Updated April 24, 2014: Today, the FDA announced a proposal to extend its regulatory power over tobacco products to e-cigarettes. While the proposed rules would not touch on safety of e-cigarettes, the rules would establish restrictions on sales and labeling guidelines. HHS Secretary Kathleen Sebelius voiced her support for the rules in the FDA’s press release, stating “This proposed rule is the latest step in our efforts to make the next generation tobacco-free.”
Electronic cigarettes (e-cigarettes) have been dubbed the safer alternative to smoking, but ever since their introduction, they have been under fire. An e-cigarette is essentially a cigarette that does not have to be burned. It is a device that heats a liquid substance, containing nicotine, with a battery that produces a vapor. This vapor is then inhaled in the same manner as smoking a traditional cigarette. This nicotine liquid comes in a variety of flavors with the amount of nicotine varying, depending on the e-cigarette.
Many advocate for the use of e-cigarettes because of their benefits over traditional cigarettes. While companies generally refrain from directly contending that they are healthier than traditional cigarettes, the manufacturers claim that e-cigarettes lack many of the health hazards associated with traditional cigarettes. E-cigarettes still emit some chemicals, but that amount is much less than traditional cigarettes. This is partially due to the fact that e-cigarettes emit a vapor rather than the smoke emitted from traditional cigarettes, which contains tar, among other things. In addition, although not generally marketed as such, many use them as a way to wean themselves off of traditional cigarettes.
Other added benefits include the fact that e-cigarettes may be cheaper and they offer the social benefits of not emitting offensive smells and ash. One such e-cigarette manufacturer, Eversmoke Electronic Cigarettes, even markets them as “much safer” because e-cigarettes do not have the risk of causing fires.
Presently, there is nothing to show whether the long term consumption of the vapor emitted from these e-cigarettes has any negative health consequences.
The problem with determining whether e-cigarettes have harmful effects is exacerbated by the fact that there has not been a full study to determine either their health risks or benefits. Presently, there is nothing to show whether the long term consumption of the vapor emitted from these e-cigarettes has any negative health consequences. The main ingredients of an e-cigarette include nicotine, which comes in varying amounts, propylene glycol, and glycerin. The Food and Drug Administration (FDA) has already determined that propylene glycol and glycerin are generally harmless and are found in many products individuals use every day, like toothpaste and asthma inhalers.
Although the FDA has not yet performed a conclusive study on the effects of e-cigarettes, it has received various voluntary reports that individuals and health professionals provide to the FDA, many of which claim a link between e-cigarettes and illness. Some of the illnesses reported have included pneumonia, congestive heart failure, disorientation, seizures, and hypotension. From these reports, the FDA is not able to conclusively determine if e-cigarettes were really the cause of the illness, but it is definitely raising some eyebrows.
While propylene glycol and glycerin may be generally harmless, nicotine in its liquid form has led to numerous poisonings. Potential poisonings can occur through ingestion, inhalation, or even absorption through the skin and eyes.
Many find this particularly concerning because it has the potential to harm children, primarily because the liquid nicotine is infused with fruity and sweet flavors, thereby enticing children to drink the substance. Ingestion by small children is not the only concern for minors. Advocacy groups, including the Campaign for Tobacco-Free Kids, argue that e-cigarettes, with their assortment of flavors, are actually encouraging middle and high school students to start smoking.
Rather than having the power to require pre-market safety approvals after lengthy clinical trials, the FDA’s hands are tied in only being able to regulate e-cigarette marketing.
Although the FDA generally has the ability to regulate cigarettes, cigarette tobacco, roll-your- own tobacco, and smokeless tobacco (products like snuff and chewing tobacco), there has been a lot of controversy over the FDA’s role in e-cigarette regulation. The issue has been whether to treat them the same as the other tobacco products or as therapeutic products that wean people off traditional tobacco.
In 2010, the FDA intercepted and seized e-cigarette shipments imported into the U.S. from countries like China. In Sottera, Inc. v. FDA (pdf), the U.S. Court of Appeals for the District of Columbia faced the issue of whether Congress authorized the FDA to regulate e-cigarettes under the “drug/device provisions” of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA claimed it was given this power based on its classification of e-cigarettes as drugs or therapeutic devices. The e-cigarette importers, on the other hand, argued that the FDA could regulate them only under the Tobacco Act. The Court held that the FDA’s power to regulate e-cigarettes was restricted to its powers under the Tobacco Act.
This classification is important because under the FDCA, the FDA would have been able to restrict the sale of e-cigarettes, instead of only overseeing the marketing of such products under the Tobacco Act. As a result, rather than having the power to require pre-market safety approvals after lengthy clinical trials, the FDA’s hands are tied in only being able to regulate e-cigarette marketing.
While the proper place for electronic cigarettes has yet to be determined, there are likely to be many more challenges to legislation preventing their use in public.
Because of the FDA’s regulatory limitations, many states and cities have initiated attempts to limit the use of e-cigarettes in public, similar to other restrictions on traditional tobacco products. New York City is one of the first places to push back against the use of e-cigarettes. The New York City Council passed a bill in December of 2013 that prohibits the smoking of e-cigarettes in public places like bars, subways, restaurants, or parks. More recently, the Los Angeles City Council has passed a similar set of regulations. These cities are instituting such regulations under the guise of protecting the public at large, especially children. The regulations seem to be based on many of the same fears of traditional anti-smoking advocate groups.
While there has been a strong push to limit e-cigarettes, smoker advocacy groups are not backing down without a fight. New York City Citizens Lobbying Against Smoker Harassment (NYC CLASH) is currently seeking a declaratory judgment finding that New York City’s ban on the use of e-cigarettes in public places is unconstitutional. CLASH has had success with similar issues in the past. In October 2013, they successfully argued to overturn a ban on smoking in parts of New York state parks. The New York Supreme Court found that while the legislature had banned smoking indoors, it had not ruled on smoking outside in state parks; therefore, the state agency that banned smoking regular cigarettes outdoors was outside of its authority.
In its present litigation, NYC CLASH argues that the ban on the use of e-cigarettes in public places is impermissible because the ban came as an amendment to the Smoke-Free Air Act, legislation aimed only at cigarettes. They claim that because e-cigarettes vaporize rather than burn, there is no smoke to ban and as such is an impermissible regulation under the New York Constitution’s “One Subject Rule.” This rule requires local laws to “embrace only one subject,” and NYC CLASH argues that because smoking and “vaping” are two distinct acts, e-cigarettes cannot be regulated under the same law. This is an important distinction that could have a drastic effect on how cities and legislatures limit e-cigarette use in public. For instance, if the court finds that “vaping” and smoking are the same act, it may be much easier for city councils and lawmakers to regulate e-cigarettes under already-existing smoking regulations, similar to what the New York City Council has attempted.
While the proper place for electronic cigarettes has yet to be determined, there are likely to be many more challenges to legislation designed to prevent their use in public. This will be an interesting topic to watch, especially as medical studies begin to conclusively reveal the effects of e-cigarettes on an individual’s health.
Photo credit: Lindsay Fox.
