On April 24, the U.S. FDA presented a new proposal that would extend its regulatory authority to cover electronic cigarettes and additional tobacco products.
Unlike conventional cigarettes, e-cigarettes do not contain tobacco; most of the battery-powered devices deliver nicotine and a flavored taste by heating liquid into an almost odorless vapor that only simulates smoke.
Under the FDA’s new purview, the sale of e-cigarettes would be banned to anyone under the age of 18 but manufacturers would be allowed to continue offering flavored nicotine liquids, which health advocates and other critics say attract children.
At this time, only conventional cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco fall under the FDA’s regulatory authority. E-cigarettes are frequently marketed as a viable product to help smokers quit tobacco-based products and a healthier alternative because they do not produce lung-damaging tar.
E-cigarettes have gained widespread popularity in both North America and Europe in recent years, expanding into a $2-3 billion per annum industry.
The “Wild West” of the e-cigarette industry
The FDA proposal also stipulates that manufacturers of ‘newly deemed tobacco products’, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority, would be required to include health warnings on their products, register all products and their ingredients with the FDA, submit new products to FDA review before marketing, and no longer distribute free samples or sell products in vending machines.
Although the proposal outlines a number of new regulations that could significantly impact the e-cigarette industry and contribute to the health of Americans, some caution that change will only come slowly and more research is needed to understand the health risks associated with smoking e-cigarettes.
The president and CEO of the American Lung Association, Harold Wimmer, stated earlier this year that nicotine is highly addictive regardless of whether it is inhaled via a regular cigarette or an e-cigarette. And with the absence of regulatory overview since their introduction to the tobacco marketplace, companies have been aggressively marketing them to both adults and children.
“For the makers of electronic cigarettes, today we are living in the Wild West—a lawless frontier where they can say or do whatever they want, no matter what the consequences,” wrote Wimmer in an opinion piece for CNN. “They are free to make unsubstantiated therapeutic claims and include myriad chemicals and additives in e-cigarettes.”
He refers in this statement to the ability of companies to promote their products as safe without providing any proof, which follows from a widespread concern and criticism that both the health risks and safety benefits associated with smoking e-cigarettes, commonly known as ‘vaping’, have not been properly determined or confirmed through rigorous study.
The concerns, benefits and unknowns of ‘vaping’
Although there have been many questions raised about e-cigarettes during debates about their risks and merits, there are three main, recurring concerns: the validity of e-cigarettes as a smoking-cessation aid, the impact they have on youths, and the health risks associated with vapor emissions.
First, while the largest benefit of e-cigarettes being promoted by manufacturers and other advocates, including celebrity spokespersons, is their potential to help smokers quit conventional cigarettes, no e-cigarette has actually been approved by the FDA as a safe and effective alternative to help people quit smoking.
Second, the Centers for Disease Control and Prevention (CDC) has reported that the percentage of middle and high school students using e-cigarettes more than doubled from 2011 to 2012.
“The increased use of e-cigarettes by teens is deeply troubling,” said CDC Director Tom Frieden. “Nicotine is a highly addictive drug. Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.”
Frieden’s statement accompanied the CDC’s finding that one in five middle school students who said they had smoked an e-cigarette also said they had never smoked a conventional cigarette. This raises the concern that e-cigarettes could become a popular gateway drug to using conventional tobacco products.
Third, the potential harm of ‘second-hand vapor’ emitted from e-cigarettes is largely unknown. However, this has not prevented some U.S. cities from taking proactive measures to mitigate potentially harmful side effects that may accompany the vapor.
At the end of 2013, New York City added e-cigarettes to its Smoke Free Air Act, which means that smokers are prohibited from using them wherever their conventional counterparts are also banned. Chicago, Boston, and most recently Los Angeles have also adopted legislation banning public e-cigarette vaping.
However, e-cigarette advocates have criticized that banning vaping in public places will force e-cigarette users to go to tobacco smoking areas, where they will be at risk of second-hand smoke and the temptation of conventional cigarettes that many seek to curb through the use of e-cigarettes in the first place.
The long-term health effects of e-cigarettes are still uncertain, but the new FDA regulations proposal and the public comment period of 75 days may provide new structure and organization to the debates. Within those 75 days, perhaps there will be concrete insights gained in the comments, data, research, and other information that is collected and reviewed by the FDA.