FDA FDA Deemed New Tobacco Product Applications Lists

[zoiDman]

From kristin's Head's Up Thread...

Deemed New Tobacco Product Applications Lists

Deemed New tobacco Products with Timely Applications

• Lists of products for which continued marketing until September 9, 2021 may fall outside of FDA’s stated enforcement priorities
  • Products with applications received through the SE and EX REQ pathways (Last updated: 04/05/21)
    
    
  • Products with applications received through the PMTA pathway (Last updated: 04/05/21)
    
    • Note: Due to the large file sizes, the files may take several minutes to download.
      • ENDS Products 1 (Company names starting with 00-IM)
        
        
      • ENDS Products 2 (Company names starting with IM-JD)
        
        
      • ENDS Products 3 (Company names starting with JD-JD)
        
        
      • ENDS Products 4 (Company names starting with JD-JD)
        
        
      • ENDS Products 5 (Company names starting with JD-JD)
        
        
      • ENDS Products 6 (Company names starting with JD-JD)
        
        
      • ENDS Products 7 (Company names starting with JD-JD)
        
        
      • ENDS Products 8 (Company names starting with JD-JD)
        
        
      • ENDS Products 9 (Company names starting with JD-JD)
        
        
      • ENDS Products 10 (Company names starting with JD-JD)
        
        
      • ENDS Products 11 (Company names starting with JD-JD)
        
        
      • ENDS Products 12 (Company names starting with JD-JV)
        
        
      • ENDS Products 13 (Company names starting with JV-OP)
        
        
      • ENDS Products 14 (Company names starting with OP-VI)
        
        
      • ENDS Products 15 (Company names starting with VI-ZE)
        
        
      • Cigar, Pipe and Other Tobacco Products
        

Important Notes:

• The lists contain deemed new tobacco products that are the subject of pending applications submitted to FDA by September 9, 2020. Products with pending applications that are included on the lists also may have been the subject of a warning letter regarding alleged violations of the Act. Check the warning letters webpage to determine if a product has been the subject of a warning letter.
• For the SE and EX REQ list, products that received a negative or positive action before February 1, 2021 are not included on the list.
• For the PMTA list, products that received a negative or positive action before April 5, 2021 are not included on the list. Due to the large file size, the information is broken out into 16 separate files, sorted by product type and then alphabetically by company name and then product name.
• These files will be updated regularly to reflect actions taken on the applications for the products

 

[zoiDman]

BTW - Here is the List of Approved PMTA's that the FDA has issued to date.

Premarket Tobacco Product Marketing Orders

 

[WorksForMe]

Good luck finding things on all those lists. The question in my mind is, if it took them since last September to publish these lists, what are the odds that they'll actually make a decision on any of them before this coming September?

.

 

[zoiDman]

I opened the 1st csv file. There were Only 430,001 entries in it. LOL.

The last entry was for Imperial Vapors LLC. So I did a Search for Heartland Vapes and saw that they had a Boat Load of Line Items.

I Don't think there is Any Big Mystery. The September Cut-Off Date will come before about 99.99% of these PMTA Submissions are Pre-Reviewed.

So those Non-Reviewed submissions will be SOL. While the FDA spends what meager manpower it has to Evaluate BT's and maybe few BV PMTA's. And those will receive Extensions.

 

[zoiDman]

I opened the 1st csv file. There were Only 430,001 entries in it. LOL.

...

BTW - Don't Try to Print the 1st csv file unless you have 35,897 Pieces of Paper laying around. Or roughly 72 Reams of 8 1/2 x 11 Paper.

 

[thanswr1]

Strictly my opinion, but the length of these lists point to the appalling ignorance of the FDA and politicians of the sheer number of different products that are out there.

All was well and good when they could simply conflate vaping with smoking.

The reality is not so good for them.