Is vaping doomed? New PMTA deadline may be just 4-months away
It’s been an eventful week for the American vaping industry as the U.S. Food and Drug Administration (FDA) finally released its much-anticipated guidelines for the Pre-Market Tobacco Application (PMTA). A crucial component of the 2016 FDA deeming regulations, the new regulations directly affect an estimated 99% of e-cigs and e-liquids currently on the market.
As the shock wave spreads across the vaping community after the FDA’s Tuesday announcement, vapor manufacturers were still missing one critical fact. When, precisely, do these applications need to be submitted?
Related Article: FDA deeming regulations update: PMTA approval process finalized
The PMTA deadline has been a moving target from almost the very beginning. In 2017, the original cut-off date of August 2018 was eventually moved forward by almost five years to August 2022. This past March, it was moved back to 2021, perhaps due to the filing of lawsuits by American Pediatric Association (APA), the Campaign for Tobacco-Free kids, and other anti-vaping groups.
Then on May 15, 2019, Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ruled in the APA case that the FDA had acted illegally by delaying the PMTA deadline in the first place (Case No.: PWG-18-883). In fact, Judge Grimm says the agency’s delay is “so extreme as to amount to an abdication if its statutory responsibilities” while also demanding that the PMTA review process begin within 30-days.
Does the FDA’s PMTA process favor Big Tobacco over vaping?
Meanwhile, the judge also allowed the APA to submit a proposed remedial order outlining how the organization would prefer the FDA to proceed. The APA recommended that the entire PMTA process be up and running within 120-days or just four months from the May 15 ruling. Mitch Zeller, Director of the Center for Tobacco Products, a subsidiary agency of the FDA and overseer of all things related to the FDA deeming regulations, shot back immediately with a revised deadline of his own.
Zeller states that the 120-day deadline would “cause significant public health concerns as well as implementation challenges…It could suddenly clear the market of thousands of e-cigarette products, raising the risk that some former smokers addicted to nicotine might migrate back to conventional cigarettes, and is likely to flood the Agency with thousands of low-quality applications that would strain Agency resources and significantly delay processing… if the Court orders a deadline for the submission of premarket applications, it should set that deadline no sooner than 10 months.”
The FDA response went on to claim that of the 401 PMTAs already received as of April 2019, “more than 99% (369/373) were closed as insufficient to accept or file, largely for failure to include an environmental assessment.” Only four applications were approved, and these were not for vaping products but for heat-not-burn technologies manufactured by Big Tobacco.
The FDA had previously announced that companies will be allowed to continue selling their products for one year after the submission of their application to give the agency enough review time to approve or deny the applications. This guideline may also change depending on the final opinions of Judge Grimms.
However, the expedited PMTA deadline is likely to be bad news for possibly thousands of smaller “Mom and Pop” retail shops selling e-liquids and other vape products. Along with the completion of an official PMTA form, which itself is highly detailed and complex, the manufacturer must also provide additional information, such as:
- A detailed description and perhaps photographic imagery of the product packaging
- The voltage, amperage, wattage, and battery chemistry
- Battery testing certifications
- Voltage protection methods and technologies for the prevention of overheating or “explosions”
- “Chemical testing, applying existing scientific literature or analyses about similar products to the proposed new tobacco product, including multiple distinct products in a single submission and referencing tobacco product master files.”
- E-liquids ingredients, if applicable
- Proof that the products is an effective tool for tobacco harm reduction
- And more
The FDA estimates that the cost of a single application would fall somewhere between $100,000 to $400,000, but most experts in the vaping industry expect the final price tag to be significantly higher. And again, many of those Mom and Pop vape shops will have a very difficult time coming up with that amount of cash… per product.
Whether the PMTA process begins in four months or ten, the earth is now shaking under the collective feet of the American vaping community. The time to stock up is now.