FDA rules e-cigarettes as tobacco products and plans regulations

By Dr. Ananya Mandal, MDApr 26 2011

The Food and Drug Administration (FDA) has ruled that electronic cigarettes should be considered tobacco products. E-cigarettes are small plastic or metal devices that heat a liquid nicotine solution, creating a vapor that is then inhaled. They are marketed as a way to help smokers quit by addressing their addiction and the behavioral aspects of smoking.

The FDA did not classify e-cigarettes as a “drug delivery device” however. That would have meant much tougher regulations. But all in all the e-cigs can now be held to the same restrictions and bans placed on other tobacco products.

With the new ruling the FDA will subject e-cigarette companies to rules that already cover the makers of regular cigarettes, such as providing the government with lists of product ingredients, the agency said today in the letter on its website. The U.S. Court of Appeals in Washington said in December the FDA can regulate e-cigarettes only as tobacco products if they aren’t marketed for therapeutic purposes. The ruling meant that while the agency can review new e-cigarette products before they go on sale, it can’t require manufacturers to conduct the types of animal and human studies mandated for FDA approval of drugs or medical devices. “The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established” by the ruling, Lawrence Deyton, director of the agency’s Center for Tobacco Products, and Janet Woodcock, director of the Center for Drug Evaluation and Research, said in today’s letter.

E-cigarettes the FDA determines are marketed for therapeutic purposes “will continue to be regulated as drugs and/or devices,” the FDA said in a separate summary of today’s letter on its website. Last year Americans spent $1.2 billion on smoking cessation products, according to the Centers for Disease Control. As many as one in five American still smokes, according to the agency.

Sottera Inc., a closely held e-cigarette maker doing business as Njoy and based in Scottsdale, Arizona, argued in the federal lawsuit that its products are tobacco products and not drugs. e-cigarettes are marketed as a tobacco alternative for “smoking pleasure,” rather than for therapeutic uses, the company said. “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 said. The company doesn’t make any health or therapeutic claims and will “flourish in a regulatory environment,” Weiss said.

Anti-smoking groups including the American Lung Association had urged the FDA to suspend sales of e-cigarettes unless manufacturers proved their safety and effectiveness in clinical trials.