E-cigarettes

FDA Says Explaining the Main Advantages of E-Cigarettes Would Confuse Consumers

According to federal regulators, companies that talk about reducing health risks by switching from smoking to vaping are breaking the law.

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Vaping360.com

In a "clarification" published this week in the Federal Register, the Food and Drug Administration indicates that e-cigarettes cannot legally be sold as tools to quit smoking unless their manufacturers go through the prohibitively expensive process of getting them approved as new pharmaceutical products. The FDA also says e-cigarettes cannot legally be sold as a less hazardous alternative to the conventional kind unless their manufacturers go through the prohibitively expensive process of getting them approved as "modified risk tobacco products." The upshot is that e-cigarette companies are forbidden to be honest about the main benefits offered by their products, a form of censorship that is bound to retard the shift from smoking to vaping, thereby endangering lives that could have been saved by switching to a much less dangerous nicotine habit.

The FDA's new rule is supposed to clarify when "a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product." That can happen in two ways, one of which is "if the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease." The FDA regulates nicotine products such as gum and patches as medical products, based on the dubious premise that nicotine addiction is a disease, the treatment for which is nicotine in a different form. The label on Nicorette gum, for instance, identifies it as a "stop smoking aid" that "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking." As far as the FDA is concerned, selling e-cigarettes as a competing form of nicotine replacement for smokers trying to quit (which is what they are) puts them in the same regulatory category as Nicorette:

Claims related to smoking cessation have long been recognized as evidence of intended use conferring drug or device jurisdiction. Smoking cessation claims have also long been associated with intended uses of curing or treating nicotine addiction and its symptoms….Against this backdrop, smoking cessation claims on any product generally create a strong suggestion of intended therapeutic benefit to the user that generally will be difficult to overcome absent clear context indicating that the product is not intended for use to cure or treat nicotine addiction or its symptoms, or for another therapeutic purpose.

The FDA does not explicitly rule out any reference or allusion to smoking cessation in the marketing of e-cigarettes. The agency even allows that "evidence may be developed showing that, in some situations, 'smoking cessation' is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco." It's a mystery why new evidence would be required to prove that point, since that surely is the way that millions of people who have used e-cigarettes to quit smoking understand the concept. In any case, the FDA promises to "closely scrutinize 'smoking cessation' claims," creating a strong presumption that will encourage manufacturers to steer clear of the subject. The FDA says "the rule's treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products." It adds that disclaimers of therapeutic intent generally will not be sufficient to keep e-cigarettes out of that category.

Boston University public health professor Michael Siegel, an advocate of vaping as a harm-reducing alternative to smoking, questions the FDA's legal reasoning, arguing that smoking (unlike nicotine addiction), is a "health-related behavior," not a disease. Hence "a claim that e-cigarettes are intended to help someone quit smoking is not necessarily a claim that the product is intended to treat a disease." Rather, "The intention is to help alter a health-related behavior." The FDA pretends to address this argument but conspicuously fails to do so:

Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence….

Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult smokers want to quit smoking completely for health reasons. Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose.

The FDA seems to be saying a product that helps people quit smoking is a drug because it prevents disease. By that logic, a host of products aimed at achieving a healthier lifestyle, ranging from motivational calendars (an example Siegel mentions) to exercise equipment, would qualify as drugs under the Food, Drug, and Cosmetic Act.

The FDA claims it is trying to prevent the "consumer confusion" that would be caused by an honest and open discussion of the benefits offered by e-cigarettes:

FDA believes that the potential for consumer confusion is increasing. This is especially true when tobacco-derived products that may otherwise appear to be products intended for recreational use make claims related to quitting smoking and treatment of nicotine addiction….

FDA continues to believe that there is consumer confusion about the intended uses of marketed products made or derived from tobacco. Evidence that at least some consumers are confused about the intended uses of products can be found in the comments themselves. We received many comments from individuals who began using e-cigarettes because they believed that e-cigarettes would help them quit smoking. Moreover, as noted in two comments, studies have shown that many consumers are using e-cigarettes to attempt to quit smoking despite the fact that no e-cigarette has been approved for use as a smoking cessation aid. We believe that the rule will help to mitigate this confusion and help ensure that consumers do not mistakenly use tobacco products, which are inherently dangerous, for medical uses.

It is hard to overstate the bureaucratic, pseudoscientific arrogance on display here. According to the FDA, smokers who switch to vaping in the hope of reducing the health risks they face are making a mistake, even though it is clear that the hazards posed by vaping pale beside the hazards posed by smoking, and the fact that smokers insist on making that mistake shows how confused they are. It stands to reason that encouraging such behavior can only lead to further confusion. E-cigarette suppliers must therefore be prohibited from suggesting their products might help smokers quit, even though that is their biggest selling point and happens to be true.

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  1. According to federal regulators, companies that talk about reducing health risks by switching from smoking to vaping are breaking the law.

    The First Amendment says they’re not.

    1. The expansive readings of the commerce clause and first amendment carve outs for tobacco companies say different, smart guy!

    2. It would be like yelling “FIRE THEM UP” in a crowded theater.

    3. It’s only free speech if the speech is government approved, Comrade!

    4. “Congress shall make no law abridging the freedom of speech, unless someone is trying to make a buck.”

      Doesn’t your copy of the BoR read that way?

  2. getting them approved as “modified risk tobacco products.”

    Oh, FFS! Like this did?

    1. Personally, I prefer these. Except the pink ones with the owl on them. Not that smoking a pink cigar would be gay (NTTAWWT) but because I don’t want to offend whatever race the owl is supposed to represent.

    2. The bubble gum cigs wrapped in paper were the best.. if you blew through them you’d see a little puff from the sugar/starch that they coated the paper with.

  3. It is amazing the public is supposed to have any confidence in that agency’s pronouncements.

  4. “the rule’s treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products.” It adds that disclaimers of therapeutic intent generally will not be sufficient to keep e-cigarettes out of that category.

    Literally.

    Anyway, if I’m grokking this correctly, it no longer spells the doom of the e-cig industry, right?

    1. But maybe subject to Obamacare medical device taxes.

  5. Most current adult smokers want to quit smoking completely for health reasons

    This can’t be true.

    1. “Want” doesn’t necessarily mean “plans to do anything about it”.

      I want 10 million dollars. But I’m not going to move to Washington DC and take a job lobbying Congress and blackmailing them to accomplish my “want”.

    2. They want the benefits of smoking, the actions and sensations they’ve become accustomed to, without the same level of risk. In that sense, then absolutely yes, most adult smokers would love to quit burning tobacco cigarettes.

  6. Thank the heavens for these wise regulators who clearly came from outer space to take care of us, poor rubes.

    Because I don’t want to think that they’re being conceited and self-righteous. I am just too dumb to think! Or vape!

  7. You know, the FDA has a lot of employees, how hard would it be to go find an actual employee to refer to rather than just keep repeating the metonym “FDA”. Specifically, get off your lazy ass and go find one named Mr. Mackey. Or hell, just make one up – you just can’t pass up an opportunity to quote Mr. Mackey when you’re reporting on a story of simplistic drivel about how drugs are bad, m’kay?

  8. Minor detail; many vapers do not include nicotine in their liquid mix.
    So we have another example of legislation based on appearance; it looks kind of like a cigarette, it must be dangerous.
    (read, we have to find a way to stop this; people are enjoying themselves without harming others!)
    At least Donald will drain the swamp of these kinds of madness, as soon as he can get EPA approval and the corps of engineers concurrence.

    1. It seems to be trying to ban the appearance of smoking. The government’s motivations have become surreal in this matter.

      1. We ban children from making gun gestures, or drawing pictures of guns.

        1. *becoming more surreal?

      2. When’s the last time you’ve seen somebody smoking on a TV show? Even looking at a picture of second-hand smoke is dangerous to your health. And wasn’t there even a flap sometime back about somebody or another like Time magazine air-brushing out FDR’s famous cigarette holder and Churchill’s cigar from wartime photos?

        1. All the time, even to this day. It’s a lot less prevalent, but when a show wants to paint someone as a rebel or as being exceptionally dangerous they inevitably smoke.

        2. Prof. Stanton Glantz, the biggest liar in Tobacco Control, who is not a medical doctor but a qualified aircraft engineer, has made an actual junk science thing of stating that millions of children start smoking because of seeing it in movies. I was surrounded by cigarette smoking, growing up in the 1950s/60s and never even thought about starting because of it. Tobacco education in schools didn’t exist then as it does now, however, kids are constantly reminded of smoking thanks to daily reported attempts by public health to stop it and pharma ads for smoking cessation therapies. Tell them they can’t do something and they will.

    2. That seems consistent with their overall actions.

    3. Yes … we need to outlaw vaporizers of any kind. After all we breathe something visible in and out that is not part of the natural air (as if there’s any such thing in most human environments).

      1. The vapour exhaled is actually cleaner than the air we breathe and normal exhaled breath. Also, both nicotine and propylene glycol are antibacterial. New study proves there is no second hand vaping: http://www.ecigarette-research…..015/226-sp

    4. Minor detail; many vapers do not include nicotine in their liquid mix.

      This is a MAJOR detail which can’t be stressed enough:

      YOU DON”T NEED NICOTINE TO VAPE.
      E-CIGS/Vaporizers ARE NOT DEPENDENT on nicotine or any tobacco or tobacco derivative.

      Jesus fucking christ.
      As long as the narrative is controlled by these fuckers the FDA will claim jurisdiction.

      This is like the FDA claiming jurisdiction over (and regulating) rolling papers, FFS.

      1. Pretty much this, although they’ll regulate the fluid too don’t you worry about that.

  9. If it comes down between being ruled by these twats at the FDA or robot overlords; I, for one, welcome our new robot overlords and will gladly kneel down and suck the nicotine from their robo-dicks for the hope they will use a giant magnifying glass to destroy every last FDA busybody like the ANTZ* they are.

    *Anti-nicotine and tobacco zealot

  10. FDA not in favor of giving citizens tools and freedom to make own choices about their health. News at 11

    1. FDA in favor of blocking citizens from the tools and freedom to make own choices about their health.

      I didn’t like how your phrasing implies the FDA gives anything.

      1. They give you time to think about whether you really need that lifesaving medicine. Lots and lots of time! So there

        1. Time is valuable, hmmm, well, now I’m torn.

  11. The FDA has no honor. A woodchipper is too good for these people.

  12. Fuck off, FDA.

  13. A host of products aimed at achieving a healthier lifestyle, ranging from motivational calendars (an example Siegel mentions) to exercise equipment, would qualify as drugs under the Food, Drug, and Cosmetic Act.

    So they made a deliberate decision to interpret the law as broadly as possible, in order to expand the agency’s regulatory power as far as they can stretch words. Mike Siegel has been around these fuckers for decades, and yet he always pretends to be shocked when they have no shame.

    Wouldn’t be surprised at all if the FDA attempts to regulate fitness products as drugs because they treat the “disease” of obesity. Just give them a few years.

  14. HOW TO QUIT SMOKING IN 12 HOURS THE EASY METHOD: http://tinyurl.com/waytoquit

  15. It’s on their website but FDA is hiding that nicotine in the quantities used is neither addictive or harmful. When pharma won approval for long term and concomitant use of their nicotine replacement therapies (NRT), with other nicotine containing products including cigarettes, there were no concerns for safety or abuse (addiction). Dr. Paul Newhouse of Vanderbilt University treats never smokers with high strength nicotine patches, for six months at a time, for depression, Alzheimer’s, Parkinson’s, Scizophrenia and Ulcerative Colitis. Nobody became addicted. These trials were cited to win FDA approval. Other nicotine experts also say it isn’t addictive. This should be highlighted everywhere because the FDA is lying and addiction is their major reason for destroying vaping.

    NRT was released in the late 1980s and suddenly “nicotine is highly addictive” was everywhere. It was a scam to sell it, with its failure rate of 94-98.2% and smokers self reinforce it. Varenicline/Champix/Chantix, a cessation drug, in 5 years in the US was responsible for 500 suicides, 1800 attempted suicides, 10,000 serious adverse events and 3000 lawsuits settled so far by Pfizer. They recently did clinical trials on 12-19 year olds. According to public health the benefits outweigh the risks. Not if you’re a smoker. 1/2….

  16. 2/2 The FDA has made the Deeming Rules prohibitively expensive and impossible to comply with for independent vaping companies. This protects the trillion dollar smoking economy, governments’ profits, the MSA payments to states and pharma’s profits for cessation drugs, smoking related diseases and treatments for diseases above which nicotine appears to protect or lessen. Big T will be given the monopoly to do as they please with vaping. If people’s lives are prolonged it means more pension payouts and more elderly care. People, organisations and pensions are heavily invested in tobacco shares which must be protected. FDA have a duty of care to protect health not work to hurt people.

    I don’t seem to be able to post links, so please see ecigarette-politics .com for excellent info on politics, nicotine and experts’ quotes

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