FDA Issues Marketing Denial Orders for 55,000 Flavored E-Cigarette Products
In August 2021, the U.S. Food and Drug Administration (FDA) denied about 55,000 flavored e-cigarette products’ marketing applications for failing to provide evidence that they appropriately protect public health.
They are the first marketing denial orders (MDOs) FDA issued for electronic nicotine delivery system (ENDS) products under its Congressional authority to regulate tobacco marketing approaches, particularly those that target youth. The agency deemed that the applications for the products, all of which came from three companies, “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
The denied products are non–tobacco-flavored ENDS, including flavors such as apple crumble, Dr. Cola, and cinnamon toast cereal, manufactured by JD Nova Group LLC, Great American Vapes, and Vapor Salon, according to FDA. The agency also reported that it sent the MDOs because the applications failed to provide the evidence of benefits to adult smokers for ENDS products in the form of a randomized controlled trial or longitudinal cohort study.
“This action represents a significant step toward making progress on the unprecedented number of applications received by the September 9, 2020, court-ordered deadline for submission of premarket applications for deemed new tobacco products, and addressing youth use of flavored ENDS products,” FDA said. “Although the agency has issued other negative actions for some applications, this is the first set of MDOs FDA has issued for applications that have reached the substantive scientific review portion of premarket review.”
ONS’s position is that FDA should regulate e-cigarettes and vaping liquids as soon as possible to protect underage users from adverse health effects and potential nicotine addiction and collaborate with the Centers for Disease Control and Prevention to investigate respiratory illnesses and deaths reported after the use of e-cigarettes. ONS members must raise their voice with ONS to advocate for e-cigarette and tobacco regulation and provide patients with information on smoking cessation.