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.
Ready to Learn More About CBP, OFAC,
BIS, FWS, and FDA?
We have dozens (literally!) of videos in our educational library on our YouTube channel related to importing, exporting, US Customs, BIS, OFAC, FWS, FDA, NFTs, and so much more. Subscribe to our channel now to stay up to date on the latest on these topics!
Our law firm helps growing companies who import and export comply with government regulations. We love what we do and we take our oath of confidentiality over your matters very seriously. How much? Watch this video to learn about it. CLICK HERE
Wondering "why should you have an attorney on your side?" Click here to watch one of our attorneys, Susan Steinman, break down the critical benefits as to why you want to have one on your side - whether you hire us to help you or another law firm.
Have questions? We are determined to help you.
We listen carefully to clients to ensure our understanding of the legal issues at hand, their factual context, and any limitations that might impact a chosen strategy. Feel free to connect with us using the contact form at the bottom of the Home page or send us an email at email@example.com.