On August 9, the Food and Drug Administration (FDA) ordered that 4.5 million vaping products from a single company be removed from the market.
The FDA’s press release, available online, states that it issued the company—JD Nova LLC, which owns Vapolocity—a Refuse to File (RTF) letter because “the company’s applications for these products lacked an adequate Environmental Assessment.”
“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.”
Vaping manufacturers had until September 9, 2020 to submit a costly and arduous “premarket tobacco product application” (PMTA) for every one of their products, including each different e-liquid flavor and component separately, in order for them to remain legal. (The RTF did not apply to every application that JD Nova submitted.)
Alex Norcia – Filter – 2021-08-09.
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