Electronic cigarettes may be closer to smoking cessation devices than regular smokes and regulators are keeping “an open mind” on their potential health benefit, said the top U.S. official overseeing their use.
In comments that may boost the developing $3 billion e-cigarette market, Mitch Zeller, head of the Food and Drug Administration’s Center for Tobacco Products, said the agency is exploring expedited reviews for tobacco products based on risk and toxicity as it prepares its e-cigarette rules.
The FDA announced on April 24 that it would regulate the new products. Zeller said he wants advocates and foes to view nicotine-containing products as a continuum -- from cigarettes, to their electronic counterparts, to cessation gums and patches.
“Cigarettes are designed to create addiction,” Zeller said yesterday at a Washington conference. “Ultimately it’s not the nicotine that kills. It’s all about the delivery mechanism.”
Most e-cigarettes deliver nicotine while leaving out the tars, arsenic and other chemicals common in tobacco products. The tubular devices, which produce an inhalable vapor to mimic smoking, were added at the end of last year to a New York ban on smoking in restaurants, bars, offices and parks. Chicago and Los Angeles followed with similar prohibitions.
The FDA is focusing on tobacco product standards that would ban or restrict levels of some ingredients to address addiction, toxicity and appeal, Zeller said. The agency has already said it will prohibit the sale of e-cigarettes to minors.
“It’s time for us to start looking at nicotine differently,” he said.
Scientific Data
U.S. regulators don’t have good scientific data on e-cigarettes, made by companies including Lorillard Inc. and Njoy Inc., and their ability to help smokers quit or entice new ones, according to Zeller. “We have to have an open mind on the potential for these emerging technologies to benefit public health,” he said.
Cigarette smokers who used an e-cigarette were 60 percent more likely to stop smoking than those who used traditional nicotine replacement therapies, researchers in the U.K. reported last month in the journal Addiction.
The FDA and National Institutes of Health intend to commit $4 million in fiscal 2014 to nicotine research and other tobacco priorities.
Products such as GlaxoSmithKline Plc’s Nicorette gums and lozenges that claim to help smokers quit must go through the FDA’s rigorous drug approval process. Zeller highlighted the U.K.’s approach in which e-cigarettes will be regulated as medicines and health agencies can encourage their use for smoking cessation. The European Union, of which the U.K. is a member, decided earlier this year that it would regulate as medicines e-cigarettes that contain a nicotine strength of more than 20 milligrams per milliliter.
FDA Proposal
In the FDA’s April 24 proposal, the agency questioned whether it should expedite review for a product that “contains no tobacco leaf, but contains nicotine, such as some electronic cigarettes.” The proposal also asks for public comment about whether low or nicotine-free products should be included in any faster review process.
Along with banning their sale to children, the FDA’s draft proposal would require e-cigarettes undergo agency review to sell new products.
The agency has said it is weighing whether it will extend the comment period on the proposal beyond July 9 after requests from within the industry and others.
Bloomberg News
