FDA E-Cigarette Regulations Give Smoking a Boost

The new rules will discourage smokers from switching to vaping, a much less dangerous alternative.


The Food and Drug Administration's e-cigarette regulations, which took effect last week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use.

The FDA's censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA's requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety.

All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account when it estimated the costs imposed by its regulations, simply assuming that good intentions would ensure good results.

Although preventing fraud is the official intent of the FDA's speech restrictions, the agency's rules prohibit statements that are accurate and highly relevant to consumers choosing between smoking and vaping. Nicopure, one of the companies that is challenging the FDA's regulations in federal court, used to tell consumers that in vaping "nothing is burned," "no smoke is released," and "no ash" is generated. It also noted that the aerosol produced by e-cigarettes contains "no tar" and only "a fraction of the 4000 chemicals currently found in standard tobacco cigarettes." Although all of these statements are indisputably true, they are illegal under the FDA's reading of the Family Smoking Prevention and Tobacco Control Act.

That law gave the FDA authority over tobacco products, a category to which it has arbitrarily assigned tobacco-free e-cigarettes, even when they contain nicotine that is not derived from tobacco or no nicotine at all. The Tobacco Control Act prohibits unapproved "modified risk" claims, including any "explicit or implicit representation that [a] tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke." According to the FDA, that means e-cigarette companies are not allowed to advertise the main advantage of their products. Even describing an e-cigarette as "smokeless" or "smoke-free" is asking for trouble, since "the Agency will evaluate an [e-cigarette] manufacturer's use of 'smokeless' or 'smoke-free' (and similar descriptive terms) on a case-by-case basis."

Instead of immediately banning all e-cigarettes and e-fluids, the FDA gave manufacturers a couple of years to seek approval for each of their products. But that grace period does not apply to any variations introduced after August 8, 2016, so the FDA has in effect banned product improvements. In a declaration supporting Nicopure's lawsuit, CEO Jeff Stamler notes that his company "introduced approximately 288 new e-liquid products, 6 new vaporizer products, and 23 new vaporizer components" in 2015 alone. Now any new product requires premarket approval, so "as a practical matter Nicopure will be unable to introduce new products for several years."

The ban applies even to minor changes. The American Vaping Association notes that "any variation of the nicotine level, bottle size, flavor amount, ingredient type, etc. in a current product (i.e., one being marketed on August 8, 2016) will result in a 'new' product that will be illegal to sell without preapproval from the FDA." But the FDA is also blocking substantial improvements in the designs of vaping systems and their components, changes that could make them easier or cheaper to use, extend battery life, or protect against pitfalls such as overheating. It is in the interest of profit-seeking companies to constantly look for changes that make their products more appealing to consumers, which in this case means encouraging smokers to make a switch that could save their lives. The FDA's response to such beneficial innovation: Cut it out.

The loss of competition, innovation, and variety will only grow worse over time, as the deadline for getting FDA approval or getting out of the market approaches. The cost of submitting a "premarket tobacco product application" (PMTA) is uncertain, and so is the extent of the resulting shakeout. The FDA estimates that each application will cost from $182,000 to $2 million for e-liquids and from $286,000 to $2.6 million for "electronic nicotine delivery systems" (ENDS). On the assumption that some applications will cover more than one product (which the FDA says is possible if they are sufficiently similar), the agency puts the average cost per product between $12,000 and $403,000 for e-liquids and between $29,000 and $2.6 million for ENDS.

Those are very wide ranges, of course, and the actual costs will depend on the nature of the product and the sort of evidence the FDA demands in order to conclude that approval is "appropriate for the protection of public health." The FDA has given mixed signals about whether and when expensive and time-consuming clinical testing, as opposed to product-specific chemical analysis and general research on the hazards of vaping, will be required, and it's not clear how the agency will try to predict future consumer behavior, as required by its mandate to assess a product's net long-term impact on "the population as a whole."

Stamler, Nicopure's CEO, says his company "anticipates that PMTAs will cost much more" than the FDA estimates, "with each e-liquid PMTA costing at least $5 million, and each vaporizer (or vaporizer component) PMTA costing at least $3 million." Stamler says Nicopure alone would have to submit thousands of PMTAs to keep its current products on the market but probably will be able to manage no more than a dozen within the next two years.

That gives you a sense of how dramatically FDA regulation will affect consumer choice. So does the FDA's expectation that it will receive only 750 or so PMTAs a year from an industry that includes hundreds of "formal manufacturers," each of which may produce dozens, hundreds, or thousands of product variations. Lost Art Liquids, which has filed its own lawsuit against the FDA, says it will "need to file over·200 PMTAs if it wishes to keep all of its current products on the market." Again, that's just one company.

The FDA's count of 168 to 204 "formal manufacturers," which it admits could be way off, does not include the thousands of vape shops (as many as 7,000, per the FDA) that qualify as manufacturers because they mix their own e-liquids. The FDA assumes they will stop doing that rather than bear the costs of regulation as manufacturers. Since custom-made fluids are a major selling point for vape shops, many of them may go out of business entirely.

These small businesses also will be hampered by FDA rules that ban free samples (supposedly to protect minors, who are not allowed in vape shops to begin with) and prohibit retailers from helping customers assemble or fix vaping systems (which would transform them back into manufacturers). "Traditionally," the American Vaping Association notes, "vape shop employees have educated new customers about proper care and usage of a device by physically assisting the customer with setting up their device or actively troubleshooting problems." No more of that.

The new rules undermine public health, their raison d'être, along with consumer choice and customer service. A brief that 16 advocates of tobacco harm reduction filed last week in support of Nicopure's lawsuit notes that the cost of the FDA's regulations will far outweigh their benefit if they cause even a small percentage of vapers to start smoking again or deter even a small percentage of current smokers from switching. That's because of the huge difference in risk between e-cigarettes and the conventional kind (at least 95 percent, according to the Royal College of Physicians), plus the high cost assigned to each lost "quality-adjusted life-year" (QALY). If just 1 percent of the country's 8.3 million vapers smoke more as a result of the FDA's regulations and that change causes just one lost QALY for each person, the brief says, "that would create a cost of $39-$65 billion undiscounted." By contrast, the FDA's regulatory impact analysis put the total cost of its rules at less than $1 billion.

Whether e-cigarettes "have a net benefit on or harm to public health at the population level," the FDA declares, "regulation of ENDS will still benefit public health." That follows only if you assume regulation has no negative impact on health-related consumer behavior, which is pretty much what the FDA does. It asserts that its regulations will benefit public health but does not attempt to quantify the effect, arguing that even the most conservative projection would justify the rules. The FDA acknowledges that its regulations might also harm public health by retarding the substitution of vaping for smoking. But it does not include that cost in its analysis, deeming it too speculative. The FDA literally assigns zero value to the lives of smokers who would have quit were it not for the agency's heavy-handed meddling.

This article originally appeared at Forbes.com.

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  1. And how much did the Big Tobacco lobby contribute to this???

    1. Quite a bit, I’m sure … you know those old smoke filled back rooms. They’ve got their own vape products lined up, probably at twice the cost of what they are today. This whole thing is so much baloney.

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    2. It’s not Big Tobacco – it’s Big Pharma. Big Pharma is who is losing out when someone decides they want to quit smoking and switch to vaping. They are losing out to vaping when the person does not buy their Chantix or other prescribed medications and their gums, patches or lozenges. Not to mention all of the anti-smoking organizations who profit from money (taxes) derived from tobacco. Why would Big Tobacco shoot themselves in the foot? They have been creating their own products for vaping.

      1. I don’t care who it is. All I know is this is further evidence that everything – EVERYTHING – the government says is a bald-faced fucking lie.

      2. I do wonder how a Vape rig significantly differs from, say, Nicotine Gum. The gum isn’t classed as a tobacco product, but rather a ‘smoking cessation aid’ which starts to look a lot like bullshit when you realize that there are people that chew the stuff for years.

        There are so many interests that are dead set against vaping that the industry doesn’t really stand a chance. Too many rent seekers that have too much capital on hand to block this for their own profit motive. This is such a wonderfully illustrative case on how politicians, industry, and lobby groups are essentially anti-capitalist from the ground up.

        I love how the burden of proof is now entirely reversed. The FDA can just ban a thing and say ‘well, we don’t know if there’s a harm but you’re going to need to prove that there isn’t one before you can sell something’ which is the exact opposite of how it should work. Apparently the government can fund the hell out of ‘climate change’ research but this is simply too hard to figure out for them.

      3. It’s both. They joined hands long ago by contributing to the coffers of both the Democrats (pharma) and Republicans (tobacco) to ensure that no one would challenge their dominance in the nicotine market. It shows in huge ways that no one gives a crap about small businesses or innovation in the marketplace anymore. The government is about keeping Godzilla and Mothra alive at all costs. They’ll lie, manipulate and kill to do it.

  2. Idiots.

    We are surrounded and regulated by diots

    1. Yep. Government is the idiots with guns who tell the experts how to do their jobs.

    2. Unfortunately, that’s not it. If they were just dumb and misinformed, that could be fixed. But they aren’t dumb, and they know *exactly* what they’re doing. They’re 100% aware of every argument in this article, and they just don’t care. The most important things are to defend and expand the FDA’s turf and defend tobacco tax revenues (by protecting major tobacco company business from vaping upstarts). Usually ‘incompetence’ is a better explanation than ‘malice’, but not in this case–this is evil, pure and simple. With their new regulations, the FDA is going to kill people. They *know* they’re going to kill people. And they don’t care.

      1. Can you explain how they’re going to kill people?

        1. Vaping is less harmful than smoking, and these regulations are going to hinder people who want to stop smoking from getting their nicotine fix in an easy way.

          1. So before vaping nobody ever quit smoking? The existence of vaping is making everyone quit smoking? If someone who chooses to smoke cigarettes dies it’s because the FDA killed them?

            Is this like the argument that letting doctors choose not to give contraceptives is forcing women to get pregnant?

            1. So the basic logic of:

              easier to quit smoking = more people probably quit smoking

              escapes you?

              1. No one needs 23 brands of deodorant.

              2. Apparently as much as the logic of:

                Taking away vaping = killing people

                Escapes you.

                1. You have built a beautiful strawman.

                  1. You say strawman, I say you should probably read the comment I replied to in which the commenter says the FDA is going to kill people.

                    1. Saying that the FDA is killing people is obviously hyperbole.

                      That being said, if the government bans floatation devices all boats and a lot of people drown would you say that was a foreseeable consequence of the ban? Would you reserve any blame for the people who said ‘no, you’re not allowed to use a life preserver if you want to’?

                      If not, then you’re being logically consistent there Sparky. Don’t pretend that the FDA is letting people choose their own risk factor though.

  3. Assholes. If the stuff I’ve been vaping goes off the market because of this I’m going to flip. Maybe I should just switch back to Camels and then sue the FDA for forcing me to go back to smoking.

    1. But the government gets to decide if you’re allowed to sue them. Maybe if we can get a big enough class action suit going …

      1. Only if it extends their regulatory purview into new areas. That’s something the EPA loves doing, encouraging environmental pressure groups to sue the agency so the agency is given legal cover for increasing its operational scope. Unless your suit somehow stands to benefit the agency, you can go pound sand.

  4. the innovations will have to come from abroad…the guy that smuggles them in: $$$$$$$.

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  6. Not that I advocate this but:

    How is it possible (given the existence of the FDA) that smoking tobacco is legal? Tobacco smoke is straight up poison.

    1. Not to recommend smoking, but if you are a light smoker your risk for cancer is significantly less than a heavy smoker. Is it risky? Yes. But if it makes you happy and you accept this risk, it’s no one else’s business.


    2. If either alcohol or tobacco were only discovered today, both would be Schedule 1.

  7. The Tobacco Settlement money must flow.

  8. So, where does the assumption come from that smokers would switch to vaping because “safety”?

    1. Plenty of smokers recognize that smoking is bad for them. Vaping is slightly healthier and cheaper than smoking. And switching from smoking to vaping is a hell of a lot easier than going cold turkey. In fact, you can buy vaping products that contains 0% nicotine.

      1. In other words, anecdata.

        I’m not sure I agree with the “common sense” belief that smokers would switch to vaping if not for government regulations.

        1. Do you agree that they should be allowed the choice to do so?

          1. Absolutely, people should be free to do whatever they want to their own bodies.

            Now tell me how that ties into the FDA forcing people to smoke by regulating vaping.

            1. By removing the choice to vape?

            2. Are you claiming that regulation doesn’t dissuade the use of a product?

              Who said they were forcing anyone to smoke? The argument is that they are limiting access to tools that replace the harmful effects of smoking, thereby inhibiting people from choosing the less harmful act.

              It’s not the same as murder, but it is immoral.

              1. So you’re making the same initial assumption that Jacob is. That the existence of vaping will somehow cause people to choose vaping because it’s safer. So back to my initial question, what drives that assumption? Is it simply the belief that because a safer thing exists people will choose that safer thing?

                1. Umm, yes. Here’s the thing, most smokers aren’t dumb, and are actually aware that smoking is bad for them. And vaping allows smokers to get their Nic-fix without all the usual problems usually associated with smoking.

                  Here’s the big important thing, smoker’s have been switching to vaping in droves because of a lack of government oversight. If vaping had stayed some odd niche product, then nobody would give a damn. Now that the government has gotten involved, you can expect vaping products to become more expensive and harder to get access to, thus killing off part of the attractiveness to vape instead of smoke.

                2. “Is it simply the belief that because a safer thing exists people will choose that safer thing?”
                  Yes. I base that belief on the fact that I personally, and many people I know have done so.

                3. So you’re making the same initial assumption that Jacob is. That the existence of vaping will somehow cause people to choose vaping because it’s safer. So back to my initial question, what drives that assumption? Is it simply the belief that because a safer thing exists people will choose that safer thing?

                  I make no such assumption. They might. They might not. I think it likely. And it doesn’t matter what they decide, it’s not a legitimate function of government to limit their choice. The decision to do so is immoral on its face and the action is even more egregious if it inhibits people from voluntarily choosing an alternative that could save their lives.

                  The regulation speaks volumes about the FDA, however. They don’t care about saving lives. They care about controlling lives and accumulating power.

                  1. Wonderful. Then your non sequitur about the legitimacy of government is, in this case, unhelpful.

                    I know for a fact that nowhere in my question were the words or the sentiment that this is an acceptable thing for the government to be doing. Since the people responding have not generated a single thing that leads to their conclusion other than “I know a guy”, I’ll just assume that most people believe that it’s common sense.

                    1. You’re retarded Sparky. Sorry, but it’s true. You’re assuming that people will not choose the safer option and will instead consistently choose the more inherently risky option while fellating the FDA’s standard of ‘FYTW’ that’s being applied here. Cigarettes are legal, and have been proven unsafe time and time again for centuries. What harm is being prevented by banning an alternative that, according to the Royal Academy of Physicans, is 95% safer?

                      Since you’ve clearly decided to ignore all available research on smoking and vaping trends, either go do some cursory research or kindly shut your ignorant fact free mouth.

                    2. It doesn’t seem like the issue really matters to him. He’s just putting in argumentative comments wherever he can. He’s a troll who likes to argue, doesn’t matter about what. Ignore people like this. They go away when no one takes their bait.

                      “Oh yeah?! HOW is the FDA gonna KILL people”?!!!!!!
                      “Oh yeah?! Why ASSUME people will switch to vaping just cuz it’s safe???! DUUUHHHH”!!!!!

                      Doesn’t matter what you say, this guy will find a reason to argue it! lol!

                4. 25 years of experience as a recovering-smoker. Last 15 years repeated cycles quitting, then restarting to avoid committing murder. Always had some jerk who “supports my quitting” and drops every hour to remind me tell how long I’ve gone without a smoke.
                  Most smokers know it’s not healthy, but quitting can be a bitch.
                  Nicorette is slow acting, so people often chew it continuously. Both smoking and vaping essentially involve the inhalation of vapors and thus have similar effects.
                  Only real question is
                  “Do you want a symphony of 600 combustion products with your THC. Well, Do you kid?”

        2. Plenty of smokers have already switched from smoking to vaping without government intervention. You could just look at the FDA’s own numbers. Almost all vapers are ex-smokers. There is a miniscule number of teen vapers that didn’t smoke before taking up vaping.

          1. That’s what I said, anecdata.

            1. Yes, data are typically used to build an argument. What’s your point?

  9. And to think we had a revolution over stamps and tea.

    I wish I could reanimate Sam Adams so I could watch him stroke out.

    1. I want to resurrect Alexander Hamilton and beat him to death with a copy of Federalist Paper #41.

  10. I like to think President Cruz would have dropped the axe unflinchingly on these assholes from day one. Maybe I’m just naive. But we’ll never know. Trump will blow his meager political capital on immigration and trade.

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  12. Fuck the FDA.

  13. this is the real result of ‘big tobacco’ and crony-CRAPitalism at it’s finest (or worst, depending on how you look at it).

    lobbysists and our ‘beloved’ congressmen, or whatever gender they pronounce themselves to be now, are behind these ‘regulations’

    but if we can ‘save just one child’, right?

    1. sp: lobbyists

  14. so what should we do, inspire peoples to avoid vape pens?

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