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Preparing for an FDA CTP PMTA Pre-Approval Inspection


The Family Smoking Prevention and Tobacco Control Act referred to as the Tobacco Control Act (TCA), signed into law on June 22, 2009 includes a number of requirements enabling FDA’s Center for Tobacco Products (CTP) to determine whether the marketing of products in their purview is appropriate for the protection of public health (APPH). One of the requirements is the submission of a Premarket Tobacco Product Application (PMTA) by all owners and operators engaged in manufacturing tobacco products and electronic nicotine delivery systems (ENDS) sold in the U.S. no later than September 9, 2020.


In Section 902 and 906(e)(1) of the TCA, a tobacco product is considered adulterated if the methods used in, or the facilities or controls used for, its manufacture, packing, or storage do not meet Current Good Manufacturing Practices (cGMPs). Although the FDA has not yet issued these for tobacco and deeming products, the FDA is “hard at work” on the Tobacco Product Manufacturing Practices (TPMPs), that will be the cGMPs for tobacco. An inspection of the manufacturing facilities as well as clinical and non-clinical laboratories to assess compliance with cGMPs, and the forthcoming TPMPs, will be a critical part of the FDA’s substantive review of all submitted PMTAs.