July 22nd, 2009:

FDA NEWS RELEASE

The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.

Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.

“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: http://www.fda.gov/Safety/MedWatch/default.htm

By MATTHEW PERRONE (AP)

WASHINGTON — Federal health officials said Wednesday they have found cancer-causing ingredients in electronic cigarettes, despite manufacturers’ claims the products are safer than tobacco cigarettes.

The Food and Drug Administration said testing of products from two leading electronic cigarette makers turned up several toxic chemicals, including a key ingredient in antifreeze.

“Little is known about these products, including how much nicotine is there and what other chemicals may be there,” said FDA’s Deputy Commissioner Dr. Joshua Sharfstein.

FDA scientists said they tested 19 varieties of cigarettes, half of which contained forms of nitrosamine, a carcinogen known to cause cancer in humans. Many products which claimed to contain no nicotine actually had low levels of the stimulant.

Agency officials said the “quality control processes used to manufacture these products are inconsistent or nonexistent.”

Brands tested by the agency included Smoking Everywhere, marketed by a Florida-based company and NJoy Cigarettes, based in Scottsdale, Ariz. The Electronic Cigarette Association, which represents the companies, had no immediate comment Wednesday afternoon.

Public health advocates have complained the products are aimed at young people and can serve as a “gateway” to tobacco smoking. Many come in flavors, including chocolate, bubblegum and mint.

“Tobacco industry research has demonstrated that fruit and candy flavors increase the social acceptance of cigarettes and curiosity to try the product,” said Dr. Jonathan Winickoff, chair of the American Academy of Pediatrics Tobacco Consortium.

Because electronic cigarettes are not covered by federal tobacco laws, they are also often easier for young people to buy.

Electronic cigarettes produce a nicotine mist absorbed directly into the lungs. Most can easily pass as a tobacco cigarette with slim white bodies and glowing amber tips. They even emit what look like puffs of white smoke.

Manufacturers have touted the products as a healthier alternative to smoking because there is no burning involved, and they don’t contain the same hazardous cocktail of cancer-causing chemicals.

Regulators said they have halted 50 shipments of electronic cigarettes at the border since last summer. The FDA said it is authorized to seize the products because — for legal purposes — they are a medical device used to deliver nicotine.

However, the FDA’s enforcement attempts have been challenged in federal court by manufacturers. The products are made primarily in China.

FDA officials declined to comment on whether they would take action against the two manufacturers whose products were tested.

The agency did say it’s “planning additional activities” to address safety issues with the products, which may include recalls or criminal sanctions.

In an effort to move beyond cigarettes, tobacco companies have introduced a number of smokeless products to keep smokers as buyers of other items. They are trying to convert smokers to products such as moist snuff, chewing tobacco and snus — teabag-like pouches that users stick between their cheek and gum.

R.J. Reynolds spokesman David Howard said the company is focused on being the “total tobacco company,” pointing to its products like dissolvable tobacco, rather than technology like e-cigarettes.

Neither Reynolds nor Altria Group Inc.’s Philip Morris USA currently market electronic cigarettes.

Earlier this year, the FDA gained the authority to regulate tobacco products for the first time. However, the agency already could regulate electronic cigarettes because they do not actually contain tobacco.

AP Business Writer Michael Felberbaum in Richmond, Va., contributed to this report.

Copyright © 2009 The Associated Press. All rights reserved.