Judge makes it official: Vape retailers have 10-months to submit PMTAs…or else
Vape retailers have ten short months to submit Pre-Market Tobacco Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) or be forced to take their products off stores shelves entirely. The Friday ruling by U.S. district court Judge Paul W. Grimm is the latest milestone in the court case saga originally filed by the American Academy of Pediatrics (AAP) and other anti-vaping groups.
The plaintiffs filed the lawsuit against the FDA and its former chief Dr. Scott Gottlieb, claiming that the agency had exceeded its authority by delaying the PMTA deadline to August 2021. According to the official ruling statement, Judge Grimm is imposing “a ten-month deadline for submissions and a one-year deadline for approval.”
What does this mean for the average vaper?
For vape retailers, this means that a PMTA must be submitted for each product at a minimum average cost of about $300,000 each. The price is so high because these PMTA submissions often must be accompanied by scientific documentation which proves that the product can significantly benefit public health.
For vapers, the Grimm ruling (pun intended) essentially means that perhaps thousands of their favorite e-liquids and discount vape pens may evaporate from the market by May of next year, especially if the products are manufactured by small business owners and Mom and Pop shops.
Co-defendant Scott Gottlieb took to twitter to express his support for the judge’s ruling, even though his failures while in office as FDA Commissioner led to the controversy in the first place. And of course, Gottlieb blamed everything on teen vaping.
“FDA’s submission to court, largely accepted today, is consistent with my view that a spike in youth use necessitated earlier application deadlines and restrictions on flavors. By marketing to kids, e-cig makers squandered the opportunity we sought in 2017.”
Reading the fine print of the court ruling
The 10-months deadline is – for now – somewhat of a compromise. When the verdict came down last month that the AAP had won the original lawsuit, the debate over the new deadline began immediately thereafter. The AAP wanted 4-months. The FDA wanted at least ten. So, things could have been much worse.
Reading the fine print of the court ruling, here are the key highlights.
- The new PMTA submissions deadline is May 12, 2020.
- Products with submitted e-cig applications can remain on store shelves no longer than one year after the date of submission or until the FDA grants an approval or denial of the PMTA.
- Vendor products that do not have a submitted application by May 12, 2020 are at risk of being confiscated by FDA officials ( per the discretion of the FDA).
- The FDA can “exempt” certain products from the PMTA process “for good cause on a case-by-case basis.”
The FDA also has the right to appeal the July 12 ruling and included deadlines. However, vaping advocacy groups seem to be split about 50/50 as to whether the newly appointed Acting FDA Commissioner Ned Sharpless will appeal or not.
When asked for a statement about the new ruling, Sharpless said, “Today’s ruling is an important step forward for public health and validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth.” With public and political pressure mounting against vapor companies in the name of a so-called “teen vaping epidemic,” the vapor community might want to take notice and stock up on their favorite vaping supplies before it’s too late. This is not a drill.
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