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67 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." 68 Before the product can be legally marketed, FDA must first grant the product an exemption from demonstrating substantial equivalence

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alone, and the majority of U.S