An open letter to my local FDA officers

[Þornbjörg]

This is the letter I just sent them, for better or worse.

Faye Bronner and Charles Watson
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, FL 32751

Ms. Faye Bronner and Mr. Charles Watson:

Hello, I am writing to you today to enquire about a study performed by the FDA this past June.

You, the Food and Drug Administration, published a report on May 4, 2009 that performed a preliminary study on electronic cigarettes. I have a few questions tht directly pertain to that study.

The results of the study can be found on the Food and Drug Administration's website at http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

The study compares the various test results found related to electronic cigarettes, which are marketed, by and large, as a safer alternative to smoking tobacco cigarettes; to the Nicotrol inhalation device, which is marketed as a nicotine cessation device. These two devices are marketed for very different purposes.

My first question.
Why were the two tested electronic cigarettes not tested with a standard tobacco cigarette as a control? This would make sense to those reading the study, as an electronic cigarette is meant to be a safer alternative to a tobacco cigarette, and not as a cessation device.

Now, in the results, tests were performed to determine the presence of tobacco specific nitrosamines. In the results of these tests, the nicotrol inhaler's findings were not included in the test results. The findings that demonstrated that these TSNA's were present did not provide quantifiable data as to the levels present. In addition to these, the results are not compared to a tobacco cigarette, which the electronic cigarette is meant to provide the safer alternative to.

To compare here, using studies performed by other laboratories, the total amount of TSNA's in electronic cigarettes are approximately 8ng/g, which after a full daily dose, does not reach carcinogenic levels of TSNA's. However, studies performed by other laboratories show that the Marlboro brand provide approximately 11190ng/g (which is almost 1400x the amount found in electronic cigarettes), which after a full daily dose, is far more than enough to provide carcenogenic levels.

These findings are of large import as they are one of the primary basis of the several statements given by the Food and Drug Administration that electronic cigarettes are 'bad'.

My second question.
Why were the details of TSNA's not provided in the FDA's report? This is important, since the findings show that the levels are not enough to cause them to exhibit carcinogenic properties.

The entire study was conducted with the control being a device that is used for a very different purpose, and in most of the results in the study the control's results were not given. This is an alarming fact to anyone who understands that the control is not being tested for comparison.

My third question.
Why was the Nicotrol inhaler's results not published in most of the results, when it was specifically stated to be the control? This is also important since even it would exhibit trace amounts of TSNA's, as even medical grade nicotine is extracted from tobacco.

Another issue I find pressing regarding the study is the presence of Diethylene glycol. In the results, it is stated to occur in a single sample, among 19 different samples. One sample, the control, did not have its results published regarding whether or not it had this substance present.

The results published did not state what level was present, or if it was present after several tests of the same sample. This is relevant, since Diethylene glycol is used in the production of tobacco cigarettes, notably in processing of tobacco and in production of filters.

My fourth question.
Why were the levels of Diethylene glycol not given, nor the number of times the sample was shown to exhibit it? This is important as it is found in the smoke produced by tobacco cigarettes, and would help determine if the amounts present are more or less dangerous than that which electronic cigarettes are meant to replace.

My fifth question.
Why were the results of the control not published regarding Diethylene glycol, when the presence of the Diethylene is one of the primary concerns of the Food and Drug Administration?


I would like to request the testing procedure be performed again, and use of a control or set of controls from the list of products that electronic cigarettes are meant to replace. This would include tobacco cigarettes distrubuted under the names Marlboro, Camel, Winston, Newport and others. It would not be conducive to findings to use a control or controls from any class of cessation devices, as electronic cigarettes, by and large, are not marketed as cessation devices.

Such a study would evaluate electronic cigarettes on more equal footing directly against the products they are designed to be an alternative to.

Of other note pertaining to the several announcements against electronic cigarettes, I would like to inquire as to why no reports by third parties have been named. In all documents by the FDA, it is stated there are 'no other studies' regarding the health effects of electronic cigarettes, when there have indeed been numerous studies performed.

Awaiting your reply,
FWishbringer

 

[jj2]

Great letter. I hope someone who isn't a flunky reads it.

I'd even reword it a little and send it to newspapers, TV, and radio news. Can't think of his name, but the guy that likes to ruffle government feathers from Fox might be a good one.

 

[PlanetScribbles]

A rather large chunk of swiss cheese would have less holes in it than the FDA study. It was a falacy. Not credible in any way at all.

 

[MaDPimP]

ahh the joys of scientific unscrupulousness and the gullible saps that buy into whatever they are told!! DAMN SNEAKY FDA!

 

[CJsKee]

Very nice letter pornbjorg...will be interesting to see what kind of response you get.

 

[LoBo]

Great letter. I hope someone who isn't a flunky reads it.

I'd even reword it a little and send it to newspapers, TV, and radio news. Can't think of his name, but the guy that likes to ruffle government feathers from Fox might be a good one.

I think you mean Glenn Beck.

 

[RobNJ74]

Great letter. I hope someone who isn't a flunky reads it.

I'd even reword it a little and send it to newspapers, TV, and radio news. Can't think of his name, but the guy that likes to ruffle government feathers from Fox might be a good one.

I took the liberty of doing that and I'm sure I wasn't alone.


Rob

 

[Þornbjörg]

Already received my first reply!

This study was conducted by FDA Center for Drugs and Evaluation and Research, in White Oaks, Maryland. I have forwarded your inquiry to that office. I am not sure how long it will take for you to receive a response. My contact person for that department is out of the office today. As soon as I receive a response I will let you know or that department may decide to contact you directly.

Faye Bronner
Public Affairs Specialist
FDA Florida District Office

Looks like its moving in the bureaucratic chain...

Thinking about it, I'm going to call her and ask if there is any chance of getting a second study done if I send a 510 along with blank carts, and some liquid and a pack of Marlboros and Camels for use as controls.

 

[Þornbjörg]

Phone call done and over.... results.

Faye was more or less clueless. She had never heard of electronic cigarettes, let alone the study. She transferred me to the director of the central Florida office.

Very nice gentleman. He said upfront he can talk on a personal level, regarding his opinions, but not to take anything he says as law, as there are simply no real laws about them.

In his opinion, as the director of the local FDA office for the last 20 years, and with what he knows about electronic cigarettes, he firmly believes they will be approved sometime in the next two or three years. He said it'll get worse before it gets better, and not to rule out them being outright banned for a year or two.

As per his take on the current legal battles, he said that word is they are about the be legally deemed a drug/device combination, and that once that happens in black and white, that electronic cigarettes will be considered illegal drugs... at least until companies start getting their products to pass FDA approval guidelines.

I asked about whether or not the FDA would conduct a second study if another brand or model was offered, and he said that my best bet is to send a certified letter to the office of compliance and ask.

Since I intend on going into manufacture and distribution of eJuice, I asked about what requirements I will need to meet to get my product approved, and again, certified letter to the office of compliance and ask.

Now, on the upside for manufacturers, he said that according to federal law, if you want to produce a product that is banned from sales domestically, you can produce all you want and export it. The only requirements are that it must be legal to import to whatever country you are sending it to, and the package must be labeled as export only. If these two requirements are met, you can produce anything you want in whatever quantities you want, and ship them anywhere but the US.

He told me, 'as a person who's been playing the bureaucratic game for over 20 years', that my absolute best means to get my voice heard is to write a letter to the FDA and show them numbers in my favor and express my interest in the product positively, followed by making an appointment with my local state and federal representatives to meet the rep in person, then meeting with them and explaining my case to them in a positive manner. He said if I can get a state or federal rep to speak to the FDA on my behalf that they would do back flips to answer to reps.

So, I'm going to go write a letter in Word now, print it and take it to the fedex store and have it sent, and monday, I'm going to make an appointment with my local reps.

 

[Tom09]

Thorn, I like to see that you are in an inquiring mood. Perhaps, you could rephrase your questions and send them dirctly to the author of the ‘FDA report’. As publicly availale: Westenberger, B.J.; Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market Street, St. Louis, MO 63101, United States; email:westenberger@cder.fda.gov. Any possible answer would be quite of interest, for sure.

 

[Þornbjörg]

Oh, they are on the list.

Just so people know, I'm playing, as far as the FDA is concerned anyway, the devil's advocate (since they SHOULD regulate what can go in eJuice and put penalties on sales to minors afaic). I would really like to get into production of e-Juice (using clean, sanitary standards and using only supplies purchased in the United States for quality control purposes) so I'm going to lengths to try and get the right information from the right people on how to do it with the FDA's blessing.

All it would take is the first one getting 'blessed', and it will start the ball rolling.

So you understand my take:
1. eJuice should not freebase nicotine. This will happen if Big Tobacco beats the present electronic cigarette manufacturers to FDA approval.
2. eJuice should be affordable. Prices will skyrocket if Big Pharma beats present manufacturers to FDA approval, as they will broadly patent their devices and have the money to tie up the 'little guys' in court for years defending their patents.
3. Nicotine products should never be sold to minors. I don't care if they are buying 0mg liquid, the device is meant as a smoking alternative.
4. eJuice needs some form of regulation. Without it, people are free to sell flavored eJuice that uses toxic flavorings or additives. Penalties should be in place for these people.

I think this thread is going to be converted to 'Open Letters and Phone Calls: My Personal Campaign'. Next up, I'm writing a message to the staff member of the local university who directly deals with nicotine in many ways that is affects e-cigarette users. Hopefully, I can get some insight in how to approach the National Institute of Health for their support.

Once its written and sent, I'll edit this post and put it here.

Here's my letter to the staff member in question:

-name left off since they are not a public servant-
-address left off since they are not a public servant-
Tampa, FL

-name left off since they are not a public servant-:

Hello, I am writing you today to inquire about the health concerns surrounding electronic cigarettes. Presently, what little research has caught the public eye in the United States was from a very flawed test performed by the Food and Drug Administration.

For reference, their report can be found at http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

Some key points I'd like to point out: their control is a nicotine cessation device, which is not the purpose of electronic cigarettes; they found trace amounts of Diethylene Glycol and every news article citing this has touted that its an industrial antifreeze, yet the control's findings were not shown and it is known to be found in much larger amounts in tobacco cigarettes; another key point they use against 'e-cigs' is presence of tobacco specific nitrosamines (TSNAs) in under half the samples tested, yet do not publish the findings of the control nor compare levels found to tobacco cigarettes.

I could go into more detail about many of the other holes, however these three are by far the biggest.

In your opinion as a staff member with experience working with nicotine and addiction, what would be the best means to pursue actual, solid testing? My ultimate goal would be a NIH funded study of the effects of a broad sampling of electronic cigarettes, with analysis of both the content of the cartridges and content of vapor after actual simulated use, while using a Nicotrol inhaler and at least 3 brand names of tobacco cigarettes as controls (the flagship product of all 3 major tobacco companies).

I have already contacted the local Food and Drug Administration office, and based on their guidance, am looking into methods to demonstrate the actual facts about electronic cigarettes. Sadly, though the New Zealand Health Institute has performed several valid and in depth tests, I was told by the FDA officer I spoke with that any study not published and primarily performed in the United States would not be looked at as valid. If you'd like to see a summary of their findings, please see... http://www.healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf

Best Regards,
FWishbringer

 

[RobNJ74]

Ok so the FDA can't or won't answer I guess??


Dear Mr. J******,

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

We are unable to address your specific questions. Please review the following reply:

The preliminary analysis of electronic cigarettes was initiated by FDA in order to test the composition of the ingredients contained in them and inhaled by users of electronic cigarettes. Due to the variability among products, these analyses is not being used to draw conclusions about what substances are or are not present in particular electronic cigarettes or brands of electronic cigarettes.


Because these products have not been submitted by any manufacturer to the FDA for formal 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.

We welcome manufacturers to submit a New Drug Application (NDA) for formal review of the products. As we do not solicit these applications, it is the choice of the manufacturer to do so.

As a matter of policy, however, we limit communications about the regulatory status of specific marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions.


Best regards,
kw
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

 

[eskimoswagg]

Wow. You are definatly making ground. This is all so crazy. I just don't see how the FDA can fool so many people with their obviously fake and malicious lies.

 

[TheScrye]

wow bjorg, you really are doing a great thing here. If I had a better presentation of information, I would definitely get involved with my state reps and see what I can get done. I want to fight for this cause with everything I got. Plus, hey, I live in Vegas, I think something can be done here.

 

[mtndude]

Þornbjörg, I know I've said it before, but I'd really like to see you elected to the board of CASAA.

best of luck!

 

[Halcyon]

Þornbjörg, just wanted to tell you "thank you" for your hard work and time spent helping this community. Have there been any updates since your last post? Best of luck getting attention and getting real answers.