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Let's Talk About PMTA Pt.2

Updated: Aug 23, 2019



The PMTA process is becoming a consistent topic for the majority in the industry of vaping, and with the submission deadline being May 2020, pressure is building. Very few companies have openly dedicated a commitment to submit, while others seem to be planning to continue until the deadline, then foresee-ably pulling their products from the market. The fact is, a tremendous amount of work will have to be done.


In this part.2 of our blog series, questions from business owners and vape industry affiliates will be answered in order to address the vast concerns arising from the deadline, the potential cost, and the uncertainty about the process. You can view part.1 here.


While the PMTA process initially presents itself as overwhelming, it is important to remember, "When eating an elephant take one bite at a time."


1. There is a mentioned public docket back in 2017 that was supposed to consist of FDA and other source studies that the vapor industry was supposed to be able to use in the bridging process. Does this docket exist, or is there a way to access the studies?


You can use the PATH study to help with population assessments but another thing to keep in mind is that the cost of registration with a PMTA is likely to be high in the first couple of years. There is an expectation to see a drop in fees after about 3 years, when registrations from initial companies are all published, making it easy to reference products already on the market for future applications.


If you have a contingency plan for a couple years, waiting is a viable option. However, given the FDA’s track record of changing deadlines, it’s possible that once this deadline has passed they may filter through the applications that are acceptable and allow them to continue on the market for several years. The only guarantee at this time is that things are going to chance. The only certainty is uncertainty itself... which is a shame when public health is at stake.

https://www.fda.gov/tobacco-products/research/fda-and-nih-study-population-assessment-tobacco-and-health



2. How many PMTA's has the FDA received since the deeming regulations were issued?

Two PMTA’s have been through the process - Swedish Match Snus, and IQOS. As of the time of our last inquiry, the number of refused or withdrawn applications was 389 out of 401. Our friends at Chemular managed to reverse one of those marked for refusal.




3. Are all products that aren't medical, that contain nicotine now deemed a tobacco product(ex. Toothpicks, dissolvables, etc)? And are PMTA's for those products due at the same time as the ones for vapor products?


Anything with tobacco-derived nicotine will be considered a tobacco product.

In the case of synthetic, we have sent several letters to the FDA which have yet to receive a reply. It is likely that synthetic is still an undecided category and will likely be classed as a drug. At this time many companies are investigating the opportunity to bridge with a synthetic nicotine to extend their time on the market. North America Nicotine currently supplies synthetic nicotine, applying our stringent requirements for quality, safety and science, while maintaining a steady supply chain and setting the highest industry standard.




4. Once the deadline hits, what's next? How will shop owners know who filed a PMTA and who didn't? Do they get to sell out their current inventories?


The expectation that currently exists is for the FDA to publish a list of accepted products and allow a grace period for selling of current stock. While this outcome would be most ideal, a clearer understanding has yet to be determined.





*We will be answering more submitted questions in our next blog spot, "Let's Talk about PMTA pt.3".

-To submit a question about PMTA's, please email:

Ashley@northamericanicotine.com

-To find out more about North America Nicotine, and our products, please email: Taylor@northamericanicotine.com

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