Nicotine pouches, containing pharmaceutical-grade nicotine and food-grade fillers, are a harm-reduced product that provides a safer alternative for cigarette smokers. A permeable pouch placed between the gum and the cheek slowly releases nicotine and, in doing so, eliminates the process of combustion.

Since 2022, the U.S. Food and Drug Administration (FDA) has evaluated and regulated the entry and marketing of non-tobacco nicotine products within the U.S. Manufacturers are required to provide comprehensive data on product composition and potential health impacts, among other data points. This data helps the FDA evaluate whether the products can indeed help reduce smoking-related diseases and deaths.

This regulatory framework ensures that authorised nicotine pouches are subject to rigorous standards for safety and effectiveness - and often serves as a good measure of approval outside the nation as well. As part of a risk-proportionate effort to provide harm-reduced alternatives to smokers and for the sake of public health, the FDA's authorisation of nicotine pouches has significant implications for tobacco regulation.

All tobacco pouches legally found in the USA have received premarket authorisation from the FDA. Therefore, the FDA certainly recognises nicotine pouches as a viable alternative product and approves those that match their criteria.

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