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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.

With that deadline past, the Agency is actively reviewing accepted applications. FDA’s next communication with PMTA filers will likely be a deficiency letter. The response to this letter must include additional information in order for FDA to determine whether it can provide market authorization. These responses will determine the trajectory of PMTA reviews, so developing the right strategy and tone is critical.

As part of the Agency’s further review, an inspection of clinical, non-clinical, and of manufacturing facilities will enable FDA to assess compliance with cGMPs, and the forthcoming Tobacco Product Manufacturing Practices (TPMPs). These inspections will be a critical part of the FDA’s substantive review of all submitted PMTAs.

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 Good Manufacturing Practices (GMPs). Although the FDA has not yet issued these for tobacco and deeming products, the FDA is “hard at work” on the TPMPs, which will be the cGMPs for tobacco.

EAS Consulting Group’s Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., Labstat’s Scientific Advisor, Dr. Willie J. McKinney, and Labstat President, Michael Bond present topics of immediate concern to the tobacco industry and PMTAs. Watch our two-part web series full of helpful information on understanding FDA’s approach and how to prepare for the next steps.

Work directly with EAS and Labstat to prepare your PMTA applications and responses by clicking here.