According to foreign reports, due to the approaching of September 9, the date of PMTA stipulated by FDA, many tobacco companies began to queue up to apply for electronic nicotine delivery system (ends) and pre marketing tobacco product application (PMTA) of other newly identified tobacco products.
According to the family smoking prevention and tobacco control act of 2009, FDA must approve PMTA of newly identified tobacco products (including electronic cigarettes and steam products) before they can be put on the market.
In the summer of 2019, district judge Paul Grimm of the District Court of Maryland set the deadline for filing applications to May 12, 2020, but due to the impact of the new crown, in April this year, Grimm agreed to extend the deadline to September 9, 2020.
Reynolds American Inc. filed two pmtas in mid April before extending the deadline. The Winston Salem, North Carolina based company is seeking FDA sales orders for its VUSE vibe and VUSE Ciro steam products. In this way, they can stay in the market after the PMTA deadline, and the declaration documents include a variety of flavor products for each brand style.
The company said the application to the agency included a series of scientific studies on VUSE vibe and VUSE Ciro using well-known methods, including a comparative assessment of cigarettes and related health risks.
'I'm very proud of our diverse team of scientists, researchers and regulatory experts who worked so hard to complete these applications long before the FDA's end product deadline,' said James figlar, Renault's executive vice president and head. We are optimistic that this will enable us to provide adult tobacco consumers with a variety of acceptable alternatives to cigarettes, and we hope that with the promotion of PMTA, the agency will give priority to the implementation of illegally sold tobacco products introduced after August 8, 2016.
VUSE vibe and VUSE Ciro's PMTA are actually the second and third complete PMTA applications submitted by Renault to FDA for review. The company submitted a PMTA application to VUSE solo in October 2019.
Fontem US LLC submitted PMTA in late April to seek authorization to continue selling its range of myblu e-cigarettes. Its submission includes data from a wide range of laboratory and clinical scientific studies, including product analysis, behavioral data, non clinical health risk information, and information on the impact on users and non users of tobacco products.
'we agree that the e-cigarette industry should maintain the highest product and marketing standards while providing adult smokers with alternative products that may be beneficial to public health,' said Antoine Jinfa, President of Greensboro, North Carolina. Fontem us wants to work with the FDA as the agency develops and implements evidence-based regulatory policies.
In early June, Altria Group Inc. launched its nicotine bag business helix on! Submitted to PMTA, helix innovations LLC is an Altria joint venture responsible for global operations, mainly producing nicotine bag product portfolio.
To support the applications, Richmond, Va. - based Altria submitted more than 66000 pages of documents, including six major studies.
Paige Magness, senior vice president of customer service regulatory affairs at Altria, said: 'we believe the scientific evidence in these applications indicates that on! Marketing for the protection of public health is a key part of our vision of responsibly leading adult smokers to a non combustible future.
Nicotine bags without tobacco leaves have seven flavors and five nicotine contents.
By the end of the first quarter of 2020, they had been distributed in more than 28000 stores, including the top five convenience store chains by volume.
E-alternative solutions (EAS) also announced PMTA documents for its leap and leap go steam products. The FDA accepted the application in early July and moved it to the substantive review stage of the process.
Jacopo d'alessandris, President and CEO of the company, said that this milestone represents an important step in eas, and our mission is to replace combustible cigarettes with our leap and leap go steam products.
He added that the FDA's acceptance and application documents demonstrate the strength and thoroughness of our application, which we believe will meet FDA requirements. We would like to thank the FDA for quickly addressing these materials in the face of challenges, and we hope to continue to work with the agency in the process.
After an administrative review of the application, the agency issues an audit notice to ensure that the documents submitted meet the baseline criteria for review. The filing letter is the result of a preliminary scientific review to ensure that the application includes the necessary ingredients and health analysis.
Chris Howard, vice president of general affairs at eas, said that after several months of hard work, we have collected more than 100000 pages of evidence that will prove our claim that leap and leap go products are suitable for protecting public health. We look forward to working with FDA in the coming weeks and months and remain optimistic that market orders will be generated in accordance with the PMTA process.
Juul labs, with Altria group as the stakeholder, submitted Juul system for PMTA process. The submission includes comprehensive scientific evidence on Juul devices and Juul cartridges in Virginia tobacco, as well as peppermint flavors with nicotine concentrations of 5% and 3%, as well as information on data-driven measures for the use of its products by minors.
The application includes detailed scientific data from more than 110 studies, totaling more than 125000 pages, to assess the impact of the product on current users and non users (including minors) of tobacco products.
The study complements information on controlled design and repeatable manufacturing processes associated with Juul systems, as well as data-driven measures to limit unintended consequences for the entire population, including non-user use.
To get a license to operate in society, we need to be a science and evidence-based company, have an open and transparent dialogue with stakeholders, and take organized and responsible action to increase the potential for adult harm reduction, smokers, and combat underage use, said KC crosswaite, CEO of Juul labs. The PMTA we submitted is a key part of this approach.
511 Solutions LLC, the owner and main distributor of prism's e-cigarette and oil production line, is also seeking FDA approval. Prism brand represents three E-liquid product lines, with 19 flavors applying for PMTA process.
Flavors range from flavors of nicotine intensity, from tobacco to menthol to fruit.
According to the company, all prism e-liquids are manufactured by BlackBerry regulatory services in an ISO class 6 cleanroom and tested in an ISO 17025 laboratory and has published test results for each bottle.