It only took five years, but the Food and Drug Administration is ready to begin regulating electronic cigarettes. While the new rule covers a lot of ground with the never-before regulated devices, it doesn’t deal with some of critics’ more controversial concerns.
The FDA’s first step in regulating the popular alternative to traditional cigarettes includes banning the sales to minors and requiring manufactures to put health warnings on the devices.
“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” FDA Commissioner Margaret A. Hamburg, says in a news release.
However, the proposed regulations fail to address one of the products most controversial qualities – the use of flavorings. Opponents of the products contend that the flavorings, such as strawberry or chocolate, are used to attract teenagers. Additionally, the regulation does not include restrictions on television advertisements.
Officials with the FDA say the regulations provide a framework for additional rules in the future, which could include restrictions on flavorings pending the results of scientific research.
Mitchell Zeller, director of the FDA’s Center for Tobacco Products says the new restrictions are a “significant step in the agency’s ability to regulate tobacco products.”
“I call the market for e-cigarettes the wild, wild West in the absence of regulations,” he tells the Los Angeles Times.
Warning labels required under the new regulations would warn consumers against the danger of becoming addicted to nicotine.
The new regulations, which also impose restrictions on nicotine gels and pipe tobacco, require manufacturers to register their products with the FDA within two years. In the meantime, companies could continue to sell new and existing devices without FDA approval.
Before the regulations could become legal they must go through a public comment process and prevail over potential legal challenges before coming into effect.
The FDA has come under fire from consumer advocates and political figures for their slow progress in regulating the e-cigarette industry. Earlier this month, senators at a Congressional budget hearing told FDA Commissioner Hamburg that the agency’s failure to issue regulations was unacceptable.
In 2009, the FDA sought to impose restrictions on the devices, which it described at the time to be medical devices designed to deliver nicotine, but a federal court struck down that attempt. The following year, the agency declared it had the power to regulate the devices under its authority to regulate tobacco products.
E-cigarettes, and their potential health-risks, have been at the center of heated debate between supports and opponents of the devices.
Companies who manufacture the devices believe they should be exempt from FDA regulations, contending it would stifle innovation, damage small business and hurt consumer trying to quit smoking.
Still, there is no clear data on the health impact associated with the devices. Supporters contend that the devices help consumers stop smoking traditional cigarettes, while opponents argue the devices are attractive to teenagers and secondary risks, such as poisoning and a tendency for the devices to explode, could be more deadly than traditional cigarettes.
Last month, the New York Times explored one of the deadliest attributes e-cigarettes pose: liquid nicotine. When ingested or absorbed even small amounts of the toxin could prove deadly.
The Centers for Disease Control and Prevention released a new report [PDF] earlier this month that show the number of calls to poison centers involving e-cigarette liquid containing nicotine rose from one per month in September 2010 to 215 per month in February 2014.
The popularity of e-cigarettes grown immensely in recent years, with sales of the devices reached more than $1.5 billion in 2012, the LA Times reports.
FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes [Food and Drug Administration]
FDA to begin regulating e-cigarettes [Los Angeles Times]