Archive for July 24th, 2009

How and Why The FDA Misled The Public

I’ve heard about the blind following of main stream media for sometime, but until now I didn’t realize how deep it ran. It runs deep.

Here are a few of the media head lines after the FDA press release on electronic cigarettes yesterday:
* Electronic cigarettes unsafe, linked to cancer – NOT TRUE – no cases or examples of electronic cigarettes causing cancer exist
* Health officials in the nation have said that the testing of two leading e-cigarette brands has shown that they contain cancer causing chemicals and other toxins, including a major compound used in antifreeze. – NOT TRUE – one cartridge from one company had diethylene glycol (DEG) in it, which is found in antifreeze
* FDA: E-cigarettes are as dangerous as tobacco cigarettes – NOT TRUE – this is crazy

Here is what they actually found:
* Out of 18 cartridges, 1 had diethylene glycol (DEG) in it at less than 1%. One.
* Tobacco specific nitrosamines (TSNA) and tobacco specific impurities were detected in both products at very low levels (taken from the FDA Electronic Cigarette Evaluation conclusion). Makes sense if the nicotine was taken from tobacco. Many FDA approved NRTs have Tobacco specific nitrosamines in them. Also, not all the samples contained TSNA.
* Since 100% of tobacco cigarettes contain multiple carcinogens and only 50% of the electronic cigarette cartridges tested contained detectable levels of carcinogens (and even then it was at “very low levels” according to the report), what is the FDA saying about it’s relative safety compared to tobacco cigarettes.

Here is what they did:
* They received the electronic cigarette test results back on May 4th, 2009.
* They postponed a scheduled press conference from May 5th, 2009 to July 23rd, 2009 at which time they released their findings.
* They tested 14 cartridges from Smoking Everywhere (including zero nicotine) and 4 from Njoy, but didn’t test zero nicotine from Njoy. The FDA has been sued by both these companies.
* They used the Nicotrol Inhaler as a “control” but didn’t test it for anything except nicotine.

For all you “journalists” here are some good questions to ask the FDA:
* Why was the report not released until now?
* Did you test any cartridges other than the 18 you published?
* Why didn’t you test the Nicotrol Inhaler for diethylene glycol or tobacco specific nitrosamines?
* Why didn’t you test the zero nicotine from Njoy?
* How many reported illness from electronic cigarettes have there been?
* How many reported deaths from electronic cigarettes have there been?
* Based on your testing, are electronic cigarettes safer and healthier than tobacco cigarettes to the user and the surrounding public? Or alternatively, are e-cigarette more dangerous or as dangerous as burning tobacco?
* Why was no American made e-liquid tested?

It is important to note for anyone who doesn’t know much about the electronic cigarettes, is that the e-liquid is a separate thing from the device. The e-liquid ingredient list can be reworked to make sure there are no cancer causing substances or even impurities. We need time and support to do this, not misleading press conferences. As an example, rather than propylene glycol (which is where many suspect the DEG came from), you can use food grade vegetable glycerin (VG) as the base. Another good question…..why didn’t the FDA test e-liquid with a VG base. This is a distinct advantage over tobacco cigarettes where it has been proven very difficult to make a combustible product safer or healthier.

Responsible suppliers and manufacturers in the industry are very concerned about the quality of the product and the safety of the users. But calling for a ban on electronic cigarettes because of this limited testing is like pulling all beer off the market because 1 bottle had a mouse in it.

So how did 1 sample with DEG and 5 samples with tobacco specific nitrosamines turn into “electronic cigarettes contain cancer causing antifreeze”? Presentation. Oh yeah….and lack of questions.

But why would the FDA want to skew public perception over the e-cigarette? Well, considering the very large $$$$ involved in NRTs (Nicotine Replacement Therapies) sold by the pharmaceutical and the fact that the FDA receives a lot of it’s funding through pharmaceutical companies, one could speculate that those selling competing products want total control over the market. Conspiracy theory? Maybe. But follow the money trail.

What the FDA wants to do is compare the electronic cigarette to nothing. Therefore, any issues with it are worse than nothing. They need to be compared to tobacco cigarettes. E-Cigarettes are used in the same fashion by the same group of people; tobacco smokers.

The FDA has told anyone with any adverse effects to report them by:
* Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

I agree. Those with adverse effects should report them. But the method by which they ask for feedback (the mock scientific data in press release form) makes it appear like the FDA wants issues to give them a reason to pull the e-cigarette off the market. For the sake of the thousands and thousands of e-smokers who find it a suitable alternative to burning tobacco, I hope this is not the case.

NJoy Response To FDA Conference Call Regarding Electronic Cigarettes

ON BEHALF OF NJOY, CEO Jack Leadbeater
July 23, 2009
NJOY RESPONSE TO FDA CONFERENCE CALL

NJOY’s products have been on the market since at least April 2007 with no reports of significant
adverse health consequences. We do not market our products to children, and indeed take
affirmative steps to ensure that our products are not sold to minors by requiring retailers to agree to where the product is placed and request verification of appropriate age as it pertains to each state law.

NJOY has been tested by an independent third-party laboratory, Exponent. This testing, as well
as our consultation with medical experts, gives us confidence that our products are appropriate
alternatives for traditional cigarettes for the committed smoker. We are therefore surprised the
FDA’s testing has resulted in the Agency suggesting that our products represent a health risk on
par with conventional cigarettes. We will provide more information on NJOY’s testing and the
results in the next few days.

The FDA’s report admits its conclusions don’t apply to all products.

* Broad statements were made on the call that Diethylene glycol (DEG) was detected in
the test samples, but the specific report shows that DEG was not found in NJOY’s
products.

* The results touted by FDA related to antifreeze are inapplicable to NJOY’s products (per
the FDA report) .

* FDA’s report simply shows that the products contain certain tobacco-specific impurities
(at much lower levels than conventional cigarettes, and this is something we are having
our experts compare in the reports conduct by NJOY and the FDA).

We find it interesting the FDA’s report is dated May fourth and is only now being released. The
FDA has not asked us to relabel our product, or to remove it from product shelves, at any point in the two years we have been in the market.

We remain willing to work with FDA to address the Agency’s concerns.

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For more information, read How The FDA Misled The Public About Electronic Cigarettes which also includes a link to the actual FDA study.