April 26, 2011
Electronic Cigarettes To Get FDA Regulation
Electronic cigarettes that are marketed for non-therapeutic use will be regulated by the U.S. Food and Drug Administration (FDA) as a tobacco product, the agency announced after a federal court ruled that the products were not a drug or medical device, and cannot be regulated as such.
The e-cigarette maker Sottera Inc., based in Scottsdale, Arizona, and doing business as Njoy, argued in the federal lawsuit that its products are tobacco products and not drugs. These battery-powered devices generate a nicotine vapor instead of smoke and are marketed as a tobacco alternative for "smoking pleasure" rather than therapeutic use, the company says.
E-cigarette supporters say that these devices provide an alternative to traditional cigarettes and may be less harmful due to the lack of smoke produced.
On the other side, the FDA argued that e-cigarettes might work with smokers in the same way methadone clinics wean heroin addicts by giving them a less harmful form of an addictive substance, reports Bloomberg.
And the American Lung Association, who is against smoking, has urged the FDA to suspend sales of e-cigarettes until the manufacturers prove that their products are safe and effective in clinical trials.
In December, the U.S. Court of Appeals in Washington ruled that the FDA can regulate e-cigarettes only as a tobacco product as long as these were not marketed for therapeutic purposes.
The decision allows the FDA to review new e-cigarette products before they are sold, but they are not allowed to require the manufacturers to conduct animal and human studies that are required for FDA approval of drugs and medical devices, reports Bloomberg.
"The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established" by the ruling, a letter by Lawrence Deyton, director of the agency's Center for Tobacco Products, and Janet Woodcock, director of the Center for Drug Evaluation and Research stated.
The Campaign for Tobacco-Free Kids said that it was disappointed the U.S. government would not appeal the federal appeals court ruling.
According to the group, the ruling has opened a loophole that lets manufacturers add nicotine to products, allowing them to bypass the regulations that traditionally apply to smoking cessation medications and other non-tobacco products that include nicotine, reports the Telegraph.
Deyton and Woodcock say that the agency is considering whether to issue rules or industry guidance on what types of marketing would qualify as a "therapeutic."
In a separate summary of its letter, the FDA says that e-cigarettes that it determines to be marketed for therapeutic purposes "will continue to be regulated as drugs and/or devices."
Five e-cigarette companies were warned last year that they were illegally marketing their products as smoking-cessation aids because they did not obtain approval from the FDA as drug-delivery devices, repots Bloomberg.
It is not mentioned by Deyton and Woodcock if the e-cigarette companies are still claiming therapeutic products, and agency spokesman did not immediately respond to an email sent by Bloomberg seeking comment.
Authority to regulate tobacco products that were not marketed as drugs or medical devices were given to the FDA in 2009.
The FDA will soon be subjecting e-cigarette companies to the same rules that already exist for makers of regular cigarettes. For example, they will be required to provide the government agency with a list of their product ingredients, the agency says on its website.
"We look forward to working with the FDA toward the creation of a regulatory framework that we can all work under together," Sottera President Craig Weiss told Bloomberg in a phone interview.
There is no health or therapeutic claims made by the company and it will "flourish in a regulatory environment," Weiss says.
The Tobacco Vapor Electronic Cigarette Association (TVECA), a group that represents companies that make such products, said in an email to the Telegraph that it always wanted the electronic cigarettes to be regulated as tobacco products.
Chief executive of TVECA says that the electronic cigarette is 14,000 times less harmful than a regular cigarette and does not alter mind or body functions.
"This product delivers five ingredients. All five are approved by the FDA," he says.
These battery operated devices consist of a heating element and a cartridge that contains nicotine in a liquid suspension. Once the user inhales the cartridge, the liquid is then heated and a vapor is emitted. The nicotine is retrieved from tobacco plants.
According to the U.S. Centers for Disease Control and Prevention, smokers spend $1.2 billion on smoking-cessation products and $80 billion on cigarettes a year.
Some smoke-cessation products on the market include prescription nasal sprays and over-the-counter gums, patches and lozenges that have been approved as drugs by the FDA.
On the Net:
- Sottera Inc./Njoy
- American Lung Association
- Center for Tobacco Products
- Center for Drug Evaluation and Research
- Campaign for Tobacco-Free Kids
- Tobacco Vapor Electronic Cigarette Association (TVECA)