PMTA - Senator Requests That the FDA Release Their PMTA List
The PMTA debacle has gotten a lot of vape companies scrambling to meet the deadline, as they must submit all of their products to be approved. The PMTA, or pre-market tobacco product application, is a requirement put forth by the FDA that requires that vaping companies submit applications to have their products approved under the blanket of tobacco products. Once vaping regulations go into full effect, only companies that have had their applications approved by the FDA can legally sell their products.
Fortunately, many vape companies have had success submitting their PMTAs, and the FDA has done a particularly good job keeping tabs on these companies. But the FDA has also been somewhat secretive, whether intentionally or not, in regard to the files that they have acquired. Now, a senator is looking to change that.
Just this past month, Senator Dick Durbin has requested that the FDA release their PMTA files. The request is asking for an incredibly detailed list of all companies that have been approved or are still pending approval.
This comes after the NACS (National Association of Convenience Stores) has requested that this information be made available to them. Supporting the request of the NACS are the Food Industry Association, the National Association of Truckstop Operators, the Petroleum Marketers of America and the Society of Independent Gasoline Marketers of America, who have each taken the time to sign the letter put forth by the NACS.
The reason why this request has been made is simple: companies want to know that they are selling legal, safe and legitimate vaping goods to customers. The FDA has been holding on to critical information about vape companies regarding the safety and legitimacy of their products, and as long as this information is withheld from these organizations, businesses can be selling illegal or unsafe products without even knowing it.
In addition to their desire to protect customers, these companies also want to know that they are not at risk of getting into serious trouble for selling unverified, unregistered products. Their fear is that the FDA now has a clear idea of which vape companies meet standards and regulations, and which do not. But, as long as businesses don’t have access to this information, they are at serious risk as they could be selling unapproved vaping goods.
The letter submitted to the FDA also says that by making the PMTA list available to these organizations, they can join forces to maintain strict standards about the vaping companies they sell, while no longer unintentionally supporting vaping brands that do not meet FDA standards.
Of course, one cannot totally blame the FDA for failing to release this information as of now. While the FDA did promise a comprehensive database of PMTA information back in September, this promise has yet to materialize. One logical reason behind this would be the enormous volume of applications they are still sifting through. The deadline took many vape companies by surprise, and companies had to scramble to submit their applications. This resulted in a traffic jam of applications that the FDA could very well be struggling to enter into a neat and readable data format. As of now, we truly don’t know just how behind the FDA is on verifying each of these companies, and we know there are still many more applications that have yet to be processed.
Still, until this information is made available, convenience stores and other businesses selling vape products don’t know whether or not they’re selling approved products, and this could come with serious repercussions down the line. For this reason, Durbin feels that the matter is urgent, and is an economical issue as much as it is a public health and safety matter.
This story is still developing, as we await a response from the FDA. For all intents and purposes, the FDA has full intention of making this information accessible as soon as possible. Durbin is simply hoping to speed up the process at the urging of the NACS, so that the vaping industry can be safer and more legitimate across the country than it ever has been in the past, up until now.