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.

“They are as effective at nicotine delivery as puffing on an unlit cigarette,” said Dr. Thomas Eissenberg, from the Virginia Commonwelth University’s Institute for Drug and Alcohol Studies.

This quote was from a CNN article titled “Study: ‘Electronic cigarettes’ don’t deliver”. This article was apparently released before the actual study was released.

When available, we recommend all e-smokers and those with a vested interested in electronic cigarettes and public health, read The Study of Electronic Cigarettes by Dr. Thomas Eissenberg from the Virginia Commonwealth University.
UPDATE: Due to potential copyright issues, the link to this study has been removed

According to Dr. Eissenberg’s graphs:

UPDATE: Graph removed due to potential copyight issues

The study subjects were not getting much nicotine in their systems, but their cravings for a cigarette were decreased as compared to the “Sham”…..even if it wasn’t significantly.

Please note that they used 16 mg/ml e-liquid in the cartridges and the participants were instructed to take 10 puffs from the chosen e-cigarette with 30 seconds between each puff. Individual usage would likely change the results of not only the nicotine content, but presumably of the craving for a cigarette. As the study itself notes, “Variability in product design may influence vapour content and chronic use and/or more intensive puffing (ie, more puffs, greater puff volume) may influence nicotine delivery.”

Based on this study, there appears to be very little danger from nicotine in electronic cigarette vapor. It also appears that the electronic cigarette may not be a suitable quit smoking device.

Good thing the Instead Electronic Cigarette is a smoking alternative. Read, enjoy, and decide for yourself if you want to keep smoking tobacco cigarettes or try an electronic cigarette.

* Clinical information about this study, named “Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers” can be found at ClinicalTrials.gov.
* This Study on Electronic Cigarettes was published in Tobacco Control, February 2010 Vol 19 No 1

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.

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.

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.

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.

Many companies who sell electronic cigarettes claim that using an e-cigarette allows you to smoke everywhere and anywhere, specifically where smoking is banned. So is this true?

In principle this is true as electronic cigarettes don’t produce smoke….they produce vapor. So unless your state or local government has created a law specifically banning the use of an electronic cigarette in non smoking areas, then legally you should be able to use it. However in practice this may not be the case.

Bar and restaurant owners have the right to ask it’s patrons to not use their electronic cigarette within their building. And the vast majority of these business owners don’t have any idea what an electronic cigarette is or what it is that you are blowing out. The knee jerk reaction is that it is smoking and thus must create the same issues that tobacco smoke creates such as the smell, the haze, and the negative health effects on those in the building.

To avoid conflict with the establishment owner, management and others within the non smoking area, I recommend being open with those in charge. This means before attempting to use your electronic cigarette in a no smoking bar or restaurant, talk to the owner or manager. Explain to them what an electronic cigarette is, how it works, and specifically what is in the vapor (propylene glycol, glycerin, water and trace amounts of nicotine….if you use the e-liquid with nicotine). Compare it to a fog machine, which also uses propylene glycol or glycerin to create visible vapor. Let them know how it is not combustion and doesn’t produce the same toxins found in tobacco smoke. Let them know how it is your preferred alternative over tobacco cigarettes.

This may or may not appease management and they may or may not allow you to e-smoke in their bar or restaurant. No matter the outcome, at least you have educated one more person about the technology.

The other option over blatantly using your e-cigarette in a no smoking area is to use it without others viewing you doing so. Hide your electronic cigarette in your hand. Blow the vapor down your shirt. Use it sparingly when you can do so without an audience. E-Smoking in this manner does run risk of someone seeing you, thinking it’s smoking, and getting kicked out of the establishment, but it is still less risky than blowing a plume of vapor into the air of a non smoking room.

If you have been in a bar or restaurant that openly allows the use of an electronic cigarette, we recommend you visit the Electronic Cigarette Directory and add their business listing. Doing so helps support businesses who embrace the e-cigarette and allows fellow e-smokers to find electronic cigarette friendly bars and restaurants!

Every now and then we get a call or an email from a smoker or e-smoker looking for a local retail store that sells electronic cigarettes. Sometimes this is due to limited time (i.e. they ran out of e-liquid yesterday) and other times it is simply because that particular consumer is not comfortable buying anything over the internet.

We believe in the technology and it’s ability to help smokers find a suitable alternative. So, for all those who are looking for a local shop that sells electronic cigarettes, we recommend the E-Cigarette Directory.

The E-Cigarette Directory not only has listings for local e-cigarette retailers, but also has listings for online e-cigarette suppliers, electronic cigarette manufacturers, bars and restaurants that allow the usage of e-cigarettes, and even groups and communities in support of electronic cigarettes.

The E-Cigarette Directory is a great resource for all those who use electronic cigarettes, make or sell electronic cigarettes, and those just curious about the technology in general.

Below is an incomplete list of electronic cigarette reviews by our customers, but some of our favorites:

The testing on the American made Instead brand e-liquid is complete.  The testing was done by Alliance Technologies and performed on both the liquid and the vapor.  Below is a summary chart of the findings:

The testing shows no detection of either Diethylene Glycol or Ethylene Glycol.  Diethylene Glycol or DEG was the compound the FDA detected in 1 sample from 1 company.  Dietheylene Glycol is toxic and is a solvent as well as sometimes used in antifreeze, among other things.  Ethylene Glycol is even more toxic and is a common ingredient in antifreeze.  Propylene Glycol has a very low toxicity and is generally recognized as safe (GRAS) by the FDA for use in food.  The EPA stated “the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol.”  Glycerin is used in medicine and food.

To download and view the complete report, visit Lab Test on Instead American Made E-Liquid