2ONE Labs announced on October 29 that its 2ONE® brand of nicotine pouches has received approval from FDA for its Pre-Market Tobacco Product Application (PMTA), according to Globe Newswire.
After receiving the “approval” notification from the FDA, 2ONE Labs CEO Vincent Schuman stated:
“This signifies that the PMTA application for 2ONE® has advanced to the next critical phase of the FDA review process. Our company will continue to provide financial backing to ensure the successful completion of this submission. Our wholesale, retail, and sponsorship partners should view this ‘approval’ as a testament to our ability to navigate the complex PMTA process and our firm commitment to supporting the long-term availability of the 2ONE® brand in the U.S. market.”
“The 2ONE® nicotine pouches were developed for adult users (21+) who face challenges transitioning from combustible tobacco or traditional oral tobacco products to alternative options. Over the past five years, the 2ONE® brand has garnered market attention and growth, thanks to strong distribution partnerships like those with CircleK®. FDA’s approval of 2ONE®’s PMTA application is exciting, and we look forward to continuing to support adult consumers seeking alternatives to traditional tobacco products.”
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