FAQs: FDA Lawsuit Challenges E-Cigarette Enforcement Policy, PMTA Guidance

The FDA received a lawsuit filed by a group comprising public health organizations, pediatricians, and parents challenging the entity’s recent policy enforcement memo for certain new tobacco products marketed without premarket authorization.¹ The plaintiffs are the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Truth Initiative, Parents Against Vaping, a pediatrician, and a parent of 2 children who became addicted to nicotine using flavored e-cigarettes.¹

Here are common FAQs about the lawsuit and why the FDA’s enforcement policy violates the Family Smoking Prevention and Tobacco Control Act.

What does the FDA's e-cigarette enforcement policy say, and why are public health organizations challenging it?

The FDA released guidance on future procedural pathways regarding the enforcement of tobacco products without premarket authorization, specifically electronic nicotine delivery systems (ENDS) and oral nicotine pouches. The guidance ultimately states that the FDA will exercise enforcement discretion by prioritizing enforcement against products marketed with “presumptively underage-appealing elements.”²

More specifically, it states that enforcement will not prioritize products that have a pending Premarket Tobacco Product Application (PMTA) that has been accepted and filed or a supplemental PMTA that has been accepted and has been pending for more than 180 days. The guidance also stated that non-tobacco-flavored ENDS products’ PMTAs with data supporting their protection of the public health may receive lower enforcement priority.²

The plaintiffs claim the guidance further insinuates lenient restrictions on tobacco marketing and deprioritizes strict guidance on flavored ENDS products despite the US’ youth nicotine addiction crisis.¹ Furthermore, the plaintiffs argue the FDA’s most recent PMTA authorization for 5 flavored ENDS products is inconsistent with the entity’s historic stance against flavored ENDS products. Of the 5 flavored ENDS products it authorized—manufactured by Glas Inc.—2 were blueberry- and mango-flavored, which many public health organizations argue appeal to youth.^1,4

“The problem with the previous policies is they potentially deterred companies from seeking authorization in part because it could take many years for the process to play out, all while the illicit market continued to grow,” Raymond Niaura, PhD, a psychologist and an expert on tobacco dependence and treatment, said in a written statement to The American Journal of Managed Care®. “My interpretation of the concerns that the plaintiffs in the lawsuit have is that this new enforcement approach will create a larger market for products such as e-cigarettes, which will be difficult to control and therefore place youth at greater risk of being exposed to marketing efforts, availability, etc.”

The lawsuit also argues that by “prioritizing enforcement,” the FDA violates the Administrative Procedure Act, as it attempts to change enforcement policy without following the notice-and-comment rulemaking procedures outlined in the act.^1,3

What is the Tobacco Control Act, and how do plaintiffs argue the FDA violated it?

The plaintiffs also argue the FDA violated the Family Smoking Prevention and Tobacco Control Act, which states a manufacturer must submit a PMTA or another authorized premarket pathway for any new tobacco product before the product can be legally marketed.⁵ Under the FDA guidance, the plaintiffs argue the enforcement policy allows some unauthorized tobacco products to remain on the market while their PMTA is pending. These are arguments stated in the lawsuit, not definitive claims.

The FDA cited “lack of resources” as a reason for opting to prioritize enforcement and stated it will publicly publish a list of unauthorized products with pending applications that are exempt from enforcement.¹

Niaura agrees that the FDA is “understaffed and under-resourced”; hence, its decision to prioritize unauthorized products, based on the theory that if more authorized products are available, consumers will be less likely to take up illicit products.

“It makes sense that the FDA would want to displace this illicit market with products that at least have gone through the rigorous process of applying for a PMTA,” he said. “A well-regulated market has a better chance of taking steps, overseen and mandated by the FDA, to prevent and discourage youth use of tobacco products compared to the illicit market.”

How does the FDA's regulation of flavored e-cigarettes relate to this lawsuit?

Flavored e-cigarettes have been a long-standing focus of the FDA’s enforcement, given their appeal to youth, which makes the government agency’s recent policy enforcement contradictory. The recent PMTA authorization for 5 flavored ENDS products—2 of which are fruit-flavored—includes several checkpoints restricting product usage by those under 21 and extensive technologies. Despite the measures implemented to deter underage usage, the promotion and approval of flavored e-cigarettes is inconsistent with the FDA’s historic position against flavored ENDS products to limit their access and appeal to younger individuals.^1,3

Current e-cigarette use among US middle and high school students has declined significantly since its peak in 2019, from 20% to 5.9% as of 2024, according to the 2024 National Youth Survey.⁶ The same survey found that fruit flavors were the most popular among adolescents and teens, supporting public concern about the FDA’s decision that would allow flavored ENDS products to remain in stores while undergoing review.⁶

“Of course it would be best if this number declined further. The question is whether FDA's new approach to enforcement will stall or reverse youth declines in e-cigarette use compared to the status quo,” Niaura wrote.

What can clinicians and managed care professionals do to help prevent youth e-cigarette use and nicotine addiction?

Education and awareness are pivotal to reducing youth ENDS product usage. Despite the aim of e-cigarettes to curb smoking habits, the American Lung Association noted 2 patterns among users: young adults, teens, and adolescents are using ENDS products and nicotine pouches without having ever smoked a cigarette, and those who are trying to quit by using these products often engage in dual or poly tobacco use.⁶

Harold Wimmer, MS, CEO and president of the American Lung Association, urged the FDA to reverse its decision and guidance in a recent press release. Numerous other health care organizations and associations have come forward sharing the same sentiments, concerned that the public health of America’s youth is at risk if the FDA’s decision stands.

References

1. Public health groups, pediatricians, and parents sue FDA over policy allowing the marketing of unauthorized e-cigarettes and nicotine pouches. American Heart Association. News release. July 14, 2026. Accessed July 20, 2026. https://newsroom.heart.org/news/public-health-groups-pediatricians-and-parents-sue-fda-over-policy-allowing-the-marketing-of-unauthorized-e-cigarettes-and-nicotine-pouches

2. Enforcement priorities for certain new tobacco products marketed without premarket authorization: guidance for industry. FDA. May 2026. Accessed July 20, 2026. https://www.fda.gov/media/192403/download

3. 5 US code 553 - rule making. Cornell Law School. Accessed July 21, 2026. https://www.law.cornell.edu/uscode/text/5/553

4. FDA expands market access, authorizes new ENDS products. News release. FDA. May 5, 2026. Accessed July 20, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-market-access-authorizes-new-ends-products

5. Family Smoking Prevention and Tobacco Control Act—an overview. FDA. August 29, 2024. Accessed July 20, 2026. https://www.fda.gov/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/family-smoking-prevention-and-tobacco-control-act-overview

6. FDA decisions on flavored vapes and pouches put youth at risk. American Lung Association. June 2, 2026. Accessed July 21, 2026. https://www.lung.org/blog/flavored-tobacco-fda-decision