NJOY released third-party “Technical Review and Analysis of FDA Report”

[TropicalBob]

i hope this report hits the media at scale stronger than the FDA's

Either you're kidding or don't understand anything about how news is judged. This report will be seen by editors and producers as a reply from a private business with a vested interest in making money from a product. The FDA report was from a public regulatory body charged with overseeing America's drug and food products. Now, which will get more publicity? Which should?

This is a no-brainer. This report will not even warrant three paragraphs in a comprehensive newspaper, and will not be given precious TV time.

[SudokuGal]

Either you're kidding or don't understand anything about how news is judged. This report will be seen by editors and producers as a reply from a private business with a vested interest in making money from a product. The FDA report was from a public regulatory body charged with overseeing America's drug and food products. Now, which will get more publicity? Which should?

This is a no-brainer. This report will not even warrant three paragraphs in a comprehensive newspaper, and will not be given precious TV time.

Of course the FDA report will get more publicity for the reasons you stated. Should it? NO. I suppose NJoy could have "brought off" the third party evalutor, but, sheesh, even that evaluation could be replicated and its veracity confirmed or denied. But then we are dealing the US media and newspapers -- both of which have lost their objective in every aspect of newsworthy and non-newsworthy info <sad sigh>.

[wv2win]

Either you're kidding or don't understand anything about how news is judged. This report will be seen by editors and producers as a reply from a private business with a vested interest in making money from a product. The FDA report was from a public regulatory body charged with overseeing America's drug and food products. Now, which will get more publicity? Which should?

This is a no-brainer. This report will not even warrant three paragraphs in a comprehensive newspaper, and will not be given precious TV time.

Bob, being in the news business, do you have any information centered in say the last 5 years where the FDA banned a widely used product and the effect of the ban on the industry producing the product. My point in asking the question is whether it is more likely that the FDA will ban and confiscate (suppliers) these devices and the liquid completely or reach some compromise with the suppliers and/or manufacturers? I may live in a cave or something, but I can't remember when a product I used was banned and never saw the light of day again.

[TnA]

1) How could have this report been prepared prior to the FDA releasing the report? It was a Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes”

2) Any reference to lab testing refers to FDA lab testing. No lab tests were performed by Exponent in this Technical Review and Analysis of FDA Report: “Evaluation of e-cigarettes”

We should all try and keep the facts straight here. I don't know what happened to Njoy's lab tests--or even if they were ever performed. They are still in litigation. That's all I know.

Mike

Wow...mebbe I caught the tone of your response the wrong way, but I immediately felt like saying, "relax".

The quotes you were commenting on are based on previous statements by NJoy.

1) NJoy stated they had already had a test of their liquids conducted and we've all been anxiously awaiting the release of those test results.......still waiting. Granted that it may have something to do with their on-going court dispute....but it does seem a little odd that they would keep "those" test results so close hold but publish a technical review of the FDA's report.

2) I think Sun understood that this was a technical review and again, he was referring to previous NJoy statement about their "still undisclosed test results" showing none of the chemicals that FDA found. That statement does not jive with what the FDA report stated, so release of their original test results would go a long way in dispelling rumors and myths.

Not trying to defend Sun....I'm sure he's more than able to do that for himself. Just commenting on how the tone of your post struck me as a third party.

[markarich159]

The issue here goes to longevity of use. The Clinical Data on the baseline product that was used---that being Nicotrol is straight forward and very well spelled out:

WARNINGS
Nicotine from any source can be toxic and addictive... the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement

PRECAUTIONS

Sustained use (beyond 6 months) of NICOTROL NS by patients who stop smoking is not recommended and should be discouraged. The clinical findings is not for extended use of the product beyond six months .

It can be readily scene that the use of NRT's balances the harm to the benefit and that the use of these products is not for an indefinate period of time like the e-cig. So it is that not that the clinical trials of approved drugs like Nicotrol dismissed the carciniginic by-products, rather they weighted the risk to benefit for short term use of these products in an effort to get the patient off of cigarettes.

On the otherhand the e-cig is marketed for an "indefinate use" time and hence must withstand the scrutinity of these by-products being induced over a long period of time by human consuption.

Sun

Is that from a patient leaflet or the actual professional Medical literature that was initially in the package insert (because all NRT's at one time were and Nicotrol NS is). If it is the original package insert from professional use, it would have still legally had to disclose the TSNA warning(if the FDA deemed it an appropriate hazard). I already know that they did not include TSNA warnings in the initial professional literature(it's not included in the Rx Nicorette inhaler insert). The key point here is the "Full disclosure" law would have applied at the time(if TSNA's were considered a carcinogenic, teratogenic, etc.. threat).

[BardicDruid]

I still wonder why the FDA is so afraid to test e-cigs against analog cigs???? It's my belief that if SE & NJ can get the e-cig in the same boat, so to speak, as cigarettes and out from under the drug class they'll have a chance.

[lotus14]

The issue here goes to longevity of use. The Clinical Data on the baseline product that was used---that being Nicotrol is straight forward and very well spelled out:

WARNINGS

Nicotine from any source can be toxic and addictive... the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement

PRECAUTIONS

Sustained use (beyond 6 months) of NICOTROL NS by patients who stop smoking is not recommended and should be discouraged. The clinical findings is not for extended use of the product beyond six months .

It can be readily scene that the use of NRT's balances the harm to the benefit and that the use of these products is not for an indefinate period of time like the e-cig. So it is that not that the clinical trials of approved drugs like Nicotrol dismissed the carciniginic by-products, rather they weighted the risk to benefit for short term use of these products in an effort to get the patient off of cigarettes.

On the otherhand the e-cig is marketed for an "indefinate use" time and hence must withstand the scrutinity of these by-products being induced over a long period of time by human consuption.

Sun

Agreed that if e-cigs do not go the NRT route, then long term consumption becomes an issue. What I don't understand is why the minuscule amounts of nitrosamines found in the liquid (not in the vapor!) are even an issue. Nitrosamines are consumed by most Americans every day in much larger quantities than found by the FDA in e-cig liquid.

From Wikipedia:
"Food

Nitrosamines are produced from nitrites and secondary amines, which often occur in the form of proteins. Their formation can occur only under certain conditions, including strongly acidic conditions such as that of the human stomach. High temperatures, as in frying, can also enhance the formation of nitrosamines. These cooking styles may be responsible for thousands of cases of colon cancer per year across the world. The presence of nitrosamines may be identified by the Liebermann's reaction. [1]
Under acidic conditions the nitrite forms nitrous acid (HNO2), which is protonated and splits into the nitrosonium cation N≡O+ and water: H2NO2+ = H2O + NO+. The nitrosonium cation then reacts with an amine to produce nitrosamine.[citation needed]
Nitrosamines are found in many foodstuffs, especially beer, fish, and fish byproducts, and also in meat and cheese products preserved with nitrite pickling salt. The U.S. government established limits on the amount of nitrites used in meat products in order to decrease cancer risk in the population. There are also rules about adding ascorbic acid or related compounds to meat, because they inhibit nitrosamine formation.[citation needed]

[edit] Consumer products

Nitrosamines can be found in tobacco smoke and latex products. A test of party balloons and condoms indicated that many of them release small amounts of nitrosamines.[1] However, nitrosamines from condoms are not expected to be of toxicological significance."


Read the ingredients on a pack of bacon or hot dogs! They (and many other foods) are loaded with sodium nitrite. Guess the FDA will have to ban beer and party balloons too.

[Tom09]

Just to add: a take on this “Technical Review and Analysis of FDA Report” can also be found on Siegel’s blog The Rest of the Story