Premarket Tobacco Product Applications (PMTA) are part of the process to make vape products legal for sale. America’s Food and Drug Administration (FDA) has denied PMTAs for 4.5 million vape products. The kicker? Every single product is from one single company - JD Nova Group LLC.
JD Nova Group LLC hold the trademarks for Vapolocity electronic cigarettes, De-Ja e-liquid, Ideal Elixirs e-liquid, Stronghold Vapery (assorted vape goods and services), and Wicked Coils.
The company has been issued with a Refuse to File (RTF) letter by the FDA notifying the owners that its PMTA’s failed to meet the requirements for new tobacco products seeking a marketing order. The positive news is that other PMTAs submitted by the company have not been included and are still moving through the review process.
The FDA said: “As a result of this RTF action, the company must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.”
The agency is very pleased with itself, saying this the action it has taken is “a significant step”. By the Sept. 9, 2020 deadline, the FDA received applications for over 6.5 million products from over 500 companies – meaning that it has denied almost 70% of them in one hit.
It continues: “The Agency is committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA.
“During the filing stages of application review, FDA reviews for basic information to ensure applications contain the required material for scientific review. If required contents for filing are missing, FDA refuses to file the application.”
The FDA explained that the company was issued with the RTF letter because the product applications lacked an adequate Environmental Assessment. Under FDA’s regulations implementing the National Environmental Policy Act, an assessment must be prepared for each proposed authorisation – all 4.5 million of them.
“As a result of this RTF action, effective immediately, JD Nova may not introduce or deliver for introduction these products into the interstate commerce in the United States. Retailers also may not introduce or deliver for introduction these products into interstate commerce in the United States. Retailers should contact JD Nova with any questions about products in their inventory,” the FDA warned.
The volume of paperwork entailed in this application process exemplifies the complaints made to the FDA as vape companies called it costly, arduous, and time consuming. Some wondered if the point was to ban by stealth, saying the PMTA process skewed the market in favour of a handful of large powerful companies and their deep pockets.
Many will now be waiting to hear about the results of their applications as the American vape market continues through this period of turmoil and uncertainty.