Draft Letter for Review

[Vocalek]

Westenberger, B.J.
Food and Drug Administration
Division of Pharmaceutical Analysis
1114 Market Street, St. Louis , MO 63101

Dear Dr. Westenberger:

I am writing regarding the analysis you conducted on 19 electronic cigarette cartridges and 1 Nicotrol inhaler. The report is dated May 4, 2009 and is published at http://www.fda.gov/downloads/Drugs/S.../UCM173250.pdf

For some reason, this report was missing a quantitative analysis regarding the tobacco-specific nitrosamines and tobacco-specific impurities that were Detected. I have several questions:

• What were the quantities detected of each substance in each sample, including the "Control"?

• What were the quantities of tar, carbon monoxide, and heavy metals detected in the vapor from the electronic cigarette cartridges?

• The report says that less than 1% DEG was detected in one of the SE cartridges. Please place this in perspective.
  What quantity of the DEG would be present in the vapor, given the temperature at which DEG vaporizes and the operating temperature of the electronic cigarette?
  If some quantity of DEG is present in the vapor, how many cartridges would be required to reach a concentration of 1mg/kg of body weight (the minimally toxic level)?

Many of us are confused regarding the FDA's selection of the "Control." We did not substitute the electronic cigarette for Nicotrol inhalers. We were all tobacco cigarette smokers. Where is the data on tobacco cigarettes? Without sufficient data, how can we make an informed decision on whether (as the report implies) it would be healthier for us to stop "vaping" and resume tobacco smoking?

In March, I stopped smoking 10 American Spirit tobacco cigarettes per day and began using 1 NJOY NPRO cartridge per day instead. I have 19 packs of un-smoked cigarettes just sitting around. I would be happy to send you some or all of these packs as my citizen's contribution to the furtherance of scientific knowledge.

This would allow you to compare the toxic ingredients in the smoke from 10 cigarettes to the electronic equivalent of the vapor from one NJOY cartridge.

It would be helpful to see a parallel to Table 1 in your report that lists all of the harmful substances found in both alternatives along with the quantities delivered by equivalent amounts of the smoke / vapor (i.e. smoke from 10 cigarettes compared to vapor from 1 cartridge).

Please let me know how many packs of cigarettes you would like me to ship to you. If you are unable to locate NJOY cartridges, I might be able to spare one or two of these as well.

Sincerely,

 

[Thulium]

No offense, Vocalek, but I am so doubtful that you'll get any response no matter how you write this that I don't see much point in giving it a critical eye. It's a good letter and fairly humorous, and I'd love to see the FDA actually give some real answers, but I suspect even a peer review asking these questions would go unanswered, but its worth a shot.

 

[smiley7]

I think you should send it. Yes, probably get no reply, but doesn't hurt to try. gl

 

[taz3cat]

Vocalek, if you get an answer to your letter, I sure hope you share it with everyone. You asked some good questions. I did enjoy the bit of humor.

 

[Vocalek]

Update: So far, no response.

Must have been lost in the mail.

 

[Janetda]

Well now, to be fair, didn't it take them something like April to July to to set up the press release from their previous findings. I'm sure they're just in the process of making all the arrangements to they can have a big phone conference and press release party to announce their findings to your questions!