Court Orders FDA To Give Status of the PMTA Process, And Why This is Good for the Vape Industry
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On April 15, 2022, a federal court ordered the Food and Drug Administration (FDA) to create quarterly reports that will detail where the biggest vaping companies are in the PMTA process. The reports should “forecast the percentages of such products for which it expects to have taken ‘action’ by June 2022 and quarterly thereafter.”
The motion, which was filed by the American Academy of Pediatrics (AAP) and other plaintiffs, groups who rally against vaping, could have ramifications that could benefit all parties, mainly small vape companies which stand to benefit from more time to continue selling their products.
Table of Contents:
- American Academy of Pediatrics vs. FDA
- What The Motion Requires Of The FDA
- Why This Could Be Beneficial To The Vaping Industry
American Academy of Pediatrics vs. FDA
In 2018 the American Academy of Pediatrics (AAP) and other plaintiffs, including AAP’s Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative, sued the FDA when they changed the due date for PMTAs from 2018 to 2022, which they reasoned did not follow the usual notice-and-comment rulemaking process.
Because of this, Judge Paul W. Grimm ruled in favor of the plaintiffs, striking down the 2021-2022 PMTA deadline and shortening it to May 11, 2020. Although the judge ruled in favor of the plaintiffs, the date was delayed further because of Coronavirus and was ultimately set for September 9, 2021.
In November of 2021, the plaintiffs filed a motion to Judge Grimm to modify his original order and to require the FDA to require progress reports and status reports of the largest players and those that made up the largest market shares to see how far along they were in the PMTA process.
On April 15, 2022, Judge Grimm granted the motion filed by the plaintiffs in November, and now the court will force the FDA to provide these progress reports.
What The Motion Requires Of The FDA
The order dictates that the FDA must give status reports of the largest industry players that have filed PMTAs, including “...brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar.” It also states that any other product that represents two percent or more market share (as measured by Nielsen market reports) will also require reports. The FDA must file the first report on April 29, 2022, and then every 90 days after that.
Why This Could Be Beneficial To The Vaping Industry
This could potentially spell good news for the vaping industry for two reasons. First, for smaller vaping companies and manufacturers, which will now (most likely) be evaluated last, this means more time to sell their products. And second, it means that the PMTA process will now be dissected in a public forum making it more transparent and perhaps, we hope, fairer.
