New FDA e-cig regulations and the million-dollar PMTA process
With the recent announcement of the new FDA e-cig regulations, manufacturers across the country began surfing the Internet for information on the mysterious Pre-Market Tobacco Applications process (PMTA). Since e-cigs and vaping devices don’t contain tobacco, most retailers have never taken the time to research the issue. But now that Obama’s Office of Information and Regulatory Affairs (OIRA) and the Office of Management and Budget (OMB) have sided with the FDA, the FDA is free to begin federal oversight of the entire industry within the next 90-days.
So what does this mean to the average vape shop owner who creates his or her own brands of e-liquid with hundreds of different flavor combinations available to the general public? According to the deeming regulations, it is still somewhat unclear.
Confusion over PMTA process mounting
While the FDA now requires all e-liquids to go through the PMTA process, they fail to give an exact overall cost per product. The FDA currently estimates that it takes about 500 hours or $300,000 to process a single application. Other political insiders believe the number to be closer to 1500 to 1700 hours with an escalating cost of over $1 million per product. Meanwhile, an Indiana News Channel is running a story that the cost is in upwards of $5 million. And a single application must be submitted for each flavor combination and each different variation in nicotine strength.
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All of these different estimates is part of the chaos. Let’s say that it takes only 500 hours. That’s about 62.5 business days. Do we really expect the FDA to process millions of applications in three-month’s time? Probably not. So where does that leave us?
- Prices will go up.
- Selections will go down.
- Vape mods will be ancient history.
For those retailers who would be lucky enough or successful enough to afford a million-dollar PMTA process, those application fees have to come from somewhere. So, retailers would transfer those costs to the consumer. E-liquid prices would soar, thousands of selections of e-juice flavors would disappear overnight, and vape mods would virtually become extinct.
Will PMTA process be the end of vape mods?
For those who are new to vaping, a vape mod is a customizable vaping device with lots of tiny parts. Vapers can mix and match these tiny parts to create a custom “vape mod” that suits their individual tastes and preferences. Some of these parts, like a wick or a coil, for example, cost only pennies to make. But if the manufacturer has to shell out a million dollars just to get FDA approval to sell it, then that’s a whole lot of wicks and coils to sell before the retailer even breaks even.
But this is all speculation at the moment. The vaping industry needs more information. The Cole-Bishop Amendment offers some hope by challenging the initial predicate date of February 15, 2007. But even if this amendment passes, it is still only a temporary solution. It’s essentially a grandfather clause to move the date forward to May 5, 1016. What do we do next? According to the FDA, we have a 2-year window to come into full compliance. While the Cole-Bishop Amendment is a step in the right direction, we need to be targeting the Republican-controlled Congress to override the FDA.
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