Loyola University Chicago School of Law, JD 2020
In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.
The Effects of Nicotine on Young Adults
Nicotine, the addictive substance found in tobacco products, has profound effects on the human brain, most notably affecting the prefrontal cortex within just seconds of inhalation of cigarette smoke and e-cigarette vapors. While smokers generally worry about the effect of smoke inhalation and the inhalation of the thousands of chemicals found in traditional cigarettes, many overlook the drastic long-term negative effects of nicotine on the human body.
The human brain develops until the age of twenty-five, which makes young people particularly vulnerable to addiction. Nicotine causes the release of dopamine, a chemical which gives users of nicotine products a feel-good sensation. However, brain cells change after repeated exposure to nicotine and reduces the ability of the body to naturally produce its own dopamine. Teenagers that regularly ingest nicotine create more receptors in their brain to be able to receive the heightened levels nicotine and, in turn, will require even greater levels of nicotine to achieve the same sensation and may lead to quick and early addiction. Some of the most serious consequences of nicotine ingestion include adverse effects on the cardiovascular, respiratory, gastrointestinal, immunological, ocular, renal and reproductive systems as well as its role in carcinogenesis.
Rise of the JUUL
While electronic nicotine delivery systems (ENDS) have had a presence in the United States market since the 1990s, the JUUL, introduced in 2015, has proven to be the most popular and mainstream among all e-cigarettes and vaping devices. The small USB-shaped device can be refilled with pods containing flavored “e-juice” that delivers a powerful and potent nicotine kick through the vapor. The discrete shape of the JUUL and its fruity pods are attractive to young users, explaining their popularity. However, the JUUL pods contain a higher nicotine concentrate than most other e-cigarettes, which contributes to its addictive nature. Even more harrowing is that around 63% of JUUL users between the ages of 15 and 24 were completely unaware that JUULs contained nicotine.
In July 2017, the FDA announced the Youth Tobacco Prevention Plan to increase the regulation of tobacco and nicotine to protect younger generations and to decrease the diseases and deaths caused by tobacco use.
In April 2018, the FDA announced a part of the abovementioned plan that specifically targets adolescent’s access to e-cigarettes and JUULs. Notable aspects of the plan include cracking down on brick-and-motor and online retailers for selling JUULs and e-cigarettes to minors and researching the appeal of nicotine products to teenagers. On April 24, 2018, the FDA sent a request for documents to JUUL Labs, Inc., the manufacturer of JUUL products, relating to their marketing practices and product research.
Between April 2018 and June 2018, the FDA issued several warning letters and civil money penalties (CMPs) to retailers as a nationwide crackdown on the access and sale of e-cigarettes and JUULs to minors. Additionally, between June 2018 and September 2018, as part of the largest coordinated enforcement effort in the history of the FDA, the agency issued upwards of 1,300 warning letters and CMPs to retailers illegally selling JUULs and other ENDS products to minors. The FDA conducted large-scale undercover investigations as part of the enforcement and even worked directly with eBay to implement new measures to prevent the posting of suspicious listings for JUUL products and to remove those listings targeting minors.
Moreover, the agency is planning to put forward additional efforts to curb marketing tobacco and nicotine products targeted at minors. The agency also intends to invest in science-based education campaigns directed at youth about the dangers of all forms of tobacco products. Since it’s nearly impossible to completely eradicate all minority tobacco use just as it is nearly impossible to completely eradicate any kind of illegal activity, the government focuses on reducing and controlling it. The FDA plans to further research measures focused on making these products less harmful and addictive, and most importantly: less appealing.
The New Policy and Potential Pitfalls
As part of its ongoing efforts to reduce tobacco-related deaths and disease, the FDA continues to put pressure on retailers to continue photo identification checks and will require manufacturers to submit tobacco product review applications for products on the market as of August 8, 2016. The Administration is continuing to develop specific regulatory and enforcement measures as part of its September 2018 initiative.
Manufacturers and distributors of e-cigarettes, however, are pushing back. Executive Director of the Vapor Technology Association (VTA), Tony Abboud, claimed in a statement that the “epidemic” consists of nothing more than “overhyped media reports.” The Executive Director of the VTA, a national trade association which represents more than manufacturers and distributors in the vaping industry, stated that while he does not object to regulating adolescent use of the products, he believes that tightening the grip on the industry too hard will force many smokers to return to traditional cigarettes.
As part of the U.S. Department of Health and Human Services, the FDA strives to protect public health by regulating drugs, vaccines, biological products, and medical devices as well as the food supply, cosmetics, dietary supplements, and products that emit electronic radiation. The regulation of tobacco products is just one part of the FDA’s responsibilities but the agency hopes to make long strides in the overall reduction of tobacco-related disease and death in the United States and to focus on the protection of adolescent health.