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Regulation needed to determine risks, benefits of e-cigarettes
FDA regulation is essential to reduce risks and maximize potential benefits of electronic cigarettes, according to a commentary published in Pediatrics.
Electronic cigarettes, or e-cigarettes, consist of a liquid cartridge that contains nicotine derived from tobacco, and an atomizer and rechargeable battery. The liquid is atomized and delivers a vapor to the user as the smoker draws on the device. Vapor flavors range from plain tobacco to bubble gum or peach schnapps.
E-cigarettes have been gaining popularity since their introduction to the market in 2007. As their popularity grows, so does the need for product and marketing regulations at the federal level and sales restrictions to minors at state and local levels, according to Emily K. Duffy, MD, and Brian P. Jenssen, MD, of the Children’s Hospital of Philadelphia, who penned the editorial.
To be considered at a federal level, e-cigarettes need to qualify as the Family Smoking Prevention and Tobacco Control Act’s definition of tobacco products. The FDA has yet to include them in this definition. As a result, e-cigarettes cannot be regulated like other tobacco products; and required to include warning labels, marketing restrictions, or biochemical testing that ensures accurate labeling.
Another route to regulation would be classifying e-cigarettes as medical devices or drugs. But this classification cannot be achieved unless they are manufactured as medical devices or nicotine replacement therapy, such as nicotine patches or gum.
Substances in e-cigarette vapor, such as diethylene glycol, an ingredient in anti-freeze, and nitrosamines, which are considered human carcinogens, have raised concerns about the harmfulness of the product. Inconsistencies between the product’s contents and its package labeling are another concern, Duffy and Jenssen wrote.
Several steps needed to address health concerns about e-cigarettes:
- Immediate FDA regulation;
- Consistent and universal regulation on a city and state level to ban e-cigarette use in public spaces and access to minors;
- Guidelines on how to counsel patients about e-cigarettes.
There are potential benefits to e-cigarettes, according to researchers. Currently, e-cigarettes are marketed as an aid to reduce smoking or stop smoking. Smoking cessation experts believe these products have potential as a cessation tool because they address behavioral and sensory needs that other nicotine replacement products do not.
Regulation will diminish the unknowns surrounding e-cigarettes, by illustrating benefits and risks, if any. Experts will then be able to determine whether e-cigarettes are a valuable tool in the battle against nicotine addiction. If the benefits outweigh health risks, e-cigarettes have lifesaving potential for smokers and children exposed to secondhand smoke.
“Over time, we will learn the true nature of e-cigarettes and use that information to help our patients. In the interim, lack of evidence regarding the science of this product should not be mistaken for lack of clarity in terms of the steps needed for its regulation…Pediatricians can advocate with their local and national lawmakers to encourage this needed oversight, a necessary step toward ensuring that these devices do the most possible good and the least possible harm,” the authors concluded.
Disclosure: The researchers have no relevant financial disclosures.
