Fresh Farms E-liquid Confirms PMTA Submission to FDA
Fresh Farms E-Liquid has confirmed it submitted a premarket tobacco product application (PMTA) on Sept. 6 to the U.S. Food and Drug Administartion (FDA)
Working with key scientific partners to ensure the highest standards of analysis as well as the world-class legal team at Keller and Heckman, Fresh Farms fully expects its submission to be accepted and move on to the substantive scientific review phase with the FDA, a press release states.
“The Fresh Farms submission encompasses dozens of products as it seeks FDA approval to continue offering its extensive portfolio, which company leaders believe is perfectly suited to the needs of adults looking for alternatives to traditional, combustible tobacco products,” the release states. During the PMTA review, the FDA will evaluate whether there is sufficient scientific data demonstrating a net-positive public health result by allowing the product submissions to be sold as alternative options to traditional tobacco products.
“From day one, we have sought to be the best,” said Fresh Farms CEO and co-Founder Tony Devincentis. “From our branding, our messaging, our team and the quality of our products – our commitment to the PMTA process has been no exception. We have spent years and countless hours evaluating our products, preparing for this moment, and the preliminary results have been phenomenal. Ultimately, our goal is to receive a marketing granted order from the FDA and begin postmarket reporting to them immediately. We plan on being a leader in our industry for years to come.”
In addition to rigorous adherence to FDA regulations and filing PMTAs, Southern California-basedFresh Farms E-Liquid has proactively led the way for safer packaging with additional warning labels, launching a “No2Minors” campaign to build additional awareness and reduce underage sales to minors. Avail Vapor partnered with Fresh Farms E-liquids, the parent company of Fruitia, in July.
“We could not be more pleased that Fresh Farms submitted PMTAs for their highly sought-after e-liquid products,” said James Xu, chairman of AVAIL. “Our customers truly love the Fruitia brand, and we look forward to continuing our shared missions by providing adult smokers with high-quality alternatives to deadly cigarettes.”
As of September 9, only those products submitted to the FDA according to their PMTA guidelines will be permitted to remain on the market in the United States.