On March 15th, 2022 President Joe Biden signed the omnibus spending bill into law. As with many such laws designed to avert a government lockdown, this one too had provisions in it called the riders — laws jammed in because some senators want to see them passed but can’t pass them without holding a bigger, more important legislation hostage.
This omnibus spending bill harbors a particularly interesting — for vapers and vape manufacturers — law that says:
All synthetic nicotine and products that use synthetic nicotine are now considered tobacco-derived products and are subject to FDA regulation.
Isn’t that interesting?
The law goes into effect on April 14th, 2022, and vape manufacturers have until May 14th to submit PMTAs for existing products such as disposable e-cigarettes and e-juice vape pens.
This. Is. Huge!
And if you’re not sure why exactly it’s huge — and why it is pissing off A LOT of vape manufacturers — read on. I’ll just say that the industry is preparing for another uphill battle against the administration… a battle that will cost manufacturers a lot, and even force some of them to shutter their businesses.
And if that happens, you as a vaper will most certainly be affected.
How is Synthetic Nicotine Regulated?
Well… that’s the thing — up until now, synthetic nicotine was not regulated.
It was a loophole for many small vape companies that either couldn’t afford their PMTAs or got rejected by the United States Food and Drugs Administration agency.
Naturally, synth nicotine products started inundating the market. Just think about the many disposable e-cigarettes now available at convenience stores, things like the Puff Bar and similar.
The U.S. Food & Drug Administration couldn’t let that one slide.
Actually, the Big Tobacco players couldn’t let that one slide. So the new wording in this law explicitly places all nicotine products, regardless of the origin of the nicotine, under the FDA’s jurisdiction.
Here’s what the updated Tobacco Control Act now says, thanks to this amendment:
“The term ‘tobacco product’ means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”
Isn’t that a nice bit of retconning?
So now that synthetic nicotine is regulated, the FDA gets to decide which products stay… and which go.
Why Did President Biden Approve Synth Nicotine Law?
Here’s the thing — Biden did no such thing.
He likely doesn’t have the foggiest idea about this. His goal was to jam through an omnibus spending law so that the government doesn’t shut down… and so that the USA can send aid to the waring Ukraine.
The better question here would be — why did some Senators and members of Congress decide that it was a good move to add this to the bill?
And the answer to that is — because they’re bought and sold by Big Tobacco companies.
It’s no secret that Big Tobacco lobbyists spend an awful lot to woo Senators and Congressmen to enact the laws that suit them. This synthetic loophole was a thorn in the side for JUUL and Vuse and vaping off-shoots of other tobacco brands. They have a lot of money to spend on putting together and prepping their PMTAs. So what better way to knock out their competition than to have the government create yet another unreasonable burden that the big boys can handle — but small privately-owned companies can’t?
And don’t fall for the story that this is being done because we’re in the throes of a ‘youth e-cigarette epidemic’, increased rates in high school students vaping, or something similar. This is not about public health and it doesn’t have anything to do with young people who decide to vape. Even the Centers for Disease Control’s own National Youth Tobacco Survey shows that vaping among young adults and kids is going down.
No, something much more sinister is in the background. And that is that Big Tobacco companies don’t care who vapes — even if it’s kids — as long as what’s being vaped is boosting their own revenues and profit margin.
What Does This Mean for Vape Manufacturers?
So, passing this bill is just tightening the noose around many necks. Figuratively.
As I mentioned before, synthetic nicotine was a way out for many e-cigarette makers trying to place their vaping products on the market while waiting to be reviewed by the FDA.
It was a loophole that is now obliterated.
The biggest concern is receiving the same treatment they got before. And while big dogs in vaping industry will only experience a decrease in their overall revenues, smaller businesses could simply die. If waiting for the product to be approved or even reviewed under FDA regulation lasts the same amount as for the prior “tobacco products” it could be disastrous.
And if the FDA starts refusing Premarket Tobacco Product Applications left and right — as they’ve been known to do — this could put a lot of synthetic nicotine companies, manufacturers of synthetic nicotine products, and e-cigarette companies out of business.
And while some might think this is a good thing (mostly non-vapers), we know that a lack of options or even legitimate sources will result in many vapers going back to traditional cigarettes.
Still, the vaping industry isn’t going down without a fight. Here’s what Amanda Wheeler (president of the American Vapor Association) tweeted right after this nicotine regulation legislation was passed:
What Does It Mean for Vapers?
Lots of bad stuff.
I can’t really sugarcoat this thing because it has no positives.
Tobacco-free nicotine isn’t a tobacco product — and it shouldn’t be regulated as one. If we want to crack down on nicotine, then why not target nicotine and put the Big Tobacco out of business? Ahhh, right — because that’s not in the best interest of the corporate world.
Well, this law doesn’t take your best interests as a vaper into consideration.
The first thing that’s going to happen once the FDA starts enforcing this law is that we’ll lose a lot of vaping options that are currently on the market.
Most small e-cigarette companies won’t even bother submitting new PMTAs for approval. They used synth nicotine as a way to skirt that rule, so now that’s come to bite them in the ass, a lot of them will just fold. Not all of them… but a lot will.
Numero dos thing that’s concerning is that Big Tobacco will have a de facto monopoly on disposable e-cigarettes sold en masse, provided this plays out as they want it to.
Which brings me to the third bad thing that might result because of this — stuff will get more expensive while the products stagnate. No innovation, no experimentation — just soaring prices that are at the whim of the bad actors in our industry.
All of this is a huge problem for new vapers with low income. These disposable vapes with synthetic nicotine were very affordable, and — while not ideal or without their dangers — offered a way for them to kick their smoking habit. Right now, it looks like those choices will vanish and they’ll be stuck with regular cigarettes.
Unfortunately, there’s no winning for our side in this situation. The best we can hope for is that small vape companies will adapt and — through sheer grit and determination — manage to get their products approved.
But that’s not a given.
What is given is that the Agency now has authority over a) tobacco products and b) products that are meant for people who want to stop using tobacco products. And since the agency and the politicians are in bed with the tobacco industry, it doesn’t take a genius to figure out how this will play out in the long term.