Up in Smoke

The regulatory concerns surrounding e-cigarettes

Published on August 1, 2013by Chris Tait

“I got into this business knowing that it was helping me. My lungs were so bad when I was a smoker that it used to sound like I ate Pop Rocks candy. It’d keep my wife up, the wheeze. It was awful. It was killing me.” 

Louis Del Sesto, above, who reported to the Providence Journal, is just one of the many store owners who has recently set up shop in an industry that believes it is doing more good than harm.

In June 2013, the city of Boston gave out twenty-eight permits to sell e-cigarettes, compared with the three permits issued during the same period in 2012. Smokers around the country have been rapidly making the shift from traditional cigarettes to their electronic counterparts with the goal of consuming a ‘safer’ product en route to eventual cessation.

In the absence of federal regulation however, the safety of e-cigarettes has been questionable at best. Anti-smoking advocates further argue that the proliferation of this tobacco alternative only serves to promote continued smoking, renormalize smoking behavior, and potentially provide a gateway into smoking culture for non-smokers who were previously deterred because of the deleterious effects of regular cigarettes.

In 2010, the U.S. Food and Drug Administration (FDA) tried to block the sale of e-cigarettes altogether, but confronted the hurdle of a federal ruling that held it couldn’t ban the importation of such products, which are often manufactured abroad. The FDA has yet to reach conclusive regulatory standards, but warns on its website that the safety of e-cigarettes has not been widely studied.

Indeed, the notion of a so-called safer cigarette is not new. Dr. Amy Fairchild, a professor of Sociomedical Sciences at Columbia University has chronicled the growing public interest in reducing the hazards of smoking through public health efforts to develop safer cigarettes over the course of the twentieth century. The past fifty years have witnessed the addition of filters to cigarettes, as well as the reduction of tar and nicotine levels in attempts to render cigarettes less hazardous.

Fairchild discusses this approach that places priority on minimizing damage rather than eliminating the behavior itself. This approach, better known as harm reduction, has polarized the issue of tobacco control for decades.

Alas, the public health community stands divided between advocates who champion e-cigarettes as yet another form of the harm reduction strategies’ manifest over the past 50 years and those who support the elimination of any type of smoking altogether.

E-cigarettes come in all shapes and sizes (and flavors) but their basic structure entails battery-operated devices that burn liquefied nicotine instead of the harmful tobacco that has been linked with lung cancer. Users, who are often donned the term ‘vapers’, are able to get the nicotine they crave without the combustion of tobacco and its chemical byproducts from regular cigarettes.

Though nicotine has been attributed to some smoking-related diseases, its effect is notably smaller than that of combustion products—a mantra employed in the marketing strategies of e-cigarette companies.

But just how safe are e-cigarettes?

If you asked Wes Sloan, who still suffers from an explosion that resulted from the charging of his e-cigarette, he would say not very safe at all.

“The battery was into about a two hour charge and it exploded and shot across the room like a Roman candle,” the Texas man told KXII TV. “Most of all, we want the consumer to know that this isn’t as safe a product as they market it to be.”

Many medical experts aren’t any more convinced.

“We don’t know what the industry puts in the electronic cigarettes,” reports Texoma Medical Center pulmonologist Dr. Don Wynn to KKII TV, who says he recommends e-cigarettes to patients as a last resort to quitting smoking. “I believe we need more research to determine whether the electronic cigarettes are harmful or helpful for patients.”

What exactly goes into e-cigarettes? In the unregulated territory in which they exist, there is no standard formula.

One common ingredient that occurs in many of the over 250 brands that are available on the market is propylene glycol. “It’s something you would find in antifreeze, and it is what’s in e-cigarettes,” explains tobacco dependence treatment specialist, Tracy Kane.

The overwhelming trend amongst the scientific community is that the safety of e-cigarettes has yet to be definitively proven.

“Most likely they’re safer than regular cigarettes. We just don’t know. So I’d like to see more research done with the e-cigarettes, so we know what it is, so before we give anybody advice to use them or not use them, let’s find out what they really have in them and if they’re safe or not,” Kane told Philadelphia’s CBS 3.

Regulatory concerns span well beyond the chemical composition of the product however.

In a recent article published in the Journal of the American Medical Association (JAMA), the authors suggest that even if e-cigarettes are proven to be safe, there are other concerns that will arise.

The acceptance and proliferation of a product that so closely mimics a real cigarette may renormalize a behavior that has long been attributed with a certain social stigma. This concern is rooted in the fact that e-cigarettes look like regular cigarettes, and their use in public could give the appearance that cigarette smoking behavior is acceptable.

While e-cigarette proponents claim that this product offers smokers a bridge towards quitting, authors of the JAMA article beg to differ.

Dr. Neal Benowitz and Dr. Maciej Goniewicz, Professors of Medicine at the University of California San Francisco and Oncology at the Roswell Park Cancer Institute respectively, provide insight into potential population harm that may result including promoting e-cigarette use such that it undermines quitting smoking. Furthermore, the current unregulated landscape in which they exist could stimulate the uptake of e-cigarettes by non-smokers, who may later become cigarette smokers or long-term nicotine addicts.

As the use of e-cigarettes continues to rise in popularity, however, the need for federal regulation is greater than ever.

In 2010, 11.4 percent of U.S. smokers report ever using an e-cigarette, with a third of those having used one in the past 30 days.

The FDA intends to subject e-cigarettes to the same taxes, regulations, and licensing requirements as traditional cigarettes, which brings with it its own set of concerns.

On the one hand, such federal regulation would ensure the quality and consistency of these products, but there is also a growing concern that requiring licensing would slow product innovation.

Under the assumption that well-regulated e-cigarettes are safe and would result in the pubic health benefits purported of e-cigarette manufacturers (i.e. lower levels of contaminants), the extent of FDA regulation becomes a critical issue.

Europe has battled similar regulatory issues as a European parliamentary committee recently voted to classify e-cigarettes as a medicinal product.

In light of the controversial decision, Fraser Cropper, CEO of the e-cigarette company Totally Wicked told The Province, “It will result in many smaller and more innovative producers of e-cigarettes going out of business. Medicine regulation creates a default prohibition and requirement for approval, leaving deadly tobacco cigarettes as the only easily marketed source of nicotine.”

The vote was intended to make smoking less attractive to young people through mandatory warnings, minimum pack sizes, and rules on flavorings.

Many U.S. states have banned the sale of e-cigarettes to minors, but their availability for online purchase offers potential loopholes to state legislation.

Moreover, health advocacy groups suspect e-cigarette companies may have a hidden agenda.

“It’s all fluff and no form. It’s really masquerading as a bill to prevent youths from getting access to e-cigarettes in order to make changes to law that will only protect e-cigarettes later on and increase sales of these products, and, in the end, do more harm than good,” Kevin O’Flaherty of the Campaign for Tobacco-Free kids told The Providence Journal about a recent bill passed in Rhode Island.

The practicality of intended FDA regulations in the event of proven safety of e-cigarettes continues to fuel this hot topic for debate, but it remains clear that much needs to be done to ensure public protection.

Whether one holds that e-cigarettes are a viable option in the harm reduction framework that could lead to eventual cessation or that smoking in any form should not be encouraged is not the most important issue.

Critical decisions on the marketing and federal regulation of e-cigarettes that carefully weigh the potential benefits against the population risks will undoubtedly have major public health effects and could present many challenges for the future. To be sure, the issue will have many fired up, and it remains to be seen whether the e-cigarette will go up in smoke, or eventually reduced to ashes.

Edited by Dana March