The intended use of a product is important not only from the perspective of categorization by the FDA but also to ensure the consumer is not misled by advertising. The FDA has been arguing that the intended use of the electronic cigarette is, or should be, to help people quit smoking. We do not believe this to be the case. We believe that this is another way to intake nicotine and participate in the action of smoking, without actually burning tobacco.

Many consumers who signed the electronic cigarette petition have stated that they have quit smoking with the electronic cigarette. However, these same consumers don’t state they have quit using nicotine, just that they have quit smoking. Smoking is not a disease according to the CDC, but nicotine addiction is, and there is no proof that electronic cigarettes help treat nicotine addiction. There is also no evidence that these consumers will not go back to smoking tobacco cigarettes.

It is a disservice to consumers to lead them to believe the electronic cigarette is a quit smoking product. There is no evidence as such. It continues the habit and the addiction to nicotine.

The intended use of the Instead Electronic Cigarette is to use it for the action of smoking. If you like to smoke, you may like the electronic cigarette. If you want to quit smoking, we recommend you go cold turkey or use a product that has been proven to help smokers quit.

August 29, 2009
Lawrence Deyton, MD
Incoming Director
FDA Center for Tobacco Products
Re: Don’t Write Off Current Smokers

Dear Dr. Deyton:
For the past half century, the American Association of Public Health Physicians (AAPHP) has served as the national voice of physician directors of state and local health departments and other like-minded physicians. We have long been involved with tobacco control, with the singular goal of doing everything in our power to reduce tobacco related illness and death.

As you assume leadership of the new FDA Center for Tobacco Products, we urge you to consider the actions FDA can take, within the powers granted by this new legislation, to rapidly and substantially reduce tobacco related illness and death in current adult smokers.

Unfortunately, FDA has not gotten off to a good start. FDA condemnation of electronic cigarettes, in its July 22 press conference, and FDA insistence that electronic cigarettes should be regulated as a drug/device combination rather than as a tobacco product makes no sense from a public health perspective. It flies in the face of FDA laboratory findings on other products already approved by FDA. If one looks at electronic cigarettes as a sentinel for all tobacco products less hazardous than conventional cigarettes – the outlook for FDA action reducing tobacco-related illness and death among current adult smokers is dismal.

With this in mind, we respectfully request your consideration of the following actions:

1. We urge FDA to make public the laboratory data behind the July 22 condemnation of electronic cigarettes, along with comparable data on pharmaceutical nicotine products and conventional cigarettes. Then, on the basis of these data, either fully justify or retract the July 22 condemnation of electronic cigarettes.

2. We urge FDA to reclassify electronic cigarettes from a drug/device combination to a tobacco product. This will enable FDA to immediately regulate manufacturing and impose marketing restrictions during this initial period of FDA Tobacco Center development. This reclassification will eliminate pressure on the several hundred thousand current American users of electronic cigarettes to switch back to the much more hazardous conventional cigarettes.

This year, about 400,000 American adult cigarette smokers will die of a tobacco-related illness. Their second hand smoke will kill about 48,000 non-smokers. About 700 more will die in residential fires. Despite progress on other measures of tobacco use, per CDC estimates, this death count continues to inch up from year to year. In contrast, even though smokeless tobacco products represent about 20% of nicotine intake in the United States, the number of deaths per year from these products is too small for reliable estimates from the CDC.

Our (AAPHP) best estimate is that smokeless tobacco products currently cause about 700 cancer deaths per year in the United States. This is less than 1% of the more than 110,000 deaths that would occur each year if smokeless products carried the same mortality as conventional cigarettes.

This last week, Boffetta and Straif published a paper alleging evidence of an increased risk of fatal heart disease and stroke among smokeless tobacco users. This is a study sure to be referenced by those seeking evidence of the harmfulness of smokeless tobacco products. Unfortunately, this study suffers from major technical and ethical flaws, including failure to note in the abstract that they found no increased risk of non-fatal heart attack or stroke. Even worse, of the many studies reviewed, only two showed evidence of even a slight increase in risk of death – and these were the ones selected for the conclusion and abstract. That having been said, their allegations of a 13% increase in risk of fatal heart attack and 40% increase in risk of fatal stroke pale in comparison with the 180% to 300% increases in risk for men and women 35-64 years of age posed by smoking conventional cigarettes.

Contrary to prevailing conventional wisdom, virtually all the heart and lung disease from conventional cigarettes, and an estimated 98% of the cancer mortality, are due to direct inhalation of fresh products of combustion deep into the lung. Our best estimate (based on the work of Pankow et al and others) is that only about 2% of the cancer mortality from cigarettes is from the named carcinogens commonly found in tobacco products. Smokeless tobacco products carry little or no risk of heart disease and no risk of lung disease. They do not kill innocent bystanders and they do not burn down houses. The risk of cancer of any kind from smokeless products ranges from a high of about 5% of the risk of cancer posed by conventional cigarettes to a low well under 1% of the risk of cancer posed by conventional cigarettes. While definitive studies have not been done, we have reason to believe that tobacco products, such as electronic cigarettes, consisting of nicotine extracted from tobacco with only trace amounts of other chemical substances, should carry even less risk.

Most of the discussion to date around the new FDA/Tobacco bill has focused on reducing initiation of nicotine use by children and teens. The only discussion of current smokers has been limited to encouraging use of pharmaceutical products to aid cessation. This has been touted as doubling quit rates – but without mentioning that this doubling is from about 3% to about 5% per year. In other words, this option fails 95% of smokers willing to try it, even under study conditions with optimal counseling.

It should be possible to save the lives of 4 million or more of the 8 million adult American smokers who will otherwise die of a cigarette-related illness over the next twenty years. This could be done by making smokers aware of selected smokeless tobacco products (including but not limited to snus and electronic cigarettes) that promise to reduce the risk of tobacco-related illness by 99% or better for smokers who are unwilling or unable to quit. Rather than discouraging nicotine cessation, however, such an approach, even with no medical intervention, would be expected to triple the rate at which current smokers eventually discontinue their nicotine use.

Those writing the new FDA legislation endorsed a harm reduction component to current tobacco control programming, but in a most peculiar way. The law encourages cigarette manufacturers to develop “reduced exposure“ products and market them with no scientific proof that such reductions in exposure will reduce risk. The law then requires presumably new “scientific evidence” for smokeless products, already known to be of substantially lower risk. This makes no sense. The law encourages a harm reduction component to current tobacco control programming that might reduce tobacco-related cancer mortality by one or two percent; while actively discouraging switching to lower risk tobacco products that promise to lower total tobacco-related illness and death by 99% or better.

The secret to success, as we see it, will be to add an effective harm reduction component to current tobacco control programming while using the tools made available by this new law to prevent this new harm reduction
initiative from increasing the numbers of children and teens who initiate tobacco use.

Reconsidering the FDA stance on electronic cigarettes would be the most logical first step.

We look forward to working with FDA to use the powers granted by this new legislation to rapidly and substantially reduce tobacco-related illness and death, among both current and potential future tobacco users.

References:
The data on smoking attributable deaths on page 2 of this letter are from the Centers for Disease Control MMWR report of November 14, 2008. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5745a3.htm

The estimate that 20% of current nicotine consumption in the United States is from smokeless tobacco was generated by Mr. William Godshall, based on the formula utilized by Fagerstrom et al, when estimating 2002 nicotine consumption by type of tobacco product in multiple countries.

The discussion on risk of heart disease and stroke from smokeless tobacco products is from Paolo Boffetta and Kurt Straif : Use of smokeless tobacco and risk of myocardial infarction and stroke: systematic review with meta-analysis. Published August 18, 2009. BMJ 2009; 339: b3060 [Abstract] [Full text]

The data on relative risk of fatal heart attack and stroke from smoking, in men and women 35-64 years of age, are data from the American Cancer Society as quoted in “Changes in cigarette-related disease risks and their implication for prevention and control.” Smoking and Tobacco Control Monograph 8. Bethesda, MD: US Department of Health and Human Services,
Public Health Service, National Institutes of Health, National Cancer Institute 1997;305-382. NIH Publication no. 97-1213.

The other references to the scientific literature that back-up the points made in this letter can be found on the Tobacco Issues page at the http://www.aaphp.org web site. There is an October 2008 “Resolution and White Paper on Tobacco Harm Reduction.” This paper, on pages 6 and 13, includes then-current CDC and AAPHP mortality projections. “The Myth of the Safe Cigarette,” is based on the paper by Pankow et al (http://cebp.aacrjournals.org/cgi/reprint/16/3/584 ) and others. It makes the case that conventional cigarettes cannot be made measurably safer. The exchange of correspondence with Zhu et al, from a paper published earlier this year, deals with the difference in quit rates, comparing conventional cigarettes to smokeless tobacco products.

Yours,
Joel L. Nitzkin, MD, MPH, DPA
Chair, AAPHP Tobacco Control Task Force
jln@jln-md.com
504 899 7893
Kevin Sherin, MD, MPH, FACPM, FAAFP
President, American Association of Public Health Physicians
ksherin@yahoo.com

Conflict of Interest Disclaimer: Neither of us, nor the American Association of Public Health Physicians, has received or anticipates receipt of any financial support from any tobacco product manufacturer or vendor, or any pharmaceutical firm making nicotine replacement products.

Visit American Association of Public Health Physicians writes on behalf of Electronic Cigarettes to the Incoming Director of the FDA to download the PDF version of the letter.

As noted in a previous about how the new tobacco legislation effects the electronic cigarette, we noted that in order for a product to be a drug it must be “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals”. And in order to be a new drug….it must be a drug.

So I contacted the Centers for Disease Control and Prevention (CDC) and asked if smoking was considered a disease. At first they just sent me all the statistics about how many people smoking kills. Then they got mad I kept asking. Then I eventually received this response:

“When reviewing responses related to tobacco use that were provided by CDC-INFO, we noticed your question asking if smoking is considered a disease. As noted by CDC-INFO, smoking is a primary risk factor for many diseases. Addiction to drugs, is viewed as a brain disease by the
National Institute on Drug Abuse (NIDA). For information about nicotine addiction, please visit NIDA’s Web site at
http://www.drugabuse.gov/ResearchReports/Nicotine/Nicotine.html and
http://www.drugabuse.gov/Infofacts/understand.html”

So, according to the CDC, smoking is not a disease, but rather it may put the user at risk of getting an actual disease. Apparently they believe that NIDA is correct and being addicted to nicotine is a disease. Thus, the electronic cigarette [e-liquid] as a new drug is one that is intended to diagnosis, cure, mitigate, treat, or prevent the addiction to nicotine. Curing nicotine addiction would involve not using nicotine anymore.

UPDATE: I recently found where Norman Edelman, M.D., Chief Medical Officer for the American Lung Association stated, “Smoking is widely recognized as a disease of nicotine addiction,”

This is why Snus or dissolvables are not Nicotine Replacement Therapy (NRT) products. They are not marketed as a way to quit smoking (quit using nicotine). They are marketed to be used indefinitely, i.e. to continue using nicotine.

The nicotine patch or gum is meant to ween the user off of nicotine until they no longer use it….thus curing them. There IS a stop usage date on NRT products.

Selling a consumer an electronic cigarette as a quit smoking device would mean it necessary to instruct the consumer to eventually move to zero nicotine e-liquid and/or to ultimately quit vaping altogether.

For those who think that the mere fact that there is a zero nicotine e-liquid available means it treats nicotine addiction; please note that there is zero nicotine Snus and even a zero nicotine patch that is apparently not an NRT, but yet does claim to help users quit smoking (quit using nicotine). Of course no drug, means no “new drug”, which means it isn’t a NRT.

If there is no stop usage date, then how can an electronic cigarette cure nicotine addiction? And how can continuing the action that got the user addicted to nicotine in the first place help cure their addiction? If smoking / vaping / using an electronic cigarette with zero nicotine is the cure, then so is smoking a zero nicotine tobacco cigarette. Oddly enough, these nicotine free cigarettes do claim to help the user quit smoking, but still they are not an NRT.

So we have products that contain nicotine, have no stop usage date, and make no quit smoking claims that are not NRTs (dissolvables, Snus)
We have products that contain no nicotine or any drugs, that do make quit smoking claims and they are not NRTs (zero nicotine patch, nicotine free cigarettes)
We have products that contain nicotine (or other drugs), have a stop usage date, and claim to help users quit smoking. These are NRTs (gum, patch, pills)

Which of these is most suitable for the electronic cigarette? To be classified as a new drug under the classification of a NRT, the product must 1) contain a drug and 2) have a stop using nicotine date or imply one with the claim of quitting smoking. Also, the American Lung Association states, “To be most effective, nicotine replacement products should be used in conjunction with a behavior change program.” (Update: we now link to the Archive.org page of the American Lung Association as it appears they recently took down this page) It is pretty obvious that electronic smoking is a continuation of the action of smoking, thus making it a rather ineffective NRT at best.

Most reputable e-cigarette suppliers don’t claim it helps anyone quit smoking and there is no proof that it does. I have yet to see any manufacturer or supplier recommending a stop usage date. It can come with nicotine or not.

So an e-cigarette that contains no nicotine (or any other drug) and makes no quit smoking claims should be labeled (and regulated) as an NRT? If so it would be the only product of it’s kind.

And with nicotine e-liquid and no stop usage date, we have a product that perpetuates nicotine addiction, not cures it. The upside? Nicotine alone kills very, very, very few people (if any) but inhaling burning tobacco kills hundreds of thousands.

The e-cigarette or electronic cigarette mimics smoking using vapor. It can contain tobacco products, but doesn’t necessarily need to. Some believe it helps people quit smoking, while others (such as Instead) believes it is not a quit smoking product. So where does it fit in? A tobacco product needs to contain tobacco. A new drug needs to cure, treat, diagnose, or mitigate a disease or condition.

There is no clear answer. But, when we look past the question of regulation, taxation, and ultimate control here is what we find:

A product that a decent percentage of smokers find to be a reasonable alternative to burning tobacco. Inhaling burning tobacco is known to cause cancer and a multitude of other problems for the user and potential for those near the user. Inhaling vapor from an e-cigarette has not been shown to cause issues for the user or by-standers. There may be unforeseen issues of inhaling propylene glycol or glycerin vapor in the long term, but there is no way to tell without decades of testing. In the mean time, inhaling burning tobacco would continue to kill. It is hard to believe that inhaling propylene glycol for 20 years would be worse than inhaling all the dangerous chemicals found in tobacco smoke for 20 years. Even if the FDA was correct and the vapor contained traces of TSNAs (which it didn’t…..it found those in the liquid), tobacco smoke contains these TSNAs in much, much higher levels.

So who should regulate it? The FDA thinks they should as an NRT (Nicotine Replacement Therapy). The issue is this; as an NRT it would need to be pulled from the market and submitted by a pharmaceutical company as a quit smoking product. The cost is in the tens of millions and the testing can go on for years. Even after it is approved, it can then only be sold in pharmacies either with or without a prescription. This is all assuming a pharmacy even sees the potential and submits the application. In the meantime, people keep burning tobacco at their regular rate and dieing.

If we skip into the future and do find electronic cigarettes sold in pharmacies, we will find tobacco cigarettes being sold in gas stations. We will likely find electronic cigarettes have now become more expensive than tobacco cigarettes (the pharmaceutical company would need to make back their tens of millions). We find at least some smokers disappointed that they didn’t quit using the e-cigarette as the package so boldly claims.

Now lets look at an alternative future, one where regulation has come in a different form such as via the tobacco bill or via the industry itself or via a newly created category. The product is sold in gas stations beside tobacco cigarettes. Companies compete to reduce their prices while consumers continue to demand innovation, safety, and function. There is competition. It is marketed as another way to smoke. Smokers freely use the e-cigarette instead of their tobacco cigarettes, whether completely or sporadically.

Which scenario is in the best interest of the smoker and of by-standers?

Electronic cigarettes are not safe. They are not healthy. But inhaling burning tobacco is known to carry a high risk of cancer.

It has been a busy few months! Our fight to keep the electronic cigarette from being seen as a quit smoking device by the FDA and anti-smoking groups continues. We have also been working hard to ensure that our supply of American Made E-Liquid is solid so we can provide our customers with better pricing!

Please note that while we may have been able to reduce our pricing on American Made E-Liquid and our Unique Stash Tin Electronic Cigarette Kits, this does not mean that we have cut back on our wonderful customer service! INSTEAD Electronic Cigarettes continues to grow by leaps and bounds as a company and hopes that our continued support of the industry will help the industry achieve it’s rightful place in the United States free market system.

Also, don’t forget to take a look at one of our newest products, the portable USB electronic cigarette battery charger. This charger can not only recharge your ecig batteries up to 18 times on the go, but it can also charge your iPhone. A must have for anyone who has portable USB devices.

Smokers have a choice! And that choice includes the Electronic Cigarette!

So what is the big deal over electronic cigarettes? Why would any public health organization or quit smoking group be against a product that doesn’t produce smoke? Why would the FDA be so determined to undermine the electronic cigarette’s current success by misleading the public with false conclusions from it’s testing?

It all started when smoking was found to kill people. Then, the pharmaceutical companies found there was money to be made by selling smokers nicotine in hopes to get them off of smoking. These companies were required to get approval from the FDA to market their quit smoking products. Approval means huge sums of money paid to the FDA.

Many public health organizations and quit smoking groups get at least some of their money from pharmaceutical companies. Whether this was the driving factor or it was their hope of less people dieing from smoking, these crusaders against smoking got motivated. Not only did they recommend smokers quit smoking (often by using a pharmaceutical product) they demonized smokers. They did a good job. There is little tolerance in America today for a smoker.

Enter the electronic cigarette. This simple little device threatens to turn the tables of years of hate speech. It is much harder to hate an action of someone else if that actions hurts only the user…..or nobody at all. Some still will, but the ads against e-smoking won’t have the same impact as those against tobacco smoking.

Left unchecked, the electronic cigarette could put a dent in the tobacco market, a dent in the pharmaceutical nicotine market, and give pause to those who feel hate towards smokers. It is obvious the pharmaceutical companies, the tobacco companies, the public health organizations, and the FDA would rather avoid some, if not all, of these outcomes.

This is about a habit and it’s social acceptance. Certain groups want to maintain the status quo. We want a practical alternative to the issue of smoking, which will continue in one form or another for the foreseeable future.

The current litigation between two electronic cigarette suppliers and the FDA has everyone in a tailspin. It certainly did not help that the FDA openly misled the public into believing that the electronic cigarette is as (or more) dangerous than tobacco cigarettes. Many medical health professionals have weighed in on this noting the following:

* Dr. Elizabeth Whelan, president of the American Council on Science and Health, called the FDA statement “distorted, incomplete, and misleading. She also noted that “products of combustion cause cancers, cardiovascular disease and lung disease, and more.”

* Dr. Joel Nitzkin, MD, MPH, DPA, FACPM, Chair, Tobacco Control Task Force, American Association of Public Health Physicians stated that “We have every reason to believe the hazard posed by electronic cigarettes would be much lower than 1% of that posed by (tobacco) cigarettes. The testing guidelines in the current tobacco act (circulating through Congress) would represent a ban on electronic cigarettes, (yet) if we get all tobacco smokers to switch from regular cigarettes (to electronic cigarettes), we would eventually reduce the US death toll from more than 400,000 a year to less than 4,000, maybe as low as 400.”

* Michael Siegel, a physician, researcher and professor at the Boston University School of Public Health noted that “What the FDA and anti-smoking groups are doing is committing medical malpractice on a massive scale: on a population basis. They are essentially condemning 100,000-plus consumers to a return to the most deadly known consumer product. So many of these individuals have reported a tremendous improvement in their health since switching to electronic cigarettes.”

Just for the record, all of the above public health officials are anti-smoking advocates.

The FDA and many anti-smoking groups are calling for the electronic cigarette to be pulled from the market on the basis that it is not a proven quit smoking device. The Electronic Cigarette Association (ECA) President Matt Salmon, former US Congressman from Arizona, noted in a letter to Congress that the ECA “acknowledges the health risks of cigarette smoking and advocates that smokers quit. But we also recognize the struggles that many have in quitting and who are looking for a more convenient and better alternative to tobacco cigarettes. While some of our customers have reported using our devices to help them quit smoking by slowing reducing the nicotine delivery in our products, it is important to note that our member companies do not market their e-cigarettes as smoking cessation products nor make any such claims.”

What is most important is the idea of claims. The FDA was formally named in 1930, and the “FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.” The original act had huge issues mainly that “False therapeutic claims for patent medicines were basically unregulated, as the manufacturer had only to show that he personally believed that his remedy worked to avoid prosecution, and standards for food purity and content were nonexistent.”

In 1938, after the 1937 Elixir Sulfanilamide Incident, where the SE Massengil Company created an elixir containing diethylene glycol as the base ingredient was given to children with strep which led to painful deaths, the Federal Food, Drug and Cosmetic Act was put into place. Following, came several examples of “incidents” and “near incidents” that lead for further revision of the Act.

But the question that lies at the heart of this debate is the electronic cigarette liquid really a “new drug” and is the electronic cigarette hardware really a “medical device”? According to the FDA’s definition of “new drug”, they state that the definition of a drug includes “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” To put this into comparison with other products on the market that do not require FDA approval, let us look at dietary supplements.

Currently, the FDA does not regulate dietary supplements. Those products do not have to be FDA approved for safety, however, they can be recalled by the FDA if there are enough complaints. The only responsibility the manufacturer holds is that “Manufacturers must make sure that product label information is truthful and not misleading.”

Keeping this idea in mind that products can be on the market without FDA regulation, lets look at nicotine. Currently, there is nothing contained within the FDA website referring to nicotine. However, there is a plant out there that has many of the same effects as nicotine and that is lobelia inflata which IS specifically mentioned on the FDA website. The FDA notes in Sec. 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent, that “Any OTC drug product that is labeled, represented, or promoted as a smoking deterrent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing.” But what happens if these claims are not to be made and the product clearly states that this product has not been evaluated by the FDA?

Now, let’s review what the FDA considers a “medical device”. The term “device”… means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

For comparison purposes, we need to look at tobacco vaporizers. Tobacco vaporizers are currently not FDA regulated. Many of the vaporizers currently sold on the market today, carry the warning that the vaporizer is not approved for medical-therapeutic purposes. If the electronic cigarette is simply a vaporizer, which is it as it uses no combustion, and there are currently hundreds of other products on the market that vaporize tobacco to deliver nicotine into the body, and those are not classified as “medical devices”, then these smaller, more compact versions should fall into the same category as the larger versions, like the Volcano.

If the electronic cigarette liquid uses ingredients that are found in traditional tobacco cigarettes, all ingredients are FDA approved as generally safe for consumption, and the supplier placing the product on the market is not making any claims, then based on the above arguments, the electronic cigarette liquid is not a “new drug” and therefor does not need to be approved by the FDA. This would also lead to the conclusion that if the liquid itself is not a “new drug”, then the hardware itself is not a “medical delivery device”.

Instead stands firm that smokers should have the option to smoke something other than tobacco cigarettes. There should be regulations and those regulations should be put forth by a regulatory body who understands that tobacco harm reduction products have a place in the free market.

The Electronic Cigarette Association has just released a letter on it’s website that it will be sending to each member of Congress as well as some other public officials. In it, along with some information about the very poor job the FDA did in testing the electronic cigarette, there is important information about the position of the ECA when it comes to selling to kids. He is a quote:

“We do agree with the FDA, however; that E-Cigarettes should not be purchased or consumed by those under the legal age of smoking. We support any legislation, be it state or federal, that makes it illegal to sell e-cigarettes to children and those under the legal smoking age. We only market our products to committed long term smokers and would never want this to entice anyone who is not already addicted to nicotine to use our product.”

We at Instead Electronic Cigarette fully support the ECA’s stance and agree that it is important to keep those under the legal smoking age from purchasing electronic cigarettes or any other product that may contain nicotine.

Read the full Electronic Cigarette Association Letter To Congress

A humorous evaluation of the FDA press release regarding electronic cigarettes:

Recent Studies Indicate That the FDA May Contain Trace Elements of Bos Taurus Egesta

Update:  Since “13 Guys Named Ed” use a one page type website and the referred story is now buried, here is the actual post:

Recent Studies Indicate That the FDA May Contain Trace Elements of Bos Taurus Egesta
By Jason Katzwinkel

An FDA News Release from July 22, 2009:

FDA and Public Health Experts Warn About Electronic Cigarettes
The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Do you happen to have a beverage at your side? What is it? … Wait, what? Are you serious? O’m'gawd, your drink contains an ingredient used in antifreeze! Yeah, that’s right. Water. The term “…is an ingredient used in antifreeze” is the comestible, fear-mongering equivalent of “…then the terrorists win.”

I must concede that diethylene glycol is indeed toxic. That much is true. But how toxic is it? It possesses one-tenth the toxicity of household aspirin, not to mention one-fortieth the toxicity of nicotine, the primary component of e-cigaratte vapor which is administered in much higher doses. So why is the FDA focusing on diethylene glycol? Because if they told you that e-cigarettes contain trace amounts nicotine, you’d stare blankly, shrug your shoulders, and take another long satisfying drag off of your e-cigarette before blowing a bunch of vapor in their faces. But when somebody starts throwing around a term like ‘diethylene glycol,’ people pay attention. Nobody knows what the hell it means and it doesn’t sound like something you’d necessarily want a tall frosty mug of.

Or does it? Diethylene glycol is also an ingredient found in toothpaste, mouthwash, cough syrup, dog food, wine and cigars among plenty of other consumer products. Do you know what it is not an ingredient of? Antifreeze. Propylene glycol is used in antifreeze. Diethylene glycol is used in coolants. Let’s get our scare tactics straight, shall we?

I’m reminded of city officials in Aliso Veijo, California who nearly proposed a ban on polystyrene containers because they heard that Styrofoam cups may contain dihydrogen monoxide, a colorless odorless chemical that is the main ingredient of acid rain and is lethal when inhaled. What is dihydrogen monoxide? H₂O.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

I have yet to see any marketing for these devices out in the wild, let alone marketing geared toward young people. My own searches bring up loads of marketing, but nothing even remotely geared toward teenagers. Every bit of e-cig marketing that I can find consists of either poorly constructed web pages that don’t appeal to anybody, or lots of heraldry, parchment and black satin. Perhaps teens are more sophisticated than I recall.
And c’mon, FDA. It’s like you’re not even trying. Chocolate and mint may appeal to young people? I guarantee that chocolate and mint appeal to young people. Chocolate and mint appeal to all people. That’s like saying scuba divers are preying on children because scuba diving places a major emphasis on breathing, an activity that many young people are known to participate in. What exactly would adult-centric flavors be? Liver & onions? Butterscotch hard candies? Dentu-Creme? What’s the flavor that appeals to twenty-four-year-olds and not sixteen-year-olds? It doesn’t exist.

Marketing aside, these things cost fifty to one-hundred-and-fifty dollars each, not including accessories and recharges. A pack of smokes? Ten bucks. The Senate has approved a number of tax increases on cigarettes with the specific logic that the higher the cost on cigarettes, the fewer the teens that will smoke them. If the FDA has anything to fear, its that tobacco cigarettes will act as a gateway to e-cigarettes.

Regardless of price, however, teens don’t start smoking for the flavor. “Boy, I sure could go for a mouthful of stink right about now.” Kids start smoking to be popular. To fit in. To be cool. To be bad ass. If some punk shows up on a street corner with an e-cigarette, it’ll be shoved up his ass within sixty seconds if he’s not laughed into oblivion.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

Do you see what they did there? Two unrelated sentences jammed together in a flurry of words to create the illusion that these specific public health experts are saying something that they never said. What that paragraph breaks down into is, “Some people have denounced e-cigarettes. The topic will later be discussed by these four other public health experts.”

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

If the FDA has no way of knowing the amounts or kinds of other chemicals in e-cigarettes, how do they specifically mention diethylene glycol and other carcinogens? And, in the very next paragraph: “The FDA’S Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of of cartridges from two leading brands of electronic cigarettes.” So this whole letter boils down to, “We’ve determined that e-cigarettes contain a number of chemicals, but we have no way of determining if there are any chemicals in these e-cigarettes because nobody has submitted these e-cigarettes we’ve been analyzing for analysis.”

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

Nitrosamines! Another ten dollar word. Scary stuff. It’s true that some nitrosamines might be carcinogenic; half of them have shown trends that indicate that they might be carcinogenic in humans. The risk is certainly there, but it’s not like the FDA has cared about it before, because anybody can find nitrosamines in many food products including beer, bacon, fish, pickles, and a variety of other meats and cheeses, as well as in party ballons and condoms. And, of course, in cigarettes.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

None of this is to say that I am pro- or anti-electronic cigarettes. Or that I am pro- or anti-smoking. I, myself, am an ex-smoker who can understand the benefits and detriments of smoking or not smoking tobacco or e-cigarettes. I’m not here to convince you one way or the other except to say that not smoking at all is probably the healthiest way to go, should you find yourself concerned about such things. My primary goal is to open the question: “What’s in it for the FDA?”

Why would the FDA put out a letter that is so obviously spun to demonize electronic cigarettes with virtually no evidence that they cause any more harm than the tobacco cigarettes that are perfectly legal today? I don’t know the answer to that, but I am curious to find out.

Below is the summary of the Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes”.

The review of the now infamous FDA report on electronic cigarettes was done by:

Janci Chunn Lindsay, Ph.D.
Exponent Health Sciences
Toxicology and Mechanistic Biology Division
10850 Richmond Ave. Suite 175
Houston, TX 77042
July 30, 2009

It was done on behalf of NJoy, who was one of the companies the FDA targeted with their testing. It is important to note that NJoy is also one of the companies currently in litigation with the FDA. The summary is below, but you can download the entire review of the FDA’s report on e-cigarettes in pdf here.

SUMMARY:

* The report failed to present standard protocols for proper study design with regards to
the testing of the referenced control device, documenting the number of samples tested
either within or across tests, or presenting statistical analyses when quantifiable results
were obtained.
* The chemical content of similar nicotine-containing FDA-approved products was not
completely described with respect to the presence of tobacco-specific nitrosamines
(TSNAs) and other tobacco-associated impurities that have also been found in nicotine
replacement therapy (NRT) devices at similar, if not higher, levels.
* In the lots that were tested by the FDA, none of the key chemicals of concern in this
study such as TSNAs and tobacco-associated impurities were able to be quantifiably
measured in the liquid of NJOY’s cartridges because they were all below the limits of
quantification (LOQ).
* All of the tobacco-associated impurities found in the NJOY products were “present
but at less than the level of the Nicotrol® inhaler [manufacturer] specification”
according to the FDA report.
* There is no indication in the published scientific literature that cotinine or β-nicotyrine
are carcinogenic or have toxicity ratings of concern. These were the only tobacco-
associated impurities found in trace levels in the vapor phase of (some of) NJOY’s
products.
* The report does not reflect the actual dose of nicotine delivered to the user from the
“control” Nicotrol® inhaler device when used as recommended by the manufacturer
(6–16 cartridges/day or 24–64 mg of nicotine, 50 mcg/100 mL puff). By comparison,
NJOY devices delivered 46 mcg/100 mL in the highest-strength cartridge tested,
according to the FDA report.
* Data presented in the report does not adequately support the opinion that users of
NJOY products would actually be exposed to TSNAs and tobacco-specific impurities
in the vapor phase during normal device use; and if exposed, that those levels would be
a health concern as compared to other FDA-approved products.