Tag: Riot Squad

  • Riot Squad E-liquid PMTAs Move to Substantive Review

    Riot Squad E-liquid PMTAs Move to Substantive Review

    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.

    Credit: Riot Labs

    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.

  • Riot Squad Receives PMTA Acceptance Letter from FDA

    Riot Squad Receives PMTA Acceptance Letter from FDA

    riot squad e-liquid
    Credit: Riot Squad

    The U.S. Food and Drug Administration (FDA) has given an acceptance letter to the UK-based e-liquid manufacturer Riot Squad for its premarket tobacco product application (PMTA), the company confirmed today.

    “We continue to move through the PMTA process and are very happy to get to this stage”, said Ben Johnson Riot Labs CEO. “We remain committed to working with the FDA throughout the process. With our award-winning products and flavors we continue to provide better alternatives to combustible tobacco products and look forward to working in this industry for many more years to come.”

    The company confirmed that it had submitted PMTAs for seven flavors in three freebase nicotine strengths (0mg, 3mg and 6mg) and 2 nicotine salt strengths (20mg Hybrid and 48mg). The flavors submitted include:

    • Pink Grenade
    • Sub Lime
    • Tropical Fury
    • Blue Burst
    • Cherry Fizzle
    • Rich Black Grape
    • Ultra peach Tea

    “Receipt of this acceptance letter is a significant milestone, which confirms that Riot Labs products have now met the statutory and regulatory requirements for a PMTA submission, based on Section 910 of the FD&C Act,” a press release states. “The application is now under preliminary scientific review, before going forward to substantive review by the FDA.”

    The FDA requires applicants to show their products are appropriate for the protection of public health. Riot Labs began building its PMTA data in 2018. The process has taken over 2 years, with 7 applications and over 1.8 million pages of scientific data submitted, according to Johnson.

    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. Riot Squad products are now available in over 86 countries.

  • U.K.-Based Riot Labs Earns PMTA Acceptance for E-liquids

    U.K.-Based Riot Labs Earns PMTA Acceptance for E-liquids

    Credit: Riot Labs

    Riot Labs, a UK-based e-liquid manufacturer has received an acceptance letter from the U.S. Food and Drug Administration (FDA) for its premarket tobacco product application (PMTA). The company is now authorized to sell seven flavors of e-liquids in the United States:

    ● Pink Grenade

    ● Sub Lime

    ● Tropical Fury

    ● Blue Burst

    ● Cherry Fizzle

    ● Rich Black Grape

    ● Ultra peach Tea

    The flavors can be found in 0mg, 3mg and 6mg in freebase nicotine, 20mg and 40mg in nicotine salt. “The PTMA submissions are a key milestone in Riot Labs journey which started back in 2016 to produce viable alternatives to combustible tobacco,” a press release states. “The PMTA submissions conclude a process which has taken over 2 years, with 7 applications and over 1.8 million pages of scientific data submitted as part of the submissions.”

    Riot Labs has one year or until the FDA acts on its application to market the products in the U.S.

    “We are delighted to announce that our first-round of PMTA applications have been accepted”, said CEO for Ben Johnson Riot Labs. “We pride ourselves on producing the highest quality products. We have been working on our submissions since 2018. Everyone at Riot Labs is fully committed to offering better alternatives to combustible tobacco products.”

    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 safety and sustainability at the forefront of the company’s values, according to the release. By 2019 Riot Squad had moved into the international market, and it’s products were available in over 86 countries.