Scare #1B Continued

Propylene Glycol >50%
Glycerol <30%
Nicotine 0 to 1.8%
Water <10%
Alcohol (ethanol) <1%
Coriandor <1%
Solanone <1%
Citric Acid <1%
Benzel Alcohol <1%
Orient Tobacco Absolute (flavor) <1%
Pepper Oil <1%
Guaiacol <1%
Menthol <1%
Fragrant Orchid Element <1%

FDA Backtracks on E-Cig Risk

FDA First Says E-Cigs Contain Toxins and Now the FDA Says E-Cigs Contain “Just Nicotine” was developed in response to the FDA’s sensationalistic July 22, 2009 press release stating that the FDA’s testing of electronic cigarettes (e-cigs) “found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.” The FDAs release set off a firestorm of activism and disinformation that has falsely demonized the first technology that 300,000+ smokers are actually consistently using to stay off of tobacco. The 7/22 press release is now leading to state bans (in deference to the FDAs lack of a national ban) based on their tests which in fact did not find any toxins or carcinogens at any levels harmful to humans.

This prelude is addressing the most recent comments the FDA has made in an interview on September 30, 2009* that state that in regard to e-cigs the FDA “wants to regulate electronic cigarette(s) so it can be sure that the people who use them are getting a reliable dose of nicotineand "There are no long-term studies on the health effects of just nicotine, minus the tobacco component.” In the same article that quotes FDA spokeswoman DeLancey also states” A federal Food and Drug Administration spokeswoman said the FDA has not moved to ban e-cigarettes, which heat a liquid and nicotine to a vapor so people can puff them.”  

The FDA has the forum to alert the public about their findings of toxins and carcinogens they found in e-cigs and to have already banned the product if there were actual and immediate dangers to the public. Months ago a very public claim was made that e-cigs were dangerous and now the FDA is only worried that they contain “just nicotine”. They were at one time so concerned about the dangers of e-cigs as to mount a very public press campaign and now their only concern is of the e-cig’s long-term delivery of “just nicotine”? By stating “just nicotine” it seems the FDA is capitulating to all the completed and mounting scientific testing and public admissions that there are no toxins or carcinogens in e-cigs at any levels that are of danger to the public and that an electronic cigarette (as has been tested in five separate tests this year included in this report) is only providing to an e-cig user their desired nicotine.  

It is very disconcerting that the FDA who has providence to regulate consumer products makes the very misleading statement that there are “no long-term studies on the health effects of just nicotine” when in fact long-term tests have been done on nicotine only ingestion as the FDA has approved Nicotine polacrilex lozenges (sold as Glaxo’s Commit Lozenges) in 2002**  and Pfizer’s Nicotrol inhalers. From Dr. Murray Laugesen who has actually done testing on the e-cig: The FDA does not seem to have heard about the famous 5 year Lung Study wherein thousands with chronic obstructive pulmonary disease(COPD) used Nicotine gum, with no increase in hospitalization or mortality. Since then 7.5 additional years of follow up for lung cancer show no added risk for gum users but plenty for smokers. If The FDA needs references for longer term nicotine only effects, Nicotine gum has been used widely in many countries since 1984.”   )

Below is the summation of the results of the 1996 study referenced above by The American College of Physicians of Nicotine polacrilex titled “Safety of Nicotine Polacrilex Gum Used by 3,094 Participants in the Lung Health Study”:

Results: The rates of hospitalization for cardiovascular conditions and cardiovascular deaths during the 5 years of the study were not related to use of NP, to dose of NP, or to concomitant use of NP and cigarettes. About 25% of NP users reported at least one side effect, but most were very minor and transient. Side effects associated with discontinuance of NP in 5% or more of users included headache, indigestion, mouth irritation, mouth ulcers, and nausea. There was no evidence that concomitant use of NP and cigarettes was associated with elevated rates of reported side effects. Participants in the smoking cessation intervention who received intensive levels of instruction and monitoring of NP use (initially at 12 meetings during 3 months) appeared to report significantly lower rates of side effects (dizziness, headache, and throat irritation) than control participants, presumed to have less instruction and monitoring.

Conclusions: NP, as used in the Lung Health Study,appears to be safe and unrelated to any cardiovascular illnesses or other serious side effects. (CHEST 1996; 109:438-45) 

Ingredients of  Nicotine Polacrilex (
Active Ingredients: Nicotine polacrilex (4mg)

Inactive Ingredients: Aspartame, Calcium Polycarbophil, Flavor, Magnesium Stearate, Mannitol, Potassium Bicarbonate, Sodium Alginate, Sodium Carbonate, Xanthan Gum

Below are all the ingredients in the inLife Regal Electronic Cigarette:Active Ingredients: Nicotine 1.3%, Propylene Glycol >50%, Glycerol <30%

Ingredients at less than 10%: Water, Alcohol (ethanol), Coriandor,  Solanone, Citric Acid, Benzel Alcohol, Orient Tobacco Absolute (flavor), Pepper Oil, Guaiacol, Menthol, Fragrant Orchid Element

In Summation To the FDA’s Revised Comments

On July 22nd 2009 the FDA first reported to the world that “These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals” and “In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans” scaring thousands of e-cig users and leading to Oregon, Connecticut, and potentially California in taking legal action and now their only concern is of the safety of nicotine, the one component it approves for use in nicotine inhalers, gums, lozenges and patches? So in summation, this current confused attitude of The FDA seems to be driven by a combination of pharmacological puritanism and bureaucratic stubbornness that does not bode well for the FDA's ability to rationally regulate tobacco products and subsequently the e-cig especially now given the fact that over 300,000+ users are reliant on. To ban the electronic cigarettes based not on scientific fact, but conclusions in search of facts would commit 300,000+ e-cig users to return to smoking tobacco, the one product we know will kill them.

* )

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