The Federal Response to the Epidemic of E-Cigarette Use, Especially Among Children, and the Food and Drug Administration’s Compliance Policy

Date: 
Wednesday, December 4, 2019 - 2:00pm
Location: 
2154 Rayburn House Office Building, Washington, DC 20515
The Federal Response to the Epidemic of E-Cigarette Use, Especially Among Children, and the Food and Drug Administration’s Compliance Policy

CHAIRMAN KRISHNAMOORTHI'S OPENING STATEMENT

PURPOSE

The hearing will examine the federal response to the epidemic of e-cigarette use, especially among children, and the FDA compliance policy entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Tobacco Products on the Market Without Premarket Tobacco Authorization.”

BACKGROUND

  • On September 11, 2019, President Trump announced that the FDA would soon issue a compliance policy clearing the market of all e-cigarette flavors, including mint and menthol.  The President announced this at a press conference jointly with Health and Human Services (HHS) Secretary Alex Azar and then-Acting FDA Commissioner Ned Sharpless. 
  • During the September 11 announcement, the President stated that the policy would be issued within the next two weeks.  Two and a half months later, the compliance policy has not been issued.  Given the pace of the accelerating youth e-cigarette use epidemic, during those extra months, untold numbers of new users have picked up their first flavored e-cigarettes and begun vaping. 
  • The Administration also specifically and repeatedly stated that the FDA’s forthcoming compliance policy would cover all “non-tobacco-flavored e-cigarettes, including mint and menthol,” and that “all flavored e-cigarettes, other than tobacco flavor, would have to be removed from the market.” 
  • On October 21, the Subcommittee sent a letter to the FDA urging it to finalize the flavor ban.  Shortly thereafter, on October 25, the FDA sent its compliance policy to the Office of Information and Regulatory Affairs (OIRA) for review, despite not being required to do so. 
  • OIRA scheduled many meetings with industry, but abruptly canceled them after the Subcommittee sent a public letter to OIRA bringing the industry meetings to light and asking OIRA to complete its review by November 8.  Weeks have passed since OIRA’s review was completed and President Trump has held meetings on the substance of the rule.  The FDA and OIRA will not verify where the flavor policy stands.
  • Reports indicate that President Trump may have considered abandoning the flavor ban over fears of upsetting voters. If nothing else, that has contributed to the delay in finalizing the ban. 

WITNESS

Mitch Zeller
Director, Center for Tobacco Products
Food and Drug Administration

DOCUMENTS

Issues: 
116th Congress