E-liquid manufacturer Riot Squad announced it’s premarket tobacco product applications (PMTA) have moved on to the substantive review phase of the regulatory process. The U.S. Food and Drug Administration has until Sept. 9 to make a decision on the more than 2 million remaining PMTAs from the nearly 7 million submitted.
Ben Johnson, Riot Squad’s CEO, said the company has always been positioned as a disruptor in the sector. “We had a laser-like focus on creating the most premium e-liquids on the market and coupled it with a brand with attitude,” he said. “The goal has always been to help people quit smoking. Continuous innovation – like our most recent PMTA going into the substantive review phase – and adopting a leadership role within the sector, is what will allow us to achieve that goal.”
The UK-based company sells to 86 countries around the world, according to a press release. The substantive review phase the final stage before the FDA grants or denies a marketing order. In order to receive a marketing order, Riot Squad must provide sufficient data to ensure its products are appropriate for the protection of public health.
The FDA has so far issued an estimated 34 marketing denial orders (MDO) for an estimated 360,000 products. The agency refused to file more than 4.5 million applications from the JD Nova Group.
Riot Labs was established in 2016 by Johnson who has an extensive background in pharmaceuticals. He set out to build Riot Squad into an innovative brand, with the aim of “encouraging consumers to find the confidence to give up smoking and engage in a healthier alternative.”
Update: On Sept. 8, 2021 Riot Squad received a marketing denial order (MDO) from the FDA for its flavored (other than tobacco) e-liquid PMTAs.