BRIEF-FDA Says More Work To Be Done To Complete Remaining Reviews Of Some Flavored ENDS Products

U.S. FDA: * FDA MAKES SIGNIFICANT PROGRESS IN SCIENCE-BASED PUBLIC HEALTH APPLICATION REVIEW, TAKING ACTION ON OVER 90% OF MORE THAN 6.5 MILLION 'DEEMED' NEW TOBACCO PRODUCTS SUBMITTED

* FDA - THERE'S MORE WORK TO BE DONE TO COMPLETE REMAINING REVIEWS OF FLAVORED ENDS PRODUCTS * FDA - AS OF TODAY, AGENCY HAS TAKEN ACTION ON APPLICATIONS FOR OVER 6 MILLION ENDS PRODUCTS

* FDA SAYS CONTINUE TO WORK EXPEDITIOUSLY ON REMAINING APPLICATIONS THAT WERE SUBMITTED BY SEPT. 9, 2020, DEADLINE, MANY OF WHICH ARE IN FINAL STAGES OF REVIEW * FDA - ALL NEW TOBACCO PRODUCTS ON MARKET WITHOUT STATUTORILY REQUIRED PREMARKET AUTHORIZATION ARE MARKETED UNLAWFULLY AND SUBJECT TO ENFORCEMENT ACTION AT FDA'S DISCRETION

* FDA SAYS IN MEANTIME, PRODUCTS FOR WHICH NO APPLICATION IS PENDING ARE AMONG HIGHEST ENFORCEMENT PRIORITIES * FDA - SINCE JAN 2021, HAVE ISSUED TOTAL OF 170 WARNING LETTERS TO FIRMS THAT COLLECTIVELY HAVE LISTED MORE THAN 17 MILLION ENDS WITH FDA

* FDA - CONTINUED REVIEW ALSO INCLUDES SMALLER NUMBER OF PENDING APPLICATIONS BEING REVIEWED UNDER "SUBSTANTIAL EQUIVALENCE" STANDARD, FOR CIGARS, PIPES, HOOKAH TOBACCO Source text for Eikon: