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(iii) The impact the product and its promoting may have within the probability of tobacco use initiation by tobacco merchandise nonusers;
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(2) A press release figuring out all tobacco item requirements issued below area 907 from the Federal Food items, Drug, and Beauty Act which might be relevant to the new tobacco merchandise and a brief description of how the new tobacco product absolutely satisfies any identified tobacco solution conventional, or if The brand new tobacco product deviates from a product typical, if relevant, the application have check here to contain sufficient data to establish and justify Those people deviations;
D. “The FDA is devoted to guarding People in america from tobacco-relevant condition and Loss of life by guaranteeing that new tobacco solutions bear acceptable regulatory overview to determine should they meet up with the public health and fitness benchmarks set by law. If new tobacco merchandise tend not to meet up with the requirements for these pathways, they cannot be marketed or marketed in The us.”
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WARNING: This products has substances, which include nicotine, which is known on the Point out of California to cause cancer and reproductive harm.
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(iv) A concluding summary describing how the applicant's strategies for promoting the new tobacco products are in line with the applicant's dialogue with the greater or decreased likelihood of modifications in tobacco merchandise use actions, which includes switching, initiation, cessation, and polyuse, less than § 1114.