Discussion of data presented in FDA material

[syntaxevasion]

This thread is to discuss the aspects of the data presented by the FDA from their testing of various electronic cigarette cartridges.

The test data can be found here:
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

I think a good point to start would be the comparison of the tobacco Specific Nitrosamine levels between the electronic cigarette and tobacco, nicotine replacement products such as Nicorette, and products like snus. But let's not stop there. Let's take a look at any data presented and see how we can compare it to what we know about the alternatives.

Ben

 

[OutWest]

here's the data for nitrosamines in other products (tobacco and nicotine products including NRTs)
http://www.starscientific.com/404/stepanov tsna in.pdf
Originally published in Nicotine & Tobacco Research Volume 8, Number 2 (April 2006) 309–313
table with results is on pg 4. Results are expressed in micrograms per gram

 

[syntaxevasion]

Any basis of determining the equivalent content of carcinogens side by side, even puff per puff?

 

[OutWest]

In the results I linked, the results for the gum, patch, and lozenges are expressed per piece. The rest of the results are per gram of product wet weight.

 

[OutWest]

Here's some more info, which shows lower nitrosamine levels for the gum (results are in nanograms). The method of collecting the data, though, is a bit suspect and not very scientific, imho.

The migration of tobacco-specific nitrosamines int...[Food Chem Toxicol. 1990] - PubMed Result
Originally published in the Food And Toxicology Journal 1990 Sep;28(9):619-22.

In many countries nicotine-containing chewing gum (Nicorette) is used to help to break the habit of smoking. Saliva was collected every 5 min from chewers of nicotine chewing gum and analysed for tobacco-specific nitrosamines. Detectable levels of tobacco-specific nitrosamines were found in all samples collected between 5 and 15 min after chewing had started. The levels of N'-nitrosonornicotine ranged from 0.4 to 19 ng/g of saliva and those for the sum of N'-nitrosoanatabine plus N'-nitrosoanabasine from 1.3 to 46 ng/g. 4-(N-methyl-N-nitrosamino)-1-(3-pyridyl)-1-butanone was not detected in the saliva. The nicotine chewing gum was found to contain up to 380 ng tobacco-specific nitrosamines/g of chewing gum.

 

[Our House]

Not sure how relevant it is (I may be misunderstanding), but has anyone else noticed this on the report:

"CombiPal Headspace autosampler parameters:
Incubation: 60°C for 15 minutes, syringe: 2000mcL gas aliquot at 145°C,
Agitation: 250RPM, syringe fill and injection speed: 100mcL/s"

Did they really heat up and simulate an inhalation for 15 minutes straight?? I thought all atomizers had a preventative mechanism in place to eliminate the dangers of inhaling for more than X seconds.

 

[palermo45]

Here's some more info, which shows lower nitrosamine levels for the gum (results are in nanograms). The method of collecting the data, though, is a bit suspect and not very scientific, imho.

The migration of tobacco-specific nitrosamines int...[Food Chem Toxicol. 1990] - PubMed Result
Originally published in the Food And Toxicology Journal 1990 Sep;28(9):619-22.

There are Nitrosamines in the Patch, Nicotine gum and Nicotrol Inhaler. We need someone with a chemical background who can compare the levels of these toxins as well as with rgular tobacco cigarettes.

It also seems as if the tests done by the FDA were not realistic. From what I gathered, they tested 100Ml of soulution (a cartridge contains appr: 1/100 of 5Ml) I believe that is close, but please correct me if I am wrong.

Many people on the boards including myself are coming up with chemical comparisons but we really need either a toxicologist or clinical pharmacalogist who can put together all this information and input it into a side by side comparative chart.

Then once the "chart" is available, we can get it all over the internet.

I just don't like the way most people "sheep" hear something so lame from the FDA which is just fear mongering and buy into it.

 

[TheIllustratedMan]

The 100 ml you refer to is the inhalation volume. They "inhaled" 100 ml of gas through the device for x number of times (I don't have it in front of me) and then tested that.

 

[syntaxevasion]

On page 6 & 7 of the report, the "MRMs" for each TSNA are reported in nG/G --are these the actual TSNA levels found in the electronic cigarette cartridges? How do these numbers compare to cigarettes on a ng/g basis?

 

[Tom09]

On page 6 & 7 of the report, the "MRMs" for each TSNA are reported in nG/G --are these the actual TSNA levels found in the electronic cigarette cartridges? How do these numbers compare to cigarettes on a ng/g basis?

The MRM numbers in the FDA report (= Westenberger 2009) are not related to actual TSNA concentrations but part of the analytical method. The MRM table just documents that Westenberger (2009) did follow the method of Wu et al. (2008), as referenced below that table on page 7. You find the same numbers in the method paper (Wu et al. 2008): "For each analyte, two ion transition pairs were used under multiple reaction mode (MRM). These ion pairs are 178/148 and 178/120 for NNN, 190/160 and 190/106 for NAT, 192/162 and 192/133 for NAB, and 208/122 and 208/106 for NNK."

Actual TSNA concentrations were not obtained, since they were below the limit-of-quantitation (LOQ). „Detected" TSNA in Table 1 (page 4 in Westenberger 2009) corresponds to „analyte was detected but at a level less than the limit-of-quantitation". LOD < actual concentration < LOQ. LOQs were given as: NAB (LOQ = 21 ppb); NAT (LOQ = 21 ppb); NNK (LOQ = 75 ppb); NNN (LOQ = 24 ppb). With this, we have the maximum possible TSNA contents for the tested carts. In case all four TSNAs were detected this would be < 141 ppb or TSNA < 141 ng/g. The limit-of-detection (LOD) is not given in Westenberger (2009), but we know that he applied quite sensitive methods. We only know that the actual concentrations for the tested samples are less than LOQ. Any value smaller than the listed LOQ.

It should be noted that these results did not come as a surprise. And they are absolutely in line with actual TSNA concentrations determined and reported for Ruyan carts, already. For instance, a value of 8 ppb (or 8 ng/g) was given in Laugesen et al. (2008). You find a comparison to NRT gum and cigarette on page 7 of the linked conference presentation (Laugesen et al. 2008), too.

IMHO, it was highly manipulative that FDA refused to put their results in perspective.

 

[quititllc]

Did they really heat up and simulate an inhalation for 15 minutes straight?? I thought all atomizers had a preventative mechanism in place to eliminate the dangers of inhaling for more than X seconds.

This is a feature on SOME batteries from SOME manufacturers, not of atomizers, and not of all manufacturers.

Cheaply manufactured PVs lack this capability.

 

[syntaxevasion]

Excellent post, Tom. Thanks for the info