Are the Deeming Regulations Coming Soon?

Washington insiders expect the long-awaited rules to drop any day


We could see the FDA’s deeming regulations announced any day now. Rumors swirled this week in Washington, and vaping advocates are on edge.

Jeff Stier, Risk Analysis Director at the National Center for Public Policy Research, thinks the regulations are imminent. And he isn’t pleased about what’s coming. “The regulation would have the effect, intended or not, of taking e-cigarettes away from former smokers who quit smoking by using these less harmful alternatives,” Stier said in a press release from the Center.

The Grandfather Date

The fear is that the FDA will force every product released after the February 2007 “grandfather date” to go through a burdensome and expensive Premarket Tobacco Application process. The FDA insists that it has no leeway to avoid the grandfather date, and that its regulations must follow that requirement.

That process will likely be too expensive for independent vapor product manufacturers, which will effectively hand the e-cig market to the tobacco industry companies that are able to afford it. The grandfather date was conceived before e-cigarettes became popular. It was intended to stifle change and innovation in the combustible cigarette market.

Will Big Tobacco win?

Cigarette Money

The Vapor Technology Association’s Tony Abboud addressed the problem in a press release. “The FDA will kill nearly a decade of innovation in the vapor technology industry and the many thousands of small and mid-size businesses in communities across this country who have invested in establishing retail stores and developing new technologies that sit outside of the influence of Big Tobacco.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids — a vocal opponent of vapor products — is eager to see the regulations. “I do believe they will come out this month,” he said in an interview with The Hill. “They are facing a serious deadline given the end of the presidential year.”

Meanwhile, Wells Fargo tobacco industry analyst Bonnie Herzog suggested the deeming regulations might be a blessing in disguise for investors. Her guidance for Big Tobacco stockholders noted that “regulation of the e­cig/vapor industry is broadly positive for the big tobacco manufacturers since it will increase the barriers to entry and likely entrench them even further.”

In other words, strict e-cig regulations will set up Big Tobacco to take over the vapor business — exactly the outcome vaping advocates have warned about for years.

Jim McDonald

I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.

  • Tim Berry

    OK maybe i’m a little confused. I’ve been hearing about the FDA crap for years. But wouldn’t the regulations only cover e-juice and cartomizers with liquid already in them? What would the FDA have to do with mod boxes, battery’s tanks etc? They are just electronic devices that should be safe from regulation right?

    • Jim McDonald

      No, they cover bottled e-liquid, and any device sold for vaping can be considered a “component or accessory.” Clearly there are many legal fronts on which the regs may be challenged, but liquid is the thing that keeps vape shops afloat financially, and what the FDA has proposed would absolutely wipe out the (legal) e-liquid industry. Without a thriving e-liquid market, the independent vaping industry would be effectively destroyed.

  • Blackg

    It’s honestly incredible how anti-vape we are in the states, so many states and cities are setting up huge roadblocks against the industry and it’s so confusing to me why they do so. The groups dedicated to stop smoking deaths are also the ones blocking current smokers from these products that have the potential to save their life. The abstinence attitude was compared in another article i read recently to the condom bans in the 40s and 50s. organizations were set up to prevent over the counter purchases of condoms to try to keep youth from having sex and in the end they realized they were just encouraging unprotected sex. I wait for the day when the general populace realizes how great these products are and get out of the way of proper regulation and improvement in the industry.

    • Jim McDonald

      You’re exactly right. I agree 100%.

    • M40

      “Government’s view of the economy could be summed up in a few short phrases: If it moves, tax it. If it keeps moving, regulate it. And if it stops moving, subsidize it.” – Ronald Reagan

      Well, they’re already taxing it, and quickly moving towards the regulation phase. Once they’ve killed it, they can subsidize it back to life (through the “too big to fail” tobacco industry, of course). Ain’t government grand?

      • Jim McDonald

        Yeah, we’ll see. No federal taxes on vapor products yet, but it’s possible.

        • M40

          Yeah… tell the vape shops and small businesses that there’s no federal taxes. I’m sure they’d be delighted! JK.

          In reality, vaping was a subculture that was off the government radar for quite a few years. A lot of small eBay transactions, guys building mods in their basements and small shops, etc. It really didn’t raise too many eyebrows in Washington.

          However, as more and more people quit the (over-regulated and 1000% tax markup) cigarettes, and switch to the (still largely underground) vapes, they realize they’re losing serious revenue. If they can regulate it into the hands of their puppet (the tobacco industry), just think of the tax revenues. They’re drooling at the thought of it.

          • Jim McDonald

            Well, I said taxes on vapor products, not income taxes. And it’s always been on the feds’ radar. The FDA tried to ban e-cig imports in 2009 and failed (the Sottera case; Sottera is now called NJoy). You’re right that cigarette taxes are declining, and we will be a target eventually.

          • M40

            Well, the VG and PG will always be available. VG is a byproduct of ethanol production and they’ll just about give the stuff away, so no problems there. I guess I’m thinking of stockpiling nicotine before they regulate all sales under new federal guidelines. Pretty sure it doesn’t go bad (at least in pure form).

          • Jim McDonald

            If you want to do that, the DIY forum on ECF has information about storing nicotine safely. But I hope you — and everyone who’s planning on stockpiling nic — will stay engaged in the fight to prevent overregulation and restrictions. Because it’s not just about us. It’s about all the smkers who still haven’t tried vaping.

          • M40

            Agreed. I already went through this with cigarettes. I was buying them from indian reservations… til the feds shut that down. Then I started making my own. For the past 10 years I never spent more than a buck a pack. I’m one of the few that may just spend more money vaping than I spent smoking. Starting to mix my own juice is definitely helping to cut down on that.

            PS – If the cigarette battle taught me anything it’s that the fed WILL jump on this regardless of whether or not we lobby against their interference. But just like those of us who made our own cigarettes… there will always be an underground. Its a simple rule… the more intrusive a government gets, the bigger the black markets grow.

            PS – The argument that we’re helping people to quit will NOT sway the fed. Do you really think they want people to quit smoking? They make more money than the tobacco companies do from smokers. The tobacco companies sell packs for 75 cents, and the rest is fed and state taxes. So arguing that we help folks quit accomplishes the OPPOSITE, and makes the fed want to regulate vaping as well.

          • Jim McDonald

            The difference is that cigarettes *weren’t* a battle. The tobacco industry was the only only stakeholder fighting regulations and taxes. Smokers didn’t fight, for the most part. And the harshest cigarette restrictions came with the tobacco industry’s cooperation (the Master Settlement Agreement between 46 states and tobacco companies was a settlement they agreed to, and the Tobacco Control Act was actually a collaboration between Matthew Myers of CTFK and Philip Morris).

            Part of the reason the tobacco control ideologues are going to such extremes to smear e-cigs is that they’ve been shocked by the pushback of vapers, and they’re lashing out. Our passion and commitment is new to them. Smokers didn’t fight back!

          • M40

            “they’ve been shocked by the pushback of vapers, and they’re lashing out.”

            Really? Talk about underestimating your opponents. You’re applying the kind of dimestore psychology one might use to analyze the behavior of a toddler. The fact is, they aren’t simply “lashing out”, and everything they do is a well coordinated political maneuver, and ALL of it worked quite well against cigarette smokers.

            They will continue to “smear” vaping and vapers until we become social pariahs and are ashamed to fight back. There will be bogus studies, and news stories that make vaping look worse than smoking. Every bit of it will be carefully coordinated to make us look like complete jerks. Just wait… some toddler will die after drinking e-juice, and they will paint every vaper as somehow complicit. The public outcry will make you want to hide under your bed.

            And when it starts, it will NOT come in a single, sweeping piece of legislation. They will nibble away patiently over the course of a decade. With each new law, tax or restriction, they will swear that’s all they want… that they will finally leave us alone. And they will be lying through their teeth.

          • Jim McDonald

            Yeah, if that’s all true, what is your answer? I maintain there was no organization by smokers at all; the only opposition came from the reviled tobacco industry. Vapers care and are involved. We also have allies from the anti-smoking ranks, and we haven’t spent fifty years lying about the safety of the products we use.

            Smokers didn’t “become ashamed to fight back.” They *never* fought back — except as part of tobacco industry astroturf campaigns. I know what you’re saying, and in my most pessimistic moments, I might even agree. But I mostly think we have science and the prospect of lives saved on our side, and we need to shout it loudly, and continue to fight hard.

          • M40

            I’d try to stay positive on this, but I have no good expectations when it comes to our government.

            You’re trying to compare apples to oranges. For a couple hundred years, there were plenty of smokers, and even most doctors… all swearing by the wonderful health benefits of smoking. Heck, most folks considered cigarettes and alcohol as part of a well-balanced diet.

            It wasn’t until the last 40 years or so when studies started to say otherwise. It was in that same time frame that the legal profession took off, and the number of lawyers per capita in America doubled, then tripled. Then the lawsuits started, followed by the government “clamping down” (but not really… they just tax the hell out of it).

            Nobody turned around and banned cigarettes… they VERY slowly made it a pain in the ass, socially unacceptable in polite society, and cost prohibitive. They justified all of this by shaming smokers with bogus “second-hand smoke” studies.

            Now they already have most people terrified of ANY kind of smoke, fume or odor they might inhale. They’re already banning vapes in most places, so they’re already 200 years ahead of the cigarette curve. All they need is a couple bogus studies (pretty easy to come by), and they’ll squash this under a federal thumb so quick it’ll make your head spin.

            Here’s the deal… I can pretty much guarantee that there’s some lab out there right now dumping insane quantities of PG and VG down the throats of lab rats, just waiting for one to go belly-up (at which point, they’ll get a multi-million dollar federal grant to study it further).

          • Jim McDonald

            I agree with much of what you say, but some of it’s not right. Yes, people have been smoking for hundreds (or thousands) of years, but industrially produced cigarettes are barely a hundred years old. And the health impacts were evident decades before the US Surgeon General’s 1964 report, which most people think of as the beginning of the tobacco control era. The difference — in danger and in addiction — between smoking a pipe or cigar and inhaling cigarette smoke are huge. Additionally, lifespans at the end of the 19th century were far shorter than they were after World War II. Simply put, people back then didn’t live long enough to run into all the smoking related problems older people do. They were too busy dying from untreatable infections and stomach cancer from eating spoiled food.

            There are already hundreds of studies completed on e-cigs, with many more in progress. The NIH has spent $250,000,000 on those studies over the last few years. So far, the studies seem to bear out that vaping is far safer than smoking — which is really all we can hope for. Is it as safe as drinking pure spring water? No. Does it need to be? No. It’s a lower-risk alternative for people who want nicotine or a smoking-like experience.

            You’re welcome to throw in the towel and not work to protect vaping. That’s your choice. But I’m choosing something different, and I think a lot of vapers are with me.

          • M40

            I REALLY hope you’re right. I am more of a pessimist with each passing decade. I’ve already seen a couple DEEPLY flawed studies on vaping that seemed designed from the onset to prove it dangerous. The problem is… those are always the studies that the media jumps on. There can be a hundred studies saying it’s perfectly safe, and they’d rarely, if ever get any air time. All it takes is one bogus pile of unscientific drivel claiming that the sky is falling, and it’ll be front page news.