Ok, glad to hear your opinion. I assumed that would be the first response. (related to what the FDA find) That's the thing with the FDA...scare everyone. They're good.
I really didn't post to get into a debate.
But please read this: (the FDA is missing some facts):
First we have the press release:
Quote:
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:
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.
--------\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:
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.
1
http://www.healthnz.co.nz/2ndSafetyReport_9Apr08.pdf
2
DIETHYLENE GLYCOL
3
Antifreeze | Common Wastes & Materials | US EPA
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