Action regarding FDA: No banter here, please

[nitewriter]

I have posted this in another thread, but I wanted to post it here as well for your opinions.

I can't help but think if we could find another use for it, they couldn't do anything about it. This company "Bogetech.com" sells vitamin e-liquids. Couldn't we change it's "purpose" to a vitamin delivery system and keep regulation away from it?

Here are some of the flavors they offer:

VitaminA, Vitamin B,Vitamin C, Vitamin E, Coenzyme Q10, CoenzymeQ10+VitaminA,Coenzyme Q10+Vitamin B, Coenzyme Q10+Vitamin C, Coenzyme Q10+Vitamin , collagen,carotene,ginseng.

Opinions please

 

[blackopz]

I’m new to E- cigs had almost a two pack a day habit and yesterday smoked zero analog cigs. Obviously, the benefits of e-cigs are countless but I think the only way to derail the FDA train if for the bigger retailer to contact and get backing from the Chinese manufactures. It would be to their interest to invest in the propagation of e-cigs. As with everything in our government money talks and no amount of logic concerning the safety of e –cigs (or should we now call them personal vaporizers) will overcome the tobacco companies from pouring campaign contributions to the e –cig opposition.

 

[TropicalBob]

That's a good thought, Nitewriter, and might be useful in the future. We have long suggested that inhaling vapor could be healthy if other healthy chemicals, such as vitamins, were included in the liquid. Just browse the herbal section of a health food store and note treatments for "cough", "stuffiness" and even "nicotine addiction." Our liquids could treat many conditions -- but makers would have to be very careful not to step over a line that makes these "medical devices".

Our problem is immediate. If the supply is halted, a new tact must be taken to get e-smoking back to the market. Problem: Most users will need nicotine, or the practice is nothing but "placebo pretend." But these might succeed as vitamin-delivery systems, although I prefer marketing them as nothing more than vapor-producing novelties.

Whatever, we need to put our thinking caps on for a legal way to obtain devices and liquid. Thanks for doing your part.

 

[IntoxiNation]

One problem. Vitamins are also under FDA control:

http://www.nytimes.com/2007/06/23/washington/23fda.html?partner=rssnyt&emc=rss

Even worse, they recently declared B-6 a drug, meaning that more vitamins are likely to follow. Someone has been on a power trip at the FDA lately. I guess its from all the bad press involving food problems, so they feel the need to go gung ho on everything.

 

[katink]

Thanks for your thoughts Yvilla (and don't hit yourself on the head for 'coming out'... it was quite clear anyway that you were in the legislative field somewhere ).
Have you also looked at not so much finding something aimed at the FDA - but instead a case (class- or individual suit, whatever) aimed at other bodies that would then in turn get the FDA away from this?
Lets say international law; or human rights under the UN; or something stopping the government (who in turn would have to stop the FDA as a result)... in short, in roundabout-ways?

 

[nitewriter]

yvilla, Katink, TBob, or anyone else. Have you ever heard of "International Society for Individual Liberty?" It seems they've dealt with the FDA over other issues. Here's an interesting article I came accross on their site. ISIL -- Death By Regulation: The Price We Pay for the FDA

I thought it was worth mentioning and getting your opinions on.

 

[katink]

Nitewriter, interesting find. And a depressing and in my view all-too-true read concerning the FDA...
What I miss, is seeing how they 'dealt' with the FDA - they write about what is wrong; but I don't read about solutions, about ways to handle the FDA... they point out the wrongs, to the degree that the conclusion almost must be 'lets dismantle the FDA'. But well, that's hardly in the hands of ordinary citizens...
Do you see how this group could be of help in a practical way? Would be nice if they had tools/ways for that of course!


@Mickey: I'm not sure if you did, but as to hazards for heavy metals/contamination that Dr. Nitzkin was mentioning: did you get along what I had posted before about that? The ROHS-certicication under which almost all chines manufacturers are working, and to which almost all or all their devices are certified by? ROHs may be a european certification; but of course that makes no difference, in effect: the devices sold in europe are the same as sold in US, so are ROHs just like the european devices are.

Also, as to bacterial worries: aren't both PG and nicotine known bacteria-killers? Also, while US might not give this any attention, afaik the liquid-manufacturers I have looked at (their sites) do state they work under compliance of government, and also have several health-certifications they are working under (deKang for instance, who supplies 90% of all liquid made, works under SGS-certificate: Yunnan Dekang Biotechnology Co., Ltd )

 

[hyperdeficit]

I think an important issue is the fact that the FDA is seizing suppliers shipments without a ban being passed. as far as I know they are randomly selecting suppliers and taking their shipments. E smokey treats just got seized, and puresmoker got seized a little while ago.

If no ban is passed then why are they allowed to do this.

I believe that the FDa just saw the news article and freaked out. When Readers DIgest slammed cigarettes before filters were around. People freaked out, but they didnt stop selling unfiltered cigarettes. They didnt ban unfiltered cigarettes, they kept selling them until somebody invented the filter.

They dont need to seize juice, some people have been e smoking for 3 years and more and havent keeled over dead. They need to stop seizing until SOLID evidence says they can or cannot. ( I know that e smoking is safer than analogs and this is ludicrous)

What they really want is profits of their own from taxes. they shouldnt be able to tax it at all since it is not tobacco. I tried to research and as far as I could see nicorette or the patch was not taxed (although it was a quick search mind you). They should not be owed to tax it. If the juice is somewhat dangerous we just need to make sure it is safe.

enough niceties aside this whole thing is F**ING STUPID

 

[miller]

The FdA study needs to be read with a critical eye. First the nitrosamines present were detected but not at a level that was quantifiable. THe FDA found tobacco impurities in ppb that is parts per billion, with ppb being the limit of measurement, you can safely surmise that the carinigens in the nitrosamine analytes are present in quantities not measurable- otherwise the FDA would have quantified the amounts, (cigarette smoke nitrosamines are present and measured in ppm, parts per million (or ng- nanograms; ex.the analyte NNN is measured at 390ng or 390 ppm.

While there was nicotine detected in the no nicotine cartridges this was only exhibited when the solution was subjected to 280 degrees centigrate, when the solution was heated to 60 degrees centigrate, the operating temperature of ecigs, no nicotine was found. The reason for the presence of nicotine in certain but not all of the no nicotine capsules can be attributed to using the same equipment to fill both nicotine and non- nicotine capsules. This cross contamination needs to be addressed and I am sure it will be.

Moreover the tobacco specific impurities detected in certain of the ecigs are present in all tobacco products and ad the nicotine in ecigs is derived from tobacco it is no surprise that they are present, it is important however to note that the impurities are a fraction of their presence in other tobacco products and even in NRT products such as Nicotrol. This fact is noted in the fine print of the FDA study. I urge you all to examine the study itself.

Moreover, the study as presented by the FDA can only serve to demonstrate that ecigs should be treated as tobacco products as all if the constituents therein and all of the elements identified by the FDA are in fact tobacco products/analytes.

I am displeased with the presence of DEG in one of the 19 samples, however the FDA in it's study does not quantify the amount detected, which I really wish they would. BTW DEG is one of the 4,000 chemicals in cigarettes, and if the amount detected exceeded what we find in cigarettes the FDA would have quantified in.

Lastly, I am surprised and bothered that 1) the FDA took this long to release the data, since the study wad conducted within one weak of SE's filing of it's lawsuit against the FDA and 2) I am amazed that the FDA did not tender this report to the court and make it apart of the record, thereby allowing Judge Leon to consider it within the scope of the parties respective arguments. With the findings of the study I don't see how judge Leon can find ecigs anything other than tobacco products. Which would subject ecigs to the new and unestablished tobacco legislation as opposed to a drug and medical device standard.

 

[lvlninety9]

Lastly, I am surprised and bothered that 1) the FDA took this long to release the data, since the study wad conducted within one weak of SE's filing of it's lawsuit against the FDA and 2) I am amazed that the FDA did not tender this report to the court and make it apart of the record, thereby allowing Judge Leon to consider it within the scope of the parties respective arguments. With the findings of the study I don't see how judge Leon can find ecigs anything other than tobacco products. Which would subject ecigs to the new and unestablished tobacco legislation as opposed to a drug and medical device standard.

Regarding their not submitting this to the courts I can see but only one reason. And it's the reasoning you gave in your earlier posts. By delaying the release of this information and not providing it as evidence in the court provides them with a number of options. The first being that it can't be argued and declared invalid by the court. For 2 if that was admitted into evidence then they would have to disclose it to the attorney's who can then proceed to rip it apart and provide the truth. To release this information at a later date it gives them the opportunity to use it as a scare tactic. And to be quite honest in a lot of ways it is working. Judge Leon would have more then likely asked for the results of the testing they had done and if he did not then the attorney's for SE and Njoy would have.

Why subject your findings to scrutiny in court and possibly have it discredited when you can sit on this information and use it as a scare tactic later on. A lot of people argue about the date of release of this information but honestly it was a VERY smart move in part of the FDA. Now it's up to us everyone else to try and bring out the truth of that study.

 

[seminolewind]

The FDA takes advantage of the fact that millions of people actually believe supermarket tabloids.
The FDA should be sued for their sensationalized generalized way they announced their findings. They should be sued for the fact that they didn't disclose all the facts, such as levels of nitrosamines in NRT's, and nitrates in foods.
It's (not) amazing how the public remembers the FDA's track record. Thalidimide? Propanolol? others?

 

[LbizMan]

I want to point some things out here...
The FDA said they found Diethylene Glycol, Not ethylene glycol that is used in antifreeze. They are different chemicals with diethylene glycol being no where near as toxic as ethylene glycol. Also find me one company that uses diethylene glycol in antifreeze... I bet you can't because they don't use it.

Note that this was taken from the transcript of the conference:

"And then a number of chemical impurities related to nicotine were
detected and then in one sample there the diethylene glycol the
presence of diethylene glycol was detected and this is a toxic of
material somewhat akin to what is the ethylene glycols in antifreeze."


This is taken from the summary:
"Diethylene glycol was detected in one cartridge at approximately 1%.
Diethylene glycol, an ingredient used in antifreeze, is toxic to
humans."

- Note how they said it is used in antifreeze and not the verbage
"somewhat akin to ethylene glycol used in antifreeze"
This is a deliberate broadcast of misinformation. How can the fda, the
same organization that tends to hammer down the tiniest details, make
this mixup. Was it deliberate?

This is how the media is portraying this:
"The Food and Drug Administration on Wednesday released an analysis of
19 varieties of electronic cigarettes that said half contained
nitrosamines (the same carcinogen found in real cigarettes) and many
contained diethylene glycol, the poisonous ingredient in antifreeze.
Some that claimed to have no nicotine were found to have low levels of
the drug."


There has to be some sort of defense that can be used against the FDA
for causing a mass hysteria for delivering wrong or under-articulated
information... This is a danger to the public. This is a deliberate
spread of wrong information, how is that legal? We need to force them
to come out with a new statement clearly pointing out that Diethylene
glycol was found and not ethylene glycol, the ingredient in
antifreeze. They say they found a chemical but then they represent it
as that chemicals dangerous relative.


Thanks,

Liam B

PS: I did include all links to references however since I am a new member I could not post links.

 

[alyx727]

The local paper here in Sarasota just published another "scare" editorial about e-cigs containing the chemical "found in antifreeze". Propylene glycol IS found in anti freeze..the non toxic variety. They neglected to state that it is also found in; baby wipes, food substances, cosmetics, contact lens solution, blah, blah, blah.

It is very disheartening that the media and the government go to such lengths to commit the sins of omission and do half@ssed research because of ignorance, greed (can you say taxes), and plain narrow-mindedness. There is no trust anymore in the factions that are in place to inform or protect us.

I am just bummed. But I have sufficient supplies to weather the storm..

E-cigs have helped me immensely in my attempt to quit tobacco!!

Alyx

 

[LbizMan]

The local paper here in Sarasota just published another "scare" editorial about e-cigs containing the chemical "found in antifreeze". Propylene glycol IS found in anti freeze..the non toxic variety. They neglected to state that it is also found in; baby wipes, food substances, cosmetics, contact lens solution, blah, blah, blah.

It is very disheartening that the media and the government go to such lengths to commit the sins of omission and do half@ssed research because of ignorance, greed (can you say taxes), and plain narrow-mindedness. There is no trust anymore in the factions that are in place to inform or protect us.

I am just bummed. But I have sufficient supplies to weather the storm..

E-cigs have helped me immensely in my attempt to quit tobacco!!

Alyx

Alyx,

They found diethylene glycol in the FDA study. That's what the concern is, not propylene glycol.

Secondly, diethylene glycol is NOT in antifreeze. Ethylene glycol is in antifreeze and is the poisonous substance. However if you read the FDA press conference transcript they very openly say "in one sample there the diethylene glycol the presence of diethylene glycol was detected and this is a toxic of material somewhat akin to what is the ethylene glycols in antifreeze."

But yet the media is portraying it as diethylene glycol is the poisonous substance in antifreeze... which it is not - It's not even in antifreeze.


Liam B
Electronic Cigarettes Inc

 

[quititllc]

Alyx,

They found diethylene glycol in the FDA study. That's what the concern is, not propylene glycol.

Secondly, diethylene glycol is NOT in antifreeze. Ethylene glycol is in antifreeze and is the poisonous substance. However if you read the FDA press conference transcript they very openly say "in one sample there the diethylene glycol the presence of diethylene glycol was detected and this is a toxic of material somewhat akin to what is the ethylene glycols in antifreeze."

But yet the media is portraying it as diethylene glycol is the poisonous substance in antifreeze... which it is not - It's not even in antifreeze.


Liam B
Electronic Cigarettes Inc

Diethylene glycol IS similar to ethylene glycol. Both are diol alcohols.
Ethylene glycol has two hydroxide groups (-OH) at the ends, with two CH2 (alkyl?) groups in the middle. Formual OH-CH2-CH2-OH
Diethylene glycol has an extra set of these CH2 pairs, with an oxygen binding in the middle. OH-CH2-CH2-O-CH2-CH2-OH.

I wish I could show the molecular geometry.
Not a rocket scientist here, just a pre-med student finished with chemistry. Can't remember what group CH2 is called though, damn organic chem.

NONE THE LESS it was a terrible scare tactic.

 

[lvlninety9]

Alyx,

They found diethylene glycol in the FDA study. That's what the concern is, not propylene glycol.

Secondly, diethylene glycol is NOT in antifreeze. Ethylene glycol is in antifreeze and is the poisonous substance. However if you read the FDA press conference transcript they very openly say "in one sample there the diethylene glycol the presence of diethylene glycol was detected and this is a toxic of material somewhat akin to what is the ethylene glycols in antifreeze."

But yet the media is portraying it as diethylene glycol is the poisonous substance in antifreeze... which it is not - It's not even in antifreeze.


Liam B
Electronic Cigarettes Inc

Actually it is used as an antifreeze. It's also used in a lot organic applications.

Diethylene Glycol

Diethylene glycol is also used in brake fluid, printing ink, and glue.. You'd be surprised at the uses of this stuff.

 

[Bill Godshall]

B. J. Westenberger's FDA "Evaluation of e-cigarettes" http://www.e-cig.org/Evaluation_e-cigarettes(2).pdf was sent to Michael Levy on May, 4, 2009, the day before the FDA's originally scheduled and announced press conference to condemn e-cigarettes Leaked FDA Email on the Electronic Cigarette

In responding to my May 1st letter
Smokefree Letter to FDA
that helped convince the FDA to postpone its May 5 press conference,
the FDA also misrepresented it policy and planned actions in its reply to me (below).

From: "Hitch, Mary C", INTERNET:Mary.Hitch@fda.hhs.gov
To: , SMOKEFREE
Date: 5/1/2009 5:05 PM
RE: Email from Heather Zawalick (CBER)

Dear Mr. Godshall:

Your communication was forwarded to me for response as a function of
FDA's Office of External Relations. The email to which you refer
contains factual errors and does not reflect an official FDA action or
policy.

Sincerely,

Mary C. Hitch
Senior Policy Advisor
Office of External Relations
U.S. Food and Drug Administration

Mike Siegel has posted some excellent criticisms of FDA on e-cigarettes at:
The Rest of the Story: Tobacco News Analysis and Commentary

Brad Rodu also posted an excellent scientific analysis at:
Tobacco Truth

A DC Examiner column "FDA wrong about e-cigarettes says FDA study." by Cameron English, El Dorado County Conservative Examiner is at:
FDA wrong about e-cigarettes, says FDA study 26 July 2009

The following references demonstrate that nitrosamines are also in many other products regulated (and approved) by the FDA, including nicotine gum and patches, water, many different foods, cosmetics and even children's balloons.

Tobacco-specific nitrosamines in new tobacco products
http://www.starscientific.com/404/stepanov tsna in.pdf

Nitrosamines
JA Cotruvo, RJ Bull, J Crook, M WhittakerWateReuse Foundation 06-004
Nitrosamine DBPs in water (and food)
Regulations.gov fdmsp...contentType=pdf

Table 2 Nitrosamine Exposures from Foods
Food Type One or more Combined Nitrosamines (ug/100g)
Potato 0.015-1.44
Cabbage 0.014-0.19
Corn 0.002-0.83
Tomato 0.187-0.27
Fermented vegetables nd-0.50
Cheese 0.02-9.75 Milk 0.03-3.70
Milk (sour) 0.08-11.9
Flour 0.02-1.44
Bacon nd to 6.50
Beef up to 788
Frankfurters up to 27
Ham 0.1-79
Salami up to 131
Sausage nd to 0.42
Fish nd to 140
Fish (processed) nd to 3.9
Seafood/shrimp nd to 13.1
Oil nd to 0.38
Beer up to 6.8
Tea 0.2-1.5
Coffee up to 0.5

Table 2
Estimates of nitrates, nitrites and nitrosamines in food items and alcoholic beverages by the National Birth Defects Prevention Study calculated serving size
PubMed Central, : Nutr J. 2009; 8: 16. Published online 2009 April 6. doi: 10.1186/1475-2891-8-16.

Food Item Nitrosamines μg/serving
Dairy Products
Cheese (1 slice or 1 oz) 0.066
Cottage or ricotta cheese (1/2 cup) 0.266
Ice cream (1/2 cup) 0.031
Skim or low fat milk (8 oz glass) 0.209
Whole milk (8 oz glass) 0.065
Yogurt (1 cup) 0.002
Fruit Products
Avocado (1) or guacamole (1 cup) 0.010
Bananas (1) 0.006
Cantaloupe (1/4 melon) 0.006
Fresh apples or pears (1) 0.007
Other fruits fresh, frozen, or canned (1/2 cup) 0.007
Peaches, apricots, plums, or nectarines (1 or 1/2 cup) 0.004
Grain Products
Biscuit, scone, croissant and muffin (1) 0.012
Cereal 0.012
Tortilla (1) 0.002
White bread (slice), pita bread, bagels and crackers 0.002
Meat and Bean Products
Bacon (2 slices) 0.219
Beef, pork, lamb or cabrito as a main dish (4–6 oz) 0.453
Beef, pork, lamb or cabrito sandwich or mixed dish 0.324
Chicken livers (1 oz) 0.007
Chicken or turkey (4–6 oz) 0.086
Fish (3–6 oz) 0.222
Hamburger (1 patty) 0.071
Hot dogs (1) 0.128
Liver, non specific (3–4 oz) 0.022
Organ meats and tongue (3–4 oz) 0.062
Processed meats – sausage, salami, lunchmeat, pâté (piece or slice) 0.124
Fats, Oils, Nuts, and Sweets
Candy without chocolate (1 oz) 0.010
Chocolate (1 oz) 0.010
Cookies (1) 0.002
Alcoholic Beverages
Beer (12 fl. oz/354.9 ml) 0.531
Wine (5 fl. oz/147.9 ml) 0.019
Liquor and mixed drinks (1.5 fl. oz/44.4 ml) 0.027
Malt beverages (8 fl. oz/236.6 ml) 0.301

Development of a Food Database of Nitrosamines, Heterocyclic Amines, and Polycyclic Aromatic Hydrocarbons
Development of a Food Database of Nitrosamines, Heterocyclic Amines, and Polycyclic Aromatic Hydrocarbons -- Jakszyn et al. 134 (8): 2011 -- Journal of Nutrition

Nitrosamines in cosmetics
Campaign for Safe Cosmetics : Nitrosamines

Presence and release of nitrosamines from children’s balloons
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_q_148.pdf

The FDA Press Release http://www.fda.gov/NewsEvents/Ne...s/ ucm173222.htm also inaccurately stated "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." But diethylene glycol Diethylene glycol - Wikipedia, the free encyclopedia is not in antifreeze, but rather it is ethylene glycol
Ethylene glycol - Wikipedia, the free encyclopedia

Altria has reported that diethylene glycol comprises up to .3% of a cigarette's total weight.
Non-Tobacco Ingredients - Philip Morris USA

Bill Godshall
Smokefree Pennsylvania
412-351-5880
smokefree@compuserve.com

 

[TheIllustratedMan]

Excellent resources! Thank you Bill. If there's anything any of us can do to help, let us know.


-Nate

 

[Cori]

Excellent work Bill ... you summed it all up very nicely. I don't pretend to understand it all but your post was very helpful and enlightening.

 

[Sharon13]

Thats why we pay these guys the big bucks

But I could not agree more. I feel Dr. Nitzkin deserves our appreciation.

I am also thinking it is time to petition to support Dr. Nitzkin's recommendations. Please send your reps and senators a copy of this release and a statement of your support for these recommendations.

Cheers,
-Mickey

I'm about to switch from tobacco to e-cigs, and I've been looking around to see what's happening in this arena. One point I agree with is that the stress has to be on regulation to insure a quality product, not refusing to allow the use of this product at all.

But with our former president, FDR, in mind, you have to remember that Mr. Roosevelt had a little black book that let him push through the legislation he wanted. It would certainly not hurt to find out which of our legislators are being supported by the tobacco industry; that would let us know if the man/woman was sincere in his/her beliefs or just trying to do what their moneymen wanted them to. You really must understand that the tobacco industry is/will be dead set against anything that takes their slaves away from them.

If we find out that a senator or representative is on the payroll, so to speak, we can either spread the word to the media or threaten to spread the word. Yes, I know, blackmail is illegal, but so is taking bribes to do something other than the job you swore you'd do. I'd love to believe that all we have to do is sit back and our reps will do what's best for us, but I only write fantasy, I try not to live it.

It's been said that the best defense is a good offense. If the time comes that you'd like more of my offensive ideas I'd be glad to provide them.

Sharon13