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Nonsensical FDA Ban On Vaping Products Faces 3 New Legal Challenges

FDA took unconstitutional action when it made electronic cigarettes subject to the Tobacco Control Act (even though they contain no tobacco), lawsuits argue.

INQUAM PHOTOS/REUTERS/NewscomINQUAM PHOTOS/REUTERS/NewscomA 2016 ruling by the Food and Drug Administration effectively banned new vaping products from the market unless they undergo an extensive, and expensive, approval process that was designed for traditional cigarettes. The so-called "deeming rule" also prevents e-cigarettes from being marketed as safer alternatives to traditional cigarettes or as a way to help smokers quit.

Lawsuits filed Tuesday in federal courts in Minnesota, Texas, and Washington, D.C., ask judges to overturn that ruling on that grounds that such regulations must come from Congress, or at least from presidential-appointed agency heads.

The decision to force electronic cigarettes and other vaping products to comply with the 1997 Tobacco Control Act is a head-scratcher for a number of reasons—not least of which being that e-cigarettes contain no tobacco. Forcing e-cigarettes to comply with a regulatory scheme devised for cigarettes, one that predates the introduction of e-cigarettes into the marketplace, has hurt vaping businesses and made it harder for smokers to switch from combustible cigarettes to the relatively safer electronic variety, which use a heating element and nicotine-laced liquids. Under the terms of Tobacco Control Act, vaping manufactures and sellers cannot market their products as a more healthy alternative to cigarettes that help smokers quit, despite the fact that study after study has shown that they are.

Steve Green, owner of California-based Mountain Vapors and one of the plaintiffs in the lawsuit filed Tuesday in federal court in Washington, D.C., says the FDA's rule-change has damaged his business and his customers. Worse, it's stopped him from being able to share his personal story of using e-cigarettes to kick his smoking habit.

"For years I smoked two-and-a-half packs of cigarettes a day, and it nearly gave me emphysema," says Green. "Vaping freed me from my addiction and the doctor says I've recovered."

Vaping businesses in Michigan and North Dakota are also part of the lawsuit launched in D.C. Separately, a lawsuit was filed in federal court in Minnesota by a group of four small vape shops in the state and the Minnesota-based nonprofit Tobacco Harm Reduction 4 Life. Joosie Vapes, a vape shop in Mesquite, Texas, filed a federal lawsuit in the state. All three challenges are being backed by the Pacific Legal Foundation, a libertarian law firm, and all three make the same basic argument about the legality of the Food and Drug Administration's decision to apply the Tobacco Control Act to e-cigarettes.

"Rules that affect the American people must be issued by officials who are answerable to the political process, not by bureaucrats who have no political accountability," says Thomas Berry, an attorney with PLF. "The Constitution requires that regulations with the force of law must be approved by agency executives nominated by the President and confirmed by the Senate."

By contrast, the FDA's deeming rule was issued by Leslie Kux, an associate commissioner for policy, a career civil service employee at the FDA.

The consequences of that rule are significant. Bringing any new e-cigarette products to the market will now require an application to the FDA and the administration's approval. That process will cost from $182,000 to $2 million for e-liquids and from $286,000 to $2.6 million for e-cigarettes themselves, the FDA estimates. That's a prohibitively high expense for many potential products, and it leaves bigger companies in control of the e-cigarette market.

Berry says the FDA's rule also flaunts the First Amendment by forcing vaping businesses to "run a regulatory gauntlet" before being allowed to speak openly about their products. Under the Tobacco Control Act, which prohibits unapproved "modified risk" claims, e-cigarette companies are not allowed to advertise the main advantage of their products—that they are healthier than traditional cigarettes.

The deeming rule survived an earlier court challenge that sought to overturn the 2016 rulemaking on the grounds that it exceeded the FDA's authority.

While the lawsuits seek the repeal of the FDA's decision to force e-cigarettes into the Tobacco Control Act's regulations, the Trump administration could reverse course on its own without input from the courts.

The FDA has an opportunity to recognize that distinction by granting a Modified Risk Tobacco Product application for e-cigarettes, allowing those products to be sold as a better alternative to smoking. As Guy Bentley, a research associate with the Reason Foundation (which publishes Reason.com) noted recently, it's the "deadly smoke caused by setting tobacco on fire sucking into the lungs that are responsible for the deaths of 480,000 Americans each year—not nicotine."

Here's more on PLF's new lawsuits:

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  • ThomasD||

    "The FDA has an opportunity to recognize that distinction by granting a Modified Risk Tobacco Product application for e-cigarettes..."

    Rather than hoping the alligator eats us slower maybe we could suggest that the FDA recognize that the presence of nicotine does not make it tobacco.

  • ||

    Kux

    Of course.

  • silver.||

    I had to consult urban dictionary to find the definition of kux, and I noticed a blurb for a "kux" coffee mug. That's a hilarious way to make money in the days of ad-block. Sell profane merchandise.

  • JuanQPublic||

    The FDA has repeatedly represented studies on e-cigarettes outside of any reasonable context, and of course, so have all the big money "nonprofit" health associations.

    For example, around 2013 they pointed to e-cigs having a negative effect on airways. But they just left it at that, without properly contextualizing it by comparing the effect to other sources that do the same thing or worse, such as cars idling on city streets.

    The FDA has relied on this method of misinformation since e-cigs hit the market in the late 00s.

  • ||

    The FDA has relied on this method of misinformation since e-cigs hit the market in the late 00s.

    I've got news for you: they've relied on this method of misinformation a lot longer and a lot more prolifically than you think.

  • Rhywun||

    "Vaping freed me from my addiction and the doctor says I've recovered."

    But it looks like smoking and is therefore unseemly and lower-class. Nobody cares about your health, dummy.

  • NoVaNick||

    In Morongomery County MD, the bus stops have signs now that say "No smoking No vaping...". Yep-the prog puritans don't like the aesthetics-so they won't allow it. They have been out to get vaping since day one, and the best they can come up with is it might damage cells in petri dishes compared to cells grown in sterile filtered air. Them there's the complete BS that teens will try vaping then move on to the real thing. Its a lot like Refer Madness, but they are our betters, so we must believe them.

  • I am the 0.000000013%||

    Not raising the spectre of health issues means you can't sin tax them.

    If unrestricted vaping is allowed, it will reduce the number of smokers thus reducing the number of people to collect sin taxes from.

    Both of those are highly suboptimal from a government perspective, and who else really matters.

  • silver.||

    As paranoid as this sounds, I'd be unsurprised if it was somewhat true. Sin tax is one of the few taxes that I actually don't mind because I can choose not to pay it. Many libertarians disagree on principal, and I get that.

    It does encourage the government to permit hurtful behavior. No small part of the recent wave of marijuana legalization is because the figures got out about how much tax revenue is being generated.

  • Rhywun||

    I would not be surprised if vaping is already sin-taxed.

    It is treated exactly like smoking in every other way I can think of: bans, insurance premiums, etc.

  • NoVaNick||

    I would not be surprised if vaping is already sin-taxed.

    In Montgomery County, MD e-cigs and liquids are taxed at something like 75% of retail value, I think MN, PA and some other states tax them too, and at ridiculous levels. No taxes on them yet here in Virginia.

  • silver.||

    Something to keep in mind while reading about e-cigs is that nicotine itself isn't particularly addictive, about as addictive as caffeine. The other compounds in tobacco, particularly the harmala alkaloids, massively increase the psychoactive properties of tobacco. Even without nicotine, MAOIs display potent antidepressant and anxiolytic effects. They were among the first antidepressants used, and they're the most powerful, but they're dangerous (although new selective ones are safer).

    This does cause problems when one switches from cigarettes to vapes, but compared to other nicotine-only therapies, vaping is by far the most effective because it has ritual aspects similar to cigarettes, and of course the actual delivery mechanism is the same. Propylene glycol in e-liquids might be detrimental when vaporized (but significantly less than tobacco), but many are switching to glycerin. The industry is over a decade old, so we have some data about long-term use, and it looks fantastic. Also, once one successfully switches to vaping, it's much easier to quit altogether due to the absence of MAOIs and availability of progressively weaker e-liquids, although the rituals of going on smoke breaks, etc. are still coercive behaviors. I know many people who vape nicotine-free now. That nicotine-free juice is subject to the TCA is ridiculous.

  • NoVaNick||

    There was some news a few months ago about how the smoking quit rate slowed dramatically once nicotine gum was introduced in the 1980s. They interviewed an anti-tobacco "scientist" who said that making nicotine so widely available only sustains smoking, and that it should require a prescription again to get Nicorette, or sales should be limited like they are for sudafed . Its easy to see where they want to go with this-a backdoor way to get rid of e-cigs.

  • silver.||

    I believe that to some extent. I know plenty of people who've quit with vapes, and I know many that just vape and smoke now. The discipline and desire to quit are still the most important factors. Vapes are just the most useful tool yet. Zyban/Wellbutrin isn't all that effective at helping people quit, and Chantix is basically a suicide pill. Many therapists recommend continuing to smoke rather than take Chantix, it causes awful depression.

  • Necron 99||

    I tried twice to quit with Chantix, first time quit for 6 months with minimal side effects. Had a blow-out with my wife and started smoking again. So I tried again, and holy shit, as I was sitting on the side of the bed with .357 magnum in my hand I asked myself if this is really how I want to quit. Put the gun up, drove to the gas station and picked up a carton.

    I started vaping about three years ago and now have 0-3 cigarettes a day. I have never thought of suicide before or since - Chantix is some fucked up shit.

  • silver.||

    It's serious, man. It makes me wonder whether the FDA really thinks smoking is so detrimental that it's worthwhile to put up with such pronounced side effects. About the only thing worse was a cannabinoid-blocking antiobesity drug which caused suicide rates to double and directly led to some completed suicides during clinical trials.

    Vaping is more effective and much, much safer than Chantix.

    'Grats on cutting back/quitting. It's still a PITA.

  • BYODB||

    Well stated, this lines up with my research into the subject pretty exactly.

    The government has not connected the dots between nicotine specifically and any harms. It looks like the harms were all related to the combustion of tobacco specifically, rather than the 'addictive' chemical itself. Nicotine and Caffeine are, of course, related chemicals. This isn't to say there aren't harms, but rather those harms don't come anywhere close to the burden of government regulation.

    Oddly enough, you don't hear people talk about the insane abundance of caffeine addiction in the United States and how the sale of coffee isn't restricted by age or law virtually anywhere. Even kids can buy it! Weird, huh?

  • silver.||

    Nicotine increases blood pressure, pulse, and has a variety of cardiovascular effects, just like caffeine. These aren't particularly dangerous for healthy individuals, but heart disease is very common, so most folks should monitor their usage of stimulants.

    The maximum recommended amount of caffeine is 300mg/day and no later than 2PM. Starbucks coffee contains between 300-550mg per cup. It's hyper caffeinated. The adenosine inhibition that caffeine induces affects sleep quality even 12 hours after consumption. It's a useful stimulant for warding off somnolence, but its half-life is quite long. I'm prone to awful insomnia, so I've cut it out almost entirely. I might have a cup of green tea in the morning if I'm sluggish.

    It's probably okay for most people to be consuming so much caffeine, but if they need to use sleeping pills / booze with any frequency, they ought to consider cutting way back. Cycling uppers and downers is stupid, even if they drugs are legal and socially acceptable.

  • BYODB||

    That was essentially my point, in that caffeine and nicotine have similar effects but only one of them is massively and pervasively regulated. A child can walk into a Starbucks and buy a large espresso but if they vape we collectively lose our minds. Last I checked you can buy mostly pure caffeine in various forms OTC as well.

    The harms simply do not justify the lengths to which they have regulated these markets. The disparity strongly indicates that it's a public perception issue rather than a true health issue even while there are harms from both substances.

  • silver.||

    Certainly. Compare the relative harms of (not smoked) marijuana to alcohol. QED.

    The government wants to protect us from ourselves, except not really. They just wants to arbitrarily control things and make money.

  • T. Lord||

    "Their," not "they're."

    Actually in this case, it's "flouts" rather than "flaunts."

  • silver.||

    I noticed "flaunts," too, but as this piece probably went across an editor's desk I assumed that both the writer and editor can't make that mistake, and I must've been wrong all these years.

    Thanks for helping me feel less crazy.

  • markm23||

    You might as well take "flaunt" out of the dictionary. If "professional journalists" misuse it, most people wouldn't understand you if you used it properly.

    And I remember one of my high-school science teachers would give a term paper an F for a single use of "they're" for "their". If you don't know the difference between a contraction or a possessive, you shouldn't be writing for a living. What in heck do they teach in J-school these days?

  • BYODB||


    That process will cost from $182,000 to $2 million for e-liquids and from $286,000 to $2.6 million for e-cigarettes themselves, the FDA estimates. That's a prohibitively high expense for many potential products, and it leaves bigger companies in control of the e-cigarette market.


    I suspect this is a feature, not a bug, and it's intended to keep the companies who are already completely under the thumb of the Fed's sending in those sweet, sweet payments into the Federal coffers.


    All of it, of course, under the easy-to-sell banner of 'public health' even while it doesn't achieve any goals towards that ostensible end.


    That said, the nicotine in E-Cig liquids (or at least some of them) is derived from Tobacco which is how I understand they manage to regulate these under the cigarettes legislation. There is some doubt that their arguments will succeed on the basis that they've laid out, I think. Best case scenario, the agency re-issues the same rules from a higher level or it's deregulated under Trump and re-regulated under some future President.


    I hate the Ping-Pong method our government seems to be using for these types of issues. God, I'd hate to be in the E-Cig business right now. Nothing is certain.

  • NoVaNick||

    One of my favorites-Johnson Creek, shut its doors at the end of last year. I suspect that they couldn't keep up with the new regs. Its too bad bc they had really good liquids and products.

  • silver.||

    A lot of nicotine is indeed extracted from tobacco. It's the cheapest method by far, especially as use of smokable tobacco has decreased about 2% a year for the past decade or two, so there is a (slight) surplus of plant material. However, the use of smokeless products is increasing at about the same rate, so maybe the supply is more limited. It's a good cash crop, though.

    I'm surprised that getting vape products through the FDA only costs ~$2 million. Pharmaceuticals are, literally, a thousand times more expensive.

    "I suspect this is a feature, not a bug.."

    Absolutely. I did an internship with a tobacco company during the summer of 2012, which was when tobacco was being fully FDA regulated. The FDA let the big tobacco companies tell them how to establish the regulations, which is actually rather prudent. Bureaucrats have no idea how to manufacture cigarettes. Conveniently, the facilities owned by my company were exactly right! The competition's equipment were insufficient, of course. The billions of dollars in upgrades and massive amounts of downtime were painful. Crony capitalism: beloved by both big business and big government.

  • BYODB||


    A lot of nicotine is indeed extracted from tobacco. It's the cheapest method by far...


    That's my understanding, and the assumption is that if it is derived from tobacco you can call it a tobacco product. That's not very logical in this particular instance because, while you're absolutely right on the cost angle, there is no way to be 'sure' if a particular house is using derived or synthesized nicotine and under the current regulatory scheme there is a legal difference (or at least this is my understanding.)


    Of course, that is almost certainly one of the reasons behind getting the FDA's ok in the first place but it's a pretty onerous burden for a 'mom & pop' vape shop. These aren't multinational pharma companies, although frankly I think they should be far less regulated as well.

    Overall it's about what I would expect from a monolithic bureaucracy trying to 'regulate' products it knows very little about beyond what they are told by the maker.

  • BYODB||

    Also, if this is their reasoning, than it gives a benefit to the more expensive options that wouldn't otherwise be there for essentially the same thing (synthetic vs. derived nicotine, for example, would be preferable as under one scheme you are a tobacco product subject to those rules, and in another you are not, even while chemically they are essentially identical).

    Effectively this drives up costs which means that the poorer you are, the more likely you are to die from using far-worse replacements such as cigarettes. Ironic, given that these groups are already more likely to die and are often touted by the nanny-state types as the very group they want to 'help' the most.

    Foolishness.

  • Longtobefree||

    Of course, all of this ignores the true fact that not all vaping liquid contains nicotine - - - - - - -

    But since we have let 'them' get away with infringing the second amendment based on 'it looks dangerous', how can we reasonably protest when 'they' ban based on 'it looks like smoking'?
    If they can't tell if it is dangerous, how can our lungs tell??!!
    It's for the children.

    disclosure; I neither smoke tobacco, nor vape. I just hate unconstitutional regulations and unconstitutional 'laws'.

  • jmlandry||

    Right, that vapinng pen could contain nicotine, thc, opoids or just cherry flavoring.

    A vaping pen is a delivery device, like a cup.

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