E-Cigarette Bans Growing // Sellers Seek Liability Insurance

Sept. 2, 2009 - PRLog -- Brazil has just joined the ever growing list of countries where e-cigarettes have been banned (including Israel, Australia, Canada, and Mexico) or restricted (Finland, Malaysia, and Singapore), with Brazil's decision being based on a critical health report issued by the U.S. Food and Drug Administration [FDA] triggered by the scheduled appearance on a national TV news program of public interest law professor John Banzhaf of Action on Smoking and Health (ASH).

In a related development, more e-cigarette wholesalers are finding it necessary to provide product liability insurance to their retail customers, and at least one insurance company is offering its own policies.  The company explains the need for such insurance this way:  "This device has not been approved by the FDA as a 'stop smoking aid' product.  In fact, the FDA has issued a warning about the product (e-cigarettes) because marketers are presenting the e-cigarette as a healthier alternative to regular cigarettes.  In addition, the cartridge contains several chemicals including nicotine that are hazardous to your health."

In the U.S., e-cigarettes have been declared illegal by the FDA, their sale has been banned in Oregon, the Connecticut Attorney General is threatening legal action against sellers, a major retailer of electronic cigarettes has been sued in a multi-count civil action which seeks penalties of $25,000 for each sale as well as refunds to customers, PayPal has stopped facilitating their sale, Facebook has reportedly dropped their ads, and at least one county has banned their use wherever conventional smoking is prohibited.

Also, a recent federal court ruling suggests that e-cigarette marketers could even face prison for the sale of products because the FDA "has already declared that electronic cigarettes are subject to FDA approval as a drug or medical device, much like nicotine patches, gum and inhalers -- and therefore they are illegal until they are cleared," and has stated that electronic cigarettes are "unapproved new drugs and/or misbranded drugs or devices," and appear "to be a combination drug-device product that requires pre-approval, registration and listing with FDA."

Federal law, which applies to individual sellers as well as to commercial drug companies, prohibits the "introduction or delivery for introduction into interstate commerce" of any misbranded drug, and provides for imprisonment for one year for each individual violation; e.g., for each individual sale.

A recent federal court ruling holds that products can be found to be "misbranded drugs" even if the sellers make no claims relating to their product, a defense some sellers seem to be hoping to rely upon.

"If, as the sellers claim, e-cigarettes can be shown to help smokers quit, or provide a less hazardous means of administering nicotine to those who are hopelessly addicted, the product will be approved for sale by the FDA -- presumably with appropriate health warnings, restriction on sales to kids, no other included drugs such as Cialis, etc. -- just like nicotine gum, patches, sprays, inhalers, and similar products," suggests Banzhaf.

"However, until such time, they remain misbranded drugs as to which the FDA has issued numerous warnings, and those who traffic in them are using their customers as human guinea pigs to test their safety, and also risking a variety of potential legal consequences, including prison."

PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law and Executive Director
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

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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.