American Society of Clinical Oncology Policy Brief: FDA’s Regulation of Electronic Nicotine Delivery Systems and Tobacco Products

2017 ◽  
Vol 13 (1) ◽  
pp. 58-60 ◽  
Author(s):  
Janette K. Merrill ◽  
Anthony J. Alberg ◽  
John R. Goffin ◽  
Suresh S. Ramalingam ◽  
Vani Nath Simmons ◽  
...  
2015 ◽  
Vol 33 (8) ◽  
pp. 952-963 ◽  
Author(s):  
Thomas H. Brandon ◽  
Maciej L. Goniewicz ◽  
Nasser H. Hanna ◽  
Dorothy K. Hatsukami ◽  
Roy S. Herbst ◽  
...  

Combustible tobacco use remains the number-one preventable cause of disease, disability, and death in the United States. Electronic nicotine delivery systems (ENDS), which include electronic cigarettes, are devices capable of delivering nicotine in an aerosolized form. ENDS use by both adults and youth has increased rapidly, and some have advocated these products could serve as harm-reduction devices and smoking cessation aids. ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or former smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the health of the public; however, definitive data are lacking. The AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the US Food and Drug Administration and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited. This policy statement was developed by a joint writing group composed of members from the Tobacco and Cancer Subcommittee of the American Association for Cancer Research (AACR) Science Policy and Government Affairs (SPGA) Committee and American Society of Clinical Oncology (ASCO) Tobacco Cessation and Control Subcommittee of the Cancer Prevention Committee (CaPC). The statement was reviewed by both parent committees (ie, the AACR SPGA Committee and the ASCO CaPC) and was approved by the AACR Boards of Directors on August 6, 2014, and the ASCO Executive Committee on September 18, 2014. This policy statement was published jointly by invitation and consent in both Clinical Cancer Research and Journal of Clinical Oncology. Copyright 2015 American Association for Cancer Research and American Society of Clinical Oncology. All rights reserved. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or storage in any information storage and retrieval system, without written permission by the American Association for Cancer Research and the American Society of Clinical Oncology.


2017 ◽  
Vol 26 (e2) ◽  
pp. e127-e129 ◽  
Author(s):  
Karen Suchanek Hudmon ◽  
Nervana Elkhadragy ◽  
Zuzana Kusynová ◽  
Luc Besançon ◽  
Tina Penick Brock ◽  
...  

2015 ◽  
Vol 61 (2) ◽  
pp. 177-188 ◽  
Author(s):  
Scott R. Weaver ◽  
Ban A. Majeed ◽  
Terry F. Pechacek ◽  
Amy L. Nyman ◽  
Kyle R. Gregory ◽  
...  

Author(s):  
Omar Andrés Bravo-Gutiérrez ◽  
Ramcés Falfán-Valencia ◽  
Alejandra Ramírez-Venegas ◽  
Raúl H. Sansores ◽  
Guadalupe Ponciano-Rodríguez ◽  
...  

The tobacco industry promotes electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP) as a safer alternative to conventional cigarettes with misleading marketing sustained by studies with conflict of interest. As a result, these devices sell without regulations and warnings about their adverse effects on health, with a growing user base targeting young people. This systematic review aimed to describe the adverse effects on the respiratory system in consumers of these devices. We conducted a systematic review and bibliometric analysis of 79 studies without conflict of interest evaluating ENDS and HTP effects in the respiratory system in experimental models, retrieved from the PubMed database. We found that the damage produced by using these devices is involved in pathways related to pulmonary diseases, involving mechanisms previously reported in conventional cigarettes as well as new mechanisms particular to these devices, which challenges that the tobacco industry’s claims. The present study provides significant evidence to suggest that these devices are an emerging public health problem and that they should be regulated or avoided.


2017 ◽  
Vol 45 (4) ◽  
pp. 532-539 ◽  
Author(s):  
Deepti Agarwal ◽  
Alexandra Loukas ◽  
Cheryl L. Perry

Background. Although use of Electronic Nicotine Delivery Systems (ENDS) is increasingly prevalent among young adults, little is known about predictors of ENDS initiation among this population. Aims. We examined the roles of the social environment (i.e., peer ENDS use and household ENDS use), normative beliefs (i.e., social acceptability of ENDS use), and attitudes (i.e., inclination to date someone who uses ENDS) in prospectively predicting initiation of ENDS over a 1-year period among 18- to 29-year-old college students. Method. Participants were 2,110 (18- to 29-year–old) students ( M = 20.27, SD = 2.17) from 24 colleges in Texas who participated in a three-wave online survey, with 6 months between each wave. All participants reported never using ENDS at baseline. A multivariable, multilevel logistic regression model, accounting for clustering of students within colleges, was used to assess if students’ social environment, normative beliefs, and attitudes predicted subsequent initiation of ENDS up to 1 year later, adjusting for various sociodemographic factors and number of other tobacco products used. Results. In all, 329 college students (16%) initiated ENDS within 1 year. Results from the logistic regression indicated that college students who were younger (18-24 years old), ever used other tobacco products, indicated a more dense peer network of ENDS users, and had a higher inclination to date someone who uses ENDS had higher odds of initiating ENDS than their peers. Conclusion. Preventing ENDS initiation should be included in college health promotion programs, which should highlight the roles of students’ social environment and attitudes regarding ENDS use.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e045724
Author(s):  
Ivan Berlin ◽  
Isabelle Jacot-Sadowski ◽  
Jean-Paul Humair ◽  
Jacques Cornuz

ObjectivesTo provide a consensus from a panel of international experts about electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP).DesignCross-sectional survey.MethodsA Delphi survey was conducted among international experts in tobacco control and smoking cessation. The first part addressed statements or recommendations about ENDS, the second about HTP, both divided into four categories: regulation, sale, use and general issues.SettingExperts from 15 countries.ParticipantsIndividuals with clinical, public health or research expertise in tobacco control and/or smoking cessation.Results268 experts were contacted, 92 (34%) completed the first, 55/92 (60%) the second round. Consensus for ENDS: components of e-liquids, an upper limit of nicotine concentration should be defined; a warning on the lack of evidence in long-term safety and addiction potential should be stated; ENDS should not be regulated as consumer products but either as a new category of nicotine delivery or tobacco products; ENDS should not be sold in general stores but in specialised shops, shops selling tobacco or in pharmacies with restriction on sale to minors; administration of illegal drugs is likely with ENDS. Consensus for HTP: HTP have the same addictive potential as cigarettes; they should be regulated as a tobacco product with similar warning messages as cigarettes; their advertisement should not be allowed. ENDS and HTP use should not be allowed in indoor public places; a specific tax should be implemented for ENDS, taxes on HTP should not be lower than those for cigarettes; use of cigarettes is more likely with both ENDS and HTP (dual use) than quitting smoking.ConclusionsExperts in tobacco control and/or smoking cessation recommend differential regulation for ENDS and HTP. The results of this survey may be useful for health authorities, decision makers and researchers of the tobacco use and cessation field.


Author(s):  
E. V. Gnuchikh ◽  
M. V. Shkidyuk ◽  
A. G. Mirgorodskaya

Studying the electronic nicotine delivery systems (ENDS), which are widely spread as substitute for traditional tobacco product is an important aim. This product differs from traditional product by absence of burning process, and it is consumed by inhaling aerosol formed by heating tobacco or liquid, containing nicotine. Monitoring of electronic nicotine delivery systems’ market is carried. Principles for classifying new product as separate category of tobacco goods are elaborated. Classification for ENDS is offered. Physical properties of single use ENDS and liquid composition are defined. “Method for machine smoking of single use electronic smoking systems and collecting its TPM and gas phase of smoke with linear smoking machine CERULEAN SM 405” was elaborated. Physical properties of reusable ENDS are defined. ENDS product is fine aerosol formed by heating. Absence of standard international regulations on nicotine containing products and methods for control of its aerosol content leads to utilizing different machine smoking protocols. Machine smoking protocols for tobacco products are presented. After researches absence of carbon monoxide in gas phase of single use and reusable ENDS is found. This proves absence of burning process. The last generation of reusable ENDS is innovative tobacco product which is heated – electric system for heating tobacco (ESHT) which completely differs from traditional tobacco products. ESHT consuming is based on tobacco heating without its burning or combustion. As the result it is possible to decrease content of harmful and potentially harmful aerosol compounds and conserve adequate to consumers levels of taste. Further studies will be aimed at defining ESHT potential for decreasing health risks compared to traditional cigarettes.


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