The U.S. Food and Drug Administration plans to oversee electronic cigarettes marketed for non-therapeutic use as tobacco products after a court ruled the products can’t be regulated as drugs or medical devices.
The FDA will propose subjecting 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 a 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.
The agency is considering whether to issue rules or industry guidance on what types of marketing would qualify as a “therapeutic” claim, Deyton and Woodcock said.
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.
The agency last year warned five e-cigarette companies that they were illegally marketing their products as smoking- cessation aids without obtaining prior approval from the FDA as drug-delivery devices.
Deyton and Woodcock didn’t say in their letter whether any e-cigarette companies are still making therapeutic claims. Jeffrey Ventura, an agency spokesman, didn’t immediately respond to an e-mail seeking comment.
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 -- battery-powered devices that generate a nicotine vapor instead of smoke -- 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 today in a telephone interview. The company doesn’t make any health or therapeutic claims and will “flourish in a regulatory environment,” Weiss said.
The e-cigarette consists of a battery, a heating element and a cartridge that contains a liquid suspension with nicotine. When a user inhales from the cartridge, the liquid is heated and a vapor is emitted. The nicotine is obtained from tobacco plants.
Smokers spend $1.2 billion on smoking-cessation products and $80 billion on cigarettes a year, according to the U.S. Centers for Disease Control and Prevention.
The FDA had said in court filings that e-cigarettes may work with smokers the way methadone clinics wean heroin addicts by giving them a less harmful form of an addictive substance.
Alternative to Smoking
Proponents of e-cigarettes say they provide an alternative to traditional cigarettes that may be less harmful because they don’t produce smoke.
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.
Smoking-cessation products approved as drugs by the FDA include prescription nasal sprays and over-the-counter gums, patches and lozenges.
GlaxoSmithKline Plc (GSK)’s Nicorette gum was the top-selling brand-name nicotine replacement drug for the year ended in June, with $144.6 million in sales, or 12 percent of the $1.2 billion smoking-cessation market, according to IMS Health Inc., a research company in Norwalk, Connecticut.
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