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163 To date, FDA has not issued such regulations

To legally market a new tobacco product, 44 a manufacturer must receive a PMTA marketing authorization order, unless FDA determines that the new tobacco product is substantially equivalent to a predicate tobacco product or is exempt from substantial equivalence

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This means providing evidence that your product can help adult smokers transition away from more harmful combustible cigarettes, while also proving it wont appeal to youth or non-smokers

In 2014, the Surgeon General's Report stated: "Death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other burned tobacco products

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