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Acting Commissioner of the U.S. Food and Drug Administration (FDA) Norman E. ("Ned") Sharpless, M.D., has presented his remarks on the FDA’s planned regulation of electronic nicotine delivery systems (ENDS), including the investigation of vaping illnesses, before the U.S. House Energy and Commerce Subcommittee.
Sharpless initially discussed the recent outbreak of vaping illnesses and subsequently directed his remarks to the agency’s efforts and planned compliance policy related to ENDS, stating that these two issues are top priorities. Sharpless said that the FDA and CDC, together with the participation of state partners, have been investigating an outbreak of lung illnesses associated with the use of vaping products.
While the investigation has not yet identified any particular substance or product related to the illnesses, most cases have reported recent use of vaping products that contained tetrahydrocannabinol (THC) – a psychoactive component in marijuana. Sharpless further mentioned that the FDA has received preliminary data from the 2019 National Youth Tobacco Survey (NYTS) that revealed an alarming increase in youth use of ENDS products despite the current awareness campaign on its use as well as other efforts made the previous year.
Sharpless also noted that another study supported by the National Institute on Drug Abuse showed that more than a quarter of high school students were current e-cigarette users in 2019, with fruit and menthol/mint flavors as the most popular choices.
“The President announced his support for the FDA’s intention to soon finalize a compliance policy related to flavored ENDS," Sharpless told the subcommittee. "This policy would prioritize the FDA’s enforcement of premarket authorization requirements for non-tobacco flavors. I want to assure the subcommittee that I am firmly committed to employing all of the tools at FDA’s disposal to tackle these problems. We will not rest until we have answers to the questions in the investigation, and until we have dramatically reduced the access and appeal of e-cigarettes to kids."
The full statement was released on Sept. 25.
