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(Notably, the FDA doesnt have to actually evaluate the public health data for companies to receive carte blanche that can happen later.) The guidance is troubling for several reasons, said Mitch Zeller, a former head of the Center for Tobacco Products at the FDA

Different studies have shown that cigarette smoke causes a reduction in cell viability and induction of apoptosis in respiratory hair cells20, opposite mitogenic effects or pro-apoptotic depending on the cigarette smoke concentration21 or even an impairment on epithelial regeneration upon injury.22 Animal studies have shown that chronic and intermittent exposure to cigarette smoke cause morphological alterations to the epithelium of the entire respiratory tract, from hyperplasia in lower concentrations, all the way to loss of cilia and metaplasia with keratinization in higher concentrations, and also submucosal thickening and inflammation with neutrofilic and mononuclear inflammatory cells infiltrate.23 Also, Hamm et al.24 showed that the cigarette-induced respiratory mucosa inflammatory reaction persists even after seven months of recovery