(Courtesy of vaporsdigest.com)
With the recent announcement by the FDA to impost massive e-cig regulations, vape shop owners and e-liquid manufacturers around the nation are asking, “How much will the PMTA cost, and am I heading into bankruptcy?”
The answers are “not sure” and “not yet.”
The vaping industry is rattled to the core over the new FDA regulations, but most particularly over the required Pre-Market Tobacco Applications process (PMTA). The FDA document that contains all of this information is about 500-pages long and filled with legal gibberish that most people can’t understand. But even for those who can, the FDA regulations are intentionally unclear, to say the least. The fee for the PMTA is not specifically stated. And industry speculation is only adding to the confusion.
According to spokespersons for the FDA, the approval process can take up to 500 hours to complete at a cost of around $300,000 per product. Further research also shows that only one PMTA application has been approved in the past six years. So, essentially, it appears as if the Federal Government is trying to eliminate vaping technology and e-cigs from the entire country, if the current statistics are any indication.
Confusion mounts over the PMTA
Meanwhile, other political insiders are saying that the FDA is lowballing the American Public because the real cost will fall somewhere in the $1 million range. To make matters worse, an Indiana television station, WISH-TV, released a story that estimates the PMTA process could cost as much as $5 million per product. Because the FDA regulations are so unclear, vape shop owners are understandably concerned about their economic futures.
One thing is certain. The majority of retailers cannot afford these fees, whether the PMTA cost is $300,000 or $3 million. But there is a glimmer of hope. Buried deep inside the 500-pages is a notation that says the vaping and e-cig industry has a full two years to comply. So, for those people asking the question “How much will the PMTA cost, and am I heading into bankruptcy,” you definitely have more than enough time to consider your options before finding a lawyer to file Chapter 13.
But two years is also enough time for the vaping industry to fight back. Instead of placing all of our hopes and dreams on Obama and the FDA, perhaps we should be targeting Congress instead. Only Congress has the power to pass sweeping legislation that safeguards an entire industry, especially one that saves millions of lives.