Health organizations challenge FDA over marketing of unauthorized nicotine products

Six major U.S. public health organizations have issued a joint letter to the US Food and Drug Administration (FDA) to denounce the intentions of the RJ Reynolds and Altria groups to launch new tobacco products without prior authorization. These NGOs call for a firm response from the agency and the Department of Justice to preserve the principle of scientific evaluation prior to any marketing, particularly in view of the risk of circumventing legal obligations regarding public health.

Ensure compliance with the prior authorization process

Since the adoption of the Family Smoking Prevention and Tobacco Control Act in 2009, the marketing of any new tobacco and nicotine product in the United States has been subject to authorization by the FDA. This system is based on a central principle: no product may be sold without first being evaluated by the public agency to determine whether it meets the regulatory requirement known as "public health protection."

To obtain marketing authorization, called Marketing Granted Order (MGO), manufacturers must submit a dossier containing scientific data on the product's composition, its potential effects on individual and collective health, as well as the expected impact on smoking initiation and cessation. This evaluation aims in particular to verify that the product does not encourage new consumption among young people or non-smokers and that it does not compromise efforts to reduce smoking. The review process is governed by the law, which provides for a theoretical deadline of 180 days for the FDA's decision. However, in practice, the evaluation can take longer due to the complexity of the dossiers and the volume of applications. Health organizations point out that this extension does not change the legal requirement: until formal authorization has been granted, the product remains prohibited from being marketed.

This system is a pillar of U.S. tobacco and nicotine regulation, as it seeks to limit the entry of untested products onto the market and maintain a high level of public health protection in the face of the industry's continued innovation strategies.

Product launches announced by manufacturers without official authorization

Despite the clear requirement to obtain prior approval before marketing, several major tobacco and nicotine manufacturers have announced their intention to bring new products to market without waiting for the FDA's decision.

According to press reports and confirmed by public statements from the companies, RJ Reynolds plans to launch Vuse One, a disposable e-cigarette based on synthetic nicotine, in several states as early as the fourth quarter of 2025. This product, available in attractive flavors such as Raspberry Chill, Watermelon Chill Or Berry-Melon, falls into a segment already very popular with young people, while official data shows that disposable vapes now represent the category most used by American middle and high school students.

This decision represents a strategic shift for Reynolds and its parent company, British American Tobacco (BAT). Until now, the company has emphasized its role as a regulatory advocate, denouncing the proliferation of non-compliant products and calling for tighter controls. But given the sheer scale of the disposable vape market—valued at several billion dollars and largely dominated by unregulated brands—the group has decided to market its own products in this rapidly expanding market segment. By adopting the "align to better control" approach, BAT hopes to recapture a growing segment, while presenting itself as a "responsible" player that would seek to have its product recognized as better regulated than those of independent brands.

For its part, Altria, through its subsidiary Helix, announced the launch of its new on! PLUS nicotine pouches in North Carolina, Texas, and Florida. Again, the product is awaiting review, but no MGO has been issued by the FDA. The company had publicly acknowledged in the past that it was illegal to market a tobacco/nicotine product without prior authorization, even going so far as to criticize the proliferation of illicit nicotine pouches. The contrast between these positions and current practices reflects a simple strategic shift motivated by commercial opportunity and underscores that the concern for legality once displayed by tobacco manufacturers was essentially a matter of competitive disadvantage.

For public health organizations, these announcements represent a direct test of the FDA's authority and the integrity of the pre-evaluation system. They fear that tolerating these practices could encourage other manufacturers to follow suit, increasing the circulation of unauthorized products and further weakening regulation of a market already saturated with illegal devices.

A call for firm action from federal authorities

In response to these launch plans, the six signatory organizations – the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids and the Truth Initiative –[1] – are calling for a strong and coordinated response from the FDA and the Department of Justice. They say allowing unauthorized products to be sold would undermine the credibility of the regulatory process and pave the way for a widespread weakening of public control over tobacco and nicotine products.

They emphasize the urgency of reminding consumers that marketing without MGO is an offense and call for enforcement action against the manufacturers involved. Their letter also highlights that Reynolds had already put Velo Plus nicotine pouches on sale without authorization as early as 2024, demonstrating a repeated pattern of circumventing regulations.

Finally, the organizations reiterate their request for a meeting with the FDA to examine ways to strengthen enforcement. They believe that protecting public health, particularly that of younger generations, now depends on the authorities' ability to respond quickly to these attempts at circumvention and to ensure that every product undergoes scientific evaluation before it is placed on the market.

©Generation Without Tobacco

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[1] Press release, Leading Health Groups Urge FDA to Stop Major Tobacco Companies from Illegally Marketing New Products Without Authorization, Truth Initiative, published September 26, 2025, accessed September 29, 2025