Jennifer Caudle says FDA regulation of electronic nicotine delivery systems is overdue
More research needed on long-term effects, especially as youth use skyrockets, she says
“Yessssss!” was my reaction to hearing the news that the U.S. Food and Drug Administration intends to regulate e-cigarettes, hookahs, vape pens, e-pipes and other electronic nicotine delivery products.
As a family physician, I often have patients ask me about e-cigarettes. Some have seen advertisements and are wondering what they are; some have simply heard that e-cigarettes are safer than traditional cigarettes and want to know if this is true.
E-cigarettes are included in the category of ENDS – Electronic Nicotine Delivery Systems – products that use a liquid containing nicotine and varying amounts of flavor, glycerin, propylene glycol and other ingredients. This liquid is heated into an aerosol that users then smoke. It is often referred to as “vaping.”
E-cigarettes have been largely unregulated. For me this has always posed a problem, because in addition to lack of oversight, we are missing answers to important questions.
For example, e-cigarettes are often touted as safe alternatives to regular cigarettes, but the truth is that we don’t have a lot of data on the long-term effects of ENDS (how safe are they? what are their potential benefits vs. harms?) to address this issue fully.
The effect of e-cigarettes and ENDS on children is also an issue – especially given the growth of e-cigarette use among teens in recent years. The FDA reports that “more than 3 million middle and high school students were current users of e-cigarettes in 2015, up from an estimated 2.46 million in 2014.”
The FDA also reports that 16 percent “of high school and 5.3 percent of middle school students were current users of e-cigarettes in 2015, making e-cigarettes the most commonly used tobacco product among youth for the second consecutive year.” With adults, the trend is similar; the FDA reports that about 3.7% of adults use e-cigarettes daily or some days.
ENDS products often contain nicotine, which is not only addictive but poses a potential risk to the developing brains of children. This, and other characteristics of these devices, have made many wonder if e-cigarettes could serve as a gateway to the use of other nicotine/tobacco products.
The FDA has finalized a rule to regulate “all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigs), e-pipes, and all other ENDS,” which I support.
The FDA will now be regulating the manufacturing, import packaging, labeling, distribution, etc., of ENDS, and this is not only wise but necessary to ensure that ingredients in ENDS products are reviewed, assessed and determined to be safe for use.
With this regulatory oversight, I also hope that more information about ENDS – those long-term effects, and potential harms vs. benefits – will be made available. Finally, FDA’s oversight will also prevent companies from making misleading claims about electronic nicotine delivery systems and will help restrict youth access to these products.
Here are a few changes that will occur with the new FDA regulations:
• ENDS may only be sold to people 18 and older.
• Free samples of these products may not be given away.
• E-cigarettes cannot be sold in vending machines (unless in an adult-only facility).
• ENDS products must contain a health warning statement on the package that the product contains nicotine and that nicotine is addictive.
To be sure, I understand that there are some who oppose FDA oversight of ENDS products. Some may be concerned that sales of e-cigarettes and other nicotine delivery systems may be affected. There is no doubt that the use of these products has surged in recent years and business has grown; it is possible that FDA oversight might affect this growth.
Others might wonder why a change is needed at all: Many believe ENDS products have allowed them to quit smoking regular nicotine cigarettes or using other tobacco products.
I understand these arguments, but the most important aspect here is safety. The regulation of e-cigarettes and other electronic nicotine delivery systems is designed to help ensure safety – not only for children and teens but for adults as well. I am thrilled that the FDA isn’t allowing the importance of safety regarding electronic nicotine delivery systems go up in smoke.
Jennifer Caudle is a board-certified family medicine physician and assistant professor of family medicine at Rowan University School of Osteopathic Medicine in New Jersey. Follow her on Twitter @DrJenCaudle. The opinions expressed in this commentary are hers.