Debunking of the latest B.S. FDA claims.

[eric]

In lieu of the recent FDA hype in regards to Electronic Cigarettes, please read through the following:

FDA NEWS RELEASE

For 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.
Online: MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Regular Mail: use postage-paid FDA form 3500 available at: Download Forms and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

Next is the FDA Safety Alert:

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]

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:

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.
--------\Cancer Lists\------------------------------------------------------
---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:

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:

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.

¹ http://www.healthnz.co.nz/2ndSafetyReport_9Apr08.pdf
² DIETHYLENE GLYCOL
³ Antifreeze | Common Wastes & Materials | US EPA

 

[eric]

Thanks to TheIllustratedMan.

 

[wjmcspirit]

The FDA/Government will do anything to control what we can and can not do. If it's not providing a benefit for them, they will find a way to make it be.

 

[AnglVapin]

Excellent post!

 

[Luke15_7]

Well done - thank you, Eric! Let's see what WFAA says to this information after their news report with the not quite accurate facts...

The truly sad thing is that those that don't know about this already will likely never hear this correct information, but will have been heavily influenced and accept as truth he poorly factual reports made yesterday.

 

[eric]

The FDA not only overstepped its bounds in seizing SE and Njoy property, but now they've bald face lied to the American people in a press release and it is very unlikely anything will ever even come of it.

Our only bet now is word of mouth.

 

[midian]

Agreed this is a very good reply to the FDA statement. In the end though we really need to identify 3 major facts surrounding electronic cigarettes and the FDA.

1) Big tobacco doesn’t want electronic cigarettes to exist; this is why they allowed the last tobacco bill to be rubber stamped without hardly ‘any’ arguments. Therefore the FDA has the full backing of big tobacco – as long as they can still produce their cash-cow.
2) Government as a whole doesn’t like electronic cigarettes either because they can’t find a way to tax it; it’s literally that simple – no surprises there. Give it time and someone with an actual science degree ‘might’ get into an office so that they can finally educate senators on how to tax based upon milligram levels…not a hard concept…but I’m sure there’s a politician who simply wont get it…
3) The FDA pretty much got a major slap to the face when the last tobacco bill (AKA: the Marlboro Bill) when most to all the verbiage was adjusted to be specifically pointed at the tobacco plant. Now the only stand they have is to completely start over with all new legislation to target electronic cigarettes – and that REALLY pisses them off.

Not sure about the rest of you, but the company who produced my eLiquid completely changed their recipe so that zero chemicals are being extracted from the tobacco plant (take that FDA). In addition, the company also can produce documentation on ‘every’ chemical used to produce my eLiquid; all of which are approved by the FDA (again – take that FDA). The bottom line is that the FDA has a long time to go before they’ll actually have ‘factual’ evidence to try and out-right ban electronic cigarettes. Until then, I’m continuing my use as normal and keeping my eyes out for any statements that actually have credibility – not baseless accusations or unfounded statistics that can’t be cited by a credible source.

Vape on my brothers & sisters! Our day has come to tell big tobacco we are no longer blind and we plan on using our constitutional privilege to chose.

 

[Bigbob]

Eric, not to pick on you, while I'm sure your data is good and comes from trusted source material, you as a vendor are biased and should refrain from commenting on the subject. Even if it's good data a vendor's opinion will be mistrusted and do more harm than good. Of course this is just my opinion and should be taken with a grain of salt.

 

[beckah54]

The government of this country is supposed to be the servant of the people. It now has become exactly the opposite. Put a warning label on the ecig if they want, but let me choose if I smoke them or not. My freedom of choice is going out the window, and I, for one, have not given them the right to monitor every aspect of my life. Geez, enough already!
Civil war comes to mind.

 

[newbutt]

Eric, not to pick on you, while I'm sure your data is good and comes from trusted source material, you as a vendor are biased and should refrain from commenting on the subject. Even if it's good data a vendor's opinion will be mistrusted and do more harm than good. Of course this is just my opinion and should be taken with a grain of salt.

I have to disagree with you Bob. I feel voices like Eric's are the ones that need to be the loudest.Why, because most of what we are hearing/reading are rants from users that are venting & don't really know what is being said. Eric on the other hand,apparently stayed up late on this one & is well versed on the subject.
At this time we need as many voices as will speak,IMO.

 

[eric]

Eric, not to pick on you, while I'm sure your data is good and comes from trusted source material, you as a vendor are biased and should refrain from commenting on the subject. Even if it's good data a vendor's opinion will be mistrusted and do more harm than good. Of course this is just my opinion and should be taken with a grain of salt.

Why would I refrain from voicing my opinion on my own threads in my own Supplier sub forum that I pay for myself? Be practical here, my friend.

 

[eric]

The more I look over this study, the more I realize how loaded it is.

This is a total farce. The FDA needs to be called on this.

I implore you all to donate anything you can to the ECA. Even if it's $1.00.

 

[lvlninety9]

Eric, not to pick on you, while I'm sure your data is good and comes from trusted source material, you as a vendor are biased and should refrain from commenting on the subject. Even if it's good data a vendor's opinion will be mistrusted and do more harm than good. Of course this is just my opinion and should be taken with a grain of salt.

Honestly I think vendors need to voice their opinions as well. I'm sure the majority of the vendors use the products they sell as well. Just like Eric. The threat of a ban not only affects the consumers but the suppliers as well. Especially those suppliers that use these sales to supplement their income. In this day of economic downturn and a rising unemployment rate, a ban could be devastating. It would mean that now only would suppliers be forced to shut down their business, but be forced into using analog cigarettes further creating a drain on their financial status. For the suppliers it's an even bigger concern. Everyone should become involved in this suit. Not just the consumers.

 

[mikol_g]

The more I look over this study, the more I realize how loaded it is.

This is a total farce. The FDA needs to be called on this.

I implore you all to donate anything you can to the ECA. Even if it's $1.00.

Where could we go to donate to the cause? I would love to do something myself to help save a product that has helped save me, and to see ALL SUPPLIERS come together if only for a brief moment to stand up for their (and all of our) rights. These things are great and are helping a lot of people.

 

[souporvapor]

Thanks Eric!

and to donate - I believe there's a link at the top of each page to
SUPPORT ECF

30 years of smoking....
Vaporized by my Screwdriver!