Health associations are calling on the US administration to take action against the proliferation of nicotine products marketed without prior regulatory approval.
Six major public health organizations in the United States recently sent a joint letter to the Food and Drug Administration (FDA) warning of the intentions of tobacco giants such as RJ Reynolds and Altria to distribute new nicotine products without obtaining the required approval. These organizations are calling for a clear and vigorous response from federal health authorities, as well as the Department of Justice, to what they perceive as a clear attempt to circumvent the legal framework established for the protection of public health.
Prior authorization as a regulatory safeguard
Since the establishment of the Family Smoking Prevention and Tobacco Control Act In 2009, all nicotine and tobacco products were required to obtain FDA approval before being released for sale in the U.S. market. This regulation aims to ensure that each product undergoes rigorous scientific analysis, measuring both its effects on individual health and its overall impact on tobacco control.
To get this marketing authorization (Marketing Granted Order or MGO), manufacturers must provide a detailed dossier including data on the composition, potential health effects, and the risks of initiation among non-smokers and young people. Although a legal deadline of 180 days is set for processing applications, in practice, this process can take much longer due to the complexity of the products being evaluated. However, until the MGO has been officially issued, marketing remains strictly prohibited.
The system is considered a pillar of tobacco control in the United States, designed to curb the introduction of potentially harmful and unexamined devices onto the market while strengthening public health efforts.
Marketing projects without official approval
Despite this obligation, several industrial groups have publicly unveiled their plans to launch new nicotine products, without waiting for FDA approval.
RJ Reynolds, for example, is considering deploying View One, a disposable vape made with synthetic nicotine, in various states by the end of 2025. The device, available in flavors such as Raspberry Chill, Watermelon Chill, and Berry-Melon, targets a market particularly popular with young Americans. Recent data indicates that disposable e-cigarettes are now the most common form of nicotine consumption among middle and high school students.
This strategy represents a significant shift for Reynolds and its parent company, British American Tobacco (BAT), once staunch advocates of strict regulatory frameworks. Now, faced with the growing popularity and economic weight of the disposable vape sector—largely dominated by non-compliant players—BAT is aiming to regain control, while seeking to position itself as a "regulated" alternative to independent brands.
For its part, Altria, via its subsidiary Helix, plans to market nicotine pouches on! MORE in several states, while these products have still not received the necessary authorization. This turnaround contrasts sharply with the group's previous statements, which then acknowledged the illegality of such an approach without prior validation.
NGOs see these moves as a clear attempt to erode the FDA's authority and an increased risk of proliferation of unapproved products, which are already increasing sharply on the US market.
NGOs demand an immediate and determined response
The six organizations behind this alert – including theAmerican Heart Association American Academy of Pediatrics, Campaign for Tobacco-Free Kids or, Truth Initiative – are demanding firm action from the FDA and the Department of Justice.
According to them, allowing these products to circulate freely without sanctions would undermine the regulatory assessment process and permanently weaken the health authorities' power of control. They insist that selling them without MGO constitutes an offense and call for legal action to be taken against the manufacturers concerned.
In their letter, the NGOs also point out that RJ Reynolds had already marketed sachets in 2024 Velo Plus without authorization, reflecting a deliberate strategy of circumventing the law.
Finally, they reiterate their request for a meeting with the FDA to explore concrete solutions to strengthen enforcement. They believe that the credibility of the regulatory system and the protection of younger generations now depend on the authorities' ability to respond firmly to these industrial maneuvers.
