E-Cigarettes Hit With Patent Infringement Threat // Effect Could Disrupt Industry Already Under Fire

Oct. 14, 2010 - PRLog -- The trade association for the electronic cigarette [e-cig] industry reportedly has been advised by a law firm claiming to have a patent covering all e-cig products that it intends to prevent the sale of such products which are not licensed, notes Action on Smoking and Health (ASH), America's first antismoking organization.

Although the initial communication referred specifically to enforcement of the patent claims only against e-cig vendors and importers throughout the European Union and Norway, its actions could ultimately spread to other countries, including the U.S.

Meanwhile, in the U.S., the Food and Drug Administration [FDA] has just sent a letter to several leading e-cig companies, warning them that their products are drug-delivery devices which cannot be sold without FDA approval.  Several attorneys general have brought law suits - some already successful - to prevent the sale of e-cigs without FDA approval, and legislation aimed at the same result is pending in New York and other states.

E-cigs have already been banned in Australia, Brazil, Canada, Israel, Mexico, New Zealand, and Singapore, restricted in Finland and Malaysia, are pending restriction in the UK as a drug, and the subject of law suits - including a class action - in several states. In part as a result of urging by ASH, New Jersey and Suffolk County, NY, have prohibited their use in no-smoking sections, and their use is prohibited on U.S. airlines.

The FDA has warned that: e-cigs pose “acute health risks” which “cannot seriously be questioned” because they contain “toxic chemicals.” It also said 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 Air Force, and the Marine base at Quantico, have joined other jurisdictions in banning the use of e-cigarettes [e-cigs] at least in the workplace, citing the potential health dangers to users from toxic chemicals as set forth in a memo by the Air Force Surgeon General.

The Surgeon General also noted a concern originally expressed by ASH that these devices can also be used to surreptitiously administer drugs other than nicotine. ASH had previously reported ads for e-cigs which administer Cialis and also "potent" marijuana.

As the Surgeon General's memo warned: "Commanders also need to be aware that the cartridges used in these devices are replaceable and could be used to discreetly deliver substances other than nicotine."

ASH, which serves as the legal action arm of the antismoking community, has warned e-cig sellers, and those companies which aid and abet them, of their potential liability for selling a product which the FDA has determined is "illegal."

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
Internet: http://ash.org/
Twitter: http://twitter.com/AshOrg

# # #

Action on Smoking and Health (ASH), America's first anti-smoking and nonsmokers' rights organization, serves as the legal action arm of the anti-smoking community. It is supported by tax-deductible contributions.