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Cancer Epidemiol Biomarkers Prev., 14(2):467-475

Simply submitting an application does not give companies safe harbor from enforcement - if a product has not been authorized for sale by the FDA, it's on the market illegally

Many tribes used it for rabbit tobacco revival rituals

Abera, et al

94 Although FDA has the authority to establish new tobacco product standards (as previously described), Section 907 of the FFDCA establishes a tobacco product standard explicitly banning characterizing artificial or natural flavors (other than tobacco or menthol), herbs, or spices in any constituent, additive, and component or part of a cigarette