FDA recently announced a plan to propose product standards banning menthol as a flavor in cigarettes and banning all characterizing flavors (including menthol) in cigars within the next year. If implemented, this ban will apply to all manufacturers, distributors, wholesalers, importers and retailers. The next step will be for the agency to publish proposed rules in the Federal Register allowing an opportunity for public comment. The effort stems from a granted citizen petition requesting that the agency pursue rulemaking to prohibit menthol in cigarettes and affirm its commitment to proposing such a product standard.
The decision to ban menthol as a characterizing flavor, FDA says, is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009. Menthol is the last allowable flavor in these products. FDA also remains focused on its regulatory oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS), issuing warning letters to ENDS product manufacturers and retailers who continue to sell products that are illegally on the market after the Premarket Tobacco Application (PMTA) deadline in September 2020.
FDA is currently preparing responses to PMTAs and firms whose initial applications were not rejected and are waiting on FDA responses, anticipating FDA’s request for additional documentation and preparing for FDA’ pre-approval inspections. EAS is ready to help you. Contact us to discuss your regulatory challenges.