Paper: ENDS use and awareness in the USA [Tobacco Control]
- Thread starter Tom09
- Start date
- th_trl_thread_readers 0
- Status
Yes, FDA tested Cixi. Serves well as a posterchild, since Cixi is easily recognized as probably the least reponsible company worldwide. Cixi samples were not included in the 2009 report (only NJOY and SE). Some of the data grown by extending the initial snap shot became formally published in Hadwiger et al. 2010 and Trehy et al. 2011. The first paper is a Cixi special volume, second paper includes Cixi samples. Therein published data was probably the background data briefly mentioned in the Cixi warning letter. As of now, FDA team has two formal publications focussing on (1.) Cixis special pharmeceuticals, and (2.) tobacco alcaloids. One could expect this paper series to be continued [e.g. (3.) TSNAs, (4.) PG/VG-related impurities] to formally cover the remaining issues from FDAs consumer information and warning letters.
Intention of my previous post was just to make aware of a weak argument (sample count).
From the letter FDA sent to Cixi:
Hot Topics: USP Glycerin Information
So it is possible to deduce from the letter and from the USP information that the FDA found 0.5% DEG in one of the Cixi products (i.e., fivefold the USP upper limit). References for peer-reviewed scientific journal articles are usually scientific reports, other published journal articles etc. It would be unusual for a letter to be considered a good reference.
When investigating several deaths that were suspected to be caused by diethylene glycol and measuring the quantity ingested, the FDA found that there was a 10-fold variation in human sensitivity. They tested DEG on animals and again found a 10-fold variation in sensitivity. To provide a margin of safety for humans, the FDA began the practice of dividing a chemical's NOAEL by 100, meaning that humans should not be exposed to more than a hundredth of the dose that shows no adverse effects in animals.
For children, dividing the NOAEL by 1000 is used to calculate a safe dose.
NOAEL = No observable adverse effect level
There is a huge margin of safety built into the USP upper limit.
In 2007, the European Commission's Scientific Committee on Consumer Products issued an opinion on Diethylene Glycol Monoethyl Ether (DEGEE). They reported that in animal testing, the L50 (lethal dose that kills 50% of subjects) ranged from 3900 mg/kg bw for guinea pig to 8690 for rat.
in an isolated case report, a 44 year old alcoholic male drank approximately 300 ml of a liquid containing 47% DEGEE (about 2000 mg/kg). Severe symptoms of central nervous and respiratory injury, thirst, and acidosis occurred. The subject recovered following symptomatic treatment. [This works out to about twice what is believed to be the lethal dose (1 g / kg bw)]
The conclusion reached by the SCCP was that the use of DEGEE at concentrations of up to 1.5% in cosmetic products does not pose a risk, provided that the level of ethylene glycol in DEGEE used is < 0.2%; however DEGEE should not be used in oral hygiene and eye products.
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_082.pdf
Let me double check. You're telling me that Smoking Everywhere 555 with less than 1% DEG is GRAS, and the ONLY device to have perhaps 5x GRAS levels wasn't even an END (Electronic Nicotine Device), it was actually a Vitamin C delivery device?
Almost right. Since the upper limit was reset to a tenth of a percent (0.1%) right around the time that the FDA released the results of e-cig testing, the SE cartridge, at 1%, contained 10 times the USP upper limit. But as I pointed out, the margin of safety is huge.
Plus, keep in mind that what is really important is not the percent of the potentially toxic chemical in a substance, but rather the subject's total exposure. Exposure is a calculation based on quantity of the chemical ingested and body weight of the subject. The dose of DEG at which 50% of the subjects are killed (LD50) is 1 gram per kilogram of body weight (or 1000 mg / kg bw)
If our 44 year old alcoholic had only drunk 3 ml of a liquid that was 47% DEGEE, his total exposure would only have been 20 mg / kg bw (0.2 g / kg bw) which is only 20% of the lethal dosage of 1 g / kg bw, and probably well below any level of harm whatsoever. Time is also another factor, as is metabolization of the chemical (i.e., how quickly it clears out of the body). If our alcoholic drank the entire 300 ml of liquid, but at the rate of 1 ml per day for 30 days instead of all at once, he probably wouldn't have noticed a thing, because DEG clears the body in about 24 hours.
Disclaimer: I'm not a chemist, but this is my understanding of the situation. Chemists, please feel free to jump in and correct anything I got wrong.
Plus, keep in mind that what is really important is not the percent of the potentially toxic chemical in a substance, but rather the subject's total exposure. Exposure is a calculation based on quantity of the chemical ingested and body weight of the subject. The dose of DEG at which 50% of the subjects are killed (LD50) is 1 gram per kilogram of body weight (or 1000 mg / kg bw)
If our 44 year old alcoholic had only drunk 3 ml of a liquid that was 47% DEGEE, his total exposure would only have been 20 mg / kg bw (0.2 g / kg bw) which is only 20% of the lethal dosage of 1 g / kg bw, and probably well below any level of harm whatsoever. Time is also another factor, as is metabolization of the chemical (i.e., how quickly it clears out of the body). If our alcoholic drank the entire 300 ml of liquid, but at the rate of 1 ml per day for 30 days instead of all at once, he probably wouldn't have noticed a thing, because DEG clears the body in about 24 hours.
Disclaimer: I'm not a chemist, but this is my understanding of the situation. Chemists, please feel free to jump in and correct anything I got wrong.
Okay, so while 1% is 10x GRAS, we never got the exact figure SE was in the cartridge. And 1.5% is allowed in cosmetics, and a S.E. cartridge is designed to be used over the period of a day, so that would be 1/16th the exposure per hour, which would put it well into the GRAS class in those terms.
Wasn't the actual figure cited for S.E. 555 much lower than 1%?
The report reads "at approximately 1%". http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf
There are a couple of complicating factors:
1. The only way an e-cigarette user would get any DEG whatseover would be if it vaporized and the user inhaled it.
2. There is doubt that DEG will vaporize at the temperature reached in the average atomizer.
3. If DEG did vaporize in e-cig atomizers, we don't know what fraction of what's in the liquid would make it into the vapor.
The 1.5% figure for cosmetics was from a 2007 EU document. My guess would be that in the US today, cosmetics are now only allowed 0.1%. In 2009, the EU issued a directive prohibiting DEG use as an ingredient and allowing the presence at 0.1% in the finished product as trace amounts that might be present in other ingredients such as glycerol.
So this is the only citation you have? Because that technically is a secondary source. The primary source would be the lab report, and I don't see the actual figure.
Yes I know, this is what I told Gabbi Promoff.
"Please note that DEG was not detected in the vapor, which would be consistent with why Sterno fuel is allowed to use DEG, DEG has a high boiling point. "
I suggested this to Gabbi too
"Further fact checking should include testing if 2% nicotine, 97% propylene glycol, and 1% DEG would vaporize at 60C. It would be embarrassing if the FDA assertion could be demonstrated false in a simple lab experiment. "
Matt, as far as I know, that was the "primary report" issued. The FDA lab in St Louis did the analysis and generated that report to the FDA in Washington.
Okay, just to be clear, the primary report literally listed DEG about 1% in the commentary, but didn't include the the results of the test, or what test was performed?
Correct. And that wasn't the most egregious omission, by a long-shot. NJOY hired an outside lab to critique the FDA's report and they, in effect, gave it a grade of "F". http://www.casaa.org/files/Exponent Response-to-the-FDA-Summary.pdf
Nevertheless, it is far superior to the FDA's very unscientific press release.
In the lab report, I searched for and could not find words like "carcinogens" and "antifreeze". I wouldn't expect to find "antifreeze" unless there was reason to suspect that the manufacturer was adding Prestone as an ingredient, but I would expect to see a discussion of cancer-causing chemicals had the lab found potential carcinogens in quantities that have been shown to trigger cancer.
Using the wording "known carcinogens" in the press release implies that the FDA's lab found potential carcinogens in quantities that are known to cause cancer. IMHO failing to report the quantities of TSNAs detected demonstrates incompetence if this was done inadvertently or unethical obfuscation if done purposely.
Last edited:
- Status
Similar threads
- Locked
- Locked
- Locked
