Riot Labs receives acceptance letter from U.S. FDA for PMTA
MILTON KEYNES, England, Dec. 11, 2020 /PRNewswire/ -- Riot Labs, are pleased to confirm they are in receipt of the FDA's acceptance letter for the Pre-Market Tobacco Applications (PMTA) for the following products:
- Pink Grenade
- Sub Lime
- Tropical Fury
- Blue Burst
- Cherry Fizzle
- Rich Black Grape
- Ultra peach Tea
All in Freebase 0mg, 3mg & 6mg / Nic Salts 20mg Hybrid & 48mg.
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. 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. Therefore, the PMTA is a rigorous regulatory process, essential for any new tobacco product seeking a marketing order.
Riot Labs journey began their PMTA in 2018. So far the process has taken over 2 years, with 7 applications and over 1.8 million pages of scientific data submitted.
"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."
Riot Labs joined the Washington D.C. based Vapor Technology Association (VTA) at platinum board level in 2020. The VTA represents wholesalers, small business owners, entrepreneurs and manufacturers of quality innovative, vapor products. Johnson added, "as a reputable manufacturing company, we are always looking to ensure we are at the forefront of any US regulatory changes, how the industry develops and to assist the VTA in their efforts to save an industry which can change lives."
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.
Contact:
Global Head of Marketing
Peter Bacon
[email protected]
+44 (0)1908 229 934
SOURCE Riot Labs
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