FDA Center for Tobacco Products.

FDA’s policy memoranda provide details about key areas of regulatory science and were written to assist reviewers with the evaluation of new tobacco product applications.  FDA has made these documents public because they may provide useful information for the preparation of tobacco product applications.

Information contained in these memos is subject to change based on advances in policy, the regulatory framework, and regulatory science, and is not binding on FDA or the public. These memos may serve as a useful additional reference, however, they should not be used as a comprehensive manual for preparing or anticipating review of tobacco product applications, as they represent FDA’s approach at the time these memos were written. 
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