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S24: Youth Nicotine Addiction: Strategic Regulation Defiance by the Disposable Electronic Nicotine Delivery System (ENDS) Industry

Poster Presenter

Griffin Riggs

Research Assistant
University of Southern California
United States

Objectives

To identify factors that enabled disposable Electronic Nicotine Delivery Systems (ENDS) to emerge in popularity and further youth nicotine addiction by defying federal, state, and local regulations following strengthened regulations and crackdowns on ENDS companies.

Method

This study synthesizes data of ENDS regulations from FDA.gov, information about disposable ENDS gathered from sources across the internet, and youth nicotine addiction statistics and risk factors gathered from various primary and secondary sources.

Results

In the U.S., the sale of tobacco products, including ENDS, to anyone under the age of 21 is prohibited, and tobacco products are required to display a nicotine addictiveness warning statement on the packaging. Moreover, all new tobacco products must have a premarket tobacco product application (PMTA) approved before being marketed. In the U.S., it is prohibited to manufacture, distribute, or sell flavored ENDS, excluding menthol and tobacco flavors. Flavored ENDS were banned because they increase youth interest in vaping by reducing the perception of harm. Youths using flavored ENDS vape more and take more puffs per use, compared to those who use tobacco, mint, and menthol flavored ENDS. In July 2020, Cool Clouds Inc., a distributor of Puff Bars (a brand of disposable ENDS), received a warning letter for failure to comply with FDA regulations for manufacturing a new tobacco product without a PMTA, selling Puff Bars in many flavors other than menthol and tobacco, and marketing Puff Bars, on puffbar.com, as a safer alternative to smoking. Despite the threat of legal action by the FDA, a google search of “puff bar” yields 71,000,000 results, with 16 websites on the first two pages selling Puff Bars while only one result of the FDA warning letter and two results from Truth Initiative, an anti-nicotine addiction organization. Of the 16 websites, all but one, puffbar.com, sell other brands of disposable ENDS similar to puff bars. The first result, eliquidstop.com, sells 30 additional disposable ENDS that are not Puff Bars but look similar and sold in similar fruity flavors. Of youths aged 15-17 years: 31% obtained their ENDS from a vape shop or online retailer, 16% bought from another person, 15% from a straw buyer, and 14% received them as a gift.

Conclusion

The manufacture and sale of disposable ENDS such as Puff Bars and similar products continue to defy federal, state, and local regulations. Even though Cool Clouds Inc. has agreed to cease all sales within the U.S., Puff Bars continue to be sold online and in convenience stores/vape shops across the nation. The issue is that the FDA misrelated all Puff Bar sales to Cool Clouds Inc. when there are numerous websites online that sell Puff Bars, both individually and wholesale. This study was unable to determine any one major wholesaler of Puff Bars that is responsible for the continued sale in the U.S. However, this study revealed weak points within ENDS regulations that are being exploited by disposable ENDS wholesalers to continue sale in the U.S., and how they are furthering youth nicotine addiction by making ENDS easily accessible. Puff Bars, and similar disposable ENDS, are attractive to underage users as they come in a variety of fruity flavors and are presented as bright-colored devices that give the illusion of safety. These attributes have been shown to be risk factors in attracting youths to ENDS. Additionally, due to their all in-one nature, disposable ENDS position themselves as an effortless path to nicotine use for adolescents by eliminating the need for items like a charger, battery, and e-liquid. The FDA has been unable to prevent the sale of Puff Bars through warning letters, as they are not capable of determining and tracking down each distributor, and there is no enforcement for retailers selling such products. To properly combat the sale of unregulated disposable ENDS, the FDA must directly warn and impose threat of legal action to all retailers selling products that violate federal regulations, as it has proven too difficult to stop the wholesalers of such products, many of which operate outside the U.S. In doing so, access to disposable ENDS that violate FDA regulations would diminish greatly as online sales would be the only way to obtain them.