indicates any person who submits a premarket tobacco solution application to receive a marketing granted order to get a new tobacco product.
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(eight) If applicable, the dates in the event the tobacco product or service was commercially marketed in the United States;
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), hereby certify the applicant will sustain all records to substantiate the precision of the application to the stretch of time needed in 21 CFR 1114.45 and ensure that such information continue being readily available to FDA upon request. I certify this facts as well as the accompanying submission are real and correct, that no substance fact has become omitted, and that I am approved to submit this within the applicant's behalf.
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(iv) Copies of all versions of investigator Directions, if any were being made In combination with the protocol;
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WARNING: This solution incorporates chemical compounds, which include nicotine, which is known to your State of California to lead to cancer and reproductive damage.
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This solution can expose you to chemicals such as nicotine, which is known into the Condition of California to cause cancer and reproductive harm or more information, visit p65warnings.