Mitch Zeller: FDA will provide list of PMTA applicants for vaping products
Today is the last day for manufacturers of vaping products and e-liquids to submit their pre-market tobacco applications (PMTAs) to the U.S. Food and Drug Administration (FDA). Those which fail to do so will be forced to remove their products from store shelves indefinitely. Per the federal guidelines, retailers must submit one PMTA per product at an estimated cost of between $117,000 to $466,000 per application.
Most small business owners cannot afford the expense of a single application, let alone the cumulative costs of an entire catalogue of flavored e-liquids and other vape gear. In short, the American vaping industry is now facing extinction at the hands of the U.S. government.
Related Article: September 9 FDA PMTA deadline is Big Win for Big Tobacco
For former smokers relying on vaping as a tobacco harm reduction tool, the consequences are perhaps equally as dire. According to The Motley Fool, approximately “14,000 small vape businesses employing 166,000 workers will be destroyed, representing $24 billion in economic activity.” As local vape shops beginning rapidly closing their doors permanently, vaping enthusiasts will struggle to locate new vendors willing to offer a vastly depleted selection of flavored vape juices.
PMTA process threatens to kill the vaping industry
Furthermore, the submission of a PMTA does not necessarily guarantee FDA approval. Those retailers who are financially fortunately enough to submit applications by the deadline will only receive a 12-month window of opportunity to continue selling their vapes. If FDA approval is not granted within the next year, the related products and e-liquids will also be forced from the market.
In a recent FDA press release, Mitch Zeller, director of the agency's Center for Tobacco Products, stated that the FDA has already received about 2,000 applications. Out of an estimated 400 Million vaping products eligible prior to the September 9 deadline, that is a minuscule 0.000005 percent of the overall market share.
In an effort for enhanced regulatory transparency, Zeller also stated that the FDA will be posting a complete list of all vaping products with submitted PMTAs. In theory, the list will also be updated once FDA approvals or denials are confirmed.
“Although we do not know how many applications will be submitted by the September deadline, we do know that there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced. However, FDA has been planning and preparing to receive the expected influx of applications for years. Our preparations are intended to help ensure that our approach to product review protects public health and is fair, consistent, efficient, and as transparent as possible.”
Bloomberg News also reports that Mitch Zeller is declining to provide -at this time - the date in which the list will become available. Zeller apparently also said that the 12-month grace period will immediately expire should any PMTA be rejected by the FDA during the one-year timeframe.
(Image courtesy of CNBC/YouTube)