08/27/2021
I know a lot of people are getting discouraged about the news the FDA keeps putting out. But you have to realize they have to look like they are doing their job and by posting these news releases that shows they are. If you actually read why these were declined it makes sense. As long as your PMTA specifically addresses everything that was listed in the guidance and CFR don't throw in the preverbial towel. They can still submit an amendment or additonal information to cure this deficiency.
Scare tactics is all this is.
READ TO THE END
"The FDA’s review of new to***co products before they can be legally marketed ensures that they meet the standard Congress set in the law to protect the public health. In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable. >>>>>>>Because this evidence was absent in these applications, the FDA is issuing MDOs."
FDA issued marketing denial orders for flavored e-cigarettes after determining applications lacked sufficient evidence.
