The U.S. Food and Drug Administration (FDA) filed its notice in the Federal Register for its new regulatory restrictions that would ban all flavors except menthol and tobacco in closed-pod systems.
The filing started the 30-day countdown for manufacturers of closed-pod systems, such as Juul, Vuse and Blu products, to stop making, distributing and selling the “unauthorized flavorings,” or risk enforcement actions.
Retailers must also stop selling the products by Feb. 6.
“[Health and Human Services] HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” HHS Secretary Alex Azar said on Jan. 2.
FDA Commissioner Stephen Hahn said federal regulators will regularly review the use of tobacco and menthol flavorings by youth and will be prepared “to take additional restrictive actions.”
The FDA also reminded producers of nicotine e-liquids that they are considered as manufacturers, thus subject to a court-ordered May 12 deadline for submitting a premarket tobacco product application (PMTA) to the FDA.
The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and nonusers, particularly compared with traditional cigarettes.
E-liquids for use with open systems will remain available in tobacco and vape shops — primarily because the FDA and other Trump administration officials stated that those products don’t appeal to people under 21 and that those shops are more responsible about age verification than traditional retail outlets.