United States: Unauthorized therapeutic claims on nicotine product sales sites

A study[1] A recent study published in the journal Tobacco Control highlights the worrying practices of certain companies operating in the United States. These companies market vaping products or nicotine pouches as smoking cessation aids. without any established scientific basis and without any official authorization.

This circumvention of the regulatory framework raises serious questions about consumer protection and the proliferation of unassessed substances, particularly nicotine analogues.

The study is based on a content analysis of the websites of two brands marketing their products in the United States: KickNic, a nicotine-free vaping device containing a compound called NoNic6 presented as a nicotine replacement, and YELLO, an international brand of nicotine pouches, present on the American and British markets.

Misleading health claims on websites

The researchers examined various promotional content formats: product pages, FAQ sections, visual elements, and claims integrated into packaging. They noted numerous explicit claims attributing therapeutic effects to these products, particularly in terms of smoking or nicotine cessation. Among the claims observed were: "helps quit nicotine in 4 weeks," "nicotine-free substitute," and "clinically proven to reduce withdrawal symptoms."

These claims lack any validated scientific basis and are not based on any prior regulatory authorization. As such, they contravene the Federal Food, Drug and Cosmetic Act (FDCA), which prohibits any therapeutic communication on a product that has not been the subject of prior authorization issued by the Food and Drug Administration (FDA). In particular, any statement that a product would help to stop the consumption of tobacco or nicotine must be subject to the rigorous evaluation of the Center for Drug Evaluation and Research (CDER) of the FDA, in charge of drugs and therapeutic treatments.

To date, no vaping devices or nicotine pouches have been approved by the FDA as a cessation aid. This means that the products studied are not recognized as safe and effective for this use.

The situation is even more problematic for KickNic, which contains a synthetic substitute – NoNic6 – and not nicotine. As such, it does not fall under the FDA's regulatory definition of a "tobacco product" and is outside the jurisdiction of the Center for Tobacco Products (CTP), the authority responsible for regulating nicotine products. This regulatory gap, currently unfilled at the federal level, makes it difficult to control this type of product, even though it is distributed to the general public with messages that are highly likely to mislead consumers.

A strategy to circumvent regulatory frameworks

The study's findings highlight a growing strategy to circumvent the rules governing therapeutic claims, particularly through the use of synthetic substances that have remained largely untested. The authors warn of the spread of compounds such as NoNic6, a nicotinamide-type analogue, whose presence in vaping devices and oral pouches is becoming more widespread, without their safety being established or their addictive effects mentioned.

Among these emerging substances is 6-methyl-nicotine (6-MN), identified in several countries, including France, and used as a covert nicotine substitute. Marketed in products with claims such as "0 mg" or "nicotine effect 5 %," this molecule misleads consumers about its true pharmacological nature. Preclinical studies indicate that 6-MN has an affinity for nicotinic receptors up to three times greater than that of nicotine, with a pronounced dopaminergic effect, reinforcing its addictive potential. Its impact on lung cells is also a cause for concern, due to the increase in oxidative stress observed in vitro. To date, no comprehensive toxicological assessment or studies on long-term effects have been published.

These products are often promoted as smoking cessation alternatives, outside of any regulatory framework and without scientific validation, which risks turning users away from validated treatments. The study also highlights that some companies do not hesitate to use, without authorization, advertising elements from brands marketing approved nicotine substitutes, increasing confusion for the public.

Finally, the authors call on health authorities to address these regulatory gaps. At the local level, some states, such as California, have already expanded their legislation to cover nicotine analogues. A similar extension at the federal level—or in other countries facing this issue—would be essential to ensure consistent and appropriate oversight of the rapidly evolving nature of these products.

©Generation Without Tobacco

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[1] Robichaud MO, Schroth KRJ, Steinberg MB, et al. Unauthorized therapeutic claims on e-cigarette and nicotine pouch company websites in the USA Tob Control Epub ahead of print: [May 2025]. doi:10.1136/tc-2025-059338