A deeper look into the proposed new regulations for electronic cigarettes, and why many experts claim they could signal a death knell for many businesses in the industry.
By Jerry – November 11, 2015
If you pay attention to the news and chatter around vaping communities, or have been following us on Google+ (which you should absolutely do, by the way), you know that the biggest news story over the past month in the vaping world has been the waiting game surrounding new electronic cigarette legislation.
The process behind getting new governmental regulations has been happening for years, as nothing at the congressional level of our Federal Government can seem to happen quickly. But only recently has the legislation cleared enough necessary hurdles for its passing to be right around the corner.
Let’s take a look at the process, what the proposed regulations are believed to enforce, and why many insiders are so fearful if they do come to pass.
As vaping began to grow wildly in popularity in the mid to late 2000s, health and government officials alike began to see the need for oversight. It’s unclear hether this oversight and need for regulation was borne out of concern for the consumer (the health effects of vaping were even less known then than they are today), a pure regulatory need to ensure this fledgling industry was following the rules, or from big tobacco throwing lots of money at their lobbyists and in turn our lawmakers to kill this huge threat to their business (we admit that is a bit of a conspiracy theory, but when you consider how much the tobacco industry lobbies each year and how big of a threat vaping poses to smoking, it’s not THAT crazy). What is clear is that in 2009, Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which among other things, allowed the Food and Drug Administration (FDA) to start venturing into the new world of e-cigs.
The FDA soon started to publicly warn us about the dangers of vaping, and even went so far as to begin seizing electronic cigarette shipments at the U.S. border. After it was ruled by a federal appellate court that they didn’t have the legal authority to do so, the FDA was essentially told if it wanted to stop vaping, it would have to have to treat and classify e-cigs as a traditional tobacco product (even though e-liquid contains no tobacco).
So that’s exactly what the FDA decided it would do in 2011 – which was, as this New York Times article points out, initially seen as a victory for e-cig makers since the alternative was treating them as drug delivery devices (with much stricter regulation). Unfortunately, it wasn’t clear at the time what sort of rules the FDA would be enforcing on e-cigs.
For several years, there was a lot of discussion about what the final form of the FDA’s regulations would look like. In April 2014, they released their proposed regulations, which included an 18-years-old age requirement, mandatory proof of ID for anyone purchasing e-cigs or vaping products, prohibition of giving out free samples, and requiring warning labels informing consumers that these products contain addictive nicotine. While some of these are detrimental to the vaping industry as a whole (particularly the free sample prohibition as many vape shops would allow users to try new flavors and devices in shop), it wasn’t necessarily a big shock. After all, the FDA regulates cigarettes, chewing or smokeless tobacco, and snuff in pretty much the exact same way, and it did announce in 2011 it would begin regulating e-cigs like other tobacco products.
No, the major hang-up in the regulations comes from a seemingly innocent date included in the purported legislation: February 15, 2007.
Why Grandfathering Date is So Bad for Business
That date – February 15, 2007 – is without a doubt the biggest cause of concern for the vaping industry. As previously mentioned, the other regulations were somewhat expected and could be seen as a minor annoyance more than anything else. The grandfather date is a completely different story. As we mentioned, the process of enacting legislation to regulate e-cigs was a long time coming. As such, the FDA wants to retroactively apply these new rules. Here’s essentially how it breaks down, with special thanks to this article over at Motherboard.
Any e-cig product that has had its product on the shelf since before February 15, 2007 is in good shape – you’ll have to maybe change your label to incorporate the warning if you haven’t already, but that’s about it. If you are one of the majority of e-cigarette and e-juice companies that didn’t introduce your product to market until after February 15, 2007, you’ve got your work cut out for you.
The FDA would require you to seek a Pre-Market Tobacco Application (PMTA) and get it approved through the FDA. Which doesn’t sound that bad initially, but consider this – companies will have to fill out, file, and gain PMTA approval for each and every product they produce. If you’re a small e-liquid manufacturer and produce 50 different flavors, that’s 50 PMTAs for you – and that’s only at one nicotine strength per flavor. Each varying strength would need its own PMTA. As you can see, this is a laborious process, and one that will take up a shocking amount of time, money, and paperwork. In fact, the FDA itself estimates the process will cost millions.
Not every e-cig company has that kind of money. In fact, most don’t, and the few that do tend to be the ones who have the most products (coils, tanks, clearomizers, e-liquid, etc.…all needing PTMAs), which becomes exponentially more costly. It’s easy to see now why Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association (TVECA), has called these new proposed rules “a de facto ban.”
The final, official regulations have yet to be released, but all signs are pointing to what’s outlined in this article as being the final rules. We’ll be sure to follow this story as it develops and come back with any updates. In the meantime, follow our blog and circle us on Google+ to stay up to date with the latest vaping news.