FDA REPORT INDICATES E-CIGS MUCH SAFER THAN TOBACCO

Michael Siegel, MD, MPH
Professor
Department of Community Health Sciences
Boston University School of Public Health

Read Dr. Siegal articles Below:

Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones

Prominent Tobacco Researchers Expose Double Standard in FDA’s Study of Electronic Cigarettes and Challenge FDA’s Alarmist Attitude Toward the Devices

List of Identified, Known Carcinogens in Electronic Cigarettes vs. Conventional Cigarettes, and Which Anti-Smoking Groups are Telling Smokers to Smoke

E-Cigarette Clinical Trials

Clinical trials have now been carried out in New Zealand by Dr Murray Laugeson of Health New Zealand.

The test found that the E-Cigarette was:

“…very safe relative to cigarettes, and also safe in absolute terms on  all measurements we have applied. Using micro-electronics it vaporizes,  separately for each puff, very small quantities of nicotine dissolved in  propylene glycol, two small well-known molecules with excellent safety  profiles, – into a fine aerosol. Each puff contains one third to one half the  nicotine in a tobacco cigarette’s puff. The cartridge liquid is tobacco-free  and no combustion occurs.”

Source: Safety  Report by Health New Zealand http://www.ecigarettedirect.co.uk/extra%20info/e-cigarette-safety-report.pdf (PDF)

Further research into electronic cigarettes continues to be carried out in  New Zealand.

Safety of the E-cigarette cartridge liquid and inhaled aerosol

1. Propylene Glycol

According to the manufacturer, propylene glycol makes up 89-90% of the liquid in the nicotine cartridge that generates the mist and vapor in the e-cigarette ‘smoke’.

Properties and uses.

Propylene glycol C3H8O2 is a completely water soluble liquid, and is prepared by hydrolysis of propylene oxide under pressure at high temperature without a catalyst. It is used in pharmaceuticals, as a drug vehicle (for example as an FDA approved solvent for intravenous diazepam) and preservative. It is used also in personal lubricants. It is used in
semi-moist pet food and as a humectant for tobacco. In the food industry it is used as a solvent, humectant and preservative. Its mist is used in theatrical stage productions.1 At low humidity, PG is a vapor; as dose and humidity increase it is held in the form of mist or fog, and at 100% humidity as in the lungs, it is dissolved.

Animal studies

Rats. In a study of rats exposed for 60 hours over two weeks, the highest concentration tested, 1800 mg/m(3), which was the highest concentration that could practically be generated, was the no-observed-effect level (NOEL). PG does not appear to pose a significant hazard via inhalation of either the vapor or a vapor/aerosol mixture.
Addition of propylene glycol at 2.2% w/w tobacco does not increase the toxicity of cigarette tobacco. In rats PG levels in plasma and lung are super-imposable within half an hour. A mild cumulative build up (30% or less) occurred after 28 days.

Monkeys, rats. Doses 50-700 times the amount absorbable from PG saturated air were administered for 12-18 months to monkeys. With a view to determining the safety of employing the vapors of propylene glycol and triethylene glycol in atmospheres inhabited by human beings, monkeys and rats were exposed continuously to high concentrations of
these vapors for periods of 12 to 18 months. Equal numbers of control animals were maintained under physically similar conditions. The doses administered represented 50 to 700 times the amount of glycol the animal could absorb by breathing air saturated with the glycol.

Comparative observations on the growth rates, blood counts, urine examinations, kidney function tests, fertility and general condition of the test and control groups, exhibited no essential differences between them with the exception that the rats in the glycol atmospheres exhibited consistently higher weight gains.

Propylene glycol in humans

The toxicology website http://toxnet.nlm.nih.gov/ was searched for PG, using terms such as human, aerosol, NOEL, carcinogenicity, inhalation. A review of PG has concluded it is safe for use in cosmetics at concentrations up to 50%.

Absorption. PG vapor has 100% deposition efficiency in human airways.

It is partly absorbed on inhalation. PG is absorbed completely from the gastrointestinal tract and partly and partly through the skin.

Metabolism. It is metabolized to lactic acid and pyruvic acid, and further oxidized to glycogen or carbon dioxide and water. In man, approximately 20-25% of the PG is eliminated unchanged via the kidney.

Inhalational safety in children. In a series of experiments to control airborne infections, over 105 children were subjected to bactericidal concentrations of propylene glycol in the wards of a children’s convalescent home in experiments conducted over 3 years.

For further reading, click here to download the full study in PDF form.

The toxicology website http://toxnet.nlm.nih.gov/ was searched for PG, using terms such
as human, aerosol, NOEL, carcinogenicity, inhalation. A review of PG has concluded it is
safe for use in cosmetics at concentrations up to 50%.6
Absorption. PG vapor has 100% deposition efficiency in human airways.7
It is partly absorbed on inhalation. PG is absorbed completely from the gastrointestinal
tract and partly and partly through the skin.
Metabolism. It is metabolized to lactic acid and pyruvic acid, and further oxidized to
glycogen or carbon dioxide and water. In man, approximately 20-25% of the PG is
eliminated unchanged via the kidney.
Inhalational safety in children. In a series of experiments to control airborne infections,
over 105 children were subjected to bactericidal concentrations of propylene glycol in the
wards of a children’s convalescent home in experiments conducted over 3 years.
Method. Six wards of the Children’s Seashore House in Atlanta containing 105 bedfast
children aged 3 to 15 years were divided into 3 control and 3 undergoing vaporization for
3 week periods with 2 to 3 days between, before the control wards become vaporized, and
the vaporized wards became controls. This rotation continued for 7 months. The PG was
heated to vaporize it, but not above 80 degrees C, and vaporization continuously
maintained a concentration of 0.069 mg per liter. (0.07 ppm)
Results. No ill effects were reported. In the first year, 100 infections occurred in control
wards without PG, and 5 in wards with PG vaporization, with rates of 0.18 per wee