“The clock is ticking for tobacco companies to file premarket tobacco product applications (PMTAs) with the Food and Drug Administration (FDA) for electronic nicotine delivery systems (ENDS) and other newly deemed tobacco products. Reynolds American Inc. submitted two PMTAs in mid-April, before the deadline was extended. The Winston-Salem, N.C.-based company is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapor products, which would allow them to remain on the market after the PMTA deadline. The filings include multiple flavor variants for each brand style. Fontem US LLC submitted PMTAs in late April seeking authorization to continue marketing a range of its myblu electronic vaping products. Altria Group Inc. received word in early June that the FDA accepted and filed for substantive review (the second phase of the process) the company’s PMTAs for 35 on! products. To support these applications, Richmond, Va.-based Altria submitted more than 66,000 pages of documentation, including six primary studies. E-Alternative Solutions (EAS) also announced PMTA submissions for its Leap and Leap Go vapor products. The FDA accepted the filings in early July, moving the applications to the substantive review phase of the process. “The substantive review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health,” said Chris Howard, vice president, general counsel and chief compliance officer at EAS. Juul Labs, which counts Altria as a stakeholder, filed its JUUL System. The application includes detailed scientific data from more than 110 studies totaling more than 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage, according to the San Francisco-based company. 511 Solutions LLC, owner of the PRISM e-liquid line and master distributor, is also seeking FDA approval by filing what it said is the first of many PMTAs for its nicotine-based e-liquid products.”
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Tobacco Cos. Line Up to File Vapor PMTAs as New Deadline Nears
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