Seven national health organizations, a pediatrician, and a parent have sued the FDA to overturn a May policy that lowers enforcement priority for some unauthorized vaping products and nicotine pouches with pending premarket applications.
If they win, the agency would lose its new distinction between products backed by accepted applications and unauthorized products that do not qualify for lower enforcement priority.
The complaint filed July 14 in the U.S. District Court for the District of Maryland names the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Truth Initiative, and Parents Against Vaping as plaintiffs. Pediatrician Dr. Susan Walley and an unnamed parent also joined the case.
The lawsuit targets the FDA’s May enforcement guidance for electronic nicotine delivery systems and oral nicotine pouches. The policy says all new tobacco products marketed without authorization remain illegal. But the agency generally will not prioritize enforcement when a premarket tobacco product application (PMTA) has been accepted and filed, or when an accepted supplemental PMTA has remained pending for more than 180 days. Non-tobacco-flavored vaping products must also have application data that the FDA considers sufficient for a public health evaluation.
The guidance does not protect products with obvious youth-appealing features, such as cartoon characters or designs resembling toys, phones, or gaming devices. The agency may also prioritize products presenting unusual safety concerns, including fire hazards, missing child-resistant packaging, or high nicotine content.
The plaintiffs argue that this enforcement discretion is an unlawful marketing safe harbor. Their complaint says the policy exceeds the FDA’s authority under the Tobacco Control Act, reverses earlier enforcement positions without adequate explanation, and should have gone through public notice and comment. They also want the court to stop the agency from publishing a promised list of products covered by the lower priority.
The FDA offered a different rationale in its Federal Register notice announcing the immediately effective guidance. The agency said limited resources should focus on products least likely to satisfy the public health standard, while encouraging better applications and a more orderly transition toward a regulated market.
The new case deliberately returns to the Maryland court where many of the same organizations won a 2019 ruling against an earlier FDA compliance policy. That decision helped force manufacturers of products already on the market to submit PMTAs by Sept. 9, 2020.
This time, the court must decide whether enforcement discretion can distinguish between an applicant waiting in the FDA’s line and a seller who never joined it—or whether both must be treated alike until the agency acts.
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