VAPING NEWS: FDA PMTA SUBMISSIONS

“Wednesday’s long-delayed deadline for e-cigarette companies to seek permission from the Food and Drug Administration to keep selling their products is launching a new era of uncertainty for the industry and a slog for regulators facing applications that can exceed 100,000 pages. The FDA has a year, under a court order, to assess the companies’ data and decide which devices or flavors can be legally sold. In the meantime, the agency says it will start deciding whether applications are complete and warrant a further review. Applicants whose submissions are accepted can keep selling their existing products for a year.”

NOTE 1: Theoretically [and possibly Legally], if FDA decides to accept application (including ‘incomplete submissions) and processes it quickly with a FAILED or DECLINED [perhaps based on it being ‘Incomplete’ so that they wouldn’t actually need to even read it to process it], it would eliminate the rest of the ‘year’ period remaining for them to stay on the shelves

NOTE 2: Dimitris Agrafiotis and Mark Anton have short commentaries supporting the e-liquid vapor product industry in the video

ARTICLE LINK:

FDA to review huge applications from vaping companies

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Author: Bill Tarling