Health Groups Demand FDA Action over Unapproved Nicotine Product sales
Washington D.C.- A coalition of leading public health organizations is urging the Food and Drug Governance (FDA) to immediately halt the sale of nicotine products being marketed without required authorization, citing a growing trend of regulatory circumvention by major tobacco companies. The groups allege that companies like Reynolds American are illegally introducing new products, potentially undermining years of progress in tobacco and nicotine control.
The concerns center on the marketing of products, including Velo Plus nicotine pouches, without undergoing the FDA’s pre-market review process-specifically, lacking a Modified Risk Order (MGO). This lack of evaluation raises significant health concerns, especially regarding youth access and exposure to potentially harmful products. The organizations warn that this represents a broader weakening of public oversight over the tobacco and nicotine industries, jeopardizing public health gains.
According to a letter sent to the FDA, reynolds American began selling Velo plus pouches without authorization as early as 2024, demonstrating a pattern of disregarding regulations. The coalition, including Generation Sans Tabac and Truth Initiative, emphasizes that marketing products without MGO approval is a direct violation of federal law and calls for swift, enforceable action against the companies involved.
“The protection of public health, and especially our young people, depends on the FDA’s ability to respond decisively to these attempts to bypass the law,” stated a representative from one of the organizations. they are requesting an urgent meeting wiht FDA officials to discuss strategies for strengthening enforcement and ensuring all new nicotine products are thoroughly vetted before reaching consumers.
the groups point to a September 26,2025,press release from Truth Initiative detailing the concerns and the call for FDA intervention [1]. This latest development underscores the ongoing challenge of regulating the rapidly evolving tobacco and nicotine landscape and the critical need for robust oversight to protect public health.
[1] Truth Initiative. “Leading Health Groups Urge FDA to Stop Major Tobacco Companies from Illegally Marketing New Products Without Authorization.” September 26,2025. https://truthinitiative.org/press/press-release/leading-health-groups-urge-fda-stop-major-tobacco-companies-illegally-marketing. Accessed September 29, 2025.
