With their one-year anniversary of PMTA quickly approaching, the FDA has dropped a major bombshell on the vaping industry: the rejection of 4.5million PMTA applications. While one thinks this might clear the massive backlog of PMTA applications, there are still millions to go. What does this mean for the vaping industry, and how will it affect the PMTA process?
Does This Clear Up PMTA?
PMTA has been delayed many times, and the COVID-19 pandemic was the latest reason to delay PMTA in 2020. The deadline passed on September 9, 2020, but the sheer volume of applications has forced the FDA, particularly the Center for Tobacco Products (CTP), to sift through the mountains of paperwork filed for these products. The rejection of 4.5 million applications may seem like a huge win for the FDA on paper, but there are still numerous question marks raised around the PMTA process and the countless vape products still under review in the PMTA process.
The silver lining is that these 4.5 million products were all from JD Nova LLC, the owners of Vapolocity. The FDA issued a Refuse to File (RTF) letter due to the company’s applications lacking an environmental assessment (EA). “Under FDA’s regulations implementing the National Environmental Policy Act (NEPA),” the memo reads, “an EA must be prepared for each proposed authorization, and an EA adequate for filing addresses the relevant environmental issues.”
What This Means For Your Business
As of this writing, no vape products have received final approval from the FDA. This places the FDA and specifically the CTP in the position of judge, jury, and executioner regarding the vaping industry. The rejection of 4.5 million products may seem like a large amount of products, but there are still many products left to approve. This may take a long time given the scope of the project and some insiders are guessing that there might beanother extension of PMTA despite the anti-vaping stance of the Biden administration, particularly previous statements from Biden himself and Secretary of Health and Human Services (HHS) Xavier Becerra.
The best thing you can do right now is to take action and stay informed. The FDA has admitted that they would not be able to review all submitted products before the September 9, 2021 deadline, which could push the deadline out even further. An FDA spokesperson said, “The likelihood of FDA reviewing all of the applications received by Sept. 9, 2021 is extremely low.” While this may seem to be a case of uncharted territory, keep in mind that the PMTA deadline has constantly been pushed back previously. The combination of EVALI, COVID-19, the PACT Act, collection of vaping taxes, and the inaccurate conflation with traditional methods of nicotine consumption also places the vaping industry under a new microscope.
That’s all for the State of Vape. If you have any questions, comments, or concerns, feel free to contact your eJuices.co account manager or sales representative. We’re looking forward to speaking with you and helping you navigate the ins and outs of the vaping industry.