Last week, the Food and Drug Administration (FDA) announced a series of critical enforcement actions related to the sale and marketing of e-cigarettes to children and young adults. With the use of e-cigarettes among youth growing at an alarming rate in recent years, the agency has taken record actions to address this challenge and protect youth from the dangers of tobacco products through its Youth Tobacco Prevention Plan.
In June of this year, the findings from the National Youth Tobacco Survey (NYTS) showed an increase in e-cigarette use from 2011 to 2017. The survey noted that e-cigarettes have been the most commonly used tobacco product among both middle and high school students for the fourth year in a row, with a total of over 2.1 million youth using e-cigarettes in 2017[i]. Previous reports had also shown that youth use of e-cigarettes increased from 2011 to 2015, surpassing the use of regular cigarettes. E-cigarettes are sold in over 7,700 flavors that are marketed for youth consumption and place kids and teens at risk of nicotine addiction and other health harms.
The effects of electronic nicotine delivery systems (ENDS), including e-cigarettes are not yet fully known. A congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine published in January suggests that e-cigarettes are not without biological effects in humans and the consequences on long-term use on morbidity and mortality are not yet clear.
As part of the largest coordinated enforcement efforts in the FDA’s history, more than 1,300 warning letters and civil money penalty fines were issued to retailers who illegally sold e-cigarette products to minors. The retailers were identified in a summer-long undercover effort of brick-and-mortar and online stores.
The FDA has identified five national brands – JUUL, Vuse, MarkTen XL, blu e-cigs, and Logic – that collectively comprise over 97% of the current e-cigarette market in the US and make up the majority of the products illegally sold to minors based on the summer’s undercover efforts.
Each company has been asked to submit plans to the FDA within 60 days describing how they will address the widespread youth use of their products. If the companies do not comply or the FDA finds their plans inadequate, the agency will consider revisiting policies that could result in requiring these brands to remove some or all of their flavored products from the market.
The FDA also issued 12 warning letters to other online retailers for selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products. Several of these retailers were also cited for illegally selling the products to minors.
The FDA will continue to conduct checks of retail establishments that sell tobacco products to ensure compliance and the agency also has issued more than 135 No-Tobacco-Sale Order Complaints, which can result in retailers being prohibited from selling tobacco products for specified periods of time.
ASCO is committed to policies that will contribute to the reduced prevalence of tobacco use and prevent the occurrence of cancer and other smoking-caused diseases. In the absences of clear data on ENDS aid to cessation, ASCO recommends the use of proven smoking cessation medications such as nicotine replacement therapies, bupropion, and varenicline. Additionally, behavioral counseling paired with cessation medication has been associated with increased cessation[ii].
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Learn more about the FDA’s latest actions.
[i] Wang TW, Gentzke A, Sharapova S, Cullen KA, Ambrose BK, Jamal A. Tobacco Product Use Among Middle and High School Students — United States, 2011–2017. MMWR Morb Mortal Wkly Rep 2018;67:629–633. DOI: https://dx.doi.org/10.15585/mmwr.mm6722a3.
[ii] Stead LF, Koilpillai P, Fanshawe TR, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database of Systematic Reviews 2016, Issue 3. Art. No.: CD008286. DOI: 10.1002/14651858.CD008286.pub3.