Unauthorized sale of vapes, nicotine pouches: US FDA sued over policy allowing products to stay on market

WASHINGTON, D.C.: The US Food and Drug Administration (FDA) is facing a federal lawsuit over a new enforcement policy that public health groups say allows certain unauthorized vapes and nicotine pouch products to remain on the market without the marketing authorization required under US law.

The lawsuit was filed in the US District Court for the District of Maryland by a coalition of leading public health organizations, pediatricians and parents. It challenges FDA guidance issued in May 2026, under which the agency said it generally would not prioritize enforcement against certain unauthorized electronic nicotine delivery systems (ENDS) and nicotine pouch products if manufacturers have submitted premarket tobacco product applications (PMTAs) that are still under review.

The plaintiffs include some of the most prominent public health and medical organizations in the United States:
• Campaign for Tobacco-Free Kids
• American Academy of Pediatrics
• American Cancer Society Cancer Action Network
• American Heart Association
• American Lung Association
• Truth Initiative
• Parents Against Vaping

The lawsuit also includes a pediatrician and a parent whose children allegedly became addicted to nicotine after using flavored e-cigarettes.

The plaintiffs argue that the FDA's latest guidance effectively permits thousands of unauthorized vaping products and nicotine pouches to remain available to consumers even though they have not received the legally required marketing authorization under the Family Smoking Prevention and Tobacco Control Act.

According to the lawsuit, many of these products—including flavored e-cigarettes and nicotine pouches—are especially attractive to adolescents and young adults, potentially worsening youth nicotine addiction.

The coalition also argues that the FDA introduced the policy without following the public notice-and-comment process required under the Administrative Procedure Act and failed to adequately explain the basis for the policy change.

The lawsuit also seeks to block the FDA's proposal to publish a list of unauthorized products that the agency does not intend to prioritize for enforcement.

The plaintiffs contend that publishing such a list could encourage retailers and distributors to continue selling unauthorized products by signaling that they are unlikely to face immediate regulatory action.

What does the FDA say?

In its May guidance, the FDA said it remains committed to enforcing federal tobacco laws and emphasized that all new tobacco products are still legally required to obtain FDA marketing authorization before they can be marketed in the United States.

However, the agency explained that, because of limited enforcement resources, it intends to focus on the highest-risk unauthorized products and manufacturers, including those with no pending marketing applications, products that appeal to youth, counterfeit products and products imported through false declarations.

The FDA also stated that the guidance represents its current enforcement priorities and does not change the legal requirements established under federal law.

Has the FDA responded to the lawsuit?

As of publication, the FDA has not issued a formal response to the lawsuit.

Reuters reported that the agency did not immediately respond to requests for comment when the case was filed, and no additional public statement addressing the litigation had been released at the time of publication.

The lawsuit is expected to become a closely watched legal battle over how the United States regulates vaping products and nicotine pouches amid ongoing concerns about youth nicotine use.

The case is also being heard in the same Maryland federal court that previously struck down an earlier FDA policy allowing many unauthorized e-cigarette products to remain on the market, making the outcome potentially significant for future tobacco regulation and FDA enforcement practices.

While the litigation is still in its early stages, the court's eventual ruling could influence how unauthorized vaping products are regulated and whether companies with pending FDA applications can continue selling their products during the review process.

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