The Food and Drug Administration has decided to regulate electronic cigarettes as a tobacco product, rather than under the stricter rules set for drug-delivery devices. It was said that the proposal is to treat electronic cigarettes the same as traditional cigarettes and other tobacco products.
In 2009, the FDA lost a court case when trying to treat e-cigarettes as drug-delivery devices. They had told customs officials to refuse entry of shipments into the United States. The ruling to regulate electronic cigarettes as tobacco products means they don’t have to go through such rigorous requirements such as clinical trials which are very expensive.
Tests completed by the FDA found there were minor levels of toxins besides nicotine in electronic cigarettes, as well as a few carcinogens that occur naturally in tobacco. However, the carcinogens were comparable to the ones found in other nicotine replacement therapy (NRT) because the nicotine in all of the products are extracted from the tobacco plant.
A Victory for The “Vaping” Community
Regulating e-cigarettes as tobacco products is a victory for the industry who makes the devices and the distributors. The devices continue to gain popularity worldwide. As a way to quit smoking, both the users and the distributors say electronic cigarettes address nicotine addiction and the behavioural aspects of smoking. The fact that you emulate real smoking is comforting to the user. Smokeless cigarettes also leave behind the over 4,000 chemicals that are found in traditional nicotine cigarettes.
Electronic cigarettes could still be regulated by the FDA as drug-delivery devices is marketed as “therapeutic,” such as a stop smoking aid. This will mean the product will have much stricter regulations and will have to go through rigorous tests.
A CEO of one of the leading electronic cigarettes is “very happy” with the FDA’s decision on the ruling. Another praised the decision and stated that the FDA’s rules covering electronic cigarettes will help in “weeding out the shady companies.” “[Right now,] you can potentially sell snake oil,” He said.
New York Considering Becoming First State to Ban E-Cigarettes
The state of New York has pushed to be the first state to ban electronic cigarettes, followed by Chicago and others. The debate surrounds the device and its safety. The devices are unregulated and come in all kinds of cute colors and fun flavors like bubble gum and chocolate. They are easy to obtain over the internet and at mall kiosks. Lawmakers are afraid electronic cigarettes may be too appealing to young people and they have been pinned as a gateway to nicotine addiction among the younger population.
New York’s criticisms clash with the equally strong arguments in favor of the devices. Electronic cigarettes are tobacco-free and don’t carry the 5,000 known chemicals in a traditional tobacco cigarette. Advocates for e-cigarettes also point out thousands of testimonials from smokers who used the devices to quit.
Although the U.S. Food and Drug Administration struggle to gain regulatory control on electronic cigarettes, studies are a work in progress. Electronic cigarettes isolate the nicotine and carry far fewer chemical risks than regular cigarettes. Michael Siegal, a tobacco researcher from Boston University states that tobacco contains about 5,000 known chemicals and as many as 100,000 more that have yet to be identified. Using an e-cigarette eliminates most of those because there is no tobacco involved.
A study published in the Journal of Public Health Policy found that the levels of harmful chemicals in electronic cigarettes were in the same ball park as levels found in cessation devices such as nicotine patches. The levels were hundreds of times lower than the chemical levels found in traditional cigarettes. The study also found evidence that electronic cigarettes helped reduce cravings among smokers. Many smokers have trouble quitting with the patch because they still have a need to hold something in their hand or put something in their mouth, because of this, e-cigarettes are more appealing to someone trying to quit than patches of gum.
Electronic cigarettes are certainly safer than smoking and can aide in quitting but there are simply too many unknowns still. The FDA will keep studying them and work toward regulation. Without proper regulation, cartridges may contain undisclosed chemicals which could turn out to be more dangerous than tobacco smoke. The Journal of Tobacco Control did a recent study of six brands of e-cigarettes and found that not all of the devices were labelled clearly with nicotine levels, expiration dates, etc. For now the devices remain unregulated but they certainly seem to be the better alternative to smoking.