America / Healthcare / Regulation

Electronic Cigarettes – Therapeutic Device or All Smoke, No Substance?

Over the past five years, electronic cigarettes – devices that electronically vaporize a refillable, inhalable nicotine-laced liquid – have exploded into a $1.5 billion industry with over 4 million users. Although this is a small portion of the tobacco market, Bloomberg Industries projects that e-cigarettes may surpass traditional tobacco product sales by as early as 2023. However, the controversy surrounding e-cigarettes and the upcoming FDA regulation ruling on these devices might threaten the growth of the industry and leave its future up in the air.

While the Tobacco Control Act of 2009 gives the FDA the authority to regulate e-cigarettes either as a “tobacco product” (like traditional cigarettes) or as a therapeutic medical drug/device (like nicotine gum or patches), the FDA currently does not regulate the e-cigarette in any capacity. Proponents of e-cigarettes believe that the apparatus should be regulated as a medical drug/device, since they claim that e-cigarettes help smokers quit. Despite multiple testimonies, however, these statements have not been corroborated by scientific research, partly because these claims have not been tested in large clinical trials. In addition, advocates of e-cigarettes insist that these products are healthier alternatives to real cigarettes. Unlike traditional cigarettes that use carcinogen-containing smoke to deliver nicotine to the lungs, e-cigarettes heat a nicotine-containing liquid into a vapor that the user then inhales. Consequently, studies indicate that the level of toxic chemicals in an e-cigarette is 9 to 450 times lower than a traditional cigarette. E-cigarette users also state that the devices do not cause unpleasant odors or stained teeth and that the sensory aspects of physically smoking a device (versus using nicotine gum or a patch) may help curb the habit. Yet, like the other unverified claims, these statements are also unsubstantiated.

To help the federal government test these unverified claims and come to a decision on e-cigarettes, the FDA is spending $270 million on 48 studies, so that the agency has a better understanding of the device, its effect on users, its influence on public health, and how to best regulate it. In addition, the FDA is allowing a public comment period through August 8th, at which point, it will begin to review the data before releasing policies on regulation. However, a final decision could take months, or years with litigation, and it is imperative that the FDA regulates these devices as soon as possible to reduce many of the adverse societal effects resulting from an unregulated industry.

Without federal regulation, Margaret Hamburg, the FDA commissioner, has described the e-cigarette industry as the “wild, wild West.”   The biggest problem with unregulated e-cigarettes is the danger it poses to children and adolescents. Shockingly, 20 States still have not outlawed the sale of e-cigarettes to minors and e-cigarettes can be purchased online. Many e-cigarette companies advertise to minors and young adults by glamorizing the product as fashionable, cool, and sexy. E-cigarettes also hook younger audiences by advertising fun, flavored vapors – including bubblegum, cherry cheesecake, and apple pie – that downplay the risks of smoking. As a result, in one survey conducted by the Missouri Department of Health and Senior Services, nearly half of high school smokers had used e-cigarettes, and surprisingly, 12.4 percent of non-smoking high school students had tried these products. As a result, officials worry that e-cigarettes may be a gateway drug for younger populations, rather than a device that helps smokers quit.

The refillable nicotine-containing liquid also poses a threat to e-cigarette users and young children. Liquid nicotine is more potent than nicotine in smoke, and is therefore more readily absorbed by the body. While e-cigarette liquids usually contain 1.8 to 2.4 percent nicotine by volume, higher concentrations, such as 7.2 percent or 10 percent are readily available on the Internet. At these concentrations, less than a tablespoon of liquid could kill an adult. These colorful, flavored liquids have caused a dramatic spike in e-cigarette related emergencies, especially among children over the past few years. The CDC reports that in 2010 there was, on average, one e-cigarette related call to poison control a day; however, in February 2014 alone, there were 215 emergency calls, of which 51.1 percent were regarding young children who had ingested, absorbed, or inhaled the liquid in some capacity.

In lieu of FDA regulation, 11 States and some cities, such as Chicago and Los Angeles, have passed laws to regulate e-cigarettes within their jurisdictions. If the FDA eventually decides to regulate e-cigarettes as a “tobacco product,” flavored vapors would be banned and advertising would face more restrictions. While the jury may still be out on whether e-cigarettes have any health benefits that may warrant a designation as a medical drug/device, the e-cigarette is adversely affecting too many children and adolescents. Government officials at all levels are moving too slowly on this issue, and regulation is required as soon as possible to improve public health and safety. The United States has come too far in its war on tobacco, and we should not let this new device negate decades of hard work.