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Juul Labs Documents Collection for North Carolina: FDA Involvement in JUUL Product Regulation
This guide provides searching assistance and key information for the NC JUUL documents database.
Created by Health Science Librarians
US FDA's Center for Tobacco Products
The database includes a section of documents received through a 2018 FOIA request by the UCSF Center for Tobacco Control Research and Education (CTCRE) to the US FDA's Center for Tobacco Products regarding Juul Labs. These records included published scientific papers and reports, internal memos, fact sheets, lab reports, and presentations collected or created by Juul Labs. The records contain documents related to nicotine chemistry and addiction, toxicology, research on e-cigarettes and e-cigarette use, evaluation of Juul Labs products, and draft product quality standards.
Below are some key documents highlighted under this collection in the database.
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A Curated Tour through the Deeming Regulation Comments - Presentation at e-Cig Vegas 2014This presentation was given by Gail Cohen, the Head of Scientific and Regulatory Affairs at Ploom Inc. at the e-Cig Vegas conference in September 2014. It discusses the regulations and approval pathways that Ploom and Pax Labs had to navigate to get their products on the market.
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2016 FDLI Annual Conference Presentation by PAX Labs on Hot Topics in Food and Drug LawThe presentation was given by Gail Cohen, the Head of Scientific and Regulatory Affairs at Pax Labs, in 2016 to the annual Food and Drug Law Institute Conference in Washington D.C.
The presentation has a focus on the intended use of the Pax Labs product on switching vs. cessation, and how they are building off of scientific study opportunities on the difference between the two mechanisms of quitting tobacco. -
Quality, safety and efficacy of unlicensed Nicotine Containing Products report by the Commission on Human Medicines, Working Group on Nicotine Containing Products (NCPS)The 100 page report from 2013 outlines the research found by the Commission on Human Medicines, Working Group on Nicotine Containing Products about e-cigarettes on the UK market that were not licensed medicines but were being advertised for tobacco and smoking cessation.
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Draft Product Quality Standard for Electronic Cigarettes and E-LiquidsThe document outlines a draft that was going to be presented at a September 2014 meeting about product quality standards for electronic cigarettes. It outlines standards for e-cigarettes, product standards in their devices and the mechanisms for e-cigarette product testing.
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Abstract submitted by Juul Labs to the Global Forum on Nicotine Conference 2018: HPHC Analysis of Eight Flavors of a Temperature-Regulated Nicotine Salt-Based ENDS ProductThe abstract is for a study funded by Juul Labs to analyze the flavors of pods manufactured to be used in JUUL products, and the difference in the smoke and toxicants coming from the pods compared to smoke aerosol by a traditional tobacco product.