Response from Senator Brown (Ohio)

[TomC]

I just received this from Sherrod Brown's office. He is one of our US Senators from Ohio. I had originally emailed his office whining about some bill that unfortunately ties funding for some very good programs to some reclassification that could impact this community. I have to admit I don't know all of the details but I don't want my e liquid taxed like tobacco or regulated like prescription medication.

That said, however, if the tests that were run are indicative of the quality control out there, that's kind of scary. I'm trying to SLOWLY reduce my nicotine consumption by getting weaker and weaker liquids (I'm ordering 12 mg / ml now) I expect the stuff that I find on the grocery shelves to contain what it says it contains on the label, in the amounts stated. I should expect no less from our suppliers.

Hopefully the results were an anomaly and that further testing reveals that quality control is pervasive throughout the supplier community.
----------------------------------------------------------------------------------------------------------------
Dear Mr. Crable:

Thank you for sharing your views on electronic cigarettes and for taking the time to write about your experiences.

Electronic cigarettes are an alternative to tobacco cigarettes designed to deliver nicotine or other substances in the form of a vapor. They have a rechargeable heating component that warms an internal cartridge containing the nicotine and converts the contents of the cartridge into an inhalable substance.

In September 2010, The Food and Drug Administration (FDA) stated that the production quality of electronic cigarettes is substandard or non-existent in terms of Federal health standards which are in place to protect the public’s well-being. The FDA tested cartridges labeled as containing no nicotine but in fact, did contain nicotine. Additionally, after testing cartridges with the same label, the FDA found drastically different amounts of nicotine in each of the cartridges. Consumers should be able to trust a label and not unknowingly inhale nicotine or higher levels of nicotine as many are when using electronic cigarettes.

Consequently, the FDA sent letters to five electronic cigarette distributors citing violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA has stated that if the Electronic Cigarette Association is willing to cooperate with the Federal Agency, it is possible for the product to receive FDA approval.

I will continue to monitor this situation with your letter in mind. Thank you again for being in touch with me.

Sincerely,

Sherrod Brown

United States Senator

 

[cigarbabe]

That is the standard form letter every senator I wrote to {and there were quite a few!} sent out tomc. I also sent a letter to Sherrod Brown.
Listen, the testing that was done on those few (18?) cartridges were all from China I believe and those tests are now years old. Most of us don't buy that kind of stuff and they only tested a couple of brands anyway.
Why anyone would believe what the FDA says is beyond my comprehension and I'm really not taking a shot at you personally tomc. It is just that they have a history of obfuscating the truth about what they do and what is "safe".
If you read the whole study you'll see what they found and that does not jibe with the reports they have put out. Their own study actually did not find anything in the vapor including nicotine and honestly they didn't find any dangerous chemicals in the juices beyond what you'd find in any other NRT.
They lied about the severity of what they actually found. They really didn't find any "poisonous,deadly anti-freeze" or enough levels of dangerous chemicals to harm you although I'm sure they would have liked to!
Their press release was just a scare tactic to make it look as if they were doing something worthwhile for the people who fund the FDA's coffers and whom ecigs are in direct competition with imo.
I do agree with you that when you ask a company to disclose what is in their juice it should be the same ingredients that they say is in there.
C.B.

 

[Huffelpuff]

IMHO when Big Brother gets involved we will be paying $5 a ml and vaping 2mg juice - if we get a prescription.

 

[Ande]

I agree that we should be able to count on vendors to supply what it says on the label.

The best way to ensure this, though, is NOT to take them off the market. Which is what the FDA has tried (and failed, so far) to do.

Interesting that they don't mention that the FDA was being sued (in a case they LOST) when they did that one study. Pressure to find negative results must have been high, but as far as negative results go, they didn't get much.

Science is meant to be repeatable in order to be believable. Yet we still hear about the ONE FDA study. Why has nobody, ever, not even the FDA, has been able to repeat. I'm getting ready to believe that there was only ever ONE cartridge with diethylene glycol in it (if there were that many) and the FDA found it. Either that, or...they wouldn't lie to us, would they?

Best,
Ande

PS- last line would have been adorned with a "scathing sarcasm" emoticon, if I knew how to do such things.

 

[ByStander1]

Thank you for posting this, tomc.

Please bare in mind the following... We must always try to compare apples to apples.

The only valid comparable for a personal vaporizer is to tobacco cigarettes. When's the last time you saw a cig pack with the 599 ingredients listed? Hmm? Oh yeah, those manufacturers didn't even disclose the ingredients to the FDA until the 90's! Yet this product was on the market for decades. This product will continue to be on the market without a consumer listing of the ingredients -- it's an economic "cash cow."

If anything were to be a valid labeling requirement, it would be "use at own risk." There could be no analog warnings like, "May cause emphysema" etc., because there's no such history (ever).

Proper labeling is a customer service issue. Customers expect truthful labeling. If they don't get it, the company will not last long. Just like timely shipping, customers will take their business to those vendors that supply quality service.

But even with all of the slapshod service, non-existent quality controls, etc. that some vendors have offered their customers, there have been ZERO serious side effects from using personal vaporizers.

Regulation is not the answer, it is a sound bite for politicians and lobbyists. A free enterprise market is the best way to get the best products. Period.

 

[TomC]

I hope I didn't give anyone the impression that I am for more regulation. Far from it. What we need if for the supplier community to police themselves. I truly believe that the only way to avoid excessive regulation is to be able to show that the proposed targets of those regulations can do a better job themselves.

Thanks for reading and responding. Didn't mean to get anyone fired up.

 

[Vocalek]

Dear Tomc: It's a shame that Brown's letter generated enough concern on your part to make you want to stop using e-cigarettes ASAP.

Brown's letter relied on the Press Release issued by the FDA. The press conference was aimed at discrediting e-cigarettes and made use of several propaganda techniques. Take the word "antifreeze" for example. One propaganda technique is Name Calling: It is the use of derogatory language or words that carry a negative connotation when describing an enemy.

We all know that antifreeze has poisoned children and animals, so using that word is calculated to engender feelings of unease, if not outright fear. But the truth of the matter is that diethylene glycol is better known for being a widely used solvent. So imagine the emotional impact if we reworded the FDA's press release to say, "...toxic chemicals such as diethylene glycol, an widely used solvent." Still feeling anxious, but not necessarily experiencing panic. Or even if the sentence ended after the word "glycol." They already stated that it can be toxic. That should be enough.

But just how toxic is it? The FDA allows concentrations of up to 0.1% in products used by humans, and they did find 1% concentration in one cartridge that holds at most, 0.5 g. So let's say there was a total of 5 mg of DEG in that cartridge. According to toxicologists, the lethal dose is between 1.0 and 1.63 g/kg of body weight. So to reach a lethal dose, one would need to uncap and drink the contents of 200 cartridges for each kg of body weight. And since DEG clears the body quickly, these several liters of liquid would need to be consumed in a single day.

But wait! People don't drink the liquid! They vaporize it.

If you check the lab report issued by the FDA, they did not find any DEG at all in the vapor, perhaps because DEG vaporizes at higher temperatures than PG. http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

In view of the fact that e-cigarettes are used a replacement for smoking, to paint a more complete picture, the FDA should have mentioned that DEG is present in cigarette smoke. Progress Report for the Month Ended 360430 Philip Morris & Co., Ltd. Industrial Fellowship No. 230 - 5 Examination of Alcohol Smoke Solutions From Glycol Cigarettes Proposed Polaregraphic Work on Smoke Solutions Quantitative Estimation of Aldehyde Co

Speaking of an incomplete picture, another propaganda technique is Card Stacking, or selective omission. It involves only presenting information that is positive to an idea or proposal and omitting information contrary to it. Notice how the FDA press release states that they found "carcinogens" (another incidence of name-calling). But nowhere does the FDA mention the quantity found. Professor Murray Laugesen conducted tests in October of 2008 and found that a 16 mg. carrtridge contains 8 ng/gram of Tobacco-specific Nitrosamines (TSNAs) and notes that this is the same quantity found in an approved medicinal nicotine patch! Out of curiosity, I looked up how much of this stuff is in cigarette smoke, and discovered that Marlboro full flavor contains 6,200 ng/g. http://www.starscientific.com/404/stepanov tsna in.pdf

The bottom line: Don't believe everything a politician tells you. Don't believe everything the FDA says.

The most important thing for your health is that you continue to be able to stay off smoke. If you can stop using the e-cig and still remain smoke-free, that is fine. But if you feel urges to smoke, please consider going back to e-cigs before you even dream about going back to smoking.

 

[Bill Godshall]

Sherrod Brown's reference to FDA actions in September 2010 failed to acknowledge that at the time, FDA was still falsely and unlawfully alleging that e-cigarettes are unapproved "drug devices", was still unlawfully claiming e-cigarettes were banned, and US Customs was still unlawfully seizing e-cigarette shipments by enforcing FDA's unlawful ban.

Brown's letter also failed to mention that all 13 federal judges who considered the lawsuit (filed by SE and NJOY challenging the FDA's attempted e-cig ban) unanimously rejected the FDA's fearmongering claims and ruled that FDA's attempt to ban e-cigarettes was unlawful. And of course, Brown's letter failed to mention that on April 25, 2011, the FDA conceded the lawsuit and agreed to abide by Judge Leon's ruling (rendering all of FDA's previous actions on e-cigarettes to be legally null and void).

Sherrod Brown's letter also grossly misrepresented the FDA's two different laboratory report findings in a deceitful attempt to demonize the products and scare the reader. Both FDA lab reports have been discussed here on ECF on other threads.

The FDA grossly misrepresented its own 2009 lab report findings (which were conducted on just two e-cig company's products, the same two companies that had just sued the FDA) because the FDA wanted to win the lawsuit, and because demonizing the products and scaring the public was part of FDA's failed legal strategy. Although FDA's 2009 lab report found no hazardous levels of anything in any e-cig products, the FDA issued a press release and held a press conference claiming that toxic chemicals and carcinogens were found.

In the second FDA lab test in 2011, FDA researchers confused the nicotine levels in various e-cigarette cartridges by inaccurately presuming (and insinuating in their report) that all e-cigarette cartridges contained 1 ml of e-liquid (even though the cartridges they tested only contained about .4 ml of e-liquid). Instead of realizing their own incompetence, the arrogant FDA researchers then falsely accused many e-cig companies of mislabelling the nicotine content of their products.

To its credit, the FDA's second lab test did discover and report some legitimate labelling anomolies in the products sold by one Chinese e-cig company (Cixi) that I never heard of before or since, and that apparently has very little sales. I suspect that Cixi's products were only included in the FDA's second lab test because the company had some mislabelled products.

Brown's letter also misrpresented the five letters sent by FDA (in September 2010) to e-cig companies, as those letters cited alleged "therapeutic" claim violations made by the five companies. While several claims by several companies could legally be considered to be "therapeutic", most of the allegedly illegal claims cited by FDA were truthful, were legal, and were clearly not "therapeutic" (e.g. e-cigarettes can help smokers reduce their cigarette consumption). But even if all five companies had made blatantly illegal claims, five companies represent just one percent of e-cigarette companies in the US, which of course Brown's letter never mentioned because its goal was to demonize all e-cigarette companies.

Brown's letter also misrepresented the FDA's letter to the then defuct ECA, as FDA's letter stated that the agency wanted the ECA to collaborate with the FDA in enforcing FDA's unlawful attempt to ban e-cigarettes by falsely classiffying them as "drug devices".

Would Brown similar demonize all car tires and all tire companies based in Ohio because just one or two tire companies made a misleading claim about one tire brand, or because several tires were mislabelled. Of course not, as he's just grandstanding against all e-cigarettes.

In sum, Brown's letter is deceitful.

 

[DaveP]

Amidst the turmoil, maybe we will see some education of our government officials as they make an attempt to learn about the product they are regulating. Our input will help.

 

[wfx]

Speaking of an incomplete picture, another propaganda technique is Card Stacking, or selective omission. It involves only presenting information that is positive to an idea or proposal and omitting information contrary to it.

excellent point. this is exactly the method being employed.

fortunately it's easy to fill the gaps and complete the picture, but the party to communicate those gaps is critical.

for example, if health canada were to do a serious analysis it would expose these guys as the pharma shills that they are.

 

[Placebo Effect]

TomC, make a copy of your original letter and Senator Brown's response, and then copy Bill Godshall's response into a document, but attribute it to yourself.

Sign the letter and send it to his legislative office in D.C., but address it to Jeremy Hekhuis. Hekhuis is Brown's legislative director.

Might not make a dime's worth of difference, but you might as well.

 

[cigarbabe]

TomC let me know if you do as Placebo Effect suggested if not I would be willing to send it to his legislative director in my name.
I think I will send it to all those who sent me this same lame form letter as a matter of fact if Bill doesn't mind?
C.B.

 

[BadThad]

Brown is an idiot and worthless.

 

[BadThad]

Dear Tomc: It's a shame that Brown's letter generated enough concern on your part to make you want to stop using e-cigarettes ASAP.

Brown's letter relied on the Press Release issued by the FDA. The press conference was aimed at discrediting e-cigarettes and made use of several propaganda techniques. Take the word "antifreeze" for example. One propaganda technique is Name Calling: It is the use of derogatory language or words that carry a negative connotation when describing an enemy.

We all know that antifreeze has poisoned children and animals, so using that word is calculated to engender feelings of unease, if not outright fear. But the truth of the matter is that diethylene glycol is better known for being a widely used solvent. So imagine the emotional impact if we reworded the FDA's press release to say, "...toxic chemicals such as diethylene glycol, an widely used solvent." Still feeling anxious, but not necessarily experiencing panic. Or even if the sentence ended after the word "glycol." They already stated that it can be toxic. That should be enough.

But just how toxic is it? The FDA allows concentrations of up to 0.1% in products used by humans, and they did find 1% concentration in one cartridge that holds at most, 0.5 g. So let's say there was a total of 5 mg of DEG in that cartridge. According to toxicologists, the lethal dose is between 1.0 and 1.63 g/kg of body weight. So to reach a lethal dose, one would need to uncap and drink the contents of 200 cartridges for each kg of body weight. And since DEG clears the body quickly, these several liters of liquid would need to be consumed in a single day.

But wait! People don't drink the liquid! They vaporize it.

If you check the lab report issued by the FDA, they did not find any DEG at all in the vapor, perhaps because DEG vaporizes at higher temperatures than PG. http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

In view of the fact that e-cigarettes are used a replacement for smoking, to paint a more complete picture, the FDA should have mentioned that DEG is present in cigarette smoke. Progress Report for the Month Ended 360430 Philip Morris & Co., Ltd. Industrial Fellowship No. 230 - 5 Examination of Alcohol Smoke Solutions From Glycol Cigarettes Proposed Polaregraphic Work on Smoke Solutions Quantitative Estimation of Aldehyde Co

Speaking of an incomplete picture, another propaganda technique is Card Stacking, or selective omission. It involves only presenting information that is positive to an idea or proposal and omitting information contrary to it. Notice how the FDA press release states that they found "carcinogens" (another incidence of name-calling). But nowhere does the FDA mention the quantity found. Professor Murray Laugesen conducted tests in October of 2008 and found that a 16 mg. carrtridge contains 8 ng/gram of Tobacco-specific Nitrosamines (TSNAs) and notes that this is the same quantity found in an approved medicinal nicotine patch! Out of curiosity, I looked up how much of this stuff is in cigarette smoke, and discovered that Marlboro full flavor contains 6,200 ng/g. http://www.starscientific.com/404/stepanov tsna in.pdf

The bottom line: Don't believe everything a politician tells you. Don't believe everything the FDA says.

The most important thing for your health is that you continue to be able to stay off smoke. If you can stop using the e-cig and still remain smoke-free, that is fine. But if you feel urges to smoke, please consider going back to e-cigs before you even dream about going back to smoking.

Thank God for people like you! I've been blowing holes in utter garbage from the FDA/Gov for decades, you did an excellent job at this frustrating task.

 

[Vaprific]

I agree that we should be able to count on vendors to supply what it says on the label.

The best way to ensure this, though, is NOT to take them off the market. Which is what the FDA has tried (and failed, so far) to do.

Interesting that they don't mention that the FDA was being sued (in a case they LOST) when they did that one study. Pressure to find negative results must have been high, but as far as negative results go, they didn't get much.

Science is meant to be repeatable in order to be believable. Yet we still hear about the ONE FDA study. Why has nobody, ever, not even the FDA, has been able to repeat. I'm getting ready to believe that there was only ever ONE cartridge with diethylene glycol in it (if there were that many) and the FDA found it. Either that, or...they wouldn't lie to us, would they?

Best,
Ande

PS- last line would have been adorned with a "scathing sarcasm" emoticon, if I knew how to do such things.

Although I feel slightly irresponsible saying this without providing the reference, on a medical science site I visited there was a thread about that study. One seemingly intelligent and informed vaper explained the existence of trace amounts of Diethylene Glycol (sp?) as due to that cartridge being a tobacco flavored cartridge with tobacco abstract used in the flavoring. He said that DEG is used to keep the tobacco leaves moist in transit which is why some ended up in that cartridge. The misleading bit he called out was that they reported it as a KEY ingredient in the liquid, although it was measured less than one percent. I'll see if I can find that site again, I hate putting out info without the references, makes me feel as I'm as bad as the spin doctors we're fighting lol

 

[Vaprific]

Here I believe this is the one:

Science-Based Medicine » e-Cigarette Safety

Pretty long but a compelling read. As usual it gets ...a bit frisky. Scientist types ready to throw down lol