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Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States.
Nicotine Tob Res. 2018 07 09; 20(8):970-976.NT

Abstract

Introduction

Prior to the US Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample.

Methods

Research staff randomly selected four electronic cigarette liquid manufacturers/distributors from four US geographic regions. Staff documented the characteristics of product packaging and content of warning statements on 147 electronic cigarette liquids (0-30 mg/ml of nicotine) purchased online from 16 manufacturers/distributors in April of 2016.

Results

Data showed that 97.9% of the electronic cigarette liquid bottles included a warning statement, most of which focused on nicotine exposure rather than health. Only 22.4% of bottles used a warning statement that indicated the product "contained nicotine." Of bottles that advertised a nicotine-based concentration of 12 mg/ml, 26% had a warning statements stated that the product "contains nicotine." None of the statements that indicated that the product "contained nicotine" stated that nicotine was "addictive." All bottles had a safety cap and 12% were in plastic shrink-wrap. Fifty-six percent of the websites had a minimum age requirement barrier that prevented under-aged persons from entering.

Conclusions

Most manufacturers/distributors printed a warning statement on electronic cigarette liquid bottles, but avoided warning consumers about the presence and the addictiveness of nicotine. Studies are needed to examine manufacturer/distributor modifications to product packaging and how packaging affects consumer behaviors.

Implications

These data can inform future FDA requirements related to the packaging and advertising of e-cigarette liquids; regulation related to the content of warning statements, including exposure warning statements, which are not currently mandated; and requirements on websites or language on packaging to help manufacturers adhere to the minimum age of purchase regulation. The data can also be used to help FDA develop additional guidance on the framing of statements on packaging that helps consumers make informed decisions about purchasing the product or protecting young people from use or unintentional exposure to the product.

Links

PMC Free PDF

Authors+Show Affiliations

Fagan P
Center for the Study of Tobacco, Department Health Behavior and Health Education, Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences, Little Rock, AR. Center for the Study of Tobacco Products, Department of Psychology, College of Humanities and Sciences, Virginia Commonwealth University, Richmond, VA.
Pokhrel P
Cancer Prevention and Control Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.
Herzog TA
Cancer Prevention and Control Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.
Guy MC
Center for the Study of Tobacco Products, Department of Psychology, College of Humanities and Sciences, Virginia Commonwealth University, Richmond, VA. Department of African American Studies, Virginia Commonwealth University, Richmond, VA.
Sakuma KK
Department of Health Promotion and Behavior, College of Public Health and Human Sciences, Oregon State University, Waldo Corvallis, OR.
Trinidad DR
Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.
Cassel KD
Cancer Prevention and Control Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.
Jorgensen D
Cancer Prevention and Control Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.
Lynch T
Cancer Prevention and Control Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.
Felicitas-Perkins JQ
School of Community and Global Health, Claremont Graduate University, Claremont, CA.
Palafox S
Center for the Study of Tobacco Products, Department of Psychology, College of Humanities and Sciences, Virginia Commonwealth University, Richmond, VA. Cancer Prevention and Control Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.
Hamamura FD
Cancer Prevention and Control Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.
Maloney S
Center for the Study of Tobacco Products, Department of Psychology, College of Humanities and Sciences, Virginia Commonwealth University, Richmond, VA. Department of Psychology, Virginia Commonwealth University, Richmond, VA.
Degree K
Center for the Study of Tobacco Products, Department of Psychology, College of Humanities and Sciences, Virginia Commonwealth University, Richmond, VA. Department of African American Studies, Virginia Commonwealth University, Richmond, VA.
Sterling K
Department of Health Promotion and Behavior, School of Public Health, Georgia State University, Atlanta, GA.
Moolchan ET
Independent Consultant, Cambridge, MA.
Clanton MS
Accenture, Austin, TX.
Eissenberg TE
Center for the Study of Tobacco Products, Department of Psychology, College of Humanities and Sciences, Virginia Commonwealth University, Richmond, VA. Department of Psychology, Virginia Commonwealth University, Richmond, VA.
Addictive Carcinogens Workgroup
No affiliation info available

MeSH

AdolescentAdultElectronic Nicotine Delivery SystemsFemaleFlavoring AgentsHumansInfantMinorsNicotinePregnancyProduct LabelingProduct PackagingRandom AllocationSafety ManagementTobacco ProductsUnited StatesVaping

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28520985

Citation

Fagan, Pebbles, et al. "Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States." Nicotine & Tobacco Research : Official Journal of the Society for Research On Nicotine and Tobacco, vol. 20, no. 8, 2018, pp. 970-976.
Fagan P, Pokhrel P, Herzog TA, et al. Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States. Nicotine Tob Res. 2018;20(8):970-976.
Fagan, P., Pokhrel, P., Herzog, T. A., Guy, M. C., Sakuma, K. K., Trinidad, D. R., Cassel, K. D., Jorgensen, D., Lynch, T., Felicitas-Perkins, J. Q., Palafox, S., Hamamura, F. D., Maloney, S., Degree, K., Sterling, K., Moolchan, E. T., Clanton, M. S., & Eissenberg, T. E. (2018). Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States. Nicotine & Tobacco Research : Official Journal of the Society for Research On Nicotine and Tobacco, 20(8), 970-976. https://doi.org/10.1093/ntr/ntx101
Fagan P, et al. Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States. Nicotine Tob Res. 2018 07 9;20(8):970-976. PubMed PMID: 28520985.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Warning Statements and Safety Practices Among Manufacturers and Distributors of Electronic Cigarette Liquids in the United States. AU - Fagan,Pebbles, AU - Pokhrel,Pallav, AU - Herzog,Thaddeus A, AU - Guy,Mignonne C, AU - Sakuma,Kari-Lyn K, AU - Trinidad,Dennis R, AU - Cassel,Kevin D, AU - Jorgensen,Dorothy, AU - Lynch,Tania, AU - Felicitas-Perkins,Jamie Q, AU - Palafox,Sherilyn, AU - Hamamura,Faith D, AU - Maloney,Sarah, AU - Degree,Kaylah, AU - Sterling,Kymberle, AU - Moolchan,Eric T, AU - Clanton,Mark S, AU - Eissenberg,Thomas E, AU - ,, PY - 2016/06/28/received PY - 2017/05/11/accepted PY - 2017/5/19/pubmed PY - 2019/9/11/medline PY - 2017/5/19/entrez SP - 970 EP - 976 JF - Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco JO - Nicotine Tob Res VL - 20 IS - 8 N2 - Introduction: Prior to the US Food and Drug Administration's (FDA) regulation of electronic cigarettes and warning statements related to nicotine addiction, there was no critical examination of manufacturer/distributor voluntary practices that could potentially inform FDA actions aimed to protect consumers. This study examined the content of warning statements and safety characteristics of electronic cigarette liquid bottles using a national sample. Methods: Research staff randomly selected four electronic cigarette liquid manufacturers/distributors from four US geographic regions. Staff documented the characteristics of product packaging and content of warning statements on 147 electronic cigarette liquids (0-30 mg/ml of nicotine) purchased online from 16 manufacturers/distributors in April of 2016. Results: Data showed that 97.9% of the electronic cigarette liquid bottles included a warning statement, most of which focused on nicotine exposure rather than health. Only 22.4% of bottles used a warning statement that indicated the product "contained nicotine." Of bottles that advertised a nicotine-based concentration of 12 mg/ml, 26% had a warning statements stated that the product "contains nicotine." None of the statements that indicated that the product "contained nicotine" stated that nicotine was "addictive." All bottles had a safety cap and 12% were in plastic shrink-wrap. Fifty-six percent of the websites had a minimum age requirement barrier that prevented under-aged persons from entering. Conclusions: Most manufacturers/distributors printed a warning statement on electronic cigarette liquid bottles, but avoided warning consumers about the presence and the addictiveness of nicotine. Studies are needed to examine manufacturer/distributor modifications to product packaging and how packaging affects consumer behaviors. Implications: These data can inform future FDA requirements related to the packaging and advertising of e-cigarette liquids; regulation related to the content of warning statements, including exposure warning statements, which are not currently mandated; and requirements on websites or language on packaging to help manufacturers adhere to the minimum age of purchase regulation. The data can also be used to help FDA develop additional guidance on the framing of statements on packaging that helps consumers make informed decisions about purchasing the product or protecting young people from use or unintentional exposure to the product. SN - 1469-994X UR - https://www.unboundmedicine.com/medline/citation/28520985/Warning_Statements_and_Safety_Practices_Among_Manufacturers_and_Distributors_of_Electronic_Cigarette_Liquids_in_the_United_States_ DB - PRIME DP - Unbound Medicine ER -