FDA proposes new rules to regulate e-cigs like cigarettes

The FDA yesterday proposed a new rule that would permit it to regulate e-cigarettes in the same way the agency regulates other tobacco products.

E-cig advocates were reportedly pretty happy with the proposed regulations, as they take a much lighter touch than was expected.  While they would ban the sale of e-cigarettes to children, they would not limit advertising.

The FDA regs also, interestingly, call for the regulation of cigars and hookahs, among other tobacco delivery devices.  From the FDA’s press release:

Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

The basic structure of an e-cigarette, courtesy of the FDA.

The basic structure of an e-cigarette, courtesy of the FDA.

Our own Dr. Mark Thoma penned an E-Cig 101 post for us, explaining the basics of how e-cigarettes work, and summarizing some of the health and safety concerns surrounding them:

E-cigarettes have been around for about 10 years. First developed and marketed in China (not known as a bastion of consumer safety), they were designed to offer a convenient way to enjoy smoking. The e-cigarette is designed to vaporize a liquid (that contains nicotine, flavorants and other substances) and allow it to be inhaled. The liquid can have varying amounts of nicotine. It can also have other substances (flavorants) added (mint, fruit flavors and others.) These flavorants are seen by some as a marketing ploy to get children to start smoking. The liquid may contain other chemicals or impurities, as well.

As Mark reported earlier, because e-cigarettes are not currently regulated, companies can make them any way they want, with no standards whatsoever as to safety or quality.

What studies have found to date is that even nictotine-free e-cigarettes can contain nicotine, the amount of nicotine that e-cigs deliver can vary by as much as 60% from puff to puff, and that some e-cigs tested positive for nitrosamines, which may increase the risk of cancer in humans.

Mark noted that there are also concerns about refillable e-cigs, in which you buy pure nicotine that you use to refill the delivery system.  The NYT noted the potential problems with refillable e-cigs:

These “e-liquids,” the key ingredients in e-cigarettes, are powerful neurotoxins. Tiny amounts, whether ingested or absorbed through the skin, can cause vomiting and seizures and even be lethal. A teaspoon of even highly diluted e-liquid can kill a small child.

But, like e-cigarettes, e-liquids are not regulated by federal authorities. They are mixed on factory floors and in the back rooms of shops, and sold legally in stores and online in small bottles that are kept casually around the house for regular refilling of e-cigarettes.

E-cig advocates argue that e-cigs are still safer than cigarettes, since cigarettes contain such a long list of carcinogens.  From the American Lung Association:

There are approximately 600 ingredients in cigarettes. When burned, they create more than 7,000 chemicals. At least 69 of these chemicals are known to cause cancer, and many are poisonous.

The problem, experts say, is that we just don’t know enough about e-cigs, because they’re not regulated, and because there aren’t enough health and safety studies, so while we think they may be safer than cigarettes, we simply don’t know for sure.  From WebMD:

So far, evidence suggests that e-cigarettes may be safer than regular cigarettes. The biggest danger from tobacco is the smoke, and e-cigarettes don’t burn. Tests show the levels of dangerous chemicals they give off are a fraction of what you’d get from a real cigarette. But they aren’t regulated by the FDA, so what’s in them can vary.

“E-cigarettes may be less harmful than cigarettes,” Drummond says. “But we still don’t know enough about their long-term risks or the effects of secondhand exposure.”

I for one am glad to see the regulation.  This is something you ingest.  We ought to at the very least have standards for how it’s made, to ensure it’s safe.


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  • RDinNH

    Have you called on the FDA to limit access to perfume yet?

  • Duke Woolworth

    Nicotine is a poison. Read the package in the garden supply store. Ingesting it certainly couldn’t make you healthier. Simple as that.

  • Kimm Ryland

    My Uncle Isaac just got a nice 12 month old
    Jeep from only workin on a pc at home… Read Full Article F­i­s­c­a­l­P­o­s­t­.­ℂ­o­m

  • Drew2u

    Naw, as I said below I’ve been out of the loop as of late and have been playing catch-up. By the time I was hearing about the General Mills conditions, they already retracted it and left it at signing up for their website and coupon newsletters only. I am sure that if I try signing up now, that there will be a T&C I can look at, but not a week ago, before they changed their policies due to bad publicity.
    But that brings up my overall point of businesses and corporations like General Mills using such tactics to manipulate the average person, just like the “Hot Coffee” lawsuit which McDonald’s could go and proclaim it frivolous but the 70-year-old woman who suffered 3rd-degree burns was under a gag-order. It’s something the Consumer Protection Bureau should be keeping an eye on.

  • http://www.intoxination.net intoxination

    Same here. E-Cigs have been great for me. Even my doctor agrees, and she was highly skeptical when they first came out. I’m just glad the FDA isn’t doing a full out ban, like they were originally trying. I personally know tons of people who have quit with the help of an E-Cig. Companies like Pfizer don’t like that though, as they want you to purchase Chantix. Yeah, I tried that before the E-Cig and all it did was make me smoke more and almost blow my brains out.

  • http://www.intoxination.net intoxination

    Actually they started in 2008 through the courts. That turned into a joke, with the FDA submitting “independent” studies showing E-Cigs are more dangerous than regular cigs, but it turned out those studies were actually written by Pfizer and other companies producing smoking cessation products.

  • Thom Allen

    I never looked at the site. I just read an account of what General Mills was doing. Did anyone actually see how the “contract” was presented on the site? A banner only? A specific page outlining the terms, like on FB? SOmething else?

  • BillFromDover

    Puff, the magic dragon…

  • docsterx

    No. But those companies stop you right there and don’t let you go past that page till you agree to their TOS. From what I read, all General Mills had was a banner at the top of a page that could be bypassed without agreeing to it’s terms.

  • perljammer

    The third paragraph of the article I linked to, says General Mills first backed down on the social media thing, and then quickly completely retracted. In other words, you can sue even if you download coupons.

  • http://www.rebeccamorn.com/mind BeccaM

    Yep. I mean, IF these things are safer (relatively speaking) than real cigarettes, that’s good. If they help people give up combusted tobacco in favor of aerosolized nicotine, that’s probably a net positive.

    But they do have an aroma that can be detected quite easily by people nearby. (It’s worse, but not exclusive to, the ‘flavored’ e-cig fluids.) That does mean there’s a chemical in the air, and therefore there’s a ‘second-hand vapor’ thing going on.

    Most of all, there has been no testing, so we not only don’t know what this new nicotine delivery system is doing to its users, we also don’t know its effects on others. (Plus if a kid can be literally killed by a teaspoon of the refill liquid, I’d say we might have some basic product safety issues to consider…)

    Like you, I don’t trust the tobacco companies not to do exactly as they did in the past — to deliberately conceal the health threats of their highly profitable products.

  • Drew2u

    Ever read the iTunes update terms & conditions? Facebook’s? Instragram’s?

  • Thom Allen

    Maybe John will have something on this. But I thought that a contract had to be clear to both parties. Just having a banner on a webpage, that could be easily overlooked, doesn’t seem to fulfill the requirement that both parties have knowledge of what’s in the contract. If you got directed to a page that just had the contract info (“use our coupons and you can’t sue us”) on it so that the user was made aware of the terms, might be different.

    Also, I would think that there needs to be some record of the contract. The user would have to sign, initial or acknowledge in some way, that he agreed to what the company proposed. Doesn’t seem to me that there would be any record for the company or the consumer that they entered into a contract.

  • Drew2u

    I’ve been out of the news loop for the past few weeks, so yes I am trying to keep up, lol
    But to my point, they did reverse the: “You can still Like us!” decision, but as far as I’ve heard, if you’re still signed up to receive coupons from them, the “you can’t sue us” policy still applies.

  • http://www.americablog.com/ Naja pallida

    The ultimate concern anyone should have is that these things are produced and marketed by the tobacco industry… who have spent nearly a century proving they don’t give a shit about killing their customers, and have spent countless billions to hide the fact that their product kills people. You’d have to be a complete gullible rube to not believe they’re going to do the exact same things all over again.

  • perljammer

    Sure, here’s a thought: they’ve changed their minds. I would snark, “Please try to keep up,” but this really happened quickly, so no snark.

    http://www.fool.com/investing/general/2014/04/22/general-mills-says-sorry-you-can-like-us-again.aspx

  • Drew2u

    OT: Does anyone have a thought about General Mills saying if you use their coupons or follow them on Social Media, that you can’t sue them? http://www.theatlantic.com/business/archive/2014/04/general-mills-facebook-sue/360826/

  • http://parkandbark.wordpress.com/ Houndentenor

    At the very least you should know what’s in what you’re ingesting. I’ve wondered about these things because they are EVERYWHERE. How did it take 10 years to get any intervention from the FDA?

  • http://www.rebeccamorn.com/mind BeccaM

    That’s been my concern. Allergy and migraine trigger. Whatever they put into the e-cig solutions is highly aromatic and affects me in the same way as when I stand next to someone who uses too much perfume.

    But the thing that concerns me far more has been (1) the country of origin for most of these devices and the chemical solution put into them (let’s not forget, China is the country where they make and sell sewer oil) and (2) the explosive popularity of these devices with virtually no health and safety testing having been done on them yet.

    I’m all for the testing — it needs doing. And for sensible regulations regarding where and when the devices can be used.

  • Indigo

    I’m glad to know it works for you. I stopped smoking tobacco about 20 years ago and don’t miss it but echoes of the congestion linger . . . apparently for a lifetime.

  • JDH

    Vaping let me quit smoking. I’ve been with my longsuffering, non-smoking partner for 7 years, and vaping has really helped our relationship. He knew I was a smoker when we got together, and he never gave me an ultimatum. But he can’t stand the smell or taste, and it was really hard on the sex life. Vaping has none of those consequences.

    Aside from that, vaping has been great for my health, at least in comparison to smoking. Whatever the risks, we know for sure that it is a safer alternative to tobacco. I’m thrilled to see the industry regulated and studied, as it will only improve safety in the long run. I honestly expected a ham-handed overreaction that would ban them outright.

  • Indigo

    That sounds like one more allergy trigger. There’s plenty of those around without adding to the supply.

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