Wednesday, July 24, 2024

Attorneys General Ask FDA To Decline Vaping PMTAs


A coalition of 31 US state attorneys general is urging the Food and Drug Administration to deny several PMTA applications for flavored vaping products.

WASHINGTON — Attorneys General from 31 states have signed a joint letter asking Janet Woodcock, the acting commissioner of the federal Food and Drug Administration (FDA), to deny scores of premarket tobacco product applications for electronic cigarettes and vaping products in a bid to protect youth and young adults through “swift, effective measures.”

“As the FDA reviews pending Premarket Tobacco Product Applications, the undersigned
Attorneys General urge it to deny applications that will exacerbate America’s youth nicotine epidemic and jeopardize our children’s health,” notes the end of the letter, dated August 18, 2021. “In addition to addressing the explosion of high-nicotine, flavored e-cigarette products popular among youth, the FDA should be proactive—not reactive—in its approach to newer nicotine products, such as pouches, gums, and lozenges, to ensure they do not add to that epidemic. Now is the time to take decisive action to rein in all youth-appealing products before irreversible damage is done to the public health.”

Industry regulatory analysts for report that the call comes “at a key time in the FDA’s PMTA process, with 1.5m applications still awaiting approval after the mass rejection of 4.5m submissions from a single manufacturer.”

The analysts further note that “the number of applications already thrown in the metaphorical dumpster is huge, but so is the number of outstanding applications, and the question remains how the FDA can possibly deal with all of them.”

FDA has until September 9 to make decisions on all remain PMTA applications.

Here is a list of the Attorneys General who signed the August 18 letter:

  • Idaho Attorney General Lawrence Wasden
  • Illinois Attorney General Kwame Raoul
  • Nebraska Attorney General Douglas Peterson
  • New York Attorney General Letitia James
  • North Carolina Attorney General Josh Stein
  • Tennessee Attorney General Herbert H. Slatery III
  • Alaska Attorney General Treg R. Taylor
  • Arkansas Attorney General Leslie Rutledge
  • California Attorney General Rob Bonta
  • Colorado Attorney General Phil Weiser
  • Connecticut Attorney General William Tong
  • Delaware Attorney General Kathleen Jennings
  • Washington D.C. Attorney General Karl A. Racine
  • Guam Attorney General Leevin Taitano Camacho
  • Maine Attorney General Aaron M. Frey
  • Maryland Attorney General Brian Frosh
  • Massachusetts Attorney General Maura Healey
  • Michigan Attorney General Dana Nessel
  • Minnesota Attorney General Keith Ellison
  • Nevada Attorney General Aaron D. Ford
  • New Hampshire Attorney General John M. Formella
  • Acting New Jersey Attorney General Andrew Bruck
  • New Mexico Attorney General Hector Balderas
  • Oregon Attorney General Ellen F. Rosenblum
  • Pennsylvania Attorney General Josh Shapiro
  • Puerto Rico Attorney General Domingo Emanuelli-Hernández
  • Rhode Island Attorney General Peter F. Neronha
  • Utah Attorney General Sean D. Reyes
  • Vermont Attorney General T.J. Donovan
  • Washington (State) Attorney General Robert W. Ferguson
  • Wisconsin Deputy Attorney General Eric J. Wilson

Read the entire letter to the FDA here.

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