US FDA Rejects 4.5 Million PMTA Applications From The Same Vape Brand

A recent press release by the FDA, stated that the vape brand JD Nova LLC, which owns Vapolocity was issued with a Refuse to File (RTF) letter. “Under FDA’s regulations implementing the National Environmental Policy Act (NEPA) an EA must be prepared for each proposed authorization, and an EA adequate for filing addresses the relevant environmental issues,” stated the letter.

The Family Smoking Prevention & Tobacco Control Act requires that all tobacco products must receive a PMTA before they can be sold across the United States. Initially set for May 12th 2020, the PMTA deadline was moved back and forth several times, until on April 3rd 2020, Judge Paul Grimm of the United States District Court for the District of Maryland finally moved the deadline to September 9th, 2020.

The PMTA process is unaffordable for smaller vape businesses

The PMTA regulatory process has been criticized for being designed for product manufacturers who can afford the time and financial costs that come with it, leaving the smaller business in ruins. This equates to approximately 14,000 small and medium-sized vape businesses across the United States being placed in a precarious situation, as brands have to submit PMTAs for every one of their products, including each different e-liquid flavour and component separately.

A recent article on Filter highlighted that this first action related to the PMTA licencing for JD Nova LLC is concerning. “While the agency did appear to just eliminate 75 percent of the total PMTAs, they are all from one relatively small company that apparently did not fulfill the requirements of the process, or could not afford to do so. The FDA has another 2 million to go, and many of them are from major, well-financed companies with the means to submit robust, scientifically thorough applications.”

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