As of September 17, 2019, there have been 7 reported deaths and 530 cases of lung injury associated with e-cigarettes and vaping. Doctors across the country are struggling to determine the true cause of this illness with a high incidence among vape product users. Doctors are unable to even prescribe a uniform diagnosis to the condition, with some using the term “vaping-associated lung injury,” or “VALI.”
Many believe these vaping-related illnesses are due to additives—namely Vitamin E acetate—found in some THC vaping products. The Center for Disease Control and Prevention (CDC) has detected Vitamin E acetate in many of the samples tested during , but it has not been present in all. While the CDC cannot conclusively determine that Vitamin E acetate is the cause of these mysterious illnesses, they recommend avoiding inhaling the oil.
In response to this mysterious vaping illness, governments and private corporations alike are striving to heavily regulate e-cigarettes and vaping products. On September 11, 2019, the Trump administration announced it would seek to ban the sale of flavored e-cigarettes at the federal level. The U.S. Food and Drug Administration (FDA) is currently outlining a plan to remove all non-tobacco flavored e-cigarettes and nicotine pods from the market.
This is not the first time the FDA has sought to regulate e-cigarettes. Before the FDA finalized a rule in 2016 that extended its authority to encompass all tobacco products, there was no federal law prohibiting the sale of e-cigarettes to minors. The 2016 regulation was aimed at curbing youth e-cigarette use but has since proven ineffective. In 2015, one year prior to the FDA’s attempts at regulation, 16% of high school students used e-cigarettes. This year, that number has risen to represent nearly a quarter of all high school students in the United States . In 2017, the FDA announced that it would delay further e-cigarette regulations until 2022; however, a recent uptick in vaping-related illnesses has instilled a renewed sense of urgency.
Senators Romney and Merkley also introduced a bill on September 12, 2019, that would overhaul the e-cigarette business in the United States. the legislation would “ban e-cigarette flavors other than tobacco, specify e-cigarette design standards, monitor the public health risks of using tobacco products, apply existing cigarette taxes to e-cigarettes and direct the Department of Health and Human Services to educate the public about health implications of using e-cigarettes.”
Two states and the District of Columbia have advanced regulations on the vaping industry at the state level. On September 4, 2019, Michigan announced a ban on all flavors of e-cigarettes (besides tobacco-flavored). Michigan’s ban will only last for six months, but state officials can opt to renew the legislation for an additional six months while permanent regulations are drafted.
On September 15, 2019, the governor of New York announced his plans to enact an emergency regulation banning all flavored e-cigarettes throughout the state. This regulation would be issued by the Public Health and Health Planning Council of New York, which has “a broad array of advisory and decision-making responsibilities with respect to New York State’s public health and health care delivery system.”
Two bills introduced in the District of Columbia, if passed, would impose even more restrictive measures on the e-cigarette industry. These measures would not only prohibit the sale and distribution of flavored e-cigarettes but would also require that all vaping products be sold only at pharmacies and medical marijuana dispensaries.
In addition to these governmental regulations, the largest retailer in the country, Walmart, has announced its decision to stop selling e-cigarettes. This decision comes six months after pharmacy giant Rite Aid announced a similar resolution.
E-cigarettes and vaping products constitute an $11 billion market where profiteers include both large corporations, like Juul Labs, Inc., as well as small businesses across the country. The proposed public and private regulations threaten not only the business of the large manufacturers but also the mom-and-pop specialty shops that are spread throughout the country.
While the FDA has had the authority to prohibit the sale of flavored e-cigarettes since its ruling in 2016, they did not act until a U.S. District judge in Maryland issued an order in early July requiring makers and importers of e-cigarettes to submit applications for their current products by May of 2020. On September 20, 2019, the FDA proposed a new rule to set the requirements e-cigarette and other tobacco product manufacturers will be required to follow when submitting these premarket tobacco product applications (PMTAs). In accordance with the Administrative Procedure Act, the proposed rule will be open for public comments for 60 days, through November 25, 2019
This rule is not the ban on flavored e-cigarettes the Trump administration was seeking; however, the FDA could use this process to take those products off the market after the May 2020 deadline. For manufacturers to obtain approval, they will have to prove their products provide more public health benefit than harm. Manufacturers of tobacco flavored products designed to help adults quit smoking are likely to have an easier time convincing the FDA of this than will makers of other flavored products as the FDA continues to re-affirm its commitment to prevent the use of e-cigarettes by kids. In the meantime, Alex Azar, the Secretary for Health and Human Services, said the FDA would take several weeks to announce a new policy removing all non-tobacco flavored products from the market.
It is likely that flavored e-cigarettes will soon be off the market nation-wide, at least until the FDA begins its approval process next year. However, by that time, state governments and Congress could enact laws even stricter than the FDA regulations.
Hayden Rutledge is a second-year at Cornell Law School. He grew up in Tennessee and has a political science degree from Belmont University. Hayden is a member of Cornell’s First Amendment Clinic and enjoys writing pieces on pressing issues and First Amendment concerns.
Suggested citation: Hayden Rutledge, Jumping on the Ban-wagon: As Vaping Associated Illnesses Rise Governments and Corporations Take Action, Cornell J.L. & Pub. Pol’y, The Issue Spotter, (Sept. 25, 2019), http://jlpp.org/blogzine/jumping-on-the-ban-wagon-as-vaping-associated-illnesses-rise-governments-and-corporations-take-action/.