News

Regulatory plan for tobacco and nicotine regulation-from FDA Commissioner Scott Gottlieb

8/16/17-New England Journal of Medicine

The article can be found below or at this link: http://www.nejm.org/doi/full/10.1056/NEJMp1707409?query=featured_home

"Despite extraordinary progress in tobacco control and prevention, tobacco use remains the leading cause of preventable disease and death in the United States. Combustible cigarettes cause the overwhelming majority of tobacco-related disease and are responsible for more than 480,000 U.S. deaths each year. Indeed, when used as intended, combustible cigarettes kill half of all long-term users.1

With the tools provided to the Food and Drug Administration (FDA) under the Family Smoking Prevention and Tobacco Control Act of...


Our view on FDA Commissioner Scott Gottlieb's press conference today~

7/28/17-

Below is a link to the full video of FDA Commissioner Scott Gottlieb's press conference, where he shares the Agency's vision for the future regulation of tobacco products including electronic nicotine delivery systems (ENDs) and vapor products.

https://www.youtube.com/watch?v=rn_p7iut1jU

We highly recommend watching Commissioner Gottlieb's remarks in conjunction with FDA's press release (link below), to gain the most insight as to what FDA is intending to do.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm

 

FDA's announcement today is a significant shift in the government's approach to regulating tobacco products, including ENDs (electronic nicotine delivery systems). 

 Commissioner Gottlieb, among other things, announced today that...


FDA Extends PMTA deadline to 2022

7/28/2017

YouTube link: https://www.youtube.com/watch?v=rn_p7iut1jU

Press Release: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm

The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an...


Lost Art vs FDA Update 7/26/17

Lost Art vs FDA Update 7/26/17

7/26/2017-

Last Friday, July 21st 2017, The United States District Court in the District of Columbia published a 93 page opinion in the cases brought against FDA by our friends at Nicopure and The Right to be Smoke Free Coalition. As you may know, these entities through their attorneys, challenged the deeming regulation as applied to ENDS products.

The US District Court for DC is a trial court, and in the ruling, upholds the deeming regulation. Our legal team suspect this case will be going up for appeals but have not yet spoken with counsel for these Plaintiffs.

While we...


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