The U.S. Food and Drug Administration (FDA) has taken action in response to a new study that found nearly 10% of middle and high school students are using e-cigarettes. The agency has announced warnings and crackdowns on e-cigarette manufacturers who were reportedly popular with youth users.
The 2022 National Youth Tobacco Survey (NYTS) was a national study conducted by the federal government. This online study was conducted from January to May and found that 2.5 million students in middle and high school are currently using e-cigarettes. “Current” was defined by the study as use in the last 30 days. Of the students that reported using e-cigarettes in the last 30 days, 85% used flavored e-cigarettes and 27.6% use e-cigarettes daily. This data aligns with the FDA’s actions against flavored tobacco products due to the ease of attracting new users.
The FDA found that most youths preferred disposable e-cigarettes as opposed to reusable devices. Among the current most popular brands used by youths, the top three are Puff Bar, Vuse, and Hyde who were preferred by 14.5%, 12.5%, and 5.5% respectively. The FDA notes that while Puff Bar and Vuse were preferred brands that were prewritten responses, Hyde was a write-in response that was most likely underrepresented.
The FDA responded on two fronts. First, the FDA issued a warning letter to EVO Brands LLC and PVG2 LLC who do business as Puff Bar for receiving or delivering e-cigarettes in the U.S. without a marketing authorization order. Puff Bar has 15 working days to include dates of discontinuation of sale and distribution of tobacco products.
Puff Bar’s warning includes an exercise of new powers granted to the FDA by Congress on April 14 to regulate tobacco products that contain non-tobacco and synthetic nicotine products.
On the second front, the FDA issued marketing denial orders for 32 Hyde e-cigarette applications submitted by Magellan Technology Inc. In their denial order, the FDA determined that the applications lacked evidence demonstrating that the 32 flavored e-cigarettes would provide a benefit to adult users that outweighed the risks to youths. With the marketing denial, Magellan Technology must now stop selling and distributing Hyde products or risk enforcement actions including seizure.
FDA Commissioner Dr. Robert M. Califf M.D. spoke on the NYTS and FDA actions stating “The FDA remains deeply concerned about e-cigarette use among our nation’s youth. It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use.” Commissioner Califf went on to state that the FDA is steadfastly committed to using its full authority to address e-cigarette use by youths.