Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 15

Fontem US Inc. Statement on Court Ruling Regarding PMTA Timeline

Posted by fidest press agency su lunedì, 15 luglio 2019

Fontem US Inc. (Fontem), leader in next generation nicotine products and marketer of blu® electronic cigarettes, issued the following statement regarding the ruling by the U.S. District Court for the District of Maryland adjusting the timeline establishing the Food and Drug Administration’s premarket tobacco product application (PMTA) pathway for electronic nicotine delivery systems.“We are disappointed with the court’s decision imposing an accelerated timeline on the premarket review process. This will undoubtedly hamper the ability of manufacturers to conduct the scientific research needed to ensure that potentially less harmful products are available to adult smokers seeking to make the switch from combustible tobacco products. Fontem has worked in good faith with the FDA as it seeks to establish an appropriate and effective regulatory framework. We share the priority of keeping tobacco products out of the hands of minors and have taken several proactive steps aimed specifically at youth access prevention. The FDA’s initial decision to delay the PMTA process was intended, in its own words, to allow for ‘a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease.’ As recently as June 11, the FDA acknowledged the importance of retaining an achievable timetable even as the court’s initial ruling required the agency to move the goalposts for manufacturers. While we continue to believe that the originally outlined process was the most reasonable approach, Fontem is committed to complying with all applicable laws and regulations wherever our products are sold and will continue to work cooperatively with the FDA.”


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