Deeming Regulations Litigation Update – FDA Files Second Status Report on Pending Vapor Products PMTAs - JD Supra

FDA reports that the progress of its review of popular vapor products’ pending PMTAs remains in line with its first report.

On July 28, 2022, FDA filed a status report in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), addressing its review of pending premarket tobacco applications (“PMTAs”) for certain popular vapor products.  FDA filed the status report pursuant to a court order previously covered on this blog.  This is FDA’s second status report filed pursuant to that order, the first having been filed on May 13.

As previously reported by this blog, the May 13 status report estimated that FDA would resolve 240 pending PMTAs – for JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin, and Puff Bar vapor products and other vapor products reaching certain retail sales benchmarks – by June 30, 2023.  FDA estimated that it would resolve more than half of those 240 PMTAs in 2022: 51% (or approximately 122) by June 30; 52% (or approximately 125) by September 30; and 56% (or approximately 134) by December 31.  The remainder would be resolved in the second quarter of 2023.

On July 28, FDA reported that it “met its prior estimate of taking action on 51% of [those 240 PMTAs] by June 30, 2022,” and “[t]he other estimates in the FDA’s May 13, 2022 status report remain the agency’s best forecast based on current information.”  FDA added that it “remains committed to completing review of the applications it has received as soon as feasible to protect and promote the public health,” having expressed the same commitment in its May 13 status report.

The court thanked FDA for its status report.  The next one is due on or before October 26.

It appears that FDA has not published decisions on any more PMTAs between June 30 and the date of this blogpost.*  As such, FDA’s estimates suggest it should resolve three of the above-referenced PMTAs between the date of this blogpost and September 30 and nine more before the year’s end.  The remaining 106 are expected to be resolved in the months of April through June 2023.

We will monitor for further developments.

* As of the date of this blogpost, FDA’s website does not show any marketing granted orders or marketing denial orders issued after June 30; however, its marketing granted order list is current as of June 10.

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Deeming Regulations Litigation Update – FDA Files Second Status Report on Pending Vapor Products PMTAs - JD Supra
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