Long-awaited steps finally announced The FDA will restrict the sale of flavored electronic-cigarettes, and move forward with a plan to ban all menthol cigarettes over the next few years, FDA Commissioner Scott Gottlieb announced Thursday. The move comes several months after Gottlieb declared the use of e-cigarettes among teens an "epidemic" and survey data -- including some released Thursday -- confirmed Gottlieb's assertion. The FDA action will immediately ban the sale of most flavors of so-called ENDS (electronic nicotine delivery systems), with the exception of tobacco and mint and menthol flavors, "sold in age-restricted, in-person locations and, if sold online, under heightened practices for age verification," according to Gottlieb's statement. Menthol and mint flavors are excepted, Gottlieb said, because -- at least for the time being, menthol cigarettes will remain available, and "I don't want to create a situation where the combustible products have features that make them more attractive than the non-combustible products." Gottlieb said he was persuaded by evidence that e-cigarettes are less harmful than combustible tobacco products, and therefore individuals intent on using nicotine should be encouraged to use safer versions. Pediatrician Rachel Boykan, of Stony Brook Children's Hospital in New York, told MedPage Today that the FDA's decision to prohibit the sale of fruit and candy flavors of the most widely sold e-cigarettes is a step in the right direction. But she criticized the exemption for mint- and menthol-flavored ENDS. "If they're going to ban one flavor they should ban them all," she said. "It doesn't make sense to me to take some away, but not all of them." Gottlieb also stated the agency's intention to ban menthol cigarettes, but that will require a lengthier process. "I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes. The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities," he said. "And, unlike menthol-flavored ENDS, there's no evidence to suggest that menthol-flavored cigarettes may play a role in harm reduction for adult smokers," he added. He said the agency "will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars." This effort will include proposing "a policy through appropriate means to ban flavors in cigars," Gottlieb said. Finally, Gottlieb threatened more draconian action if these steps do not lead to reductions in youth tobacco use. "I could take more aggressive steps. I could propose eliminating any application enforcement discretion to any currently marketed ENDS product, which would result in the removal of ALL such products from the marketplace. At this time, I am not proposing this route, as I don't want to foreclose opportunities for currently addicted adult smokers," he said. "But make no mistake. If the policy changes that we have outlined don't reverse this epidemic, and if the manufacturers don't do their part to help advance this cause, I'll explore additional actions." Source
