In stunning twist, Appeals Court denies FDA’s request for PMTA extension
In the seemingly never-ending saga of what is the FDA approval process for vaping products, the U.S. Court of Appeals for the Fourth Circuit has just thrown a new twist into the debate. After the FDA petitioned the courts several weeks ago to push the September 9 deadline forward by 120-days due to the COVID-19 pandemic, the public health agency won an initial victory last month.
On April 3, the U.S. District Court for the District of Maryland ruled in favor of the FDA’s request, but the decision was contingent upon the approval of the Appellate Court. Yesterday, the three-judge panel dismissed the appeal entirely, which means that the September 9 date still stands.
The PMTA – Pre-Market Tobacco Application – is a relatively new requirement that stems from the FDA deeming regulations released in May 2016. While its deadline has changed almost a dozen times in the years since, an FDA-approved PMTA is required for every vaping product whose manufacturers wish to keep selling that product on the market. A PMTA is required for nearly every kind of vapor product, including e-liquids, mods, tanks, and coils.
Without a PMTA submitted by the manufacturers for FDA review by the September 9 deadline, all related products must be pulled from store shelves and e-commerce sites by that date. PMTA submission – not necessarily approval – is all that is required at this time.
Essentially, the Federal Appeals Court said that if the FDA wants to change the PMTA deadline yet again, it has three possible pathways to do so.
- The FDA could revise its August 2020 guidance policies, which is now highly improbable due to a lengthy court battle which the FDA has already lost. (In the case American Academy of Pediatrics v. FDA, the plaintiffs demanded that the FDA pick a finalized PMTA deadline, stick with it, and quit stalling. The plaintiffs won.)
- The FDA could petition the courts within 45 days for a rehearing in front of the three-judge panel, which might be a plausible option.
- Or the FDA could take their issues to the U.S. Supreme Court.
Of course, the FDA could also choose to challenge in a court of law the newly revised FDA 2020 guidance policies which resulted from the American Academy of Pediatrics v. FDA ruling. But in the official appellate ruling, the judges seem to indicate that the FDA would not likely be successful taking that route.
“On January 20, 2020, while these appeals were pending, the FDA finalized its new Guidance after receiving over 15m,000 comments during the comment period (the ‘2020 Guidance’). The 2020 Guidance replaced the August 17 Guidance and set the PMTA compliance deadline as May 12, 2020.”
In other words, the court is saying, “Okay. You just issued this latest “guidance” in January, and you’ve already wanted to change the PMTA deadline at least twice in the four months since? Good luck with that.”
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