E-cigarettes

The FDA's E-Cigarette Regulations, Mostly Mild for Now, Could Set the Stage for a Crackdown

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FIN e-cigarette ad

Today the Food and Drug Administration (FDA) finally proposed regulations for electronic cigarettes. The rule, which probably will take effect in a year or so, does not include any restrictions on advertising or flavors, steps that some activists and politicians had urged in the name of protecting the youth of America from the menace supposedly posed by e-cigarettes. Nor would the rule require the immediate removal of existing products, although it creates a process that may eventually have that result. Much hinges on whether the FDA, which currently claims to be agnostic on the subject, ultimately views vaping as a threat to public health or a harm-reducing alternative to smoking.

The rule would prohibit e-cigarette sales to consumers younger than 18, as most states already have done. It would ban free samples and e-cigarette vending machines in settings open to minors but allow online sales, which are an important distribution route for the industry, with age verification. It would require manufacturers to put the following message on e-cigarette packaging:

WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.

E-cigarette companies would have to register their products with the FDA, report ingredients, and flag potentially harmful chemicals. They would not be allowed to advertise their products as safer than conventional cigarettes or make comparisons that might lead to that conclusion unless they went through the process required for approval of a "modified risk product." That process entails presenting enough evidence to convince the FDA that a product "will benefit the health of the population as a whole." It is not enough for a company to show that the comparisons it wants to make are accurate.

In fact, says Boston University public health professor Michael Siegel, "an electronic cigarette company cannot even inform consumers that the product does not produce smoke because such a claim would be considered a 'reduced exposure' claim." Siegel, who sees e-cigarettes as a promising smoking cessation tool, worries that the FDA's censorship of accurate information will "undermine the public's appreciation of the health hazards of smoking and prevent companies from telling consumers the truth: that e-cigarettes are a lot safer than tobacco cigarettes."

Attempts to get e-cigarettes approved as "new tobacco products" face a similarly daunting barrier: The applicant has to persuade the FDA that "permitting such tobacco product to be marketed would be appropriate for the protection of the public health." Companies can avoid that requirement, which probably would entail prohibitively expensive and time-consuming research, if their products were on the market as of February 15, 2007, or if they are "substantially equivalent" to products that were. "Substantial equivalence" means having "the same characteristics" as a grandfathered product or raising the same public health issues, although the FDA may require "clinical data" to support the latter conclusion.

The U.S. e-cigarette industry was just getting started in 2007, but there were a few brands, including NJoy, that arguably can serve as acceptable "predicate products" for the hundreds of e-cigarettes available today, since the basic technology—heating a propylene glycol solution to produce a nicotine-laced aerosol—is the same. Yet the FDA expresses doubt on that point:

For some products, there may not be predicate products that were on the market as of February 15, 2007, to which to claim substantial equivalence. This may be particularly true for e-cigarettes and similar novel products.

Chip Paul, founder of the Oklahoma-based e-cigarette franchise Palm Beach Vapors, believes existing products generally will qualify as substantially equivalent to the early brands, meaning companies can continue selling them without presenting data they do not have. "I think everybody will be able to make that argument, that they are just furthering the technology that existed in 2007," says Paul. One major change has been the shift from disposable cartridges of e-cigarette fluid to refillable tanks, but the underlying principle remains the same. "We don't think what's on the market today is substantially different from what was on the market in 2007," Paul says. "There have been improvements in the technology, and there have been some design changes, but the way the liquid is delivered to the user is fundamentally the same, and the liquid is fundamentally the same. I think everybody who is in business today will be able to [satisfy that test] and be OK."

Paul does worry that FDA regulation could deter future innovation. The more innovative a vaping device, the less likely it is to be deemed substantially equivalent to the products available in 2007. Siegel expresses a similar concern:

This provision is going to present a huge obstacle to innovation in this category. The newer products tend to be safer and more effective, so it makes no sense to allow the older products to remain on the market while requiring pre-approval for the newer and better products. The implications of this regulation is going to depend on the evidence that the agency requires to approve these applications. A stringent interpretation of the regulations will put a huge dent in electronic cigarette innovation and could limit the expansion of the market. In addition, this provision is going to place an undue burden on smaller companies and give a huge advantage to larger companies, including the tobacco companies that have entered the e-cigarette market.

None of this will happen for a while. The FDA is giving companies two years after the rule becomes final to submit applications for product approval. In the meantime, and while the FDA considers the applications, existing products can remain on the market, so it will be years before any of them are removed, assuming regulators ultimately rule against them.

The adjustment period suggests the FDA is considerably less hostile to e-cigarettes than it was when it tried to ban them as unapproved drug-device combinations (a move that was rejected by the courts). Paul also takes comfort from the proposed rule's scattered references to evidence that e-cigarettes are safer than the real thing and that they can help smokers quit. "There is a lot of optimism in that document regarding the electronic cigarette industry," he says. "They are holding their powder in the hope that further study will show this is a viable smoking cessation method." 

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  1. Much hinges on whether the FDA, which currently claims to be agnostic on the subject, ultimately views vaping as a threat to public health or a harm-reducing alternative to smokingstate and federal government revenue generation via vice taxes.

    FIFY Jacob

  2. Wonder what this means for my local vape shop and their in-house juice.

    1. It means that unless they wish to pay for an expensive and lengthy approval process, they will likely go out of business, or at least not be able to sell their own juice (which is likely the largest factor in them being able to remain in business), leaving the approval to the big companies that can afford it, which, of course, is exactly what this regulation is designed to do.

  3. “The FDA’s E-Cigarette Regulations, Mostly Mild for Now, Could Set the Stage for a Crackdown”

    could?

    will

  4. I started smoking again after being quit for four years thanks to playing around with e-cigs. Got back on Chantix and quit again. Still getting over the side effects. Fucking flatulence and crazy dreams. Beats smoking though.

    1. Hey! You leave flatulence out of this!

      1. Flatulence and Crazy Dreams was the name of my college rock band. I’m suing!

    2. I’m not sure you can blame ecigs for you starting to smoke again.

  5. WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical

    How about replacing it with this. More effective:

    WARNING: Vape if you wish, but remember that it makes you look like an giant, uncool douchebag.

    1. Obligatory Onion headline:
      Man Smoking E-Cigarette Must Be Futuristic Bounty Hunter

  6. I wonder what this all means for VPCO.

  7. “As is currently the case, they would not be allowed to advertise their products as safer than conventional cigarettes or make comparisons that might lead to that conclusion unless they…convince the FDA that a product “will benefit the health of the population as a whole.””

    Help me out here – even if they can show that a person who switches from regular cigs to e-cigs would improve his health prospects, they can’t *say* it? Maybe the product *won’t* benefit the population as a whole because it will recruit a lot of new smokers who otherwise would have been nicotine-free. But even so, does anyone deny that using e-cigs rather than regular cigs benefits the person who makes the replacement?

    1. But even so, does anyone deny that using e-cigs rather than regular cigs benefits the person who makes the replacement?

      I’m sure the prohibitionists would come up with some contorted, logic-impaired “reasoning” that would allow them to deny that.

      My old boss is Mormon, and when we discussed this issue, there was no way he was going to admit that smoking e-cigs might be a good idea compared to the alternatives, because tobacco is bad in the Good Books he grew up on.

  8. OT: I just saw Shikha Dalmia actually wrote these words…

    “Progressives would be foolish to resist this inevitable outcome. Instead, they should shift their fight to eradicating the remaining relics of white privilege that still distort the playing field against minorities.”

    Oy.

    http://theweek.com/article/ind…..1481237582

    1. Oy, indeed. Asking progressives to “eradicate the remaining relics of white privilege” is like asking backwoods Baptist preachers to eradicate sin. It’s EVERYWHERE, don’t you know.

      1. Even if they killed off all the whites?

        1. Then they’d go after people of mixed race, and Asians and other “honorary whites.”

  9. It’s like the bureaucrats at the FDA shrug and say, “Truth? What is truth?”

  10. How many times have we witnessed this incrementalist kabuki theater to not know that this is but the first of many “sensible, common sense, sensibly common” regulations the FDA will throw onto e-cigs?

  11. The regulations are mild because of the patented Micronite filter.

  12. E-cigarette companies would have to … flag potentially harmful chemicals.

    WTF?

    1. Actually, due to shoddy manufacturing of the vaporizers themselves, you are not just inhaling nicotine laced propylene glycol but also vaporized heavy metals. Which is kind of scary. (I’m not trying to spread needless FUD about e-cigs; my wife used to work in the industry and read every study out there (there aren’t many).)

      Anyhow, whether a safer product could actually make it to market under these new regulations is an open question (I think that’s ironic but I just don’t know anymore).

      1. Where exactly do the heavy metals come from?

        Aside from the nicotine you’ve got vegetable glycerin, propylene glycol, and water. These are all carbon, hydrogen, and oxygen molecules.

        I suppose some of the flavor components might have metals in them, but I expect those are mostly carbon, hydrogen, oxygen as well.

        1. They come from the materials of the vaporizer device itself. Hot metal tips and such. It could be a real issue.

        2. Or I should learn2read…coils

          I would expect that it would be trace levels of these metals.

      2. you are not just inhaling nicotine laced propylene glycol but also vaporized heavy metals.

        Bullshit.

        Contamination by metals is shown to be at similarly trivial levels that pose no health risk, and the alarmist claims about such contamination are based on unrealistic assumptions about the molecular form of these elements.

        Read the science, not the “science.”

        The conclusion of the study?

        onservative (erring on the side of caution) assumptions, the exposures from using e-cigarettes fall well below the threshold for concern for compounds with known toxicity. That is, even ignoring the benefits of e-cigarette use and the fact that the exposure is actively chosen, and even comparing to the levels that are considered unacceptable to people who are not benefiting from the exposure and do not want it, the exposures would not generate concern or call for remedial action.

    2. Well, I’m pretty sure the vapor contains dihydrogen monoxide.

      1. Yep.

        Fuck the FDA in the ass with a rusty chainsaw.

  13. And today is the day that e-cigs begin to triple in cost.

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