Phillip Morris International (PMI) has recently filed the very first Pre-Market Tobacco Application (PMTA) since the new FDA deeming regulations went into effect in August of 2016. The application is for a new product that the company is labeling as a QOS heat-not-burn method of ingesting smoked tobacco. Not to be confused with vaping technology, the new PMI system uses applied heat rather than fire to vaporize a tobacco leaf concoction.
The vaping community’s reaction to this new form of tobacco consumption is tending towards the negative. While the e-liquids used in vaping technology are 100% tobacco-free, heat-not-burn systems are decidedly not.
As the general public continues to confuse the concepts of conventional smoking with the new trend of vaping, e-cig activists often feel as if they are fighting an uphill battle in their attempts to convince the Average Joe that e-cig vapor is not as toxic as the smoke from cigarettes. Many fear that the entrance of heat-not-burn technology into the marketplace will likely only muddy the waters of public perception even further.
PMTA threatens to wipe out vaping industry by 2018
The requirement for a PMTA process is something entirely new for the American vaping industry. In the past, this application was typically only reserved for new conventional tobacco products. When the FDA deeming regulations were first announced, many vape shops, retailers, and manufacturers were taken by surprise.
How long would the PMTA process take? Will the process require only one pass-or-fail decision? Or can a company re-apply with a revised application if the first one is denied? And how much will the PMTA cost? The answers to these questions provided on the FDA website have been murky at best.
By Philipp Morris filing the first PMTA since the new deeming regulations took effect, the vaping industry might learn a great deal about the FDA approval process. After all, filing a PMTA is not as easy as filling out an application for a job at Dave and Busters.
The application must be submitted along with scientific research, case studies, and perhaps clinic trail evidence that prove the product’s worth for FDA approval. All of this stuff costs money, not including the very costly PMTA fee itself. Theoretically, if even one of these supporting documents is out of place, then the entire approval process could be stymied.
What would happen next? Will an additional PMTA fee need to be paid? And how long with the second round of oversight last?
Approval or denial of the PMI PMTA may shed some light
While PMI has already been selling its QOS system in numerous countries abroad, it needs PMTA approval to launch the product in the United States where the vaping boom is at its peak. Meanwhile, PMI has already spent millions of dollars in research to perfect its heat-not-burn technology.
The FDA deeming regulations were originally released with a pre-defined two-year grace period before the PMTA would be required for all new or alternative tobacco products (even though vaping technology is 100% tobacco-free, the FDA still considers e-cigs a “tobacco product” legally). By August 2018, some 16 months away, the PMTA will become a reality.
Any product released to market after Feb. 15, 2007 (over ten years ago!) will need PMTA approval. Estimated to cost between $300,000 to well-over $1 million, local vape shops are understandably anxious to see how the PMI PMTA approval process pans out. After all, there are no refunds by the FDA for PMTA denial.