Filter (NY) reports newly released FDA memos “give an indication, from the agency itself, of something else the vaping community has long inferred: that the FDA – despite some protestations to the contrary – has taken a systemically different approach to PMTA applications for the flavored products on which so many former smokers depend.” According to Filter, the memos show “explicitly how the agency handled the heavy volume of applications for flavored vaping products.” A July 9 memorandum from the Director of CTP’s Office and Science indicated a “Fatal Flaw review” would be used to determine if PMTAs not in Phase III lacked any requisite studies. However, a “former CTP employee said that they had never heard of the ‘Fatal Flaw’ standard until now.”

From the news release of the American Association for Justice.