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FDA's DOOMING Regulation - What You Need to Know

by Chris Ford May 06, 2016

FDA's DOOMING Regulation - What You Need to Know

The Food and Drug Administration announced yesterday its final “DOOMING” rule bringing e-liquids containing nicotine and e-cigarettes under the Federal tobacco regulations, changing vaping as we've come to know it. With this final rule, FDA is extending the Agency's "tobacco product" authorities in the FD&C Act to all other categories of products that meet the statutory definition of "tobacco product" in the FD&C Act, except accessories of such newly deemed tobacco products. 

Don’t panic… there is a 90-day “grace period” from the time a final rule is signed, until it becomes effective, meaning e-liquids and e-cigarette manufacturers must comply with the new regulation on August 8, 2016. FDA has given a one-year grandfathering period during which time you’ll need to prepare your PMTA for the Agency’s intense scrutiny.

The first step is to register your facility and list your products with FDA. There are fees associated with registration, and you’ll need to create an account for your business on the FDA registration database.

It’s important to point out that the FDA is allowing a one-year grandfathering period, because it can easily take that long to prepare a PMTA. Concurrent with your first submission, you’ll need to prepare your internal systems to provide the necessary supporting evidence.

With a two-year review cycle, and a price tag upward of $1 Million, the PMTA process is very lengthy and costly. To reduce research burdens on manufacturers and increase efficiency of PMTA preparation and submissions, FDA encourages you to use nicotine sources with FDA-approved tobacco product master files (TPMFs), like Nicobrand and Nicoliquid whenever possible. This will speed the review process and reduce your costs drastically, by referencing the information in TPMFs rather than develop the information on your own. Nicobrand nicotine is also REACH registered, so it’s ahead of the curve in Europe, as well.

The clock is ticking

Taking this first critical step will greatly facilitate your subsequent obligations to prepare and submit your PMTA, and a certified Quality Management System by a reputable, recognized certification body will provide the assurance that your processes can repeatedly produce the product.It is critical that you immediately begin planning and implementing the systems necessary to demonstrate control over processes and suppliers, consistency in manufacturing processes, control over materials, and assurance of product safety. This starts with establishing a Quality Management System - the organizational structure, policies, procedures, processes and resources needed to implement quality management to demonstrate with evidence that your processes are capable of producing products that meet requirements. You’ll this evidence for all of your submissions.

It’s important that you begin implementing a Quality Management System now, if you have not yet implemented one, not only to meet the TPD2 requirements, but more importantly, to establish the evidence you will need for your PMTA and to comply with FDA requirements. Your Quality Management System should provide the laboratory controls, clean manufacturing, exporting, labeling and marketing practices to highlight the importance of e-liquids safety and quality for consumers, while meeting all requirements of the TPD2 and setting your baseline for FDA’s deeming rule requirements. This will provide the assurance that your product has stability and is reproducible.

The Quality Management System should adopt a process approach based on the ISO 9001 management system, as this is the global benchmark for quality management systems. These processes are interrelated, and provide for a cycle of continuous improvement throughout the management system. By identifying the top-level processes within the company, and then managing each of these discretely, we reduce the potential for nonconforming products and services discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes.

Benefits of the process approach … A focus on the more important (“highrisk”) processes and their outputs

  • improved understanding, definition and integration of interdependent processes
  • systematic management of planning, implementation, checks and improvement of
  • processes and the management system as a whole.
  • better use of resources and increased accountability
  • more consistent achievement of the policies and objectives, intended results and
  • overall performance
  • process approach can facilitate the implementation of any management system
  • enhanced customer satisfaction by meeting customer requirements
  • enhanced confidence in the organization
  • ensures conformity with all requirements, such as TPD2 and FDA’s deeming rule by identifying Key Process Indicators, and monitoring the performance.

The bottom line is if you’re a manufacturer of e-liquids containing nicotine or e-cigarettes, you’ve got 90 days to comply with the FDA tobacco regulations. If you don’t begin planning and preparing now, you’re doomed.

Chris Ford
Chris Ford


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