Monday, September 9, 2019

The FDA is an agency within the United States Department of Health and Human Services responsible for protecting and promoting the nations health. It's reach spreads worldwide and it has the means and ability to influence any and all products entering our marketplace.

Tobacco ... decades of research on these products has been documented and compiled into safety reports and proposals by organizations worldwide. Everyone knows smoking is a problem, we are bombarded with anti-smoking campaigns and nicotine replacement therapy products on a daily basis. There is no doubt in anyone's mind as to just how deadly and toxic these products are. Peer pressure, skyrocketing taxes on the tobacco products, smoking bans, Health Advisory warnings, to name just a few, all point to one thing ... tobacco products kill.

This is a product that for decades, has never been held accountable for their devastating impact on the lives of the consumers they affect. Decades have passed and they have yet to provide detailed information regarding these products, but they roll out of the manufacturing plants and onto the store shelves daily. They are the only manufactured product authorized for sale around the world that is exempt from providing adequately detailed information on their products.

Decades of research have shown this is the deadliest most toxic product on the market ... yet, they remain available. It is a fact that tobacco usage is the single largest cause of preventable deaths worldwide and contributes to approximately 400,000 deaths annually. Granted, they do have to put large warning labels on each product that rolls out their door ... but really now, a warning label?

One person took an interest in the problem and decided to make a difference and has ... the electronic cigarette was invented by Hon Lik of electronics company Ruyan in Beijing, China and Ruyan sold its first electronic cigarette in May 2004. When a user inhales through the device, air flow is detected by a sensor, activating a battery, which in turn vaporizes a nicotine solution stored in the mouthpiece. It is this vapor that is then inhaled by the user. It looks and feels like a cigarette and has an LED light on the tip that simulates a cigarette and it is a product that offers the smoking consumer a choice ... something that has never been available to them before and both the ongoing interest in the product and sales, have been growing steadily ever since.

A few months ago, the FDA did preliminary testing on products from two manufacturers of the electronic cigarette ... then a few months after receiving the results, sent out a press release warning the public of the dangers in using this product. As a result of that Press Release, many countries have banned the products and sales have been restricted, going even so far as to charge the manufacturers still selling the product.

Since no one else seems to want to state the blatantly obvious ... I will.

On average an electronic cigarette is made up of 10-20 ingredients, which is approximately 579 less than it's tobacco counterpart. These are the basics of what is included, although recipes may vary with each manufacturer. Propylene glycol 80 - 90%, Nicotine .01 - 6%, Glycerol 2 - 5%, Tobacco essence 1 – 4.5%, Essence 1 – 2%, Organic acid 1 - 2%, Anti-oxidation agent 1%, Butyl valerate 1%, Isopentyl hexonate 1%, Lauryl laurate 0.6%, Benzyl benzoate 0.4%, Methyl octynicate 0-5%, Ethyl heptylate 0.2%, Hexyl hexanoate 0.3%, Geranyl butyrate 2%, Menthol 0.5%, Citric acid 0.5 – 2.5%, Water 2.9%, Alcohol 8%

Smoke or any partially burnt organic matter, is carcinogenic (cancer-causing). Based on research studies, tobacco products are believed to contain up to 599 additives, many of which are also safely included in many food and drink products, but ... the major toxicity of tobacco products are created during the required burning process, when temperatures reaching between 450 and 1200 degrees. It is at that point a mix of approximately 5000 deadly, toxic, carcinogenic agents are formed. Since the electronic cigarette is battery operated and temperatures average between 30 and 65 degrees ... they are incapable of reaching the required temperature to facilitate the carcinogenic process associated with these additives.

Although the FDA did not have jurisdiction over these products, they had been illegally detaining and examining shipments of e-cigarettes being held at the border. Since then, the FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. At that time, the agency also stated it intended additional activities to address its concerns about these products. In an extremely controversial move, the electronic cigarette was banned due to the findings within a preliminary report, which analyzed a “small sample” of cartridges from only two of the many manufacturers worldwide.

The FDA stated in their July 22nd Press Release ... “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 analysis detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analysis 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.”

According to preliminary testing results performed by the FDA:

The products were tested for possible tobacco specific impurities, which are derived from, you guessed it ... tobacco. This means they are also contained in all approved tobacco products in the marketplace, but at a much more toxic level.

Testing limit of detection, Cotinine 20 ppb. Anabasine 10 ppb; myosmine 69 ppb; β-nicotyrine 170 ppb were present in the electronic cigarette, but at less than the level of the Nicotrol specification. With higher levels of these impurities, Nicotrol is an “Approved” product already on the market. The other tobacco specific impurity, DEG(diethylene glycol) tested positive in one sample. Tobacco specific impurities are found in all nicotine based approved products.

The products contained detectable levels of nitrosamines. The FDA merely misled the public about the comparison between the electronic and tobacco products:

Maximum Tobacco-Specific Nitrosamine Levels in Various
Cigarettes and Nicotine-Delivery Products (ng/g, except for nicotine gum and patch which are ng/patch or ng/gum piece)







Electronic Cigarette






Nicotine Gum






Nicotine Patch






Swedish Snus


Canadian Mild Ultra






Du Maurier Regular






Export A Ultra Light King






Gitanes Kings






Benson & Hedges Ultra Mild




































If 8.183 is cause for alarm, I'd like to know why the tobacco products haven't been removed from store shelves and also banned for use by the consumer.

They also expressed a deep concern regarding the carcinogens detected, so I wanted to share those results also:

Table 1. List of Identified, Known Carcinogens in Electronic Cigarettes, Present at More than Trace Levels (defined as 1 nanogram per cigarette)

Table 2. List of Identified, Known Carcinogens in Tobacco Cigarettes, Present at More than Trace Levels (defined as 1 nanogram per cigarette)
Benz(a)anthracene, Benzo(b)fluoranthene, Benzo(j)fluoranthene, Benzo(k)fluoranthene, Benzo(a)pyrene, Dibenz(a,h)anthracene, Dibenzo(a,l)pyrene, Dibenzo(a,e)pyrene, Indeno(1,2,3-cd)pyrene, Quinolineb, Dibenz(a,j)acridine, Benzo(b)furan, Furan, N-Nitrosodimethylamine, N -Nitrosoethylmethylamine, N -Nitrosodiethylamine, N -Nitroso-di-n-butylamine, N -Nitrosopyrrolidine, N -Nitrosopiperidine, N -Nitrosodiethanolamine, N -Nitrosonornicotine, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone, 2-Toluidine, 2,6-Dimethylaniline, 2-Naphthylamine, 4-Aminobiphenyl, AaC, PhIP, Formaldehyde, Acetaldehyde, 1,3-Butadiene, Isoprene, Benzene, Styrene, Acetamide, Acrylamide, Acrylonitrile, Vinyl chloride, DDT, DDE, Catechol, Caffeic acid, 1,1-Dimethylhydrazine, 2-Nitropropane, Nitrobenzene, Ethyl carbamate, thylene oxide, Propylene oxide, Methyleugenol, Hydrazine, Arsenic, Nickel, Chromium, Cadmium, Lead, Polonium-210

According to the test results, electronic cigarettes do not contain lethal doses of anything that would be cause for alarm and clearly shows that the Nicotrol Inhaler yields a higher level of tobacco specific impurities. Electronic Cigarettes show less than trace levels of carcinogens, whereas tobacco products yield toxic levels. The electronic cigarette consists of a handful of ingredients which can easily be adjusted to conform within any safety requirements which may apply. The manufacturers have marketed the product as a smoking alternative and as such, have captured a growing market base of former tobacco users.

Is it a good thing?
Yes ... of course it is.

Is it safer than tobacco products?
My assumption is that it would be.

Thanks to the tobacco manufacturers, tobacco related sicknesses and diseases are an extremely profitable business, providing billions of dollars of revenue annually. Since there don't seem to be any readily available statistic, one can only guesstimate the actual profit margins, but Governments, communities, municipalities, research developers and facilities, scientists, health care workers, hospitals and health care facilities, anti-smoking campaigns etc, etc, etc ... all share in the wealth.

When placed side by side with a traditional cigarette, it's obvious they can't possibly be as dangerous as the tobacco products that have been killing people for decades. Tobacco products kill people ... people ... we're talking about people held hostage to a product that has been manufactured for decades, by companies that have chosen not to fix the problem. This is and always has been a conscious decision by these manufacturers to keep producing a lethal product, that has never had to abide by any statute pertaining to health and safety regulations. Studies have shown that tobacco products kill approximately 400,000 people a year. There is no other product manufactured for consumer usage has ever done so much damage to it's users. Is it time for a change? Definitely.

The FDA an agency responsible for protecting and promoting the nations health has intentionally misled the general population worldwide, by deliberately misleading them about “suspected health risks” of the electronic cigarettes, when the actual test results showed that there was absolutely no need for any real concern.

Instead of taking reasonable steps to help develop the product and allow it it's rightful place in the marketplace, they instead created a smokescreen, stating half truths and recruited other large extremely influential corporations and associations, public officials and heads of state to shoulder side by side to remove what had been an already accepted and highly regarded product for the last five years.