2009-07-24 18:13:02 - The Food and Drug Administration's [FDA] media event on Wednesday ignored virtually all of the major concerns with e-cigarettes, focused on some dubious ones which might harm its credibility, and apparently was pushed into hurriedly reactivating a long-delayed press outreach effort by word that NBC-TV Nightly News was about to air a piece that evening about the agency's refusal to unambiguously apply its clear legal jurisdiction over nicotine delivery products to e-cigarettes.

DANGERS HIGHLIGHTED BY THE FDA

The principal dangers of e-cigarettes highlighted by the FDA -- that they contain "known carcinogens and toxic chemicals" -- appears overblown. Virtually all nicotine replacement products - e.g., nicotine gum, nicotine patches, nicotine sprays, nicotine inhalers, etc. -- reportedly also contain tiny amounts of these known carcinogens because the nicotine used in the products is extracted from tobacco which contains these naturally-occurring chemicals.

However, notes Professor John Banzhaf -- whose legal petition to the FDA to regulate e-cigarettes, and whose scheduled appearance on the NBC-TV news report, apparently helped trigger the agency's hurriedly-arranged news conference -- notes that the other nicotine products have been approved for sale and use by the FDA although they likewise apparently contain

many of the same carcinogens.
www.pr-inside.com/fda-finds-deadly-chemicals-in-e-cigarette-r140 ..
www.pr-inside.com/fda-to-regulate-e-cigarettes-as-toxins-r140360 ..

The FDA also warned in its media blitz that e-cigarettes contain tiny amounts of diethylene glycol. But it has long been known that propylene glycol is one of the major ingredients in e-cigarettes, and indeed is what is largely seen when the user exhales when using the product. It is well known that propylene glycol, which is used in antifreeze, may cause respiratory tract irritation. Moreover, its chronic use may cause reproductive and fetal effects, and laboratory experiments have triggered mutagenic effects. Still, minute amounts of diethylene glycol were highlighted, while propylene glycol was not.

MUCH MORE SERIOUS POTENTIAL DANGERS OF E-CIGARETTES

1. Current smokers who would otherwise be persuaded to quit -- by health warnings, restrictions on public and workplace smoking, etc. -- may instead switch to e-cigarettes; a move which may reduce their overall health risks, but is a course of action still far more dangerous than quitting.

2. Current smokers at elevated risk for cardiovascular problems may switch to e-cigarettes, thinking that they are far safer. But actually any decrease in health risk relates to cancer (since e-cigarettes reportedly contain far fewer carcinogens), and not to cardiovascular problems (as to which nicotine is the main culprit).

3. E-cigarettes may be less likely to reduce nicotine dependence that other nicotine replacement products because the almost-instantaneous absorption of nicotine through the lungs is more likely to provide the nicotine "kick" or "high" addicted smokers crave than other methods where the absorption is much more gradual.

4. Those in the vicinity of e-cigarette users -- including infants breastfeeding and in arms, other young children, the elderly and others at higher risk -- will be forced to inhale a mixture of nicotine (a deadly poison) and propylene glycol; the health consequences of which are not known.

5. E-cigarettes -- especially those sold with flavors -- may serve as training wheels for youngsters still too young to smoke, but not too young to become addicted to nicotine, and to becoming accustomed to the gestures and mannerisms of smokers. Being able to imitate teenagers who smoke, while avoiding the smell of real smoking, may be tempting to young children; a temptation apparently not present with nicotine gum, patches, sprays, etc.

6. Regardless of the safety of any particular e-cigarette, the danger of the FDA's failure to take decisive action is that it can open the door to many other nicotine-delivery products which may be even more dangerous, and as to which smokers will serve as guinea pigs. All other nicotine delivery products are regulated by the FDA, and must contain warnings. Some still require prescriptions.

Banzhaf emphasizes that only scientific experiments and medical studies can determine the magnitude and importance of these and other potential risks, and that they must be evaluated by an impartial and competent body like the FDA, not by Chinese manufacturers and American importers who have an obvious bias.

"The role of the FDA is not just to warn people about new drug products once their market becomes established, but rather to insure that they are not marketed until their safety have been authoritatively and impartially established, and then only with appropriate safeguards like warnings and possibly even prescription requirements," suggests Prof. Banzhaf, Executive Director of Action on Smoking and Health (ASH), America's first antismoking organization.

THE FOLLOWING LINKS PROVIDE ADDITIONAL BACKGROUND INFORMATION IF DESIRED:

SUMMARY OF FDA ANALYSIS OF E-CIGARETTES:
www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm

COMPLETE FDA ANALYSIS OF E-CIGARETTES:
www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

E-CIGARETTE CRITICS ACCUSED OF "LIBEL" AND "SLANDER" // BUT FDA IS ALREADY ASSERTING JURISDICTION OVER PRODUCT
www.pr-inside.com/e-cigarette-critics-accused-of-libel-and-r1402 ..

ASH'S LEAD FOLLOWED; BILL BANS E-CIG USE IN NO-SMOKING SECTIONS
www.legislatorcooper.com/pressrelease_259.html

FDA BEGINS REGULATING E-CIGARETTES AS DRUG-DELIVERY DEVICES // ASH'S LEGAL PETITION SPURS/EXPLAINS ACTION
www.pr-inside.com/fda-begins-regulating-e-cigarettes-as-r1262323 ..

ASH SEEKS REGULATION OF E-CIGARETTES - COPY OF PETITION
ash.org/ecigpetition

FOUR NEW DANGERS TO NONSMOKERS - INCLUDING E-CIGARETTES
ash.org/4dangers.html

PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law and Executive Director
Action on Smoking and Health (ASH)
2013 H Street, NW, Washington, DC 20006, USA
(202) 659-4310 // (703) 527-8418 // ash.org/