E-Cigarettes Will Remain Legal but Unregulated Until the FDA Issues New Rules

I recently asked FDA spokesman Jeffrey Ventura to answer some of the questions raised by the agency's plans to regulate electronic cigarettes as tobacco products. The most important point he confirms is that e-cigarettes will remain legal but unregulated, like cigars and pipe tobacco, until the FDA gets around to issuing new rules. That may take a while. "The timeline for proposing the rule and subsequent enactment of the proposed rules has not yet been determined," Ventura says.

Meanwhile, the FDA will take action against e-cigarettes only if they are marketed based on "therapeutic claims," which would render them unapproved pharmaceutical products subject to seizure. Exactly what counts as a therapeutic claim is unclear. Cautious e-cigarette companies obviously should avoid saying their products cure the common cold or relieve migraine headaches. But what if they promote e-cigarettes as a safer alternative to smoking or as an aid to quitting? Last week the FDA said it was "considering whether to issue a guidance and/or a regulation on 'therapeutic' claims," but Ventura says "there is no timeline currently set for the issuance of this guidance."

While the FDA has issued a "guidance" (PDF) regarding the Family Smoking Prevention and Tobacco Control Act's grandfather clause, it does not offer much, uh, guidance. Under the grandfather clause, which will be important after the agency starts regulating e-cigarettes, tobacco products that were "commercially marketed in the United States" as of February 15, 2007, and "substantially equivalent" products introduced after that date are not subject to premarket approval.  The FDA says evidence that a product qualifies for the grandfather clause may include "dated copies of advertisements," "dated catalog pages," "dated promotional material," "dated trade publications," "dated manufacturing documents," "dated bills of lading," "dated freight bills," or "dated waybills." It does not mention websites, but it sounds like a foreign-based company could qualify by showing that it made online sales to Americans in 2006 or early 2007.

Most e-cigarette brands were not available in the U.S. that early, so the question for them is whether they are "substantially equivalent" to any that were. One could argue that all e-cigarettes are "substantially equivalent" to each other, using the same basic technology. But the FDA may decide to make finer distinctions, and we won't know until it starts responding to applications from companies, which won't happen until it issues the new regulations, which could be months or years from now. Likewise the question of whether e-cigarettes that don't qualify for the grandfather clause can pass muster as "new tobacco products" or "modified risk tobacco products," a label that applies to products marketed as safer than the competition. Regarding the latter issue, Ventura says:

In assessing these products, the Agency is charged with making several findings, including that the product will significantly reduce harm to individual users and benefit the health of the population as a whole.  The FDA is currently assessing how best to implement these requirements. 

At this point, no product has been determined by the Agency to be a safer alternative to conventional cigarettes.  Furthermore, the harm potentially caused by inhaling the various chemical substances in e-cigarettes has not been adequately evaluated.  Experts have also raised concerns that the marketing of products such as e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products.

Those caveats suggest that approval of e-cigarettes would not be the slam-dunk it ought to be, given the enormous difference in risk between smoking and vaping, which does not involve tobacco (except as raw material to produce the nicotine) or combustion products. The "population as a whole" standard, as I've pointed out before, means the FDA can block the sale of a product even if it is indisputably safer than existing alternatives. So it looks like the more the FDA drags its feet, the better off consumers will be.

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  • ||

    Saying e-cigarettes are safer than cigarettes violates the narrative that any smoking anywhere is evil and will kill you immediately. Therefore anything of the sort will be harshly punished by the state.

  • Cyto||

    You think your tongue is firmly planted in your cheek, but you know not of what you speak. Just this morning is found this gem from the anti-smoking crowd. Headline reads:

    Ignore big tobacco's absurd fight against plain packs

    "plain packs", for the uninitiated, are cigarette packages on which the state replaces the companies branding with its own anti-smoking imagery, like tumors, etc. designed to make smoking unappealing. In this case it is Australia that wants to trample the rights of merchants rather than man-up and ban something outright.

    Yet our author from New Scientist thinks it is absurd for the manufacturers to protest having their branding replaced with state-mandated branding designed to stop people from purchasing their products. Wait, which side of this argument is absurd again?

  • sarcasmic||

    TEH CHILDRENZ!

  • Anonymous Coward||

    Isn't there some kind of list that people like you are required to be on?

  • Barely Suppressed Rage||

    FDA spokesman Jeffrey Ventura

    Jesse's little brother?

  • Lord Googoo||

    No. Ace's.

  • ||

    ALLRIGHTYTHEN

  • rather ||

    Please tell me that your kitten ran away

  • ||

    You're so useless, rectal. That must really bother you.

  • rather||

    you are little boy and im pedobear and your butt hurts

  • rather retarded||

    Tell me anotheh bed time stowy. The one wheh Daddy rapes my butt.

  • Restoras||

    "E-Cigarettes Will Remain Legal but Unregulated Until..."

    ...we can figure out how to tax them like cigarettes.

  • ||

    "Wait, it seems like a 'sin' product, but there's no health concerns? How do we justify an absolutely egregious tax, then? This is going to take time!"

  • Bingo||

    So what's the death toll so far of this dangerous, unregulated product that was sold for a profit by corporations?

    Any of the leftist trolls know?

  • OO||

    at least u know not to ask any of the corporatists here

  • Bingo||

    OO please don't ever change...

  • Shorter OO||

    "Derp."

  • mad libertarian guy||

    I would say that the number is very close to the number of deaths via smoking marijuana, or ZERO.

  • Thulium||

    Not only has no one died from using e-cigarettes, no one has even suggested a way for e-cigarettes to make someone sick. E-liquids are made of ingredients that are approved in many other consumer and medical products. Propylene glycol, for example, can be found in nearly as many products as water. Any serious risk of acute or long term injury from e-cigarette use would be self-evident. They may not be completely harmless, but there is no reason to expect them to be any more dangerous than pharmaceutical nicotine products. More people are killed by the nicotine patch.

  • markgjvaper||

    possibly 1 person died with vaping so far out of all the people using these worldwide over the past 10 years or so and even that one is only supposition by a doctor that it could have been the cause!
    you do the maths! lol

  • prolefeed||

    Is it making "therapeutic" claims to say that e-cigarettes are at best neutral for your health and possibly a bit harmful, but far less harmful than the alternative of smoking?

  • Thulium||

    It is, but as individuals we are still free to tell the truth: At least 99% of the harms of tobacco use are caused by combustion hazards and byproducts. Switching to a smoke-free alternative eliminates nearly all of the known risks of continued tobacco use.

  • sarcasmic||

    They're a gateway to real cigarettes.

    Gateway I tell you!

    Gateway!

  • MS 13||

    Don't worry, if your government bans e-cigarettes the black market will always be there to supply this product for you.

  • ||

    thank you, Black market!

  • markgjvaper||

    wait are we still allowed to call it a "black" market?

  • ||

    Sounds like the only thing that gives the FDA any jurisdiction at all is the fact that the nicotine is extracted from tobacco.

    Any other sources of nicotine out there?

  • Paul James||

    As I understand it, if the nicotine was extracted from something else the FDA would have the power to ban it as an illegal drug delivery device regardless of therapeutic claims.

  • rattlegoat||

    Bell peppers, tomatoes, and nightshade are pretty good sources of nicotine. One of those is toxic, and the other a tasty on a pizza, until the FDA gets to regulate nicotine from all sources.

  • Robert||

    On the bright side, someone could petition to get a substantial equivalence determination between cannabis and tobacco cigarets. Don't laugh; that's how most medical devices are marketed, via class 2.

  • ||

    While the FDA has stated that it "intends to propose a regulation" to require e-cigarettes and other currently uregulated tobacco products (i.e. cigars, pipe tobacco, e-cigarettes, e-liquid, nicotine gums, lozenges, patches, nasal sprays, skin creams, water and at least several dissolvables) to comply with all of the many different sections in Chapter IX, there is no scientific or empirical evidence indicating that doing so (especially for noncombustibles) "would be appropriate for the protection of the public health," which is a requirement any proposed regulation must meet before it can be approved by the Secretary of HHS.

    In fact, requiring e-cigarettes to retroactively comply with Section 910 (which would ban products not marketed before or not "substantially equivalent" to a product marketed before Feb. 15, 2007) and Section 911 (which would prohibit e-cigarette companies from truthfully claiming that the product is less hazardous alternative to cigarettes) would harm public health.

    Also, since the FDA must consider the potential of creating a black market before approving any new regulation, it makes no sense for the FDA to propose a regulation that could/would create a black market for e-cigarettes(i.e. by requiring e-cigarettes to comply with Section 910).

    It is important to note that none of the Chapter IX regulations were adopted by Congress based upon scientific or empirical evidence (but rather because of a privately negotiated deal between Philip Morris, CTFK, Waxman and Kennedy, lots of compaign contributions by PM and extensive lobbying and misleading propaganda by CTFK).

    So while the FDA has previously stated that it intends to base its tobacco regulatory decisions on scientific evidence, the agency's announcement last week indicates that the FDA is basing at least this tobacco regulatory decision on politics.

  • Dawn||

    Since switching to e-cigarettes, I am spending way less to "vape". They will, however, manage to figure out a way to tax them eventually, so get yours quick!

  • nichoel ||

    Just leave us all alone and let us vape for crying out loud. We are not hurting anyone. Regular cigarette smokers are but ecig users are not. My baby stopped coughing and lost ALL symptoms of asthma within a week of my using ecigs instead of real cigs. That is enough for me. I will never go back!!

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