FDA Finalizes Enforcement Policy Against Vaping

Michael Manganelli

Associate Editor

Loyola University Chicago School of Law, JD 2021

Amid the epidemic levels of youth use of e-cigarettes, the U.S. Food and Drug Administration, released a policy on January 2, 2020, requiring enforcement against certain unauthorized flavored e-cigarette products that appeal to kids. According to the policy, the FDA intends to prioritize enforcement against fruit and mint flavored, cartridge-based electronic nicotine delivery system (“ENDS”). The FDA looks to regulate all ENDS products that manufactures have failed to make safe for use, as well as any ENDS product marketed for use by minors. The 2019 National Youth Tobacco Survey (“NYTS”), a survey conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, shows approximately 1.6 million youths were using ENDS products frequently, with nearly one million using e-cigarettes daily. The FDA’s enforcement policy is not a “ban” on flavored cartridges. If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considerations on how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.

How did we get here?

The vaping craze appears to have come out of nowhere, but when it did hit, it hit hard. According to a New England Journal of Medicine study, from 2017 to 2019, ENDS products use has more than doubled among middle school and high school students. Additionally, data from 2017 to 2018 shows that current e-cigarette use significantly increased from 6.6 percent to 10.4 percent among 8th graders (a 58 percent increase), 13.1 percent to 21.7 percent among 10th graders (a 66 percent increase), and 16.6 percent to 26.7 percent among 12th graders (a 61 percent increase). Among high school students, 4.11 million reported having used an e-cigarette in the past month in 2019 with 1.24 million middle school students reporting the same. The New England Journal of Medicine report argued that the upswing in youth vaping has been driven by a number of factors, including advertising, the attraction of fruity flavors, and the availability of easily concealed devices that deliver higher levels of nicotine.

As of February 4, 2020, number of deaths attributable to vaping has grown to 64. These individuals’ ages ranged from 15 to 70, with a median age of 51, according to the CDC.

The outlook may not be bright for the vaping industry. Recent developments made by the CDC indicate that lung fluid samples taken from 29 patients all contained the oily substance vitamin E acetate. This substance is sometimes added to cannabis vaping oils to stretch their THC content. On November 8, 2019, the CDC released a statement urging individuals to not use e-cigarette or vaping products that contain THC, particularly from informal sources like friends and family, online dealers, or illicit markets. The CDC went on the update this statement with information that confirmed that many people used products purchased from a “bootleg” network of illicit cannabis products before getting sick.

The Future of the vaping industry

In January 18, 2020, the CDC rolled back some it its overarching recommendations that people refrain from vaping during its investigations. This comes as a result of new data showing a link between vitamin E acetate and lung illnesses associated with vaping. The CDC is finding that vaping may not be the real cause of such illnesses. The CDC has admitted that the injuries appear to be exclusively linked to marijuana vapes, most of which have been purchased on the black market.

Some news outlets have interpreted the data to show that approximately sixteen percent of these cases involved legally purchased cannabis vapes at commercial locations. But, as Jacob Sullum at Reason points out, the number is skewed. This percentage discrepancy can be attributed to the  CDC’s definition of “commercial.” This definition includes not only licensed dispensaries, but also pop-up shops, which are decidedly illegal in states with legalized marijuana. Furthermore, the definition includes “stores,” without clarifying what this means. It is possible “store” includes bodegas and corner shops, which have been known to sell illegal drugs. Taking into account the vague and inconsistent definitions, only eleven percent of the cases reported buying their products at commercial outlets, which may still be an inflated number. The main issue, as identified by Michelle Minton of the Competitive Enterprise Institute, is that black market cannabis—not nicotine—vapes were the cause of the illnesses, which ultimately led to the CDC rolling back its overarching recommendations.

So long as the unregulated market for these devices remains, the illnesses associated with them will remain too. The CDC and the FDA have attempted to create boundaries and regulations to control the legal sale and use of ENDS products, and hopefully as a result, fewer individuals will suffer as a result of these dangerous products.