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(B) The chance that nonusers of tobacco products and solutions who undertake the tobacco product or service will switch to other tobacco items that may possibly existing higher levels of particular person overall health threat; and
Handed in 2007, the regulation also relates to any current tobacco product that undergoes any read more modify in design, ingredients or elements.
documentation of whether or not the analyze was executed in accordance with fantastic laboratory procedures, which include those laid out in portion fifty eight of this chapter;
(six) Every other adverse expertise that, dependent upon proper health-related judgment, may possibly jeopardize the health of someone and should have to have healthcare or surgical intervention to stop among the other outcomes outlined in this definition.
The appliance have to comprise the subsequent certification, with the suitable information inserted as indicated by parenthetical italicized text, signed by a certified agent from the applicant:
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(iv) A concluding summary describing how the applicant's programs for marketing and advertising the new tobacco solution are per the applicant's dialogue of the enhanced or lessened chance of modifications in tobacco item use habits, which include switching, initiation, cessation, and polyuse, less than § 1114.