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Inside FDA's TPMP: What Vape and Tobacco Companies Need to Know


In this video, Jacob provides a heads up to businesses in the tobacco and vape sector on a long-awaited FDA Proposed Rule, the Tobacco Product Manufacturer’s Practice (TPMP). Click the play button above to hear more from Jacob.


The Tobacco Product Manufacturer's Practice (TPMP) is a fairly significant proposed set of rules and standards from the Food and Drug Administration (FDA) with which tobacco product manufacturers will ultimately need to comply with, whether a manufacturer of bulk components or of finished tobacco products. While wide-ranging, the basic purpose of TPMP is to create tobacco product manufacturing standards which will help ensure the consistency, safety, and traceability of all tobacco products manufactured in the United States.


The TPMP is currently comprised of ten subparts, all but two of which relate to different categories of tobacco product manufacturing topics or activities (such as tobacco product manufacturer management system requirements, and tobacco product design and development controls). Primarily TPMP will require the implementation of good manufacturing standards; personnel (particularly management) standards; personnel training programs; facilities and equipment standards; tobacco product design, composition, labeling, and packaging standards – and impose recordkeeping requirements for virtually all these components. Importantly, the recordkeeping requirements must show that the procedures put into place are actually used, and that there is a system in place for monitoring product consistency and quality (referred to as acceptance criteria), as well as program in place for taking both preventive and corrective action where products fail to meet standards. This is, of course, a generalization of the TPMP, but one which presents a basic picture of the rule’s purpose.


At first glance, the TPMP is sure to intimidate – for small tobacco product manufacturers who have been dealing with a relative avalanche of new regulations over the past few years, the TPMP can look like an effort to drive manufacturers out of business. Indeed, any manufacturer who puts off TPMP until the last minute will be overwhelmed. This isn’t necessary, however. With a planned effective date a minimum of two years AFTER publication of the Final Rule (and even longer for small manufacturers) – industry has time to assess TPMP and begin creating a TPMP program piece by piece.


Interested in creating your own TPMP program? We are determined to help you. Have other questions? Give our office a call today at (917) 546-6997, we would be happy to speak with you.


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