Ask and ye shall receive!
http://www.e-cigarette-forum.com/fo...2186-se-vs-fda-discussion-22.html#post1572810
thanks, kristin! that's really amazing...september is looking a lot brighter...
Class Action Against the FDA
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thanks, kristin! that's really amazing...september is looking a lot brighter...
Check out the ingrediants below! Propylene Glycol, Strawberry Flavoring!
The World Health Organization recommended name for albuterol base is salbutamol.
Albuterol Sulfate Syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol Sulfate Syrup also contains the inactive ingredients citric acid, FD&C Yellow #6, flavor enhancer, hypromellose, propylene glycol, purified water, sodium benzoate, sodium citrate, "strawberry flavor". Sodium hydroxide may be added to adjust pH.
The pH of the syrup is 3.5 to 4.5.
Read more: http://www.drugs.com/pro/albuterol-syrup.html#ixzz0pYGznzgM
http://www.propylene-glycol.com/download/BPA_Broschure.pdf
Unfortunately, they'll just say, "That product is for swallowing, not breathing in copious amounts daily. We still don't know the long-term effects of breathing in PG and flavoring."
And they'd be right.
But they'd still be ignoring the obvious - all that crap we WERE breathing in in copious amounts before using e-cigs and that tobacco cigarettes/smoke contains all of the same ingredients plus nearly 4,000 more. We may have increased the flavoring and PG intake vs. tobacco cigarettes, but out of all of the ingredients in tobacco cigarettes/smoke, the PG and the flavoring are the most innocuous!
Put it this way - cookies contain a lot of flour, butter, sugar and a little salt. The most "dangerous" ingredients are the butter and sugar, as they cause obesity, which can lead to diabetes & heart disease. Say they make diet cookies by completely eliminating the butter and sugar and increasing the flour ten-fold and double the salt. Would the FDA & the WHO seriously want to ban those diet cookies because they contain a little extra salt?? Would they seriously not recognize the greater benefit of eliminating the fats and sugars?
Yet they fail to see the same logic when it comes from e-cigs. It's crazy.
And they'd be right.
But they'd still be ignoring the obvious - all that crap we WERE breathing in in copious amounts before using e-cigs and that tobacco cigarettes/smoke contains all of the same ingredients plus nearly 4,000 more. We may have increased the flavoring and PG intake vs. tobacco cigarettes, but out of all of the ingredients in tobacco cigarettes/smoke, the PG and the flavoring are the most innocuous!
Put it this way - cookies contain a lot of flour, butter, sugar and a little salt. The most "dangerous" ingredients are the butter and sugar, as they cause obesity, which can lead to diabetes & heart disease. Say they make diet cookies by completely eliminating the butter and sugar and increasing the flour ten-fold and double the salt. Would the FDA & the WHO seriously want to ban those diet cookies because they contain a little extra salt?? Would they seriously not recognize the greater benefit of eliminating the fats and sugars?
Yet they fail to see the same logic when it comes from e-cigs. It's crazy.
One of my favorite sources for the Shadow file was George Seldes, who was best known for his In Fact newsletter, which frequently exposed information that was intentionally ignored or suppressed by the mainstream media of his time (1930s and 40s).
One of his main topics was the media blackout on the discovery that (gasp!) tobacco is harmful. The media surpression of the truth about tobacco has been an institution since the 1930s, and is alive and well over 80 years later.
Big Money in Cigarets
January 27, 1941, pp.3-4
Six cigaret companies grossed $200,000,000 in 1937 (SEC report). A combined profit after all charges of $83,000,000 that year was reported by the Census of American Listed Corporations (April 5 1939). The major companies spent as high as $50,000,000 a year on advertising . . . [Source]
What was once purchased with advertising money is now secured through donations and grants from BT, BP, and the government, to these "public health" groups whose primary consideration is not the health of the public, but the continued health of their funding. And still, the mainstream media silently watches while millions die.January 27, 1941, pp.3-4
Six cigaret companies grossed $200,000,000 in 1937 (SEC report). A combined profit after all charges of $83,000,000 that year was reported by the Census of American Listed Corporations (April 5 1939). The major companies spent as high as $50,000,000 a year on advertising . . . [Source]
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Feel the Power of the Vapor!
During WWII, the effect of long-term Propylene Glycol exposure on animals was studied, with the following results:
Examination at autopsy likewise failed to reveal any differences between the animals kept in glycolized air and those living in the ordinary room atmosphere. Extensive histological study of the lungs was made to ascertain whether the glycol had produced any generalized or local irritation. None was found. The kidneys, liver, spleen and bone marrow also were normal.
The results of these experiments in conjunction with the absence of any observed ill effects in patients exposed to both triethylene glycol and propylene glycol vapors for months at a time, provide assurance that air containing these vapors in amounts up to the saturation point is completely harmless. [Source]
And this one is my favorite:The results of these experiments in conjunction with the absence of any observed ill effects in patients exposed to both triethylene glycol and propylene glycol vapors for months at a time, provide assurance that air containing these vapors in amounts up to the saturation point is completely harmless. [Source]
In previous communications (1-2), the killing of air-suspended bacteria by means of very small concentrations of vapors of various compounds, particularly propylene glycol and triethylene glycol, was reported. Under the experimental conditions employed, numerous kinds of bacteria, including pneumococci, hemolytic streptococci, staphylococci,//, influenzae, etc., as well as influenza virus, when sprayed into atmospheres containing such vapors, were killed so rapidly that no microorganisms or virus could be recovered from the test chamber. Propylene and triethylene glycols were chosen for especial study, since these compounds are relatively non-toxic and in vapor form are odorless, tasteless, and non-irritating to the respiratory mucosa. [Source: THE BACTERICIDAL ACTION OF PROPYLENE GLYCOL VAPOR ON MICROORGANISMS SUSPENDED IN AIR - Robertson OH, Bigg Edward, Puck Theodore T, Miller Benjamin, June 1942]
PG kills the flu, strep, staph, etc. I'd like to see a survey of eCig vapers and incidence of upper respiratory infections, or the lack of them.
The problem with those studies is two-fold. First, they are so old that people can easily dismiss them because science wasn't as "advanced" back then and people were more naive on health issues. Considering it was done during an era where pregnant women still smoked and drank, it's an easy claim to make. Second, the studies didn't show the effect of inhaling PG with food flavorings meant for ingestion and nicotine, so they can easily claim it's not comprehensive enough. Just inhaling PG alone isn't the same as inhaling PG with other additives.
It's not that I feel this way - it's just what the antis can argue.
It's not that I feel this way - it's just what the antis can argue.
Does this help? And if it does, can you explain what it means?
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May The Vapor Be With You
Yes it helps very much, thank you. However, this guideline only addresses short term exposure(24 hours or less) at very low concentration levels(mg/L). I was hoping it would be more analogous to actual vaping conditions(longer term exposure at much higher levels). Hopefully, future safety/toxicity tests will be performed on vaporized PG to evaluate possible pulmonary toxicity at closer to vaping conditions. Thanks again.
Would the studies done on the use of glycols in theatrical fog machines, and the resulting standards that are currently in place, be closer to what you're looking for? I believe they look at higher concentration levels? For example:
http://www.esta.org/tsp/working_groups/FS/docs/cohen.pdf
http://www.esta.org/tsp/working_groups/FS/docs/HSE.pdf
http://www.esta.org/tsp/documents/docs/E1-5_2009.pdf
http://www.esta.org/tsp/working_groups/FS/fogdocs.htm
And in case you haven't seen it, here is a study done on varying levels of PG in tobacco cigarettes, that was looking for biological effects from increased PG, but did not find any:
Toxicological considerations on the use of propyle... [Toxicology. 2010] - PubMed result
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All these are good starting points & certainly are closer, however, there still needs to be an actual double-blinded, controlled, randomized trial on e-cigs themselves(not 2nd hand fog-machine vapor or lower concentration PG humectant in tobacco) which establish the safety of concentrated PG vapor, directly inhaled into pulmonary tissue. PG and Glycerin are used safely in inhalers and nebulizer solutions as well, but again in much lower concentrations. I, for one, feel it is safe, unfortunately my(or anyone elses anectdotal opinion) is not enough. Once actual e-cig studies are done, I feel it will go a long way to mitigating any "product safety" arguments that the FDA can field.
I agree that more testing is needed, but I'm not clear how you would do a double blinded test on e-cigs. Further, part of the problem with testing is that no one can get past an IRB to do the studies even if they had the money. I memory serves, even Eissenberg mentioned some trouble with IRB approval as one of the reasons his initial study was designed the way it was.
Could this be why a puff of e-cigarette vapor delivers 1/10 the amount of nicotine as a puff of smoke?
From Yvilla's last link http://www.ncbi.nlm.nih.gov/pubmed/...ed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=12
You can design a double blinded, randomized, controlled test for anything. The Institutional Review Board problem usually only becomes an issue when human testing is involved(in later phases of clinical studies). At this point(except for a few limited pilot studies, one in NZ, that I'm aware of), we haven't even gotten any hard pre-clinical(animal data) on basic toxicology/histology of e-cig vapor on pulmonary tissue.
The problem, as I see it(and this was a marketing decision on the part e-cig/e-liquid manufacturers, here and abroad) is the whole process is going backwards. Usually, a new/novel product intended for human comsuption is tested FIRST for safety(through pre-clinical animal studies) then , if that goes well, moves along to clinical human testing. Then it is marketed to the population. In the case of e-cigs, the marketing to the population occurred first(before any real safety data had been gleaned). To me this is the crux of the entire issue and the reason the industry is now embroiled in the legal nightmare it finds itself.
As a former smoker(now vaper) who owes the end of his 20 pack/year smoking habit to e-cigs, I can assure you that vaping is orders of magnitude safer then tobacco smoking, and should be encouraged as an excellent harm reduction tool rather then banned. However, as a health-care professional who knows and has seen firsthand the Healthcare bureaucracy with which our country operates under(and it's odd , backwords logic in regards to abstinence vs. harm reduction), I can understand why the powers that be (i.e. FDA) are proceeding the way they are in the face of the "backwards marketing" of e-cigs. To the average vaping citizen who owes their continued health to e-cigs, it seems ludicrous(and, in a way, it is).
How do you do a double-blind test in this application? The subject would know whether they were vaping, smoking or using an NRT. Or if you intend for some subjects to smoke and others to vape, you'd have a hard time getting IRB approval for a study which encourages the subjects to smoke. That is one of the issues with studies for getting "reduced-harm" approval for tobacco products. It's a catch 22. (I read about this very topic on Brad Rodu's blog: http://rodutobaccotruth.blogspot.com/2010/06/congressional-craziness-requiring.html).
The point is that e-cigarettes shouldn't have the requirement to be proven safe for intended use so long as tobacco cigarettes aren't required to be proven safe for intended use!
All that should be required is accurate labeling, no toxic levels of chemicals added as cheap fillers, warnings about nicotine poisoning if ingested, no health claims or advertising aimed at children and child-resistant caps/packaging. The same standards given to tobacco cigarettes (plus a few specific to e-cigs.)
The point is that e-cigarettes shouldn't have the requirement to be proven safe for intended use so long as tobacco cigarettes aren't required to be proven safe for intended use!
All that should be required is accurate labeling, no toxic levels of chemicals added as cheap fillers, warnings about nicotine poisoning if ingested, no health claims or advertising aimed at children and child-resistant caps/packaging. The same standards given to tobacco cigarettes (plus a few specific to e-cigs.)
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I'm talking about a double-blinded, randomized, toxicity test starting from the pre-clinical process(animal models) this is how the process is supposed to start(they did them daily in the vivarium at the PTC building at the University I went to). We havent even gotten past animal models to even think about clinical human testing.
And ,your right, IF the e-cig marketers would have CHOSEN to initially market their product AS tobacco entities and gotten the proper Local, State or Federal bureaucracies to sign up with this scenario from the start. But that (as I mentioned in my previous post) did not happen. Nothing happened, they just started selling through local distributors and mall kiosks.
It all comes down to this. No Federal, state or local government in the USA is going to let anyone into their market with an untested , novel product(intended for human consumption) without SOME type of prior approval or, at least, basic communication of intent with some health official, somewhere in the bureaucratic apparatus. Thid did not happen with e-cigs. So it doesn't matter what you want to classify or call or label e-cigs NOW, after the fact. Someone selling these things should have had the miniscule amount of foresight to have spoken to an attorney or governmental official back in 2007. It's too late now, e-cig manufacturers/distributors have woken the ire of the sleeping FDA tiger through plain marketing negligence. And ALL vapers now have to live with the consequences of this lack of foresight. I've had this conversation now with dozens of different people in 4 different forums. I'm done. Believe what you want to believe, but that is the plain and simple truth about what is happening here.
It's not "after the fact." In SE vs. FDA the judge ruled that the e-cigarette sellers in the suit had always advertised their product as a smoking/tobacco product. Intended use (as marketed) determines whether or not it's a drug delivery device, NOT just the FDA's opinion or how people actually use it. This is the very argument being made in the WLF amicus brief. It was the FDA (and the public health groups pushing them) that created this and the same situation would have resulted no matter what channels the e-cig sellers traversed.
The manufacturers had every reason to believe that they were covered as a tobacco product and testing as a cessation device was not necessary. If the FDA had issue with those sellers who WERE advertising as smoking cessation devices, then they should have gone after those specific companies - not the industry as a whole. When the FDA went after Cheerios for making health claims, they did not attempt to ban EVERY cereal brand.
So long as tobacco cigarettes remain on the market, there is no valid claim to require any higher standards (ie. safety testing) for electronic cigarettes.
No matter what channels the e-cigarette sellers attempted to go through, they would have been blocked, because of the potential financial impact they have on the bottom line to government and Big Pharma revenue. The FDA still would have required them to go through testing as a drug delivery device, which would have kept them off the market indefinitely. They'd actually be worse off, because there would be no vapers to argue for keeping them - we never would have had the chance to try them. Getting them out to consumers first gave them the best chance for survival.
This has nothing to do with e-cigarette sellers going through the right channels or having proper testing, because the goal of the FDA and the public health groups is not really protecting public health - they are protecting their financial interests.
The manufacturers had every reason to believe that they were covered as a tobacco product and testing as a cessation device was not necessary. If the FDA had issue with those sellers who WERE advertising as smoking cessation devices, then they should have gone after those specific companies - not the industry as a whole. When the FDA went after Cheerios for making health claims, they did not attempt to ban EVERY cereal brand.
So long as tobacco cigarettes remain on the market, there is no valid claim to require any higher standards (ie. safety testing) for electronic cigarettes.
No matter what channels the e-cigarette sellers attempted to go through, they would have been blocked, because of the potential financial impact they have on the bottom line to government and Big Pharma revenue. The FDA still would have required them to go through testing as a drug delivery device, which would have kept them off the market indefinitely. They'd actually be worse off, because there would be no vapers to argue for keeping them - we never would have had the chance to try them. Getting them out to consumers first gave them the best chance for survival.
This has nothing to do with e-cigarette sellers going through the right channels or having proper testing, because the goal of the FDA and the public health groups is not really protecting public health - they are protecting their financial interests.
Has anyone gone over the Runyan financed, but independent lab, tests on their brand of electronic cigarettes?
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May The Vapor Be With You
On the basis of findings to date, inhaling mist from the e-cigarette is rated several orders of magnitude (100 to 1000 times) less dangerous than smoking tobacco cigarettes. The nicotine dose per puff is comparable to that of a medicinal nicotine inhaler. E-cigarette nicotine is apparently not absorbed from the lung, but from the upper airways.
<http://www.healthnz.co.nz/ecigarette.htm>
Is this the most comprehensive study done to date?<http://www.healthnz.co.nz/ecigarette.htm>
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May The Vapor Be With You
The problem is that what "should" have been done re: toxicology and animal studies related to identification as a drug delivery device wasn't. So the real question is where do we go from here?
A clinical trial is being designed END-IT: Electronic Nicotine Device Intervention Trial by a group that published a limited clinical trial http://www.healthnz.co.nz/2010%20Bullen%20ECig.pdf. Even the Eissenburg study -as poorly done as it was- showed no safety issues.
Personally, I see e-cigs as a consumer product, not a medical device. IMO regulation should be along the lines of other consumer products. Since the track record for safety in terms of new medicines and drugs isn't great, the greater regulation associated with drugs and drug delivery devices doesn't appear to give much additional protection. More money and a false sense of security...there are some scary products on the market these days.
A clinical trial is being designed END-IT: Electronic Nicotine Device Intervention Trial by a group that published a limited clinical trial http://www.healthnz.co.nz/2010%20Bullen%20ECig.pdf. Even the Eissenburg study -as poorly done as it was- showed no safety issues.
Personally, I see e-cigs as a consumer product, not a medical device. IMO regulation should be along the lines of other consumer products. Since the track record for safety in terms of new medicines and drugs isn't great, the greater regulation associated with drugs and drug delivery devices doesn't appear to give much additional protection. More money and a false sense of security...there are some scary products on the market these days.
Hmmm ... There is at least one negative fact identified in this study :
Propylene oxide is an epoxide. Epoxides are known mutagens and carcinogens, although there was a study done in France which showed no co-relation between epoxides inhaled in cigarette smoke and lung cancer.
Also, it could be that combustion is responsible for the oxidation process, or that the propylene oxide is a remnant from the process used to make propylene glycol, as propylene glycol is hydrolized propylene oxide.
It might bear looking into ...
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