British American Tobacco is banking on synthetic nicotine to establish itself in the disposable vape market

British American Tobacco (BAT) is preparing to launch Vuse One in the United States, a synthetic nicotine vaping device currently under review by the Food and Drug Administration (FDA). This decision marks a turning point for the company, which had previously focused its efforts on exposing and limiting unauthorized disposable vapes. The announcement raises numerous questions, both about the evolution of industrial strategies and the ability of public authorities to regulate and control a rapidly evolving market.[1].

A repositioning in the face of an expanding market

The disposable vape market has been growing rapidly for several years, particularly in the United States. These products appeal to a diverse audience, thanks to relatively low prices, a wide range of fruity or sweet flavors, and a ready-to-use format that is perceived as practical and discreet. This dynamic has fostered the emergence of a multitude of brands, many of which operate outside of regulated channels. As a result, millions of units are now sold without official authorization, making the market difficult to control.

Until now, British American Tobacco (BAT) had favored a denunciation strategy with regard to this proliferation. The company, through its subsidiary Reynolds American, had focused on communicating the massive presence of non-compliant products, while calling for increased controls on this point. This defensive stance was part of a logic of protecting its brands already authorized by the FDA and its investments in existing vaping ranges.

However, the rise of the disposable vape phenomenon has changed the landscape. This segment now represents a market valued at several billion dollars and occupies a central place in usage, particularly among young adults and minors. For the established players, not being present meant depriving themselves of a considerable source of revenue and leaving the market space to often unauthorized competitors.

The launch of Vuse One thus reflects a strategic adaptation. By choosing to develop its own disposable vape model, BAT is seeking to reclaim territory largely dominated by independent brands. This decision illustrates the logic of "aligning to better control": rather than remaining confined to a critical role, the company prefers to offer a product under its banner, relying on established distribution channels and a brand image perceived as more regulated.

This repositioning is also explained by a desire to have a greater say in regulatory debates. By entering this market with a product currently being evaluated by the FDA, BAT is attempting to distinguish itself from informal players while exerting pressure on the authorities to accelerate the authorization process. The underlying objective is clear: to gain recognition for its role as a "responsible" operator and to occupy a dominant position in a booming segment, while transforming a former battleground into a commercial opportunity.

Synthetic nicotine, a new industrial and regulatory tool

One of the main features of Vuse One is the use of synthetic nicotine, produced in a laboratory rather than extracted from the tobacco plant. For manufacturers, this innovation represents both a technical and economic advantage and a strategic lever. It allows them to break away from the constraints of tobacco cultivation, standardize concentrations more precisely and ensure more consistent production. Commercially, it can be presented as a "purer" form of nicotine, free from certain plant residues, and therefore associated with a modern and technological image likely to strengthen the product's appeal.

This direction, however, is part of a now-clarified regulatory framework. Since April 2022, the Food and Drug Administration has had full authority to regulate nicotine from non-tobacco sources, including synthetic nicotine. Manufacturers, importers, and distributors of these products are thus subject to the same obligations as for traditional nicotine: filing a prior application for marketing authorization, product registration, prohibition of sales to minors, and compliance with rules relating to marketing claims. In this context, the FDA has already rejected a large number of applications deemed incomplete or non-compliant and does not hesitate to sanction those who market products without authorization.

While innovation allows companies to diversify their offerings and maintain their competitiveness in a changing market, it does not change the nature of the substance. Synthetic nicotine retains the same addictive properties as nicotine from tobacco and poses the same risks of dependency. Its use therefore does not reduce health issues but complicates the work of public authorities, who must adapt their actions to a constantly changing environment. This development illustrates a broader dynamic: the introduction of new technologies by the vaping industry is not aimed at reducing risks for consumers, but at maintaining the presence of nicotine in new forms, in a framework where regulatory vigilance remains essential.

Major pressure on supervisory authorities

The FDA's review process continues to be marked by long delays and significant delays, well beyond the 180 days initially stipulated by law. These delays fuel a waiting period that some manufacturers seek to exploit by launching their products even while the review is underway. The Vuse One case illustrates this situation: although an application has been filed, the product could be marketed before the final decision is issued. Regulators are faced with a dilemma: balancing the need to rigorously control new devices with the pressure exerted by the size of the market.

These uncertainties are compounded by the scale of the phenomenon of unauthorized disposable vapes, which account for a significant portion of sales in the United States. In a market already saturated by products circulating outside legal channels, the arrival of new ranges based on synthetic nicotine further increases the difficulty of regulatory action. The FDA must, on the one hand, continue its control efforts in the face of the proliferation of illegal products, and, on the other hand, examine a considerable volume of applications from industrial players seeking to legitimize their presence in this segment.

Public health professionals are highlighting the consequences of this situation and are particularly concerned about the consequences of making addictive products, which are particularly attractive to young people, available too quickly.

©Generation Without Tobacco

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[1] Emma Rumney, Battling unregulated vapes, Big Tobacco tries a new strategy: joining in, Reuters, published August 21, 2025, accessed August 22, 2025