PMTA is entangled in lawsuits, FDA finally admits counsel, 18 million to build a rapid tobacco monitoring center
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PMTA is entangled in lawsuits, FDA finally admits counsel, 18 million to build a rapid tobacco monitoring center
According to news from the US media on June 1 local time, FDA and NIH jointly announced the establishment of a new CRST (Tobacco Rapid Monitoring Center) with a grant of US$18 million for a period of five years.
According to news from the US media on June 1 local time, the FDA (US Food and Drug Administration) and the US National Institutes of Health (NIH) jointly announced the establishment of a new CRST (Rapid Tobacco Monitoring Center) with a grant of US$ 18 million. five years. The function of the Tobacco Rapid Monitoring Center is to provide more data on the sales and marketing of tobacco products to various institutions, focusing on rapid production data.
When the relevant media reported on this incident, it was clearly mentioned that the establishment of the Tobacco Rapid Monitoring Center was to deal with the rapid popularity of electronic cigarettes (especially among young people). Regulatory functions (cigarettes, smokeless tobacco, medical products) in the United States do not have sufficient capacity to address issues related to e-cigarettes.
To put it bluntly, the FDA has moved to the rescue - it is really unable to deal with the current massive PMTA applications, and has to introduce more professional monitoring capabilities to help it improve its regulatory capabilities and efficiency for e-cigarettes.
The Tobacco Rapid Surveillance Center is staffed by eight faculty members from Rutgers University, as well as from Roswell Park Cancer Institute, East Carolina University, Stanford University, University of Kentucky, Ohio State University, Columbia University and Westat, Inc. 13 "co-investigators" lead.
In response, Cristine Delnevo, principal investigator of the Tobacco Rapid Monitoring Center and director of the Center for Tobacco Research at Rutgers University, said in a press release: "This has never been attempted before. No one has collected such comprehensive information, let alone Said to be sorted out and disseminated quickly. We believe this will provide FDA with timely and valuable data to assist the tobacco regulatory work authorized by Congress.”
The report mentioned that the goal of the Tobacco Rapid Monitoring Center is to "reduce the time between identifying the signal and understanding the signal, because these large data systems previously relied on by the FDA and CDC are difficult to quickly optimize to monitor new tobaccos.
Tobacco rapid monitoring not only helps FDA to make appropriate enforcement, but also helps to assess the impact of policies that have not yet been characterized. For example, if the use of menthol in cigarettes is banned, will people who smoke menthol cigarettes quit smoking? Should I switch to non-menthol cigarettes? Switching to e-cigarettes or nicotine pouches? Our goal is to monitor market and consumer changes in as real time as possible. "
In fact, the FDA’s move is not difficult to understand. Gewu Consumer tweeted yesterday, “Fight PMTA lawsuits every day! The FDA director sells miserably to ask for a "sword of justice", and recently met with the Ministry of Justice" mentioned that FDA Director Robert Carley has recently poured out bitter water. The FDA has been unable to cope with the current situation and is facing more than 40 lawsuits against PMTA (among them mostly from companies that failed to apply).
In the assessment of the Reagan-Udall Foundation in December last year, it was clearly stated that the FDA lacks a clear and comprehensive long-term plan for the regulation of e-cigarettes. Diamond took over the porcelain job again.
The lack of FDA's ability to monitor and analyze is best reflected in the throughput and progress of PMTA.
On September 9, 2020, the FDA required that all e-cigarettes that were launched before August 8, 2016 must submit a PMTA application or withdraw from the United States, and promised to complete all reviews on September 9, 2021. As a result, until today, only 7 (There are even a bunch of outdated antique products in it), and the promised completion approval time has been delayed again and again.
