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Following a rigorous science-based review of the premarket tobacco product applications (PMTAs) submitted by the company, the agency determined that authorizing these reduced nicotine products for sale in the US is appropriate for the protection of the public health because of, among several key considerations, the potential to reduce nicotine dependence in addicted adult smokers, who may also benefit from decreasing nicotine exposure and cigarette consumption

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In addition, there is potential for overestimation because we assumed a smoking initiation of zero for the TFG scenario whereas social supply is expected to be feasible 12