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If, at any time, FDA determines that any of the grounds for withdrawal in section 911(j) apply, including a determination that the applicant, based on new information, can no longer make the demonstrations required under section 911(g) for a modified risk order, FDA is required to withdraw the order

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Table 1 Demographic and clinical characteristics of RETUNE pilot study participants (intervention arm only) randomized between February and September 2025 in Switzerland (N=98) The most common reason for refusing all offered products was that the participants had no interest in quitting tobacco smoking (34/45

Mass spectrometric analysis of tobacco-specific nitrosamineDNA adducts in smokers and nonsmokers