Washington, D.C. -Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, sent a letter to the Office of Information and Regulatory Affairs (OIRA) calling for the swift review of the Food and Drug Administration (FDA)’s compliance policy and to defer to the expert judgment of the FDA to ban all vaping flavors, especially mint and menthol.
“The health and safety of our nation’s youth are at stake. I urge you to approve FDA’s ban within the next ten days and reject any attempts to weaken FDA’s flavor ban," wrote Chairman Krishnamoorthi. “No flavor exclusions serve the public interest. In connection with this letter, I also request a briefing from your office as soon as possible on OIRA’s plans with respect to the e-cigarette flavor ban."
On Friday, Oct. 25, 2019, the Food and Drug Administration (FDA) sent the compliance policy to OIRA, entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Tobacco Products on the Market Without Premarket Tobacco Authorization."
OIRA’s review should be fast. This policy is straightforward because it concerns only how FDA will exercise its discretionary enforcement authority and is not designated as “economically significant." It does not require a cost benefit analysis, which, if included, could slow OIRA’s review. This compliance policy is a matter within FDA’s discretion, and FDA’s determination regarding the extent of a flavor ban should not be overturned by the OIRA review process.
Due to the epidemic of e-cigarette use by young people, on Sept. 11, 2019, the President announced that the Trump Administration would ban all flavored e-cigarettes, which are strongly associated with industry efforts to market to youth.
Secretary of Health and Human Services Azar specifically stated that mint and menthol would be included in the ban-without them, the flavor ban will not be effective at keeping kids away from e-cigarettes. Before the Economic and Consumer Policy Subcommittee, Dr. Anne Schuchat, Principal Deputy Director of the Centers for Disease Control and Prevention (CDC), agreed, testifying that for the flavor ban to be effective, mint and menthol must be included. Mint and menthol are used by 64% of youth users.
