The end of an era: E-cigarette manufacturers face regulatory oversight
The e-cigarette business, like the product itself, seems to have arisen from vapor. In the U.S. for less than a decade, e-cigarettes are now a $2 billion worldwide industry. And with that growth comes something new: The near-certainty of heavier regulation.
In April, the U.S. Food and Drug Administration moved to regulate e-cigarettes. This is not the FDA's first attempt at reining in the e-cigarette industry. In 2009, FDA sought to ban them entirely by defining them as unapproved "drug-device combination products." Since 2009, FDA has had the authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act. Although e-cigarettes do not contain tobacco, they do deliver a nicotine-containing aerosol. So like nicotine gum, the patch or any other nicotine-containing product, e-cigarettes will now be regulated like tobacco-based products in some respects; however, e-cigarette companies will still be free to advertise on television and the raido--unlike conventional cigarettes, which have not had access to those outlets since the 1970s.
Currently, states and municipalities independently regulate e-cigarettes, but until now there has been no broad regulatory oversight on this rapidly growing industry. The new rules, which have not been completely finalized, could decrease this industry’s rapid growth.
Since e-cigarettes were introduced into the U.S. marketplace, awareness and product uptake among adolescents has grown rapidly. In 2012, 6.8% of adolescents had used or were using e-cigarettes, compared with 3.3% in 2011, according to statistics from the Centers for Disease Control and Prevention.
Under the new proposals, e-cigarettes can no longer be sold to minors, nor given away as free samples, and packaging must include full disclosure of all ingredients. Perhaps the most far-reaching change is FDA’s decision regarding product approvals. All e-cigarettes will eventually have to be FDA-approved in order to stay in the market, and new versions of e-cigarettes will require approval in order to launch.
This is an abrupt shift in a market that until now has been a free-for- all in many ways, with unfettered television, print and Web-based advertising in markets where e-cigarettes are available. Marketers have also developed aggressive sampling campaigns and positioning that is not completely supported by a solid body of clinical evidence. To counter this, many individual states and municipalities have outlawed vaping in smoke-free venues. Some states, such as Iowa, require a retail tobacco license in order to sell e-cigarettes, and New York state outlawed sale of e-cigarettes altogther in January 2013.
In fact, e-cigarettes have been positioned as healthier alternatives to tobacco products and as an effective aid for smoking cessation. The issue of cytotoxicity has been almost completely overlooked, and because product perception is driven by marketing, there is a widespread notion that e-cigarettes are less unhealthy, cheaper, and cleaner than cigarettes. For many young people “vaping” or inhaling e-cigarette vapor is perceived as not only cool, but a healthier choice.
What does the evidence show?
The main question for researchers is whether e-cigarettes fulfill the original goal stated in the patent application: to function as a cigarette substitute and help smokers stop smoking. According to a scientific review published in May in the journal Circulation, the results of clinical studies are mixed. In general, controlled studies show that e-cigarettes can significantly reduce the number of cigarettes a person smokes daily, but has no significant impact on smoking cessation. Studies also show that the predominant pattern of use is dual use of e-cigarettes and conventional cigarettes---80% of e-cigarette users also smoke cigarettes.
Will regulation stifle growth?
E-cigarette companies have had several years of unrestricted advertising and have gained a foothold in the youth market. However, although advertising has been effective in promoting the use of e-cigarettes, the industry’s messaging has not had an overwhelmingly positive impact on smoking cessation. In an online survey, published in Tobacco Control Journal in November 2013, 519 smokers revealed how watching an e-cigarette made them feel: 66% of viewers said there were likely to try e-cigarettes in the future; 74% said it made them think about quitting; and 76% of viewers said it made them think about smoking a cigarette.
E-cigarette advocates contend their product is not only less unhealthy than conventional cigarettes, but an effective way to quit smoking. They are determined to take market share away from the $80 billion cigarette industry. At this point, implementation of the new regulations will be slow moving: Companies have two years to complete their filings for FDA approval. Add to that the relatively unrestricted ability to continue to market e-cigarettes outside of the 18-and-under market and the opportunity for robust growth remains. Only time—and additional clinical data---will tell.
- FDA E-cigarettes
- Circulation E-cigarettes: A scientific review
- The New York Times FDA wiull propose new regulations for e-cigarettes