Electronic cigarettes (e-cigarettes) are devices that deliver vaporized nicotine. Whether or not to regulate e-cigarettes as tobacco products, smoking cessation products, or as an unregulated product is an important public health concern in the United States. One problem is that there are currently minimal data on the safety and health effects of e-cigarettes and on if they would lead users to move on to other tobacco products, such as standard cigarettes. While the FDA has not yet banned the sale of e-cigarettes, states and cities across the country are considering bills to regulate them. In other countries, e-cigarettes are treated like medicines and some have banned them outright. After a failed attempt by the FDA to regulate e-cigarettes as drug-delivery devices, the agency is now focusing on regulating them as tobacco products.
We believe that e-cigarettes should be regulated like drug products that require safety and efficacy data to support a specific health claim prior to being marketed. From a consumer standpoint, if e-cigarettes are being used as a nicotine replacement medication there is a need for safety information and product standardization. Additionally, regulation via the FDA could ensure that the drug delivery systems provide a uniform dosage during use and between products, while also being packaged in a manner that could limit accidental exposure to pediatric and other at-risk populations. In the current situation, the data to support e-cigarette usage is sparse, and until such data is provided e-cigarettes should be removed from the consumer market.
Social, Cultural & Behavioral Issues in PHC & Global Health 
March 8, 2014 at 12:52 pm |
If you are suggesting that e-cigarettes be considered “medication”, wouldn’t they then need to regulated by the FDA? If they are removed from the “Over the Counter” market & require a physicians prescription, fewer individuals would use them. Isn’t that perhaps a step-backward in the fight against tobacco use?
March 8, 2014 at 3:56 pm |
Thanks for the comment on our blog. While it could seem like a step backwards I would argue that e-cigarettes–in their current incarnation–are a lateral step with problems of their own without necessarily fixing the problem of tobacco. At the most basic level, e-cigs are a way of dispensing a drug without any type of the normal safety controls normally in place, AND without data to show that the e-cigarettes are accomplishing what they are being marketed for (which is either to help a person quit or to serve as a “safe” substitute for a real cigarette.)
The FDA regulates both OTC and prescription medications. Other nicotine replacements (nicorette gum, nicoderm patches) are OTC. The Nicotrol inhaler, which is similar to the idea of an e-cigarette but not in the same “slick” packaging is prescription, but at some point may be changed to OTC status. It is reasonable to assume E-cigs could have OTC status when under FDA authority and they could continue to be readily available.
Without any type of regulation, e-cigs currently have been shown to contain additional toxic chemicals, like antifreeze. The doses are not standardized between devices and nicotine is a stimulant that can cause cardiovascular problems, excessive doses can cause death in extreme cases, such as when a child gains access to the replacement cartridges. Regulated medications have stipulations for child resistant packaging. E-cigs are flavored and colorful and of the sparse data that exist about them, some of it has shown that E-cigs are being picked up by young people who are then becoming addicted to nicotine. Rather than solving a fight against tobacco, they may be causing new problem with nicotine addiction.
March 8, 2014 at 7:15 pm |
Regulation for safety sake definitely seems like a positive step in dealing with e-cigarettes. Generally most anything taken into our bodies is regulated by the FDA, so it makes sense that this would expand to e-cigarettes as well, although I agree that in and OTC option as opposed to prescription.
My home state, Utah, has a ban on e-cigarettes in indoor public places, including bars. Just a few days ago I saw in the news that Los Angeles has adopted a similar policy. It will be interesting to see how policies will continue to change for both the regulation of, and environmental restrictions involved with e-cigarettes.
To my knowledge there are still no federal age limits set for the use of e-cigarettes, unlike various age restrictions set for traditional cigarettes. Adults using these products is their own judgement call, but knowing that youth of all ages legally have access to hefty quantities nicotine is something that legislation should definitely define.
March 8, 2014 at 8:50 pm |
I agree that regulation is needed!!
At first I thought, “Anything is better than smoking a real cigarette,” but further research proved me wrong:
On the web site, http://www.medicalnewstoday.com/articles/249784.php
Professor Christina Gratziou, who is Chair of the European Respiratory Society (ERS) Tobacco Control Committee, said:
“We do not yet know whether unapproved nicotine delivery products, such as e-cigarettes, are safer than normal cigarettes, despite marketing claims that they are less harmful.”
“We found an immediate rise in airway resistance in our group of participants, which suggests e-cigarettes can cause immediate harm after smoking the device. More research is needed to understand whether this harm also has lasting effects in the long-term […] The ERS recommends following effective smoking cessation treatment guidelines based on clinical evidence which do not advocate the use of such products.”
AND,
An article in the New York Times talks about how companies are aggressively marketing e-cigarettes as “cool” fruit and candy flavored e-hookahs, and how young people are attracted by this
( http://www.nytimes.com/2014/03/05/business/e-cigarettes-under-aliases-elude-the-authorities.html?_r=0 )
AND,
The public agrees:
In a study done by the C.S. Mott Children’s Hospital at the University of Michigan Department of Pediatrics and Communicable Disease, and the University of Michigan Child Health Evaluation and Research (CHEAR) Unit,
85% of adults favor prohibiting the sale of e-cigarettes to people under 18,
82% support FDA regulation of e-cigarettes, and
69% support prohibiting the use of e-cigarettes in indoor places and workplaces.
( http://no-smoke.org/learnmore.php?id=645 )
March 8, 2014 at 9:01 pm |
Sorry – my links don’t open in a separate window!