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74 For such a product to be exempt, FDA must determine that (1) the modification would be considered minor, (2) an SE report that demonstrates substantial equivalence would not be necessary to ensure that marketing the tobacco product would be appropriate for protection of public health, and (3) an "exemption is otherwise appropriate." 75 Before the product can be legally marketed, FDA must first grant the product an exemption from demonstrating substantial equivalence

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As explained in NCIs Tobacco Control Monograph 21, The Economics of Tobacco Use and Tobacco Control, published in 2016 in collaboration with WHO, Tobacco control policies, such as increased taxation, anti-smoking media campaigns, and comprehensive smoke-free policies, increase the demand for tobacco dependence treatment and the rates of subsequent cessation. Research conducted over many decades and in many countries has established that significant increases in the excise tax and price of tobacco products is the single most consistently effective tool for reducing tobacco use

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