E-Cigarettes Cause “Acute Health Risks” - FDA // Imminent Court Ruling May Bar Their Importation

Feb. 16, 2010 - PRLog -- E-cigarettes pose “acute health risks” which “cannot seriously be questioned” because they contain “toxic chemicals,” and the devices also “presents a serious risk of addicting new users, including children,” the Food and Drug Administration [FDA] has just reported to a court about to decide whether sellers may continue to import the new products into the U.S.

With a ruling by the U.S. Court of Appeals imminent, the FDA has also warned that:
* e-cigarette users suffer from a wide variety of potentially serious symptoms "including racing pulse, dizziness, slurred speech, mouth ulcers, heartburn, coughing, diarrhea, and sore throat"
* "nicotine [one of the two major chemicals used in the product] in high doses can be dangerous and even fatal"
* the toxic chemical diethylene glycol was found in the e-cigarettes which were tested
* various mutagenic, carcinogenic, and genotoxic chemicals were also present in the products
* the cartridges containing the nicotine and other toxic chemicals, many of which come from China, are subject to "none of the manufacturing controls required for FDA-approved nicotine-delivery products" [like nicotine gum, patches, inhalers, sprays, etc.].

The FDA concluded that: "the danger posed by the unrestricted distribution of unregulated products containing toxic chemicals cannot seriously be questioned. Even apart from the acute health risks that these products pose, there is no dispute that the nicotine is 'a highly addictive pharmacological agent.'"

Jonathan P. Winickoff, MD, MPH, the chair of the American Academy of Pediatrics Tobacco Consortium who helped the FDA study the issue noted: "The primary claim that there is a net benefit for the public health is just unproven, and there's a very real risk that even people who have not used any tobacco products -- including children and young adults -- start with an e-cigarette thinking it's safe."

These appear to be some of the concerns that prompted the World Health Organization to say that it does not consider e-cigarettes to be a legitimate therapy.  Many major public health organizations have called for them to be banned.

Action on Smoking and Health (ASH) has been leading the battle to have these new products regulated by the FDA, and to protect those around e-cigarette users (including the elderly and those with allergies) from being forced to inhale large amounts of nicotine (a highly addictive and deadly drug which can trigger fatal heart attacks), and propylene glycol (a respiratory irritant used in antifreeze and known to cause respiratory tract infections).

ASH pointed out in court that at least one manufacturer has been adding Cialis to its e-cigarettes, at least suggesting that other sellers might also add additional drugs to their products.  ASH's concerns about e-cigarettes include:

1. Smokers who otherwise would be able to quit with sufficient assistance and/or because of higher taxes may instead switch to e-cigarettes which, while they may have a lower cancer risk, may present an equal or even higher risk of fatal heart attacks, the major cause of death from smoking.

2. There may be a potential risk from users repeatedly inhaling, over a considerable period of time, large amounts of propylene glycol  -- a respiratory irritant used in antifreeze and known to cause respiratory tract infections.

3. Just as generations of children were led to become smokers by pretending to puff on candy cigarettes, today’s teenagers may likewise find e-cigarettes -- with their many kid-friendly flavors -- training wheels for becoming smokers.

4. There may be a serious risk to those around e-cigarette users (including young children, the elderly, and those with allergies) from being forced to inhale large amounts of nicotine (a highly addictive and deadly drug which can trigger fatal heart attacks), and propylene glycol (a respiratory irritant used in antifreeze and known to cause respiratory tract infections).

E-cigarettes are now subject to FDA regulation, but it remains to be seen how strictly they can and will be regulated, says public interest law professor John Banzhaf, who participated in the court proceedings.

ASH also helped persuade both the State of New Jersey and Suffolk County, New York, to ban the use of the product in no-smoking sections to protect bystanders, including the elderly, those with allergies, and children. E-cigarettes have already been banned in Australia, Brazil, Canada, Israel, and Mexico, and restricted in Finland, Malaysia, and Singapore, and the UK is posed to begin regulating them as drugs. They are the subject of law suits brought by attorneys general in several states, and of a national class-action law suit which is pending.

PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law at GWU,
FAMRI Dr. William Cahan Distinguished Professor,
FELLOW, World Technology Network, and
Executive Director and Chief Counsel
Action on Smoking and Health (ASH)
America’s First Antismoking Organization
2013 H Street, NW
Washington, DC 20006, USA
(202) 659-4310 // (703) 527-8418
http://ash.org/