The US Food and Drug Administration has declared a war on vaping products some time ago now. August 8th, 2016 marked the day when e-cigarettes and other vaping accessories (such as vape juices and other vaping gear) started being considered ‘tobacco products’ under the Tobacco Control Act. This changed everything, both for vapers and for vaping businesses.
We were left with numerous questions – is vaping now illegal? Did the FDA ban vaping? More importantly, how will this affect millions of current vapers and those who were hoping to quit smoking by switching to vaping?
I wish I could tell you for certain. While vaping is not banned per se (at least not yet), the FDA’s deeming regulation has placed a heavy burden on the industry. In a nutshell, we might call this a de facto ban of vaping, if we were so inclined. Why? Because no new vaping products will be seeing the light of day for a considerable time to come.
Allow me to walk you through the hoops that vaping businesses now have to jump through in order to introduce new products (and keep the old ones) on the market.
What the FDA Is Asking For From Vaping Businesses
First of all, since August 8th, 2016, all vape products are considered tobacco products. This means that the labeling and marketing restrictions that apply to cigarettes now apply to vaping gear. For a while, this also included e-juices that do not contain any tobacco or nicotine, which is absurd. In fact, this might still be an issue in some cases. The FDA has issued a clarification, stating that ‘it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product’.
This seems like a bit of good news but is it really? Well, it ‘possibly’ (as the FDA officials put it) isn’t – although there’s no reason to deem non-tobacco or non-nicotine vape juices as tobacco products, the FDA still reserves the right to do so, and they will judge things on a ‘case by case basis’, as they say.
If you think this is hilarious, wait, there’s more. The FDA established something they call the predicate date. Simply put, that’s a date that determines which vaping products can stay on the market without their manufacturers submitting a PMTA (Pre-Market Tobacco Application) for them.
That predicate date is set as February 15th, 2007!
Yes, you’ve read that right! Every vape product that was introduced after that date will have to obtain FDA’s permission to be manufactured and sold. But here’s the thing – going through the PMTA process is tough and the requirements are draconian. Vaping businesses will have to conduct thorough scientific studies and prove that their products have a net positive effect on public health. That costs money and companies will have to invest millions upon millions of dollars to just enter the process. For example, a vape juice manufacturer with 12 flavors in 6 different strengths would need to submit 72 PMTAs. With a (very) conservative assumption that a single PMTA process costs around $300,000, they are looking at an expense of over 21 million dollars!
Here’s a kicker – even after jumping through all those hoops, there’s no guarantee that their product will be approved by the FDA. There are very few vape businesses who can afford that kind of money. Even the biggest manufacturers will struggle to get a handful of their most popular products approved.
Who is this good for?
Only Big Tobacco companies, who have enough cash and manpower to go through the lengthy PMTA process. It’s no wonder that they greeted this FDA ruling with open arms – they are the only ones who stand to benefit from it. In fact, Philip Morris International has already entered a PMTA process for their new ‘heat-not-burn’ device, the IQOS.
To sum up, if companies don’t secure an approval for products manufactured after February 2007, they will have to pull them off the market. Considering what is needed to do so, there’s a very real chance that all we’ll be left with in the near future are cigalike vaping devices!
What Happened to the FDA’s Deeming Rule in 2017?
When the administration changed, US vapers hoped that they could breathe a collective sigh of relief. Well, we’re all still holding our breaths, unfortunately. However, there were several changes that occurred that bring just a glimmer of hope to this whole situation.
Although no new products can enter the market without an approval, the deadline for submitting the PMTA for products on the market before August 8th, 2016 has been extended. The previous deadline was August 2018. It had manufacturers scrambling and a lot of them announced that they won’t be submitting it, even if it meant going out of business. The new, slightly more manageable deadline (at least for businesses that can afford the PMTA process), is August 2020.
The FDA’s new commissioner, Scott Gottlieb, announced that the agency was working on making the PMTA process ‘more efficient, predictable, and transparent for manufacturers’. It’s something to applaud (if it ever comes to pass) since, right now, the manufacturers are pretty much in the dark as to how their submissions will be reviewed and they have no idea what to expect once they turn in their PMTA.
Unfortunately, not much else has changed. There are other deeming deadlines that remain in place (other than the PMTA one), which will have to be honored by the vaping companies.
These deeming deadlines include:
- September 30, 2017 – US-based companies involved with manufacturing, preparation, compounding, or processing vape products (tobacco products) need to register with the FDA. Registration will also be mandatory for foreign establishments in the future. Also, they need to send a complete list of their products to the FDA.
- November 8, 2017 – All large-scale manufacturers (over 150 employees and more than $5 million annual revenue) need to submit a list of ingredients for all products. From this date forward, no vape juice can be marketed as ‘light’, ‘low’, or ‘mild’.
- May 8, 2018 – Small-scale manufacturers need to submit a list of ingredients.
- August 10, 2018 – Packaging requirements – warning signs on all products containing nicotine. Even non-nicotine products may be required to carry a warning statement that says: ‘This product is made from tobacco’.
- November 8, 2019 – All manufacturers need to submit lists of harmful and potentially harmful constituents (HPHC’s)
- August 8, 2022 – The final PMTA deadline. Manufacturers will be allowed to keep their products on the market until the FDA approves or denies their application.
As you can see, there’s nothing here about the predicate date (February, 2007), which is the cause of all this trouble and which might effectively erase around 99% of vaping products from the market. Even with these slight concessions, we are still dealing with an FDA’s vaping ban in all but name.
Is there anything we can do about that?
Support the New Cole-Bishop Bill
The only way we will see the predicate date change is if the Congress acts on it. A new bill, designated HR 1136, has been introduced by Reps. Tom Cole (R-OK) and Sanford Bishop (D-GA) in the hopes of achieving that.
If the bill passes, the predicate date would be changed to August 8, 2016, allowing most current products to remain on the market without having to submit a PMTA for approval. Of course, all new products that hit the market after August, 2016 would still have to go through that excruciating process, but at least 99% of current vape gear wouldn’t be immediately disqualified just because manufacturers can’t afford to register them.
As of September 2017, the Cole-Bishop bill has 85 co-sponsors. However, it will need a lot more support to gain the momentum it needs to pass. You can help it garner that support. Help CASAA push it through by writing to your House member and urging them to stand behind HR 1136.
Should We Start Organizing a Wake for Vaping Already?
The question remains – will e-cigarettes ever be FDA approved? Well, if it’s up to the agency, not really. What they are interested in is a handful of products, preferably manufactured by the tobacco industry. That would make it easier for them to control.
However, we can still fight back. By supporting various vape advocacy organizations, we can bring vape-related issues front and center and remind our representatives that vapers are voters, too. We can also, each one of us, work to promote vaping in our communities, be it by answering questions, organizing events, or advocating cessation benefits of vaping. If you want to get involved, you will find a list of vaping advocacy organizations by following this link.
Feel free to vent about this FDA vaping ban in the comments. Also, if you have any constructive suggestions, I believe that we would all love to hear them so just shoot!