On Thursday, the Food and Drug Administration is expected to propose new regulations for the manufacturing and sale of electronic cigarettes. These exceedingly popular tobacco substitutes are generally considered safer than cigarettes; however, the FDA fears that teenagers who pick up e-cigs at an early age will be more likely to make the leap into more dangerous nicotine products. In spite of the FDA’s move to control these battery-powered, vapor devices, like it does with cigarettes and chewing tobacco, it is worth noting that the health risks related to e-cigs are still relatively unknown.
“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” FDA Commissioner Dr. Margaret A. Hamburg said in a statement. “Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”
The FDA’s proposal, which will be up for public comment throughout the next 75 days, will extend laws to not only e-cigarettes, but all unregulated tobacco products including cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvable tobacco. Under the new regulations, the sale of these marketed products would be restricted to those 18 and older and would be prohibited from sale in vending machines located in public places that allow minors. Rules will mimic those already set in place by the FDA for cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” HHS Secretary Kathleen Sebelius said during a conference call with reporters. “According to CDC, use of electronic cigarettes by middle and high school students in the U.S. has doubled between 2011 and 2012.”
Companies manufacturing e-cigarettes will also be required to register their products with the FDA and include a full report with a list of its ingredients. Sale of tobacco products will only be approved once the FDA has completed its review. Claims of the reduced risk for e-cigarettes compared to other tobacco products will only be permitted with scientific evidence that supports the claim and if it will benefit public health. Free samples of e-cigarette products will be prohibited and packaging must disclose that it does contain the addictive property of nicotine.
“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”
Even though the FDA has been considering an extension of regulations that will affect all tobacco-related products for some time now, the possible health risks associated with e-cigarettes is still up for debate. While many health care professionals say the different flavors some e-cigarette products come in can make them attractive to teenagers, others believe this safer alternative to tobacco has the potential to help cigarette smokers quit the habit. In fact, some research shows that e-cigarettes are just as effective in getting smokers to quit as nicotine patches.
A recent study presented at the European Respiratory Society Annual Congress 2013 evaluated e-cigarettes as smoking cessation aid compared to nicotine patches. Researchers from the National Institute for Health Innovation at the University of Auckland in New Zealand recruited 657 smokers to participating in their assessment. Over the course of 13 weeks, 292 smokers were given e-cigarette products containing 16 mg of nicotine. An additional 292 smokers were given a 13-week supply of nicotine patches, while 73 smokers received placebo e-cigarettes containing no nicotine. Out of one in 20 smokers who was able to quit, 7.3 percent were part of the e-cigarette group, 5.8 percent were part of the nicotine patch group, and 4.2 percent were part of the placebo e-cigarette group. The research team did admit that a more thorough investigation into the matter of e-cigarette’s health risks is needed before an appropriate recommendation of its safety is made.
"Our study establishes a critical benchmark for e-cigarette performance compared to nicotine patches and placebo e-cigarettes, but there is still so much that is unknown about the effectiveness and long-term effects of e-cigarettes,” lead researcher Chris Bullen said in a statement. “Given the increasing popularity of these devices in many countries, and the accompanying regulatory uncertainty and inconsistency, larger, longer-term trials are urgently needed to establish whether these devices might be able to fulfill their potential as effective and popular smoking cessation aids.”