UPDATE ON THE PMTA'S FUTURE IMPACT ON THE INDUSTRY
The FDA's PMTA deadline is here and we wanted to shed a little light on what that will mean for our customers and consumers as a whole in our industry. This deadline will restrict the types of products we are able to provide our customers with and therefore we felt our customers deserve an explanation.
The PMTA – Pre-Market Tobacco Application – is a relatively new requirement that stems from the FDA deeming regulations released in May 2016. While its deadline has changed almost a dozen times in the years since, an FDA-approved PMTA is required for every vaping product whose manufacturers wish to keep selling that product on the market. A PMTA is required for nearly every kind of vapor product, including e-liquids, mods, tanks, and coils. Without a PMTA submitted by the manufacturers for FDA review by the September 9 deadline, all related products must be pulled from store shelves and e-commerce sites by that date. PMTA submission – not necessarily approval – is all that is required at this time. This means, in order for us as a store to continue carrying any products, those products must have had their PMTA paperwork submitted to the FDA by the previously mentioned date (Sept. 9, 2020) but still may not necessarily have been approved, the FDA then has one year to either approve or deny any PMTA submissions to allow those products to remain on the market. Product submissions are done on a product-by-product basis and each submission can cost a company hundreds of thousands if not millions of dollars. A product submission consists of extensive documentation of a products materials or ingredients, lab reports for those materials or ingredients, and clinical trials demonstrating the effects of those products after prolonged usage. Many labs at the moment are working around the clock on research for covid-19 so third-party lab resources are unavailable to manufacturers right now and clinical trials have become utterly impractical, further complicating the process for them. The way things stand, we are not entirely sure what companies will be left standing when the dust settles, we are aware that many of our customers have become accustomed to certain flavors, coils, devices, etc. and although some of these products may be going away for good, we will remain committed to working with our customers to find suitable alternatives for their favorite products. This is an unfortunate situation for the vaping industry to find itself in and regrettably there isn't much we can do but wait and see what makes it through this transitional period.
Thank you for taking the time to read though this and get informed on the state of the vaping industry, we are always trying to keep our customers up to date on regulations that impact our ability to serve them or the products we have available to them and take great pride in what we do!!!