Comment on the AAPHP Petition to the FDA

As we mention in an earlier post, the American Association of Public Health Physicians has submitted two petitions to the FDA. The first asks the FDA to classify electronic cigarettes as reduced harm tobacco products. The second asks the FDA to hold a follow-up press conference to amend statements made at their July 22nd, 2009 press conference in which they potentially misled the public about the potential dangers of electronic cigarettes.

We encourage all e-smokers and those who believe in the technology, to first read the two AAPHP petitions and then make public comments about them to the FDA.

To make a comment on the first petition, asking the FDA to classify the electronic cigarette as a reduced harm tobacco product, visit this Regulations.gov page and just fill in the blanks.

If you need ideas about how to express your opinions, read the points below:

  • the nicotine in the e-liquid is derived from tobacco, thus the FDA can legally reclassify and regulate the e-liquid as a tobacco product
  • a classification of e-cigarettes as “drugs” or “devices” would limit access, increase cost, and create an unfair market advantage for tobacco cigarettes
  • e-cigarettes as tobacco products would allow for reasonable regulations such as a ban on the sale to minors
  • federal Judge Richard Leon ruled that the FDA can regulate e-cigarettes as “tobacco products”, but not as “drugs” or “devices”
  • write about your personal experience using e-cigarettes or that of someone you know
  • To make a comment on the second petition, asking the FDA to amend their earlier statements about electronic cigarettes, visit this Regulations.gov page and fill in the blanks.

    If you need ideas about how to express your opinions, first read How and Why the FDA Misled the Public and consider these points:

  • in contrast to claims made by the FDA, there is no evidence that e-cigarettes have harmed any user or nonuser
  • there is no evidence that e-cigarettes are marketed to youth
  • cigarette smokers have a right to truthful information
  • FDA officials have an ethical duty to protect consumer health and to provide truthful health risk information
  • write about your personal experience using e-cigarettes or that of someone you know
  • Please take the time to forward your thoughts to the FDA. It is important that truthful information, good or bad, is given to smokers so they can make their own choice.

    Joel L. Nitzkin, MD, MPH, DPA, Chair, Tobacco Control Task Force, American Association of Public Health Physicians (AAPHP) has created two petitions and sent them to the FDA. The first argues that the FDA should classify the electronic cigarette as a reduced harm tobacco product and abandon the idea that it is a new drug. Dr. Nitzkin and the AAPHP make many arguments as to why the e-cigarette as a reduced harm tobacco product is in the best interest of public health.

    The second petition asks the FDA to follow up on their July 22nd, 2009 press conference to, “amend certain statements on the basis of new information provided as text and attachments to the two AAPHP petitions being submitted today.”

    The petitions begin as follows:

    Dear FDA:

    The undersigned submits this petition under the provisions of the new Tobacco Center legislation for which authority has been delegated to the Commissioner of Food and Drugs under 21 CFR 5.10 to request the Commissioner of Food and drugs to reclassify nicotine vaporizers, also known as “Ecigarettes” or “electronic cigarettes” from “drug-device combinations under 201(g) and 201(h) of the Federal Food, Drug and Cosmetic Act, to “tobacco product” under the new FDA/Tobacco legislation.

    This is one of two petitions I am submitting today on behalf of the Tobacco Control Task Force of the American Association of Public Health Physicians. The other petition is a request to FDA to follow-up on its July 22, 2009 press release with another press release to amend certain statements on the basis of new information provided as attachments to both of these petitions.

    We have generated these petitions because reclassification of E-cigarettes to tobacco products could open the door to a new harm reduction component to current tobacco control programming. That new component, in turn, could rapidly and substantially reduce tobacco-related illness and death without increasing the numbers of teens initiating nicotine use.

    Neither I nor AAPHP have received or anticipate receipt of any financial support from any
    electronic cigarette enterprise, any other tobacco-related enterprise, or any pharmaceutical enterprise.

    Joel L. Nitzkin, MD, MPH, DPA
    Chair, Tobacco Control Task Force, American Association of Public Health Physicians (AAPHP)

    To download and read the petitions, visit AAPHP FDA Petition 1 and AAPHP FDA Petition 2. For more about the AAPHP visit the American Association of Public Health Physicians’ website.

    How Electronic Cigarettes Are Different From Tobacco Cigarettes

    As you browse the internet you will find many electronic cigarette supplier websites and blogs stating how much electronic cigarettes are like smoking tobacco cigarettes. While it is true that the act of vaping is very similar to smoking an “analogue” cigarette, there are some differences.

    1) Electronic cigarettes require more prep than just grabbing a lighter. When contemplating changing your smoking habit, remember, electronic cigarette batteries need to be charged and cartridges need to be filled and/or changed. There are not huge time requirements to start vaping, but it is more intensive then using a lighter.

    2) Using an electronic cigarette requires a little more planning than smoking tobacco cigarettes. When you run out of cigarettes you simply go down to the local gas station or convenience store and buy another pack. When you run out of e-liquid or cartridges or your battery/charger/atomizer go bad, it can take time to ship the product to you. It is a good idea to keep extra batteries, atomizers, cartridges, and e-liquid on hand. It also doesn’t hurt to have a back up e-cigarette charger, even if it is just a USB charger.

    3) The action of smoking continues, but the inhaling is likely to be different from your tobacco cigarette. Often with e-cigarettes you need to inhale harder or more deeply to get the full sensation of smoking. This will depend on how you smoked originally and your brand of e-cigarette. Most smokers who use an electronic cigarette get used to this difference after a week or two.

    4) The taste will be different. Although our e-liquid comes in tobacco or menthol flavor, it will taste different than your tobacco cigarettes. There is no way to fully reproduce the taste of actual smoke produced from combustion. However it is much like switching brands of cigarettes. Smokers become accustomed to it and many eventually prefer the taste of electronic cigarettes over their old “analogues”.

    Deciding to change a habit from tobacco cigarettes to electronic cigarettes does take some adjustments. However, if you are like so many others who have tried the INSTEAD Electronic Cigarette, you will find it is a great alternative to your tobacco and become a true e-smoker….or even an advocate for the technology.

    The Legal Battle Over Electronic Cigarette Continues

    This post is a continuation of our “What is Going on with the FDA and the Electronic Cigarette?” blog post from May 1st, 2009.

    So what is going on now?

    Well, as we noted, Judge Leon granted a preliminary injunction to the electronic cigarette suppliers until the case is resolved. This meant that the FDA couldn’t stop the importation of the products.

    On Feb 2nd, 2010, the FDA filed an appeal of the injunction and was granted a stay of the injunction until the Appeal Board reviews the case. This means that the FDA can once again stop the importation of electronic cigarettes from these suppliers until the appeal board makes a ruling.

    ————————–
    BEFORE: Ginsburg, Henderson, and Rogers, Circuit Judges

    O R D E R
    Upon consideration of the emergency motion for stay pending appeal and for immediate temporary stay pending this court’s consideration; and the motion to strike the emergency motion, it is
    ORDERED that the motion to strike be denied. It is
    FURTHER ORDERED that the district court’s order entered January 14, 2010, granting appellees’ motions for injunctive relief, be stayed pending further order of the court. The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the emergency motion for stay pending appeal and should not be construed in any way as a ruling on the merits of that motion
    It is FURTHER ORDERED that appellees file and serve a joint response by 10:00 a.m., Thursday, February 4, 2010, and appellants file and serve any reply by 10:00 a.m., Monday, February 8, 2010. The parties are directed to hand-deliver the paper copies of their submissions to the court by the time and date due.

    ————————–

    So, as ordered by the appeals court, Njoy and Smoking Everywhere filed a response on February 4th, 2010.

    You can download and read the full Electronic Cigarette Suppliers Response To The Appeals Court here. Here are some highlights:

    ————————–

    Page 12:
    FDA also asserts that it has jurisdiction under the FDCA because ecigarettes are intended to “prevent or alleviate nicotine withdrawal symptoms,” and, thus, are intended for therapeutic use. The District Court rejected this claim as a matter of fact. The “intended use” of a product is determined by “the objective intent of the persons legally responsible” for labeling the product.

    Page 17:
    Although FDA acknowledges that it has not provided this Court with the “benefit of specific evidence of the dangers posed by [e-cigarettes],” it insists that “the threat to the public health is apparent” and cannot seriously be questioned. That argument is meritless. FDA cannot prevail with vague allegations of potential harm; rather, it must prove a likelihood of irreparable harm to warrant a stay.

    Although e-cigarettes have been sold since 2007, FDA has not identified a
    single instance, either in this Court or below, of an adverse health effect from ecigarettes.

    ————————–

    The response from these electronic cigarette suppliers clearly outlines why they should be given an injunction:
    1) Just because a product delivers nicotine, doesn’t mean it is a new drug…….if that was the case, tobacco cigarettes would be new drugs.
    2) No therapeutic claims have been made by the suppliers.
    3) Allowing the FDA to stop importation while the case is pending will do economic harm to the companies involved in the case.
    4) The FDA has no evidence that electronic cigarettes pose any harm to the public.

    On February 8th, 2010, the FDA filed it’s response to the Appeals Court. You can download and read the full FDA response here. Please note this is not the actual document.

    Here are a few excerpts of the FDA argument for the stay of the injunction:

    ————————–

    The Court in Brown & Williamson invalidated a rule that would have, for the first time, asserted FDA jurisdiction over cigarettes and smokeless tobacco as customarily marketed. As plaintiffs do not dispute, the selling point of their product is precisely that it is “NOT a real cigarette, there is NO real smoke, flame, tar or tobacco.”

    The danger posed by the unrestricted distribution of unregulated products containing toxic chemicals cannot seriously be questioned. Even apart from the acute health risks that these products pose, there is no dispute that the nicotine is “a highly addictive pharmacological agent.”

    ————————–

    The response from the FDA argues that the injunction should be stayed because:
    1) Electronic cigarettes contain nicotine and are not tobacco cigarettes
    2) It can interpret the new Tobacco Act as it sees fit, i.e. include or exclude the electronic cigarette from this Act.
    3) Electronic cigarettes are marketed to kids and may pose danger

    Here is my response:
    1) Nicotine is not a substance only sold to treat nicotine addiction. Nicotine is regularly sold for recreational purposes in many forms, not just tobacco cigarettes.
    2) The FDA is bound by law, just as every citizen and company in the United States.
    3) There is no evidence that electronic cigarettes are marketed to minors or that they have, or will, harm anyone.

    So where are we at?

    THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA is reviewing the case, including the submitted responses and deciding if the FDA can continue to stop shipments of electronic cigarettes into the United States while the case is pending.

    It will be an outrage if the Appeals Court allows the FDA to try to end the lawsuit via financial sabotage. Money should not interpret the law…..judges should.

    Utah Takes Aims at the Electronic Cigarette

    The Utah State Legislature is considering two Bills both of which target the electronic cigarette. These Bills will not both be passed in their current form as they contradict each other, however if either gets passed they will effect adult access to electronic cigarettes in Utah.

    The first Bill, H.B. 88 – ELECTRONIC CIGARETTE RESTRICTIONS bans the sale of electronic cigarettes to minors. We agree with this portion of the legislation. However it goes on to ban the sale of electronic cigarettes that contain nicotine over the internet. The obvious assumption here is that it is easier for minors to purchase e-cigarettes on the internet. And although this may seem to be rational, consider this:

    1) Reputable online retailers of electronic cigarettes collect and store customer information including name, address, and date of birth.

    2) Reputable online retailers of electronic cigarettes make consumers take action to verify they are of legal smoking age.

    3) Reputable online retailers of electronic cigarettes almost exclusively take credit cards as payment and have the card information verified.

    4) Reputable online retailers of electronic cigarettes require a signature to accept delivery of sold products.

    5) Electronic cigarette kits have a much higher price tag than a pack of cigarettes. Minors are much more price sensitive as a general rule.

    Now consider this; for decades kids have found ways to get tobacco cigarettes. Stealing from parents, having an older friend buy them, having a fake ID, or not getting ID’d at all are pretty common ways for minors to get cigarettes. Compare this to stealing a credit card, having all the associated credit card information, falsely entering stored personal information onto a website, and taking and signing for a delivery without parents finding out. Which sounds more likely to happen?

    Limiting access for adult smokers to a non-combustible nicotine product does not protect kids.

    The second potential Bill, H.B. 71 – NICOTINE PRODUCT RESTRICTIONS bans all nicotine products in Utah that are not cigarettes, cigars, products that contain actual tobacco or nicotine products approved by the FDA. So, it bans the sale of electronic cigarettes and potentially other nicotine products that aren’t yet classified and don’t actually contain tobacco. The issue here is that there is currently a lawsuit pending against the FDA to determine the classification of the electronic cigarette. Once this is settled, it is likely the electronic cigarette will be included in sellable nicotine products in Utah. However until it is settled, Utah would be denying adult smokers access to electronic cigarettes, which have not been proven to cause any harm, while allowing the sale of tobacco cigarettes, which cause substantial harm to the user.

    We believe H.B. 71 is premature and encourage the Utah State Legislature to postpone any law banning the electronic cigarette until such time as it is categorized. Passing a law denying minors access to nicotine products is responsible. Passing a law denying adults smokers alternatives to their deadly tobacco cigarettes is counter productive to public health and common sense.

    We encourage all Utah residents who use an electronic cigarette, or believe in the freedom to choose an alternative to a known killer, contact their state representative and the Governor, Gary R. Herbert, to let them know that these two Bills are counterproductive to public health. Let them know about your experience with the electronic cigarette or how smoking tobacco has effected your family.

    CONTACT YOUR UTAH STATE REPRESENTATIVES or if that doesn’t work, try FINDING YOUR REPRESENTATIVE HERE

    CONTACT THE GOVERNOR OF UTAH

    We recommend an email and if possible a certified letter addressing your concerns over your State limiting your access to electronic cigarettes and other alternatives to tobacco cigarettes.

    UK Moves To Give Electronic Cigarettes to Pharmaceutical Industry

    The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has opened up the discussion about making all non tobacco nicotine products, including electronic cigarettes, a pharmaceutical. Specifically they are looking to make manufacturers of these nicotine products apply for a medicines Marketing Authorisation (MA) before marketing the products in the UK.

    Obtaining the Marketing Authorisation (US: Authorization) from the MHRA in the UK is “generally submitted by the pharmaceutical industry, but anyone with the necessary supporting data may apply for a licence.” according to the MHRA website. It goes on to state, “The life cycle of a new medicine begins with discovery and laboratory studies carried out by the pharmaceutical company.”

    It is pretty clear that forcing the electronic cigarette containing nicotine……who’s effects are well known, into this regulatory framework is no less than handing the pharmaceutical companies a new product to have a monopoly over. We at INSTEAD Electronic Cigarettes are against handing this industry over to the pharmaceutical industry.

    So why is pharmaceutical control over the electronic cigarette a bad thing? Here’s why:

    1) Giving any company or group of companies a monopoly is bad for the public. It means less options, higher cost to the consumer, and less recourse when consumer issues arise.

    2) Not allowing electronic cigarettes to fairly compete with tobacco cigarettes means more people smoking and less people vaping. As a pharmaceutical, the electronic cigarette could be prescription only and even more likely to only be sold in pharmacies while tobacco is sold in many high traffic areas.

    Even Philip Morris knows that making electronic cigarettes a pharmaceutical is good for them. They submitted “Philip Morris Limitied’s Response to the Department of Health’s Consultation on the Future of Tobacco Control” in September of 2008 and on page 46 they state, ‘…pharmaceutical regulation appears to be the only viable option for them [electronic cigarettes] today. The DH suggests, however, that such products would only be regulated as a medicinal product if sold with claims that the product “will help people quit smoking… However, if no such claims are made explicitly in the packaging or marketing, these products remain largely unregulated.” This is unacceptable.’ Of course this is unacceptable to the largest tobacco company in the world. Here is a product that directly competes with their product. Regulation is the best friend of big business….it keeps out competition. We should mention that PM also mentions the possibility of relaxing the pharmaceutical regulatory framework to accommodate tobacco harm reduction or create a new framework that encompasses both tobacco and reduced harm nicotine products. It’s too bad that they obviously didn’t push too hard for these ideas.

    3) Since the electronic cigarette would now be a medicine, it would need to treat something. This is against what we have found; smokers like smoking. They just want to do it, recreationally, with the least possible risk. Marketing the electronic cigarette as a way to “quit smoking” and possibly even placing a stop usage date on it would undermine it’s ability to move people who enjoy smoking over to vaping. Giving the impression that electronic cigarettes gets people off of nicotine is misleading and could result in smokers continuing to smoke rather than trying an alternative.

    So, if you live in the UK, what can you do? You can read about the proposed regulation here. You can submit your comments to the MHRA here.

    We recommend all e-smokers in the UK ask for either a separate regulatory framework for this unique product or the creation of a subcategory as a reduced harm tobacco product. The bottom line is that if tobacco cigarettes, which are known to be deadly, are allowed to be freely sold on the market, then so should smoking alternatives such as the electronic cigarette.

    Why Doesn’t The FDA Want The Electronic Cigarette As a Tobacco Product?

    Many users of electronic cigarettes, as well as suppliers and health advocates who support the technology, are scratching their heads about why the FDA is so determined to make the electronic cigarette a new drug and drug delivery device rather than attempting to regulate it as a tobacco product.  We too have pondered this question, so we did a bit of research.  Below is what we found and is our opinion, not necessarily fact.

    The FDA has regulations in place for new drugs and drug delivery devices.  They get paid to receive applications for each of these categories.  We noted this in our blog response to the American Legacy Foundation Panel on Electronic Cigarettes who didn’t seem to understand the costs associated with gaining FDA approval of a new drug and drug delivery device. The FDA fees associated with a new drug approval and the device approval fee would put many small e-cigarette suppliers out of business, while funneling a bunch of money from those who could afford it, to the FDA.  This also means that not only the e-liquid (or cartridges filled with e-liquid) would be generating revenue for the FDA, but the batteries, atomizers, and chargers would also have fees as medical devices.

    This isn’t to say that the FDA’s only goal is to make money.  We don’t believe that.  But since the FDA obviously believes that the product needs to be regulated (as do we), they appear to see it as “why not regulate it in a manner that produces the most money for us?”.  I make this speculation because if this were about public health, then they would not have so blatantly misled the public about the potential dangers of electronic cigarettes.

    So won’t regulating the electronic cigarette as a tobacco product generate funds for the FDA?  It appears very little.  In the recently passed Family Smoking Prevention and Tobacco Control Act it states:

    (A) In general.–The total user fees assessed and

                    collected under subsection (a) each fiscal year with
                    respect to each class of tobacco products shall be an
                    amount that is equal to the applicable percentage of
                    each class for the fiscal year multiplied by the amount
                    specified in paragraph (1) for the fiscal year.
                        ``(B) Applicable percentage.--
                              ``(i) In general.--For purposes of
                          subparagraph (A), the applicable percentage for a
                          fiscal year for each of the following classes of
                          tobacco products shall be determined in accordance
                          with clause (ii):
                                        ``(I) Cigarettes.
                                        ``(II) Cigars, including small
                                    cigars and cigars other than small
                                    cigars.
                                        ``(III) Snuff.
                                        ``(IV) Chewing tobacco.
                                        ``(V) Pipe tobacco.
                                        ``(VI) Roll-your-own tobacco.
                              ``(ii) Allocations.--The applicable percentage
                          of each class of tobacco product described in
                          clause (i) for a fiscal year shall be the
                          percentage determined under section 625(c) of
                          Public Law 108-357 for each such class of product
                          for such fiscal year.

    As you can see, there is no category for the electronic cigarette.  And even if they created a category for the electronic cigarette, we assume it would be at the end or near the end of the list.  When we look up Section 625(c) of Public Law 108-357, we find:

    SEC. 625
    (c) Assessments for Classes of Tobacco Products.--
                (1) Initial allocation.--The percentage of the total amount
            required by subsection (b) to be assessed against, and paid by,
            the manufacturers and importers of each class of tobacco product
            in fiscal year 2005 shall be as follows:
                        (A) For cigarette manufacturers and importers,
                    96.331 percent.
                        (B) For cigar manufacturers and importers, 2.783
                    percent.
                        (C) For snuff manufacturers and importers, 0.539
                    percent.
                        (D) For roll-your-own tobacco manufacturers and
                    importers, 0.171 percent.
                        (E) For chewing tobacco manufacturers and importers,
                    0.111 percent.
                        (F) For pipe tobacco manufacturers and importers,
                    0.066 percent.

    Of course placing the electronic cigarette cigarette into this FDA fee schedule is not that simple. First, it would need to be determined that the nicotine in the e-liquid is indeed a tobacco product. Even if it is a tobacco product, a 15 ml bottle of e-liquid of high (24mg/ml) can replace 300 tobacco cigarettes and would only contain 360 mg of actual “tobacco product”. A cigarette contains about 800 mg of tobacco. So, 300 cigarettes would contain 240,000 mg of tobacco product in comparison to 360 mg for the equivalent amount of e-liquid.

    On top of that, nowhere in the Family Smoking Prevention and Tobacco Control Act does it state that the FDA can regulate paraphernalia associated with the tobacco product. Assuming the batteries, atomizers, and chargers for electronic cigarettes fall under this new Tobacco Bill would also be asserting that all rolling paper, pipes, and tobacco vaporizers also fall under this Bill. And let’s not forget that e-liquid can be used with no nicotine at all. No nicotine means no tobacco product.

    So, that is our speculation about why the FDA continues to assert that the electronic cigarette is a new drug and drug delivery device, even after a Federal Judge indicated that the FDA should be regulating the electronic cigarette as a tobacco product.

    What does Judge Leon’s Ruling Against The FDA Mean For Electronic Cigarettes?

    Many in the electronic cigarette industry believe that Judge Leon’s ruling against the FDA is the final word in the battle over the future of electronic cigarettes. That is not the case. It was, however, a legal opinion about the potential outcome of a trial regarding the classification of the electronic cigarette. Judge Leon gave opinions on the 3 arguments that the FDA was making to show electronic cigarettes are a drug delivery device and that they have a legal right to stop the importation.

    Structure Or Function Claims

    The FDA argues that electronic cigarettes contain nicotine, a drug, and it effects the way the body works so it is a new drug.

    Judge Leon answered this argument by stating, “Because plaintiffs sell their electronic cigarette products for customary recreational use, those products (just like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.”

    The argument that the FDA is making here is the same one they made when they tried to classify tobacco cigarettes as a new drug. That didn’t work either.

    Therapeutic Claims

    The FDA argued that the sellers were making therapeutic claims, thereby making the electronic cigarette a new drug.

    By definition, a new drug must be “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

    Judge Leon’s opinion was, “there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette.”

    He also stated, “Nor does the fact that plaintiffs advertise their products as a healthier alternative to traditional smoking mean that electronic cigarettes quality as a drug-device combination under the FDCA.”

    So, making health claims does not make a product a new drug. However, he did mention that making quit smoking claims or nicotine treatment claims DOES make the electronic cigarette a new drug. In this case, there was no evidence either company was making such claims.

    Harm To Third Parties And The Public Interest

    Lastly, the FDA argued that stopping the importation of electronic cigarettes was for public health. A sad argument at best considering that electronic cigarettes are the alternative to a product that kills over 400,000 Americans each year.

    Judge Leon found that “Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.”

    Conclusion

    Judge Leon found that this was “yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA”.

    So what does this mean?

    It means that the FDA can not legally stop the importation of electronic cigarettes by Smoking Everywhere or NJoy. It means Judge Leon believes that if this goes to trial, the e-cigarette suppliers will win. It means that Judge Leon believes the electronic cigarette is a reduced harm tobacco product, as outlined in the Tobacco Bill.

    Our Conclusion

    The FDA can continue to stop other companies shipments, but leave themselves open to future lawsuits. Without specific therapeutic claims (i.e. quit smoking and treating nicotine withdrawal claims), they have no basis to stop the products until such time as they do prove it is indeed a new drug or the electronic cigarette is legally classified as a tobacco product as Judge Leon suggests. What is interesting is that Judge Leon made no mention of the distinction between the zero nicotine e-liquid and that which contains nicotine. Without nicotine, the e-liquid contains no part of tobacco. And the batteries, chargers, atomizers, and cartridges contain no part of tobacco. So it appears that the only thing that could possibly be included in the definition of a “tobacco product” is e-liquid that contains nicotine. And this has not been settled either.

    New Invention of 1963: The Smokeless Non-Tobacco Cigarette

    Many people wonder about who actually invented the electronic cigarette. Most don’t know, while others would claim it is Hon Lik from China. But in 1963, Herbert A. Gilbert filed his patent on a smokeless non-tobacco cigarette. Two years later his patent was accepted. The whole patent issue becomes somewhat complicated when you consider new technology and different designs, but what is clear is that 46 years ago Herbert submitted the idea of a smokeless cigarette to the United States Patent Office. Here is an excerpt:

    “The present invention relates to a smokeless non-tobacco cigarette and has for an object to provide a safe and harmless means for and method of smoking by replacing burning tobacco and paper with heated, moist, flavored air; or by inhaling warm medication into the lungs in case of a respiratory ailment under direction of a physician.”

    Herbert….I’m telling the FDA you said that.

    View the PDF of Herbert’s Smokeless Non-Tobacco Cigarette

    Does this look familiar?

    New Smokeless Non-Tobacco Cigarette

    Herbert A. Gilbert even got a plug the December 1965 issue of Popular Mechanics for his new smokeless non-tobacco cigarette invention:

    Smokeless Non Tobacco Cigarette in Popular Mechanics

    46 years later we now have the INSTEAD Electronic Cigarette ;)

    Smoking Bans – Are they backwards?

    Smoking bans have been popping up across the United States for over a decade now. There is evidence on both sides regarding the harmful affects of second hand smoke. Some studies show that second hand smoke is detrimental to those around the smoker and some studies have shown that with proper air ventilation, second hand smoke is not an issue.

    Smoking bans also present a great problem to the free market where these bans are literally dictating what a business owner can and cannot do in their own private business. These bans are beginning to filtrate into private homes and cars.

    Smoking is an adult behavior. Just as drinking alcohol and engaging in sexual activity are considered adult behaviors. But as we have learned over the years, shielding children from being educated in making responsible choices once they become adults, only causes children to make irresponsible choices while they are children.

    So what do smoking bans really accomplish? Do they really accomplish a greater sense of public health? Do they create a distaste for “big government”? Are smoking bans backwards?

    Let’s look at the history of smoking bans, in a nutshell of course. At first, anti-smoking advocates were against smoking inside because of the compact conditions and poor air movement quality. Their concern was that non-smoking workers and patrons could not get away from second hand smoke as it does have a tendency to “sit” in the air. The argument was that workers do not have a choice of where they work so they need to be protected. So they fought to have all smoking pushed outside.

    It is here that the private business owners began to feel an infringement upon their rights. The local government is now telling them that they can’t allow the use of a legal product in their privately owned, adult only business.

    Smoking then went outside. And business owners reluctantly complied, setting up smoking areas for their patrons, outside and at their own expense.

    Then, a few years later, these same advocates were tired of having to walk through the smoke to get into non-smoking establishments so they decided to go after smoking outside. Now, not only are private business owners lacking in their rights, but smokers were also being told that as a smoker, somehow their rights are not equal to those who are non-smokers.

    Now, for the non-smoking advocate who may be reading this, please don’t get upset. We definitely see your side of this. Why should someone who has no desire to be engulfed in cigarette smoke have to put up with cigarette smoke? Why should parents have to run quickly through clouds of smoke with their children in order to get past the front doors of one establishment? And for those who have quit smoking and struggle every day to stay on the wagon, why would one want to be subjected to such temptation? Recovering alcoholics are lucky because if they don’t want to go into a bar, they simply don’t have to.

    But what would have happened if the anti-smoking advocates had done the exact opposite? What would have happened if their original smoking bans were to restrict all smoking on public streets and only to allow smoking in private businesses that had proper ventilation systems and were physically marked on the entrance that this is a “smoking establishment”? Would we be having the heated debates today that we are? As for the workers in such an establishment; in America they have the right to choose where they work.

    One of the arguments busting this “it’s for public health” stance is the electronic cigarette. The electronic cigarette does not use combustion so therefor, does not produce second hand smoke. It produces a vapor which is similar to fog machines that even Disney parades pump into the faces of children, infants and unsuspecting adults, in mass quantities, day after day. All current testing of propylene glycol vapors, which the majority of electronic cigarette vapor is comprised of, actually suggests that these vapors are harmless. Testing done by Dr. Murray Laugensen from Health New Zealand on the e-cigarette found, “Inhaled nicotine in cigarette smoke is over 98% absorbed, and so the exhaled mist of the e-cigarette is composed of propylene glycol, and probably contains almost no nicotine; and no CO.” So why on Earth would these be included in smoking bans?

    There is no evidence to date that the second hand vapor of the electronic cigarette can even be compared to the second hand smoke of a tobacco cigarette. Studies have been done since the 1940’s on propylene glycol vapors and even the EPA suggests that propylene glycol is inert with no carcinogen levels upon inhalation, hence it’s use in hospital air sanitizing systems.

    The electronic cigarette is being including in smoking bans because the anti-smoking groups have decided that this isn’t about second hand smoke anymore. It is clear from the lack of research as presented on many of their websites, that they haven’t done any scientific research into the electronic cigarette and many do not even appear to have an understanding for the difference between combustion and vaporization. On one site, which we will leave as nameless for now, they state that cigarettes contain 4000 ingredients. No. Tobacco cigarettes do not contain 4000 ingredients. Tobacco cigarettes that are UNLIT contain 599 ingredients according to the CDC and the SMOKE from a tobacco cigarette contains 4000+ ingredients. There is a BIG difference between a lit cigarette and one that is sitting on a table, unlit.

    There is also a big difference between vaporization and combustion. Did you know that if you burn incense in your home every day for 20 years, you are being subjected to many of the carcinogens and by products of a burning cigarette? It’s because COMBUSTION produces these harmful by-products which include some of the worst ingredients including carbon monoxide, arsenic, formaldehyde, and so on. VAPORIZATION from the electronic cigarette is not capable of making these types of by-products due to the low rate at which they heat… not burn.

    The only reason to include the electronic cigarette in local smoking ordinances is because those against the electronic cigarettes usage in public are against nicotine or against the action of smoking. Both the use of nicotine AND the action of smoking are LEGAL. It’s the by-products of combustion created by a burning tobacco cigarette that should be cause for concern in regards to public health, not the action of smoking nor the intake of nicotine.

    For those who are against the use of nicotine and wish to see nicotine prohibition, well, then stop forcing unsuspecting smokers to use the patch, the gum, and the nicotine inhaler and state your position for what it is; a complete banning of the substance.

    For those against the action of “smoking”, be careful. Attempting to ban an action is a slippery slope.

    And for those who are in this for public health, consider reversing the bans so that smoking occurs in places where adult activities take place. All places should be required to have proper ventilation and the technology is there. All workers should be required to acknowledge they understand they are working in a smoking environment. All establishments should clearly mark on their entrance that smoking is allowed. This reduces the amount of cigarette butts on the street, reduces non-smokers from having interaction with cigarette smoke, and the private business owners are able to continue offering the type of establishment the free market dictates. THIS is a win win smoking ban for all.