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(eight) If applicable, the dates if the tobacco merchandise was commercially marketed in the United States;

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FDA may perhaps ask for, or an applicant could post on its own initiative, an Modification to some PMTA containing information and facts that may be necessary for FDA finish the evaluation of a pending PMTA. An Modification should include things like the right sort and specify the STN assigned to the original submission and, if submitted aside from at FDA's ask for, The rationale for distributing the amendment.

(B) Validation and verification functions for all take a look at methods employed in order that the tobacco item fulfills specs;

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WARNING: This item contains chemicals, which includes nicotine, which is known towards the State of California to lead to cancer and reproductive damage.

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(2) If an applicant is required to, but hasn't however submitted a postmarket report, the applicant have to submit a report as Portion of its application which contains all of the knowledge for the original tobacco products that would or else be needed within a report less than § 1114.

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The Place of work on the Federal Sign up publishes paperwork on behalf of Federal businesses but does not have any authority about their plans. We suggest you directly Make contact with the company connected with the written content in issue.