has been accepted and filed—or has a pending and accepted Supplemental PMTA—and FDA has determined the application includes data needed to evaluate whether the product is appropriate for protecting public health for non-tobacco flavored ENDS.

FDA also says that even for products that fall within those categories, it does not intend to prioritize enforcement where the product includes certain presumptively underage-appealing elements—such as depicting a cartoon-like fictional character, disguising the product’s nature as a vaping product, or resembling a children’s toy, phone, or gaming platform.

To promote transparency, FDA says it will create and maintain a public list of products identifying manufacturers and products that FDA does not intend to prioritize for enforcement under this policy.

Just as important: FDA’s guidance page says FDA guidances do not establish legally enforceable responsibilities; they reflect the agency’s current thinking and are recommendations unless specific regulatory or statutory requirements are cited.

Why plaintiffs say the policy is unlawful

The complaint (Case No. 8:26-cv-02767-ABA) names FDA and the U.S. Department of Health and Human Services as defendants, along with Acting Commissioner Kyle Diamantas (in his official capacity) and HHS Secretary Robert F. Kennedy, Jr. (in his official capacity).

The plaintiffs argue the May 8 guidance creates an enforcement “safe harbor” effect—allowing potentially thousands of unauthorized ENDS and nicotine pouch products to enter and remain on the market for an indefinite period while premarket reviews are underway—despite the Tobacco Control Act’s requirement that new tobacco products receive an FDA marketing granted order before entering the market. The complaint also alleges the guidance is unlawful under the Administrative Procedure Act framework.

What relief the plaintiffs are asking for

Plaintiffs are seeking declaratory and injunctive relief. Practically, they are asking the court to block the guidance’s use—potentially including vacating it—so FDA cannot rely on the policy to keep some unauthorized products in a lower-priority enforcement posture while PMTA reviews continue.

What to watch next

Next steps in court will likely focus on whether the case proceeds on an expedited schedule and whether the plaintiffs can obtain immediate relief (such as a temporary restraining order or preliminary injunction). If the court blocks or narrows the guidance, the biggest reader-facing change would be whether—and how quickly—FDA shifts from a “do not prioritize enforcement” approach to taking enforcement actions against categories of products covered by the policy.

Sources

• Court complaint (primary record)
• FDA guidance landing page (disclaimer + metadata)