Clearing Up the FDA Confusion

When Greenbulb LLC (Cyrille, Ryeon, Rudi, and Sunny) got started with Greentip, our mission was not to just deliver electronic cigarettes from one place to another, but to take a more holistic approach in educating the public with TRUTH, providing them with the best electronic cigarettes available, and ultimately creating a company that deserves the faith and trust that electronic cigarette users put in us. We wanted to create a MOVEMENT, a new beginning, a journey that starts from tossing out the cigarettes from our hands and ends at a tobacco-free community filled with fully satisfied supporters of our e-cigs.

As not just the co-founder of Greenbulb, but a wholehearted supporter of electronic cigarettes and its community, I would like to clear up some issues regarding the recent FDA report and testing on Njoy and Smoking Everywhere e-cigarettes. First, some basic review of facts:

  1. Smoking KILLS (25% of the American population still smokes cigarettes and 440,000 people die every year from smoking-related diseases). Yet, 6 years after the invention of electronic cigarettes, there has not been a single report of death from its usage.
  2. An electronic cigarette is a lithium-battery powered electronic device that delivers nicotine in a manner that regular cigarettes do without the carcinogens, tars, the terrible lingering odor, second-hand smoke, or yellow teeth.
  3. Patches and gum are great alternatives to smoking (In fact, anything that steers you away from cigarettes is a great alternative); it works wonders for a lot of people. However, we know and believe the addiction to smoking is not just a physical need of nicotine, but a behavioral addiction – the full experience of smoking that include: picking up something that you can inhale, putting it in your mouth, taking a drag, seeing the tip light up, watching the smoke (in the case of e-cig, just vapor) come out of your mouth, without actually hurting yourself by smoking and its 4800+ chemicals. This makes electronic cigarettes the most suitable fit for smokers who are looking for a smoking alternative to cure their nicotine addiction in the near future.
  4. Electronic cigarettes are not a health product. It contains nicotine and that is still a poison. However, it’s designed in hopes to deliver nicotine without the cancer causing chemicals so you can gradually decrease your nicotine intake and live a completely nicotine-free lifestyle in the nearest future as possible. According to the FDA regulations, we cannot make such claims that electronic cigarettes are a smoking-cessation aid product, because it has not gone through the years of medical research and testing that cost millions of dollars that to my knowledge, small businesses (which most electronic cigarette distributors are currently) cannot afford. Yet, the cold hard truth is this: there are over 40 carcinogens in a cigarette, electronic cigarettes contain none, despite the fact FDA recently did find Diethylene Glycol in Smoking Everywhere’s electronic cigarette (which I will get into). Logically, it only makes sense that e-cigs are the obviously healthier alternative (40 vs. 1 carcinogen, am I getting through you?)

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Now, you might have been hearing some ruckus on the news recently; FDA Warns About Carcinogens and Other Poisons Found in Electronic Cigarettes. I won’t get too political but I cannot help but feel obligated to inform the public of the less than glorious doings of the media.

If you watch the news or read the newspaper/magazine nowadays, you need to keep your mind more alert than ever and filter this constant flux of information that is being reported. Most people take many things they see on the media as cold hard facts and never question its source. Now I am not claiming that the government or every broadcasting company is out to hunt down electronic cigarettes in exchange of lobby money from tobacco companies – not only is that theory completely depressing but we have no evidence of that. All I’m asking the readers is to be aware of how the media tends to bend the truth. This is not because they’re necessarily evil, but it’s because they are nothing more than a business that’s out there to make money just like any other businesses. Like the following, it is important to pay attention to its language and do some background research beyond the single article you read. Luckily, with this report, we did the research for you. The actual FDA report of this controversial testing can be found here: http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf). Here is Nate’s post from the official Electronic Cigarette Forum that completely mirrors my take:

The Press Release (thanks Krakken):

“Quote:

FDA NEWS RELEASEFor Immediate Release: July 22, 2009
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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. 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.
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.
“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. 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. 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.

Next is the FDA Safety Alert:

Quote:

Electronic Cigarettes
Audience: Pediatric healthcare professionals and consumers
[Posted 07/22/2009] FDA notified healthcare professionals and patients 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. 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. They are also available in different flavors, such as chocolate and mint, which may appeal to young people. 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 products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. 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. 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.
[07/22/2009 - Information on E-cigarettes - FDA]

Some portions of that are debatable. Some are not. Here are the facts:

Regarding Diethylene Glycol:

Looking at the Health New Zealand study1, the presence of Diethylene Glycol was not tested for. They seem to have based their tests on manufacturer ingredient lists and known tobacco carcinogens.

So what is Diethylene Glycol?
The MSDS2 shows that chronic exposure to Diethylene Glycol can cause lesions on the liver and kidneys, as well as damage to the same organs. In the case of inhalation, the only first aid recommended is removal from the source to fresh air. The toxicalogical information is as follows:

Quote:

Oral rat LD50: 12565 mg/kg. Skin rabbit LD50: 11.89 g/kg Irritation: eye rabbit, standard Draize: 50 mg mild. Investigated as a tumorigen and reproductive effector.

—NTP Carcinogen—
Ingredient Known Anticipated IARC Category
———————————— —– ———– ————-
Diethylene Glycol (111-46-6) No No None

This shows that Diethylene Glycol is not a known carcinogen, nor is it expected to be found as one in the future. In addition, the dose required to kill half of the sample of rats tested is 12.565 g/kg and 11.89 g/kg for rabbits. Assuming this can be extended to humans, an average adult male would have to ingest 855.925 g to receive a lethal dose.

Is Diethylene Glycol the main ingredient in antifreeze?
The EPA3 has this to say about antifreeze variations:

Quote:

Antifreeze typically contains ethylene glycol as its active ingredient, but some manufacturers market propylene glycol-based antifreeze, which is less toxic to humans and pets. The acute, or short-term, toxicity of propylene glycol, especially in humans, is substantially lower than that of ethylene glycol. Regardless of which active ingredient the spent antifreeze contains, heavy metals contaminate the antifreeze during service. When contaminated, particularly with lead, used antifreeze can be considered hazardous and should be reused, recycled, or disposed of properly.

Ethylene Glycol is the main ingredient in antifreeze. While straight antifreeze is toxic, the main hazard is from used antifreeze, which absorbs heavy metals.

What about Nitrosamines? Nitrosamines are carcinogens. Tobacco specific nitrosamines (TSNAs) are found in the liquid used by Ruyan in their cartridges. According to the Health New Zealand report1, the amount increases with the amount of nicotine, and the average is 3.928 Ng (or parts per billion [ppb]). The breakdown is as follows:

Quote:

Nitrosamines
0mg – 0.260 Ng (ppb)
6mg – 3.068 Ng
11mg – 4.200 Ng
16mg – 8.183 Ng

The highest amount found was in 16mg liquid, which had an average of 8.183 Ng. In comparison, Nicorette Gum (which is approved as an NRT) contains about 8 Ng. To put that number into perspective, Swedish moist snuff contains between 1000 and 2400 ppb nitrosamines, and unburned tobacco from cigarettes contains around 1230 ppb.”

Readers, I hope you took some time to educate yourself with facts and not what the media tells you. I understand that there are still debatable material from the FDA report. Nevertheless, we believe that electronic cigarettes are the obviously healthier choice for smokers. This is a revolutionary product without a doubt in my mind and I will not rest until the day that everybody in this world sees the product for what it is, not what the other uninformed or manipulative sources tell the public. In the next post, I’ll talk about what Greentip will do for you to minimize your concerns to provide you with not only the best quality, but the safest and most trustworthy electronic cigarette available on the market.

Until then,

Sunny Kwak
Greenbulb LLC
A New Beginning...








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