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Looming FDA Regulations Threaten E-Cigarette Industry

by Thom Kilburn

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We all know history has a knack for repeating itself. Although cigarette smokers enjoyed a great deal of time puffing wherever they pleased, the fixation was eventually regulated and banned in some places across the country. Likewise, electronic cigarettes, a multi-billion dollar industry and trend that is sweeping the globe, are now slated to be regulated by the Food and Drug Administration (FDA) in the coming weeks.

Most electronic cigarettes, more commonly known as e-cigarettes, are curious devices barely larger than a pen. While they come in all shapes and sizes, each is comprised of the same basic components. To smoke, you press a button that fires up a rechargeable battery which then produces a current to power a tightly wound coil in a hollow chamber. This part of the device holds a liquid nicotine solution that is absorbed by wicks attached to the coil. As you inhale, you are essentially heating up the liquid nicotine, which produces a thick cloud of water vapor.

The liquid nicotine solution comes in a wide array of flavors. From fruity flavors like mango and apple, to more obscure flavors like banana nut bread or Dr. Pepper, the nicotine solution appeals to consumers of all preferences—even those who still crave tobacco and menthol flavors.

“Blueberry was the first flavor I got into. For whatever reason, it just struck me,” said Tom Sergent, manager at Vaporcast, an e-cigarette retail store in Centerville, Ohio. “I remember thinking, ‘I can really do this.’ I haven’t touched a cigarette since—a real rags to riches story.”

Sergent quit smoking November 21, 2012 after a seven-year affair with cigarettes.

“I hear the same story from customers almost every single day. They’ll say, ‘Since getting this thing, I haven’t bought a single pack of cigarettes.’ The story holds up and the verdict is in: e-cigarettes help you quit smoking.”

Sergent said that he has even seen customers switch from cigarettes to electronic cigarettes at the request of a doctor.

Stores like Vaporcast that specialize in e-cigarette gear and liquid nicotine have seen a tremendous boom in business over the past few years. E-cigarette popularity has recently soared not only because they have been marketed to be a substantially healthier alternative to cigarettes, but also because few locations forbid the smoking of e-cigarettes indoors.

“The e-cigarette industry is highly competitive right now,” said Sergent. “When the media calls it the ‘Wild, Wild West,’ they aren’t kidding. Vaporcast was the first e-cigarette store, but now they’re popping up all over the place. On top of that, the market is continuously putting out new technology and flavors to increase the smoker’s enjoyment of e-cigarettes.”

While the accessibility and decreased health risks of e-cigarettes have enticed over one-fifth of adult smokers to at least try them, the face of the industry will soon change. The FDA has announced proposed rules that would treat e-cigarettes like tobacco cigarettes with regard to marketing and testing, including age restrictions barring sales to minors and FDA reviews of each and every product.

The proposals to regulate the e-cigarettes are parallel to its ongoing efforts to cut national tobacco use.

“The FDA’s regulations won’t impact the business end of things too much,” said Sergent. “They’re really after the people who make the e-liquid—they want to make sure what goes in the e-cigarettes is okay to consume.”

To restrict the use of flavors, or at least limit their contents, the FDA must establish a factual record that they pose a health risk for consumers—something the scientific community has struggled to provide. Research has shown that e-cigarettes trump tobacco cigarettes in terms of decreasing health risks, but to what extent? Are they completely harmless? The debate rages on.

Propylene glycol is the primary ingredient for the nicotine solution as it constitutes up to 92% of the liquid. According to Sergent, this chemical serves a flavor-bonding purpose and is sometimes found in baby wipes, cosmetic products, asthma inhalers and other common products. A trace amount of vegetable glycerine is also in the liquid, so as to produce a visible cloud of vapor. The third ingredient is nicotine.

If the FDA’s new rules are implemented, companies that use variations of these ingredients to make their own blend of liquid nicotine (of which there are dozens of thousands) would have to apply for FDA approval. Currently, however, companies are allowed to keep their products on the market.

Some experts, like Bonnie Herzog, an analyst at Wells Fargo Securities, say that too much regulation could stifle smaller e-cigarette producers and subsequently fuel the tobacco industry, as e-cigarette consumers turn back to their old ways.

“FDA regulation benefits the entrenched players,” said Herzog, referring to Lorillard, R.J. Reynolds and Altria, the three biggest tobacco companies that produce e-cigarettes.

While the FDA’s decision to regulate the industry is still pending, businesses, residential areas, and locations across the country have moved to impose their own restrictions.

Around Wright State University’s main campus, one can see a number of students walking around with an e-cigarette any any given point during the day. Presently, the university’s smoking policy recognizes only cigarettes, pipes and cigars. According to Casey Babbitt, since e-cigarettes are relatively new, Wright State hasn’t had the chance to pose a rule on them—yet.

Casey Babbitt was a former senator for Wright State’s Student Government, representing the Boonshoft School of Medicine.

“My research has shown that, although there aren’t as many carcinogens produced by e-cigarettes as there are by real cigarettes, they still produce some,” said Babbitt. “If these carcinogens are consumed in a closed environment like a classroom, it can negatively influence students’ abilities to learn.”

Babbit’s push to ban the indoor use of e-cigarettes at Wright State has recently caught momentum.

“My resolution to add e-cigarettes to Wright State’s smoking policy has just recently passed the faculty senate,” she said. “Soon, the resolution will see the president’s cabinet. From there, it hopefully will be implemented before fall semester 2014.”

Amid scrutiny such as Babbitt’s desired ban, e-cigarettes remain a flourishing trend that has caught the attention of millions of smokers and nonsmokers alike. Everyday, the industry generates a monumental amount of money from those attempting to quit an old habit or those who simply want to join the fad and take an occasional puff.

Until concrete, empirical and peer-reviewed research rears its head, the FDA cannot proceed with much, if any, regulation. Like all new products, e-cigarettes haven’t been in existence long enough to observe any noticeable long-term health risks. For the time being, the debate over regulating the sale, marketing and consumption of e-cigarettes will continue to be nothing but smoke and mirrors.


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