The American nicotine industry is interfering in the defense of the FDA's controversial new guidelines

American Vapor Manufacturers (AVM), Helix Innovations LLC, and NJOY LLC have filed separate motions to intervene on behalf of the Food and Drug Administration (FDA) in a federal lawsuit challenging its guidelines for regulating certain vaping products and nicotine pouches marketed without prior authorization.[1]. Helix and NJOY are subsidiaries of the Altria group, active in nicotine pouches and vaping products, respectively. The lawsuit was filed in July 2026 by the Campaign for Tobacco-Free Kids (CTFK) and several public health and anti-smoking organizations, which are challenging the guidelines published by the FDA on May 8, 2026, entitled "Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization." The three plaintiffs argue that, despite their shared interest with the agency in defending these guidelines, their commercial interests should not be confused with the FDA's institutional responsibilities. They therefore wish to be able to directly defend their own interests in the proceedings, potentially further weakening public health policies.

The FDA's new recommendations reduce the priority given to the control of certain nicotine products.

On May 8, 2026, the FDA published new guidance outlining its priorities for enforcement actions against certain e-cigarettes and nicotine pouches marketed without prior authorization. It states that it generally does not plan to prioritize products whose application for authorization has been accepted and deemed eligible for scientific review. This provision applies to applications submitted on or after November 4, 2021, that have passed the required administrative review stages. It also applies to certain supplementary applications (sPMTA) accepted and pending for more than 180 days. For e-cigarettes without tobacco flavor, an additional condition applies: the FDA must have determined that the dossier contains the scientific data necessary to assess whether the product meets the public health protection criterion. The mere existence of a pending application is therefore not sufficient to benefit from this policy.

The guidelines also specify that products with features likely to attract minors may remain a priority for enforcement measures. This includes devices depicting cartoon characters, concealing their function as e-cigarettes, or resembling toys, phones, or gaming equipment. The FDA also indicates that it may intervene in the presence of specific health or safety risks, such as high nicotine levels, serious adverse effects, lack of child-resistant packaging, or fire hazards.

These guidelines do not constitute marketing authorization. Products subject to a prior authorization requirement that have not obtained it remain illegally marketed under U.S. federal law. The FDA clarifies that this policy addresses its enforcement priorities and does not prejudge the outcome of application reviews. It is maintaining its efforts to combat products lacking a valid application, counterfeit products, and products imported under false declarations. It plans to continue its cooperation with the Department of Justice, Customs and Border Protection, and other federal agencies.

Public health organizations consider this policy illegal, irregular, and dangerous.

A lawsuit was filed on July 14, 2026, in the federal court for the district of Maryland. It was filed by seven organizations: 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, Parents Against Vaping E-Cigarettes, and Truth Initiative. A pediatrician, Susan Walley, and an individual identified as Jane Doe are also among the plaintiffs. They present three main legal arguments: first, they believe the guidelines violate the Family Smoking Prevention and Tobacco Control Act, as they would allow certain new tobacco and nicotine products to remain on the market without the required authorization; second, they argue that the FDA failed to comply with the public consultation requirements of the Administrative Procedure Act; and finally, they criticize the agency for not adequately justifying its change in approach, particularly regarding flavored vaping products.

The organizations are particularly concerned about the continued presence on the market of unauthorized flavored products, which they consider a risk to efforts to prevent nicotine use among young people.

The nicotine lobby is fighting to prevent the annulment of procedures that benefit their profits.

In their petition of October 7, 2026, AVM, Helix, and NJOY highlight the potential consequences of a reversal of the FDA's new guidance for products whose Premarket Tobacco Product Applications (PMTAs) are still under review by the FDA. The companies cite risks to sales, inventory, distribution networks, and investments related to regulatory processes. They argue that this could lead to order cancellations, returns and refunds, unsold inventory, lost store visibility, and a depreciation of investments related to the authorization applications. They also mention potential repercussions on their business relationships, staffing levels, and the funding of additional scientific research.

AVM emphasizes that it has already requested some flexibility from the FDA in applying the rules, as some of its members' requests were rejected. The association believes this experience illustrates the potential conflict between its interests and those of the agency. Azim Chowdhury, an attorney with Keller and Heckman LLP representing AVM, noted that the companies involved had devoted significant resources to scientific research and their regulatory submissions. He also stressed that the FDA's guidance does not constitute marketing authorization or a waiver of the legal requirements for prior review. Finally, the applicants maintain that their intervention remains possible at this stage of the proceedings without prejudice to the parties already involved.

The requests for intervention thus directly introduce the economic interests of manufacturers into a dispute initially brought by public health organizations against the federal government. As of October 7, 2026, the court had not yet confirmed the admission of AVM, Helix, and NJOY as intervening parties. The case, titled "Campaign for Tobacco-Free Kids et al. v. Food and Drug Administration et al.," is registered under number 8:26-cv-02767 in the federal court in Maryland. The outcome of this case could determine whether the FDA will continue to give lower priority in its regulatory oversight to eligible products, such as e-cigarettes and nicotine pouches, which do not yet have market authorization while their applications are under review. Such a risk of relaxation comes amid months of serious industry interference. The Trump administration is accused of numerous conflicts of interest, controversial appointments, budget cuts, and interference from industry interests in public policy, which coincides with the FDA's sudden reversal on new products compared to its past orientations.

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[1]US Health Groups Seek to Overturn FDA Enforcement Discretion for Pending PMTAs as Altria's Helix, NJOY and AVM Move to Intervene, 2Firsts, published on October 9, 2026, accessed the same day

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