IRVINE, Calif., Aug. 17, 2020 (GLOBE NEWSWIRE) -- via NetworkWire -- 511 Solutions, LLC, owner of the PRISM e-liquid line and master distributor, announced today that it has filed its first of many U.S. Food and Drug Administration (FDA) Premarket Tobacco Applications (PMTA) for its nicotine-based e-liquid products. Within a few weeks of the submission, the application was accepted and has now moved to the substantive scientific review phase. In compliance with FDA guidelines, PRISM e-liquids will be allowed to remain on the market during the FDA review process while waiting for a much-anticipated marketing order from the FDA.
The PRISM brand represents three unique, high-quality e-liquid lines with a total of 19 flavors going through the PMTA process. The flavor profiles range from tobacco, menthol, fruits and bakery in a variety of nicotine strengths. All PRISM e-liquids are manufactured by Blackbriar Regulatory Services (BRS) in an ISO class 6 cleanroom, tested in an ISO 17025 laboratory and have published testing results available for every bottle.
“When 511 Solutions created this e-liquid line, their goal was to create something really special and to do it right the first time,” said Don Hashagen, exclusive sales agent for PRISM e-liquids. “They invested an enormous amount of resources into creating high-quality nicotine products for adult smokers looking for alternatives. And, partnering with BRS was a natural choice. Having the ability to streamline the manufacturing, distribution and regulatory needs all under one roof has been a huge win for 511.”
All nicotine-based vaping products must follow the FDA’s regulatory pathway and file a PMTA by September 9, 2020 to remain on the market. A PMTA must include significant scientific data that demonstrates a product is appropriate for the protection of public health.
About PRISM E-liquid Brands
Prism e-liquids are created using only the highest quality ingredients while providing adult smokers with an alternative to deadly combustible cigarettes. The three flavor lines, Luma, Ombra and Chroma comprise of 19 flavors ranging from tobacco, menthol, fruit and bakery in varying nicotine strengths. Learn more at www.prismeliquids.com.
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Don Hashagen
Don@prismeliquids.com
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