FDA proposes first e-cigarette rules

The Food and Drug Administration on Thursday proposed new rules that would ban electronic cigarette sales to minors and require government approval for new products, as well as health warning labels on e-cigarette packages.

While the new guidelines will not bring immediate changes, the move aims to eventually bring the fast-growing e-cigarette industry under a regulatory framework, treating it more like the traditional tobacco industry.

The agency said the proposal sets a foundation for regulating the products. But the new rules would not immediately ban the wide array of flavors of e-cigarettes, curb marketing on places like TV or set product standards, something legislators and public health groups have called for.

Any further rules "will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits," FDA Commissioner Dr. Margaret Hamburg said at a news briefing.

Once the rules are finalized, the agency could propose more restrictions on e-cigarettes, though officials did not provide a timetable for that action.

"When finalized, [the proposed rules] would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misperceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA," said Mitch Zeller, the director of the FDA's Center for Tobacco Products.

The FDA said the public, members of the e-cigarette industry and others will have 75 days to comment on the new proposal. The agency will evaluate those comments before issuing a final rule, but there is no timetable for when that will happen. The regulations will be a step in a long process that many believe will ultimately end up being challenged in court.

E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. They create a vapor that users inhale.

Many smokers like e-cigarettes because the nicotine-infused vapor looks like smoke and has a similar feel but does not contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there is no scientific consensus showing e-cigarettes help smokers quit or smoke less, and it is unclear how safe they are.

The industry started selling the products on the Internet and at shopping-mall kiosks around 2006. Since then, sales have rocketed from the low thousands to several million worldwide, and consumers can now choose from more than 200 brands. Sales are estimated to have reached nearly $2 billion in 2013. Tobacco company executives have noted that they are eating into traditional cigarette sales, and their companies have jumped into the business.

"Right now for something like e-cigarettes, there are far more questions than answers," Zeller said, adding that the agency is conducting research to better understand the safety of the devices and who is using them.

In addition to prohibiting sales to minors and requiring health labels that warn users that nicotine is an addictive chemical, e-cigarette makers would be required to register their products with the agency and disclose ingredients. They would also not be allowed to claim their products are safer than other tobacco products, nor would they be able to use words such as "light" or "mild" to describe their products.

Under the proposed new regulations, companies would be required to submit applications for products currently on the market within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. 

Wire services