Is The Vape In Your Hand Actually Illegal?

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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.

The Analysis

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.

Implications

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!

Jimmy, lover, blogger, vaper and ex-smoker. I’ve been blogging about and supporting Vaping since 2009. They changed my life and I think history will show them as one of the most significant public health invention of the 21st century.

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6 Responses

  1. Frank says:

    How about Big T, they just introduced the Mark Ten Elite which is a complete design rip off of the Phix?

  2. Michael Rice says:

    Do I think my vape has been authorized by the FDA? Nope, why would it be? Are humidifiers authorized by the FDA? Couldn’t I just load up some nicotine diluted in water in my Vicks humidifier and breathe the vapor? Look vapes are not tobacco products. Period. End of story. There is no room for discussion on this. There is no tobacco in a vape when it is manufactured or when its sold. Same goes for tanks, drippers, coils, atomizer heads. Just because I can put tobacco in it and use it to get nicotine does not make it a tobacco product.
    Bongs are legal, even though they’re most commonly used for marijuana, because they can be used with other things besides marijuana. I believe the standard is sufficient legal usage. You know what else vapes can be used with that doesn’t contain tobacco? 0 nic vape juice. Guess how many people vape 0mg nic? a lot.
    The FDA is *MASSIVELY* overstepping its bounds with the deeming rules, and there’s no logical reason for it to do so except to benefit the major tobacco companies who have the money to jump through the hoops of these ridiculous regulations and want to corner the market on vaping with their own devices (which, I might add, are designed to exclude innovation and DIY capabilites, using expensive prefilled cartrdges just like packs of cigarettes) and liquids, probably adding tons more chemicals than the current vape market to make them even more addictive than nicotine alone (just like they have with cigarettes).
    The FDA needs to go F**K right off with this deeming rule and GTFO of the market. Fine, regulate the nicotine. Regulate the ejuice with nicotine in it and restrict sales to adults, with heavy penalties for noncompliance. Ban posession and consumption by minors. Leave the tanks, drippers, coils, atomizer heads, and mods alone.

  3. Joey says:

    Yeppers. You are spot on. I’m highly pissed as well.

  4. Dan says:

    It’s only an inconvienence. I know a. I’d never go back and b. I’ve got a soddering iron and wire.. they gonna out law cotton? you’d have to outlaw buying the nicotine to really get the effect you want, for government conspiracy. It’s whatever, they will probably get sued for breaching/conspiring. Possibly force a vape monopoly (whatever).. in the end it would be the load on the specific place’s medical budgets- as more people get sick from preventable SMOKING complications (with lifestyle factors making things worse..like America’s obesity paradigm etc. etc.)

    I just don’t see big tobacco winning this, not for long anyways.. but definitely the more corrupt, underhanded move you could do. But I mean what do you expect; thats’ @merica for you!

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