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.

 Quitting, It’s About an Alternative with the Electronic Cigarette

* 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 loweigarettes), 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 conindividuals have reported a tremendousInstead 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.

Matt Salmon, former Congressmen and current President of The Electronic Cigarette Association responds to the FDA’s announcement regarding electronic cigarettes:

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.

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.” 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 kills very, very, very few people (if any) but inhaling burning tobacco kills hundreds of thousands.