FDA gives reprieve to e-cigarette makers
Electronic-cigarette makers won a major reprieve last week when the Food and Drug Administration delayed regulations that could have removed many of their products from the market and opened the door to endorsing e-cigarettes as a means to get smokers to quit.
The FDA commissioner, Dr. Scott Gottlieb, announced the delay as part of a broad plan to reduce tobacco deaths in the United States, which now number about 480,000 a year. That strategy will include steps to push makers of tobacco cigarettes to reduce the levels of nicotine in their products to make them less addictive, he said. Federal law gives the agency the authority to require lower levels of nicotine in tobacco products, FDA officials said, and the announcement was a step toward that.
Gottlieb, in a conference call with reporters, said the FDA would encourage ecigarette companies to talk to the agency about gaining approval of their products as smoking cessation aids if that is their intent.
In a later interview with The New York Times, Gottlieb sounded notably more open to e-cigarettes than many other federal public health officials, who have opposed the devices as a gateway to nicotine addiction and eventually to the smoking of tobacco cigarettes. Although Gottlieb said he was concerned about children’s use of e-cigarettes and would consider regulating flavors designed to appeal to them, he also noted the potential benefits to addicted cigarette smokers of products capable of delivering nicotine without having to burn tobacco.
“We do think there’s a potential opportunity for ecigarettes to be a lower-risk alternative to smokers who want to quit combustible cigarettes,” he said. “We still have to figure out if they are a way to get people off combustible cigarettes. We don’t fully understand.”
The announcement thrilled the e-cigarette industry, which was facing a deadline of next year for makers to seek approval to sell any product that entered the market after Feb. 15, 2007.
Makers of tobacco cigarettes were warier because the FDA said it would seek public input on a move to lower nicotine levels in combustible cigarettes to nonaddictive levels. Shares of cigarette makers tumbled after the morning announcement.