Will the FDA Pull Your E-Cigarette Out From Under You in 2022?
By Jason Artman
On August 8, 2016, the FDA made a major announcement that shook the vaping industry to its core. The announcement was that the FDA deemed e-cigarettes to be tobacco products and intended to regulate them as such under the provisions of the Family Smoking Prevention and Tobacco Control Act of 2009. The announcement meant that the FDA intended to subject vaping products to the same laws as other tobacco products.
As the owner and author of eCig One, I spend much of my time watching industry trends and explaining to vape shop owners what they must do to remain in legal compliance. The good news for you is that the compliance burden is entirely on the vaping industry itself. There’s nothing that you need to do as a consumer except continue buying and enjoying vaping products as you always have. It’s worthwhile, though, to understand how FDA regulations can transform the industry over the next few years because those regulations may affect what products are available and where you can get them.
Why Do the FDA’s Vaping Regulations Matter?
Why was the FDA’s announcement such a big deal for the vaping industry? One aspect of the Tobacco Control Act is that, after 2009, companies could no longer market new tobacco products without obtaining approval from the FDA. To obtain approval, the makers of those products would have to demonstrate that the products would benefit public health and would not encourage people who don’t use tobacco already to begin using it.
Complying with the FDA’s requirements for new tobacco products isn’t easy; that’s why new brands of cigarettes stopped appearing in stores after 2009. To date, only one product – Swedish Match Snus – has gone through the approval process successfully. The Swedish Match application was a reported 130,000 pages in length and most likely cost many millions of dollars to compile.
The worst part for the vaping industry is that no vaping product currently on the market was available to buy in 2009. Unless something changes about the FDA’s vaping regulations, every e-liquid and every vaping device currently on the market will need to go through the approval process by the FDA’s deadline, or those products will all disappear. Most of the companies that produce vaping products are small businesses that lack the capital and resources to put together more than 100,000 pages of paperwork for the FDA. When the FDA approval deadline passes, those companies will simply fold unless something changes.
What You Might Not Know: The First Deadline Has Already Passed
If you took up vaping recently, you may not know that the initial deadline specified in the FDA’s vaping regulations has already passed. The FDA announced its vaping regulations on August 8, 2016 and gave the industry two years to comply with the pre-market application deadline. In 2018, though, the FDA announced that it was extending the deadline a further four years to August 8, 2022. Although vaping product manufacturers must still comply with other regulations – they must provide product and ingredient listings to the FDA, for example – they will have until 2022 to get through the pre-market application process. The original deadline was August 8, 2018. If the FDA hadn’t pushed the deadline back, the vaping industry as you know it would already be gone.
Why did the FDA extend the deadline? One reason might be because the regulations threaten to snuff out an industry that can have an enormous positive impact on public health – and improving public health is supposed to be the FDA’s mission. The FDA’s statement announcing the deadline extension alluded to the fact that the organization would like cigarette makers to begin producing non-addictive cigarettes that contain no nicotine. For those who require nicotine and can’t quit, the FDA would like alternatives such as e-cigarettes to remain available.
So, the Vaping Industry Is Good Until 2022?
Yes and no. The vaping industry – as it was on August 8, 2016 – is good until 2022. The FDA’s regulations state that anything on the market as of 2016 can remain until the pre-market application deadline passes. However, the regulations also state that no new products can come out unless they’ve gone through the pre-market application process – and that’s where we run into problems.
If you were vaping in 2016, you know that the market today looks almost nothing like it did then. New products are still coming out constantly. After the FDA released its regulations, a few companies tested the waters by releasing new products. Those companies didn’t get in trouble, so other companies followed suit. Before long, the entire vaping industry was behaving as if nothing had ever changed. In the absence of action from the FDA, some people may have even assumed that the FDA didn’t intend to enforce that aspect of the new vaping regulations until 2022. In 2018, though, the FDA announced that it was investigating 21 vaping companies to determine whether their products were on the market legally. At the time of writing, it is still unknown what the results of those investigations will be. Many of those 21 companies’ products may soon disappear from the market.
What’s This I Hear About an FDA Flavor Crackdown?
As if the looming 2022 pre-market application deadline wasn’t scary enough for vapers, the FDA released a statement in 2018 that could make things very bad for flavored e-liquid lovers much sooner than 2022. As you might recall, flavored cigarettes were once available in the United States. Now, they’re illegal. So far, the FDA has allowed flavored e-liquids to remain on the market. There is concern, though, that the sweet flavors might entice young people into vaping when they would not otherwise do so. In fact, the FDA has already told several e-liquid companies that their flavor names and packaging resemble those of popular food and candy brands a little too closely and demanded that those companies fix their products. At the time of writing, the FDA is accepting comments and collecting opinions about a potential across-the-board flavor ban due to concerns about underage vaping. If you love flavored e-liquids, you should watch this issue closely and consider submitting your opinions to the FDA.
What’s Going to Happen in 2022?
By August 8, 2022, every manufacturer of vaping devices or e-liquid must submit pre-market applications for all of its products to the FDA. Companies who get their applications in on time can continue selling their products while awaiting approval from the FDA. Those that can’t afford to compile the applications will need to remove their products from the market. The FDA has said that it is working to streamline the pre-market application process and make approvals more predictable. At the time of writing, though, no company in the vaping industry has submitted a pre-market application – let alone had one approved. Pushing back the deadline date for pre-market applications has given vaping companies a new lease on life, but it has also only delayed the inevitable. If nothing else changes by 2022, most of the vaping products currently on the market will become unavailable. If you don’t want that to happen, call your congressional representatives and tell them to do something. It’s never too late to make your voice heard.