PMTA Pains and Gains

Posted 15th December 2020 by Dave Cross
The U.S. Food and Drug Administration (FDA) is struggling to process premarket tobacco product applications (PMTA). More than two months after the deadline, The FDA’s Center for Tobacco Products still hasn’t managed to deal with them all. Milton Keynes-based Riot Labs is one of the fortunate companies to have received an acceptance letter.

PMTAs had to be submitted by 9 September 2020 and the FDA says it received “thousands”. Lack of foresight or plain ineptitude has led to a situation where there is no definitive list of approved products and retailers do not know what products they can keep on the shelves.

Mitch Zeller, the Center’s Director, is still attempting, “to sort through thousands of applications which came in all different forms, including CDs, DVDs, hard drives and some hard copies”.

Zeller added it is an, “extremely labour-intensive manual exercise of unpacking every single application, but we have lots of people working on this, and we absolutely intend to provide such list.”

He added: “One of our goals is to transform the marketplace for these unauthorised products into a regulated marketplace. And the principle that we came up with is to devote a certain percentage of the reviewing resources to those products that have, or are having, the greatest impact on public health, either positive or negative, simply by virtue of share of market.”

British eliquid manufacturer Riot Labs celebrated receiving its approval and commented: “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.”

Smoorecig

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 flavours 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.

Related:

  • Riot Labs – [link]

Image provided by Riot Squad

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 Dave Cross
Article by Dave Cross
Freelance writer, physicist, karateka, dog walker
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