According to a new report, a significant number of the vaporizers sold in the US are unauthorized
There have been many advancements in vaping technology over the last couple years. From increasingly efficient batteries to easy to use sub ohm setups, progress hasn’t slowed down. But a new report by ECigIntelligence suggests that a significant portion of the vaporizers currently on the market in the US are actually unauthorized. They believe retailers and manufacturers are playing a dangerous game that could result in millions of dollars of lost revenue, not to mention major losses for public health.
The independent data analysis company poured through the inventory of the most popular vaping retailers and found that in just 2018 alone there were over 100 different products listed that weren’t offered during the last quarter of 2017. They do acknowledge that some of these products may have simply been rebranded, which would only require a Standard Equivalency certification from the FDA. But there’s no denying that many of these devices constitute a new product, and therefore should require passing a Pre-Market Tobacco Application (PMTA) according to the deeming rules. The only problem is, to date the FDA has never approved a PMTA application.
According to the researchers with ECigIntelligence, across the five most popular vaping stores there were over 100 products offered that not listed at the end of 2017. These ranged from box mods, starter kits, as well as pens. When looking into the products more closely, they found that 44 hadn’t been mentioned in any online reviews before October of 2017. The report concludes that this is clear evidence that these products hadn’t been on the market at all before, at very earliest, the Fall of last year.
But making these results more interesting is the confidential source that confirmed to ECigIntelligence that many devices currently on the market indeed violate the deeming rules by not having submitted a PMTA. It seems that these companies are willing to gamble that the FDA is unwilling, unable, or uninterested, in enforcing their rule meant to prevent any new devices from entering the market after the August 2016 grandfather date. So far this has worked out well for retailers and manufacturers, as the last two years have seen some great products introduced and become immensely popular. But now it appears that the FDA is preparing to take action that could result in not only millions of lost dollars for the vaping industry but also significant steps backward for the understanding of e-cigarettes as a harm reduction tool.
Possible FDA Action
The FDA’s controversial deeming rules have been the subject of much scrutiny among the vaping community since they were formally passed in August of 2016. These rules were meant to essentially freeze advancement in the vaping industry until companies could prove their device’s utility according to the Pre-Market Tobacco Application. Critics are concerned that it’s unfair to require small vaping companies to pass the same stringent and thorough testing required for traditional tobacco products. So while some have been trying to find workarounds to the “tobacco” portion of the PMTA by working on tobacco-free nicotine, most manufacturers have merely decided to ignore compliance altogether. This has worked fine for the last two years, but it seems that things may soon change.
According to the report released by ECigIntelligence, the FDA has been accepting and comparing contracts for inspectors to do a sweep of vape shops across the country looking for unauthorized devices. This is indicated by the request for proposals (RFP) that’s been issued to several contractors regarding how they’d carry out these inspections. The RFP even mentions looking for new devices as one of several significant targets including false advertising.
While ECigIntelligence was able to confirm with a closely related source that the RFPs are genuine, they were unable to acquire any more information on exactly what it means for vaping moving forward. So, for now, the only real action taken by the FDA regarding unauthorized devices is issuing cease-and-desist warnings to several noncompliant shops. But the fact they’re actively looking to fill inspector contracts strongly suggests that further action is just on the horizon.
It may just be a matter of time before inspectors across the country go into vape shops and clear the shelves of anything introduced after August 2016. That would mean that the last two years of advances in vaping technology would simply no longer be available for the American vaper. This could have a negative impact on health, as some vapers may opt to switch back to smoking if their preferred device is no longer available.
That doesn’t include the damage it’ll cause the already weak public reputation of vaping. One poll found that only 13% of adults understand that vaping is much safer than smoking, and non-users could easily misinterpret a mass recall of new vaporizers as indicative of the safety of vaping in general. So while many retailers have decided to take a calculated risk and ignore the regulations, it may ultimately be the user who suffers the most.
Do you think that your vaporizer has been authorized by the FDA? Did you realize that so many new products are unauthorized? Do you think it’s worth it for manufacturers to risk penalties and ignore the regulations? If not why? Let us know in the comments below, or reach out to our communities on Facebook or Twitter!