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FDA PMTA Filing Letter: September 4, 2020

Historical FDA filing correspondence dated September 4, 2020, preserved with all six original document pages.

This historical letter, dated September 4, 2020, records FDA filing review of the Nicopure Labs PMTA applications listed in the document. The letter states that filing permits substantive review and does not mean FDA issued an authorization order.

The six original document images below were published on the former Halo Vape Club site. They are preserved with their original redactions. This dated correspondence does not establish current product status.

View the PMTA history archive or read the other historical letter. See FDA’s explanation of PMTA review stages for the distinction between filing review and a marketing decision.

Original document

FDA PMTA filing letter 2020-09-04, page 1 of 6
Page 1 of 6. Select the image to view the original full-size document.
FDA PMTA filing letter 2020-09-04, page 2 of 6
Page 2 of 6. Select the image to view the original full-size document.
FDA PMTA filing letter 2020-09-04, page 3 of 6
Page 3 of 6. Select the image to view the original full-size document.
FDA PMTA filing letter 2020-09-04, page 4 of 6
Page 4 of 6. Select the image to view the original full-size document.
FDA PMTA filing letter 2020-09-04, page 5 of 6
Page 5 of 6. Select the image to view the original full-size document.
FDA PMTA filing letter 2020-09-04, page 6 of 6
Page 6 of 6. Select the image to view the original full-size document.