Information and opinions presented here do not always represent the views of the American Heart Association.

FDA proposes regulation of electronic cigarettes

Published: 1:00 am CDT, April 24, 2014

The Food and Drug Administration proposed new rules Thursday that would ban the sale of electronic cigarettes to minors and require health warnings on the nicotine-delivery devices. The move has long been urged by health organizations worried that the products target young people and could get them hooked on tobacco.

E-cigarettes have become increasingly popular since they were first introduced in 2008. The battery-operated devices are used to inhale vapors from liquid nicotine and other additives that come in kid-friendly flavors, such as chocolate or mint.

It has taken since 2009 when Congress passed a tobacco control law to get to this stage in establishing oversight of e-cigarettes. The FDA’s new proposed regulation also would apply  to cigars and pipe tobacco, which were not named in the law four years ago.

“Rigorous regulations for the ever-expanding arsenal of new tobacco products are mandatory if we are to protect the cardiovascular health of Americans,” said American Heart Association CEO Nancy Brown. “We thank the FDA for taking this action. However, we believe it falls short by allowing industry to continue to market e-cigarettes, often with attractive and seductive flavorings, and increases the risk that we will raise yet another generation addicted to nicotine, before we fully understand the health dangers of these new nicotine-delivery products.”

Extending existing regulations for cigarettes and smokeless tobacco, the FDA will now require manufacturers of e-cigarettes and other newly named products to register products and their ingredients with the FDA; get FDA approval before marketing; make reduced risk claims only if there’s supporting scientific evidence and proven public health benefits; and refrain from distributing free samples.

While the proposed rules would extend the agency’s authority, they do not ban the use of flavorings or advertising, unless the products make health-related claims, according to news reports.

“Alluring advertisements have likely fueled the rising use of e-cigarettes by young Americans. We must close this gap – especially on the television and computer screens, where the nation’s youth focus much of their attention,” said Brown. “The association is disappointed that the FDA has chosen to delay action in this area and we will strongly urge the agency to revise the rule to include comprehensive restrictions on the marketing of these products.”

The rules will be open to public comment for 75 days and then will undergo final changes by the agency, a process that could take many months.

Health advocates fear e-cigarettes may be a gateway to cigarettes and other tobacco products. Cigarette smoking is the most important preventable cause of premature death in the United States, accounting for more than 440,000 of the more than 2.4 million annual deaths.

A study released in September by the Centers for Disease Control and Prevention found that the number of middle and high school students who tried e-cigarettes doubled from 2011 to 2012. Overall, e-cigarette consumption also has been increasing rapidly. Many states have addressed the issue, banning e-cigarettes from public places and regulating sales.  In the absence of federal restrictions, more than half of states already have enforced bans on their sale to minors.

Meanwhile, another CDC report showed an increase in calls to poison control centers reporting exposure to nicotine liquid used by the devices, particularly in children ages five or younger.

For more information: