Facts regarding the FDA Press Release - 7/22 (repost)

[TheIllustratedMan]

I'm going to go ahead an repost this here, because I think that it's incredibly important to have figures and facts when debating this issue.

First we have the press release (thanks Krakken):

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]

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:

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

Please use this however you can to campaign for our cause.

-Nate

 

[Krakkan]

Nate I will also use your info in my campaign post as well if dont mind thanks for the great work

 

[surbitonPete]

It's putting the numbers into perspective that is really incredibly important.....they can make a carrot sound like it will give you cancer if they want.

 

[TheIllustratedMan]

Thanks to grimmer255 and OutWest:

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

This is the full report. It seems to be (upon preliminary examination) similar to the Health New Zealand study. I take it as actually encouraging (taking into account the amount of TSNAs in nicotine gum). A side-by-side analysis is probably needed here. Anyone up for it?

 

[smokinsimon]

I am so vested in this whole thing today. I've been reading for hours and hours...
I would love to see the study of other NRT's side by side with this report.

 

[rjm312]

to put in perspective , please equate nano grams with parts per billion, "mistakes" like these can undermine your credibility. As far as unwanted substances go, why not make e-liquid with only propylene glycol and nicotine, flavorings have to be rather complex to simulate other materials so they would be hard to control safety wise.

 

[TheIllustratedMan]

My understanding is that according to the Health New Zealand report, 1 nanogram/milliliter equals 1 part per billion.

Confirmed by http://www.seagrant.umn.edu/water/report/helpfulinformation/concentrations.pdf

Anything else I may have missed?

 

[DonDaBoomVape]

I was interested in learning which "two leading brands of electronic cigarettes" the FDA studied.

According to the LA Times:

Most of the e-cigarettes are produced in China, where they have become very popular. The varieties tested by FDA, however, were produced by Smoking Everywhere, a Florida company, and Njoy Cigarettes of Scottsdale, Ariz.

Also, I wish the press release and news reports hadn't equated "electronic cigarettes" (which I think of as the atomizer and battery) with the e-liquid.

And those references to "young people" package two quite different groups:

- People in their twenties (true and innocuous)
- Children and teens (false and immoral/illegal)

Government and media at their finest.

 

[TheIllustratedMan]

Don-

I appreciate your opinion, but we really need to stay on point here. Let's use facts to build our rebuttal, not speculation. As I posted in the other thread, we should develop a standard reply to the children argument and use it as often as they bandy about their claims. My suggestion is to use the price point of kiosk kits. What other kinds of facts can we use here?

-Nate

 

[OutWest]

The % of vendors caught selling cigarettes to underage persons. In 2001, 25% of the cigarette vendors in Oklahoma sold to minors Oklahoma cracks down on tobacco sales to minors. (Industry News).(Brief Article) | North America > United States from AllBusiness.com Whereas there have been 0 known incidents of selling of ecigs to minors.

 

[TheIllustratedMan]

Good stuff. That's what we need. Let's stay on that target.

Thanks OutWest!

 

[LaceyUnderall]

This was posted by Kitabz over at VF and is very insightful and warrants discussion:

For comparative details of TSNAs, the sum of the highest of each of the TSNAs listed is 768.4ng/g which equals 0.0007684mg/g which equals 0.7684mg/kg. This then allows us to compare [the highest] TSNAs in e-cigs to smokeless tobacco products¹:

Brand____________Country__TSNA level
e-cigs___________China______0.7684
Ettan____________Sweden_____2.8
Offroad__________Denmark____0.7
Phantom__________Denmark____0.7
Copenhagen_______USA_______41.1
Skoal, Orig FC___USA_______14.9
Skoal Bandts ST__USA________8.2
Kodiak W/green___USA_______11.0
Hawken W/green___USA________4.1
Skoal____________USA_______64.0
Timber Wolf______USA________7.5
Silver Creek_____USA______127.9

Unfortunately, I can't find TSNA levels by weight for cigarettes but just mg per cigarette²: 0.6 to 19.4 mg/cigarette. I don't know how many cigarettes it would take to make up a kilo (kg) but I think it's safe to say that TSNA levels in analog cigarettes are off the scale compared with either e-cigs or smokeless tobacco products.

¹ http://www.tobaccoprogram.org/pdf/TC12349.pdf
² Tobacco-specific nitrosamines in European and USA ...[Arch Geschwulstforsch. 1990] - PubMed Result
__________________

 

[LaceyUnderall]

Don-

I appreciate your opinion, but we really need to stay on point here. Let's use facts to build our rebuttal, not speculation. As I posted in the other thread, we should develop a standard reply to the children argument and use it as often as they bandy about their claims. My suggestion is to use the price point of kiosk kits. What other kinds of facts can we use here?

-Nate

What about the argument: "The electronic cigarette has nothing to do with children. This product is marketed to an adult consumer base. It is the goal to offer consumers of smoking age an alternative to known killers, not to introduce new smokers to a new product." Then we can include some real statistics regarding consumer base.

I know I can pull my statistics of average age customer: 45 is the average age. I also can pull that not one person has ever purchased from me under the age of 18, and those in their 20's make up a very very small percentage.

I could ask other suppliers to pull their statistics as well.

 

[Carlos49]

Does anyone have a link to the Heath New Zeland study?

 

[TheIllustratedMan]

Re: age - if every supplier could do that, that would be fantastic!

Re: the chart - Looks like those values are in micrograms. The Health New Zealand figures are in nanograms. 1 microgram = 1000 nanograms. I'm a little confused as to how you arrived at 0.7684 micrograms for electronic cigarettes. Did you mean 7.684 nanograms? That's more in league with HNZ's findings.

Good stuff either way!

[EDIT] Carlos, see the footnotes of the first post.

 

[LaceyUnderall]

Re: age - if every supplier could do that, that would be fantastic!

Re: the chart - Looks like those values are in micrograms. The Health New Zealand figures are in nanograms. 1 microgram = 1000 nanograms. I'm a little confused as to how you arrived at 0.7684 micrograms for electronic cigarettes. Did you mean 7.684 nanograms? That's more in league with HNZ's findings.

Good stuff either way!

[EDIT] Carlos, see the footnotes of the first post.

None of that is mine... it was all reposted and I am no scientist so I would need help deciphering as well. The real thread is: FDA and Public Health Experts Warn About Electronic Cigarettes - Page 2 - Vapers Forum post #20. If you ask, I am sure he will respond to you.

I have also started a thread in the Suppliers Private Forum requesting suppliers get some numbers together.

 

[LaceyUnderall]

Does anyone have a link to the Heath New Zeland study?

http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

http://www.healthnz.co.nz/ecig_effect-2.pdf

The later discusses the vapor.

 

[kinabaloo]

The key point is that the juice is derived from tobacco. The results show that a very high level of purity is achieved. Separating the nicotine and flavors from the not so nice stuff is not 100% perfect (nothing ever is) and a tiny amount of other tobacco constituents remains.

The 'detected' toxins are no higher than 1 part in a million, at most.

This report actually demonstrates just how very safe the juice is.

 

[surbitonPete]

It needs comparing to the chemicals in a tobacco cig and to the chemicals in the air you breath standing on a city street during the rush hour.....that might put a little bit more perspective on it all.

 

[robbiehatfield]

I absolutely agree with putting things in perspective. From what I've read here, what the FDA is saying might be akin to them saying "We're considering banning water even though it's been known to bring people pleasure by quenching their thirst because it's been brought to our attention that one can die by drowning in it"..

Robbie