NEW YORK, Oct. 7, 2020 /PRNewswire/ — MNGO, maker of e-Cigarettes and disposable vaping products, announced today that it has advanced to the “Filing” stage of the FDA’s Premarket Tobacco Product Application (PMTA) Process. MNGO becomes one of the first independent, family-owned companies to reach this phase of the complex regulatory approval process. Attaining “Filing” is the outcome of a significant amount of work and preparation on the part of MNGO. Receipt of the Filing Letter means that MGNO is now moving into the substantive review phase of the PMTA process.
“Our goal has always been to provide adults with the highest quality alternative products that are affordable and taste great,” said a spokesperson for the company. “While PMTA represents a major investment of time and resources for MNGO, we actually welcome the work. We want the industry to comprise of only companies that respect quality and customer safety as much as we do. We believe that the PMTA process is an important regulatory step for the vapor industry, and we are committed to working together with the FDA and remain optimistic about receiving a marketing order.”
According to the US federal government’s Food and Drug Administration (FDA), a Premarket Tobacco Product Application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA marketing order. The regulation comes under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The application must provide scientific data demonstrating a product is appropriate for the protection of public health.
For MNGO, the PMTA was a global effort, with teams working around the world to support the document-intensive application. The submission included thousands of pages of scientific research and other supporting data. However, while the filing decision was up to the FDA, the company was not in doubt about its position. “We believe our products are appropriate for the protection of public health,” the spokesperson added. “We have always been committed to creating products for adult smokers seeking an alternative to combustible cigarette smoking and hold ourselves to higher standards.”
MNGO, which has been on the US market since 2015, is already preparing further PMTAs for new products in early 2021 as part of an effort of sustainability within an ever-changing and advancing industry. The new products will ensure that MNGO remains relevant to its trusted partners for years to come.
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