US lawsuits against six e-cigarette manufacturers

Six e-cigarette manufacturers that received advance warnings from the FDA for failing to file prior notices are being sued for continuing to manufacture, sell and distribute their products. The slow pace of these procedures, criticized by health associations, is only partially deterring the manufacturers.

At the request of the Food and Drug Administration (FDA), the U.S. Department of Justice has just initiated legal proceedings against six e-cigarette manufacturers, under the requirements for the pre-marketing of new tobacco products provided for by the Federal Food, Drug & Cosmetic Act (FD&C) regulations.

The FDA had previously sent a warning letter to these manufacturers, reminding them that their products were being marketed without prior authorization and ordering them to comply.[1]This ultimatum having remained without effect, despite the declarations of certain manufacturers during a videoconference devoted to this subject, it is now the justice system which is taking over from the FDA, a first in the field of electronic cigarettes.

FDA's slowness called into question

"We will not stand idly by when manufacturers consistently violate the law, especially after having had multiple opportunities to comply.", said Brian Smith, the FDA's new director of the Center for Tobacco Products. "This is what the FDA should have done all along and we are very pleased to see it.", commented Erika Sward on behalf of the American Lung Society, hoping that other actions like this can follow.[2].

Several major civil society actors[3] had in fact sued the FDA in 2020 for the slowness of its procedures in the field of electronic cigarettes, while many products were and still are marketed without authorization. A judgment had then forced the FDA to update itself by September 9, 2021, but during another hearing in May 2022, the public agency announced that it would not be able to finalize this work until June 2023.[4].

FDA Targeting Errors, 2020-2021

The FDA defends itself by explaining that it sent, between January 2021 and September 2022, nearly 300 warning letters for lack of prior authorisation to manufacturers of e-liquids and electronic cigarettes, a majority of whom have since withdrawn their products from the market. 107 of these letters concerned only products based on synthetic nicotine, which remains banned in the United States. Faced with accusations that only small producers have so far been subject to reminders of the law, the FDA emphasizes that it sent a similar letter in early October 2022 to EVO Brands, which markets Puff Bar, the best-selling disposable e-cigarette. It also banned the marketing of Hyde, another famous brand, on the same day. The ban on JUUL e-cigarettes requested by the FDA in June 2022 was, for its part, suspended by federal court, with products remaining on the market pending judgment.

In a study by the Truth Initiative published on October 13, the analysis of 303 of these warning letters sent by the FDA to manufacturers between October 1^er January 2020 and September 9, 2021, confirms on the contrary that the main companies targeted were small online resellers of electronic cigarettes (97.4 %), mainly for the purpose of selling e-liquids (92.2 %) to people under 21[5]The main brands of electronic cigarettes, in some cases linked to tobacco manufacturers, were however able to market their products without being worried, which had triggered the legal reaction of civil society.

A surge from the FDA

The publication, on October 6, 2022, of the results of the 2022 edition of the National Youth Tobacco Survey has rekindled the debate. This prevalence study indicates that 2.5 million young Americans are users of electronic cigarettes, or 9.4% of young people in school. A figure slightly up compared to last year, but half that of 2019, as noted by a group of electronic cigarette manufacturers. Civil society actors believe that it is, on the contrary, high time to act given the rapid spread of these products, and are calling for a ban on all flavors, the marketing of which is mainly directed at the youngest.[6].

It can therefore be assumed that the legal proceedings requested by the FDA are only a reaction to this recent controversy and that they aim to show that the federal agency is reinvesting in its role. The appointment of Brian Smith to head the FDA's Center for Tobacco Products is seen as an encouraging signal by civil society.

Keywords: FDA, FD&C, e-cigarettes, Brian Smith, justice

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[1] FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers, FDA, published October 18, 2022, accessed October 19, 2022. [2] Dillinger K, Christensen J, Sneed T, US government seeks court injunctions against six e-cigarette manufacturers as FDA steps up enforcement, CNN, published October 18, 2022, accessed October 19, 2022. [3] Statement of American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative. [4] In yet another delay that leaves kids at risk, FDA tells court it won't finish reviewing e-cigarette marketing applications until June 2023, Truth Initiative, published May 19, 2022, accessed October 19, 2022. [5] Schillo BA, Bertrand A, Briggs J, et al., Analysis of e-cigarette warning letters issued by the Food and Drug Administration in 2020 and 2021, Tobacco Control, Published Online First: 13 October 2022. doi: 10.1136/tc-2022-057359 [6] Castronuevo C, FDA Vapor Regulations Caught in Balancing Act With Youth Survey, Bloomberg Law, published October 11, 2022, accessed October 19, 2022. National Committee Against Smoking |