ENDS Analytics, LLC

The has still been issuing . If you would like assistance with the administrative appeals process and to file individually in your Federal District within the 30 day time frame please reach out to me. We need to keep the momentum going to set case precedence. There have already been stays issued and more to come we have helped 17 manufacturers and we are awaiting the outcomes.

As an industry we need to pull together to keep fighting.

This is a group effort in collaboration with United States Va**ng Association- USVA and ourselves with the help of The USVA legal counsel.

If you would like more information please email me [email protected] or [email protected] or comment below.

I know their is a lot of worry, speculation about the FDA, and their blantent disregard for public health by their actions starting 2 weeks before the September 2021 one year period. By the FDA simply issuing MDOs to manufacturers passes the burden back to us the industry.

In September I will be working on new information that we can submit as amendments to your PMTA to address the issues they have stated, additionally these areas where specifically listed in the guidance. We just need to provide more scientific raw analysis of recent published data by a 3rd party with experience in this area. I have someone I'm working with to do just that.

As an industry we need to pull together and get the additional data and analysis. We will need to work together to fund this. We will also being doing market and product specific surveys in the areas necessary.

We will be getting pricing together very soon . This is a group effort in collaboration with United States Va**ng Association- USVA and NN Analytics

If you would like to participate please email me [email protected] or [email protected].

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 Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health FDA issued marketing denial orders for flavored e-cigarettes after determining applications lacked sufficient evidence.

If you would like to see the presentation from last night on the testing approach and slides please message Amber Cooper or comment below so I can send you an NDA from docusign and then a link for the video and slides for you to watch.

Thanks so much for your support!