Court Hearing on E-Cigarettes [8/17] Ruling Could Determine Fate of Controversial Nicotine Product

A court hearing scheduled for Monday could help determine whether e-cigarettes containing nicotine can continue to be imported (and ultimately sold) without any restrictions or required warnings, or if they are subject to the jurisdiction of the Food and Drug Administration [FDA] - like nicotine gum, nicotine patches, nicotine spray, nicotine inhalers, and even nicotine lollipops - and therefore must prove that they are safe and effective before they can be lawfully sold.

"At stake is whether e-cigarettes can continue to use customers as guinea pigs to determine whether inhaling a mixture of nicotine (a dangerous drug) and propylene glycol (which is used in antifreeze, and may cause respiratory tract irritation) is safe, and whether they can continue to add Cialis and other prescription-only drugs to the mix," says Action on Smoking and
Health (ASH), the organization which filed a legal petition demanding that the FDA begin regulating e-cigarettes.

The FDA has now determined that e-cigarettes are a "misbrand[ed]" product, an "unapproved new drug" and "are illegal until they are cleared." The agency has blocked the import of shipments, an order which is under attack in the court proceeding. In the meantime, the sale of e-cigarettes has been prohibited by court order in at least one state, e-cigarette advertising has reportedly been banned on Facebook, and several bills aimed at the product are being considered.

Recently ASH wrote to PayPal, advising the company that providing payment for e-cigarettes "appears to be aiding and abetting the sale of these illegal products by providing payment vehicles to Internet sites which are selling them, and doing so in interstate commerce and in possible violation of consumer protection laws in the individual states." PayPal subsequently announced that "we have decided not to allow the sale of electronic cigarettes."

In a news conference called in response to a scheduled appearance by ASH Executive Director John Banzhaf on NBC-TV's Nightly News program, the FDA warned the public and announced that it has discovered in e-cigarettes toxic and carcinogenic chemicals including diethylene glycol, "an ingredient used in antifreeze, [which] is toxic to humans"; "certain tobacco-specific nitrosamines which are human carcinogens"; and that "tobacco-specific impurities suspected of being harmful to humans - anabasine, myosmine, and beta-nicotyrine - were detected in a majority of the samples tested."

Public interest law professor John Banzhaf, Chief Counsel of ASH, has filed a brief amicus curiae, arguing that the FDA does have jurisdiction over e-cigarettes and describing many of the problems which could occur if the products could be sold without any restrictions or warnings. These include:

* Since at least one company is already adding Cialis to its e-cigarettes, "it would seem that the manufacturers or sellers would be free to add to e-cigarettes whatever other drugs (such as Cialis, Viagra, Levitra, mood-elevating or other anti-depression medications, etc.) they wished, provided only that the e-cigarettes also contained and dispensed some amount of nicotine derived from tobacco. This is true because no other agency would have jurisdiction to regulate them."

* A new report says that e-cigarettes contain an amount of nicotine which could be lethal to young children, especially since, as the FDA has suggested: "It was stated that parents may want to tell their children and teenagers that these products are not safe to use. Of particular concern to parents is that e-cigarettes are sold without any legal age restrictions, and are available in different flavors (such as chocolate, strawberry and mint) which may appeal to young people. In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes."

* The FDA has said it "is concerned that electronic cigarettes, cigars, or pipes may introduce young people to nicotine use which may lead to an increase in the use of conventional tobacco products with well-known, adverse, health consequences. Additionally, it is unclear what health effects these products could have on users or if misuse or product failure could lead to nicotine poisoning or other serious adverse health consequences."

* The FDA has rejected claims that these "devices are safer than smoking real cigarettes" or that the product help people stop smoking tobacco "because these devices can deliver doses of synthetic nicotine, and the agency sees them as unapproved drug-delivery devices with unknown safety. It has also not been proven whether these devices can safely help people quit smoking, while they have the clear potential to entice new smokers with their candy and fruit flavors offered."

A COPY OF ASH's BRIEF, AND MORE INFORMATION ABOUT THE PROCEEDINGS, ARE AVAILABLE TO THE PRESS.

EVENT: Oral argument concerning request by e-cigarette companies for the court to prevent the FDA from blocking imports into the country.

WHERE: Courtroom of U.S. District Judge Richard J. Leon, 3rd Street & Constitution Ave, NW, Washington, DC

WHEN: 3:00 PM on Monday, August 17, 2009

FOR MORE INFORMATION, CONTACT:

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 // ash.org

Contact Information:
Action on Smoking and Health (ASH)
America's First Antismoking Organization

2013 H St., NW
Washington, DC 20006

Contact Person:
Public Interest Law Professor John Banzhaf
Executive Director and Chief Counsel
Phone: (202) 659-4310 // (703) 527-8418
email: email

Web: ash.org