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Attorney General Nessel Joins Bipartisan Coalition Calling on FDA to Regulate E-Cigarettes, Oral Nicotine Products
August 19, 2021
LANSING - Michigan Attorney General Dana Nessel joined a bipartisan coalition of 30 other attorneys general to urge the U.S. Food and Drug Administration (FDA) to implement measures to help stem the surge of youth nicotine use and addiction related to e-cigarettes and a new generation of oral nicotine products.
Specifically, the coalition is calling on the FDA to use its regulatory power to eliminate youth-appealing flavors; limit nicotine levels in e-cigarettes and oral nicotine products such as pouches, gum, and lozenges; and impose marketing restrictions and effective age verification measures. The FDA is responsible for deciding whether to allow these products to stay on the market through the Premarket Tobacco Product Applications (PMTAs) , and these proposed measures would deny approval for products that would worsen America's youth nicotine epidemic.
"The youth nicotine epidemic is an urgent public health matter and it is on us to ensure that the health and safety of our youth is not jeopardized," Nessel said. "I urge the FDA to take immediate action and use its regulatory powers to impose restrictions on these products that are harming our young people."
E-cigarette use among high school students has increased dramatically, from just 1.5 percent in 2011 to 11.7 percent in 2017, and then to 27.5 percent in 2019. Data from 2020 shows that 19.6 percent of high school students had used an e-cigarette in a prior 30-day period, with 38.9 percent of those reporting e-cigarette use on 20 or more days of that 30-day period, and 22.5 percent reporting daily use. Additionally, oral nicotine products (most notably pouches) are quickly becoming the fastest-growing nicotine category in convenience stores, growing by about 500 percent. It is estimated that 13 percent of those between 15-24 years old used oral nicotine products in any given 30-day period.
E-cigarettes and oral nicotine products have not received marketing authorization from the FDA, as required by federal law. Companies like JUUL have been vigorously marketing flavored nicotine products, largely free from regulatory supervision, leading to what former U.S. Surgeon General Jerome Adams characterized as a "youth nicotine epidemic." In their letter to the FDA, the coalition argues that the FDA must address the epidemic by imposing restrictions and age verification on traditional and digital marketing tactics aimed towards youth.
Additionally, the coalition maintains that the FDA should limit the amount of nicotine in e-cigarettes and oral nicotine products, which are at their highest levels to date. Nicotine has particularly harmful effects on the developing brain, with youth being significantly more likely to become addicted than adults. High youth nicotine consumption is also associated with numerous adverse physical outcomes such as nicotine poisoning and toxicity, as well as mental health and behavioral problems like major depressive disorder, academic problems, and addiction to other substances.
Finally, the coalition argues that banning candy, mint, fruit, and menthol flavors is essential to eliminating the appeal of the products to youth consumers. More than 80 percent of youth using e-cigarettes choose non-tobacco flavors. Though the FDA announced that it would prioritize its enforcement against flavored cartridge-based e-cigarettes (except menthol and tobacco flavors), menthol-flavored e-cigarette sales jumped 54.5 percent in market share over the four weeks following the FDA's April 2020 guidance, and 82.8 percent over eight weeks, indicating its popularity among youth.
The FDA is expected to decide whether e-cigarettes and oral nicotine products should be allowed to remain on the market starting on Sept. 9, 2021. The coalition urges the FDA to deny all PMTAs for products containing high levels of nicotine, and for products containing menthol or other flavors.
Joining Attorney General Nessel in sending this letter are the attorneys general of Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Guam, Idaho, Illinois, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, Nebraska, New York, North Carolina, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Utah, Vermont, Washington, and Wisconsin.