While the safety of e-cigarettes remains unproven, Mass General pediatricians are pushing the FDA for more protection for children.

The proposed U.S. Food and Drug Administration (FDA) rules for e-cigarettes are a step in the right direction but must go further to protect children from the dangers of nicotine addiction and the risk of poisoning, say experts at the Center for Child and Adolescent Health Research and Policy at MassGeneral Hospital for Children (MGHfC).

E-cigarette
One of many styles of e-cigarettes currently available in convenience stores and other outlets.

“The FDA missed an opportunity to protect children by failing to require safer packaging for liquid nicotine in its proposed rule. Children are being poisoned at an alarming rate,” says James Perrin, MD, president of the American Academy of Pediatrics and  an MGHfC pediatrician. Liquid nicotine refill bottles for e-cigarettes are widely available in flavors like cotton candy and bubble gum, with no FDA-required warning labels or childproof safety caps, Dr. Perrin says.

Also, Jonathan Winickoff, MD, an MGHfC pediatrician and an expert on children’s secondhand tobacco exposure, says the minimum age for purchasing e-cigarettes and other tobacco products should be raised to 21, rather than 18 as proposed in the FDA rules. He points out that teenagers usually get their cigarettes from older teens or young adults. “Ninety percent of adults who provide tobacco products to adolescents are age 18 to 20,” Dr. Winickoff says. “So by raising the age to 21, you break the distribution system to adolescents.” Dr. Winickoff is urging cities and towns to raise the minimum age to 21 as part of the “Tobacco 21” movement.

Unregulated by FDA

mghfc-pngThe Center for Child and Adolescent Health Research and Policy at Mass General helps build the scientific evidence to support effective advocacy, policies and programs that promote the lifelong health and well-being of children and their families. Philanthropy plays an important role in supporting programs such as Tobacco 21, which has already lowered the rate of adolescent tobacco use in places where it has been adopted. For example, Dr. Winickoff says, the smoking rate among Needham High School student is 5% compared with 11% in nearby Brookline High School.

E-cigarettes, also known as “vape pens,” look like cigarettes but deliver a smokeless nicotine vapor.

E-cigarettes, also known as “vape pens,” look like cigarettes but deliver a smokeless nicotine vapor. Unlike cigarettes, they are currently unregulated by the FDA, carry no health warnings and are available in a variety of youth-friendly flavors which are prohibited for cigarettes. They can deliver nicotine vapor in amounts similar to that of cigarette smoke.

In April, the FDA proposed new rules giving the agency authority over e-cigarettes, cigars, pipe tobacco and other tobacco products for the first time. The FDA rules include a minimum age of 18 for the purchase of these products, and would require manufacturers to reveal ingredients, manufacturing processes and scientific data. But the FDA rules would not restrict the use of flavors that appeal to children or restrict marketing as it currently does for cigarettes, which are banned from television commercials.

“They say they are marketing to young adults, not children,” Dr. Perrin says. “But you don’t attract 25-year-olds with flavors like cotton candy.”

Safety is Unproven

The relative safety of e-cigarettes is also under debate but Dr. Perrin and Dr. Winickoff point out that there is no question that nicotine is highly addictive. “We have tremendous concerns about addiction and exposing the young developing brain to nicotine,” Dr. Perrin explains.

There are other dangers associated with e-cigarette vapor as well, Dr. Winickoff says. “The exhaled nicotine vapor settles on surfaces in the room like furniture and produces tobacco-specific nitrosamines—some of the most carcinogenic substances known.” Nitrosamines are chemical compounds found in tobacco, foods and other products that are known to contribute to cancer. 

The idea that e-cigarettes are a safe alternative to smoking and will help people quit smoking is an unproven concept.

The idea that e-cigarettes are a safe alternative to smoking and will help people quit smoking is an unproven concept, both doctors agree. “Nicotine patches and gum have been studied and shown to help people quit,” Dr. Winickoff notes. “E-cigarettes have not been rigorously studied to provide enough evidence for that claim.”

“E-cigarettes give out a vapor but we don’t know that it is a safe vapor,” Dr. Perrin adds. “That hasn’t been shown.”

The “Renormalization” of Cigarettes

In fact, Dr. Winickoff says, the greatest danger posed by e-cigarettes may be what he calls the “renormalization of smoking.” Children see their parents or other adults using them, he says. “They don’t differentiate between e-cigarettes and normal cigarettes. They want to be like the adults and so they try smoking.” In addition, about a third of those who use e-cigarettes are non-smokers, Dr. Winickoff says. This suggests that, unlike nicotine gum and the nicotine patch, e-cigarettes may be contributing to the growth of nicotine addiction and to the renormalization of smoking.

The FDA says it may take up to a year to implement the new rules. In the meantime, Dr. Winickoff suggests that cities and towns raise the age of sale to 21 for all tobacco products and Dr. Perrin suggests that adults take steps to prevent accidental poisoning of children by storing and handling e-cigarettes and the refill bottles safely. Where young children are present, he adds, families should store these products as they would any possibly dangerous household product, in small containers in a safe out-of-reach place.

To learn more about how you can support the Center for Child and Adolescent Health Research and Policy and other MGHfC programs, please contact us.