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Compliance of e-cigarette refill liquids with regulations on labelling, packaging and technical design characteristics in nine European member states.
Tob Control. 2020 09; 29(5):531-536.TC

Abstract

OBJECTIVE

To evaluate electronic cigarette (e-cigarette) product compliance with European regulations (Tobacco Products Directive (TPD), Implementing Decisions), with a focus on labelling/packaging practices and technical design/safety features.

METHODS

Before the implementation of the TPD, in early 2016, we randomly selected e-cigarette refill liquids from the five top-selling companies in France, Poland, Germany, Netherlands, UK, Spain, Romania, Hungary and Greece. Identical products were purchased after the implementation of the TPD (early 2018) and assessment of compliance was performed on self-matched samples (n=107) using a prospective cohort design. Compliance with the Classification, Labelling and Packaging (CLP) regulations was also evaluated.

RESULTS

Following the implementation of the TPD, improvements were noted with regards to the existence of text-only warnings (32.7% pre vs 86.0% post, p<0.001), child-resistant fastenings (93.3% pre vs 100.0% post, p=0.016), tamper-proof vials (58.9% pre vs 86.9%, post p<0.001) and maximum refill volume ≤10 mL in vials (86.9% pre vs 94.4% post, p=0.008). Lower compliance was noted with regards to the inclusion of a leaflet (26.2% pre vs 53.3% post, p<0.001), refilling instructions (28.0% pre vs 51.4% post, p<0.001) and health warnings on the box, vial or leaflet (32.7% pre vs 86.0%, p<0.001). Overall, 86.0% of products had a warning label in the post-TPD phase in comparison to 32.7% of products before the implementation of the TPD (p<0.001). Compliance with the CLP regulations, also increased in the post TPD follow-up phase.

CONCLUSIONS

This is the first study to evaluate the level of implementation of the e-cigarette regulations in nine EU member states. Our results indicate that refill liquids had substantial but not full compliance in most of the characteristics evaluated. Further effort is needed to ensure complete compliance.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Girvalaki C
European Network for Smoking and Tobacco Prevention, Brussels, Belgium. Laboratory of Toxicology, University of Crete School of Medicine, Heraklion, Greece.
Vardavas A
Laboratory of Toxicology, University of Crete School of Medicine, Heraklion, Greece.
Tzatzarakis M
Laboratory of Toxicology, University of Crete School of Medicine, Heraklion, Greece.
Kyriakos CN
Laboratory of Toxicology, University of Crete School of Medicine, Heraklion, Greece.
Nikitara K
European Network for Smoking and Tobacco Prevention, Brussels, Belgium.
Tsatsakis AM
Laboratory of Toxicology, University of Crete School of Medicine, Heraklion, Greece.
Vardavas CI
European Network for Smoking and Tobacco Prevention, Brussels, Belgium vardavas@tobcontrol.eu. Laboratory of Toxicology, University of Crete School of Medicine, Heraklion, Greece.

MeSH

Consumer BehaviorElectronic Nicotine Delivery SystemsEuropean UnionGovernment RegulationHumansNicotineProduct Labeling

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31519795

Citation

Girvalaki, Charis, et al. "Compliance of E-cigarette Refill Liquids With Regulations On Labelling, Packaging and Technical Design Characteristics in Nine European Member States." Tobacco Control, vol. 29, no. 5, 2020, pp. 531-536.
Girvalaki C, Vardavas A, Tzatzarakis M, et al. Compliance of e-cigarette refill liquids with regulations on labelling, packaging and technical design characteristics in nine European member states. Tob Control. 2020;29(5):531-536.
Girvalaki, C., Vardavas, A., Tzatzarakis, M., Kyriakos, C. N., Nikitara, K., Tsatsakis, A. M., & Vardavas, C. I. (2020). Compliance of e-cigarette refill liquids with regulations on labelling, packaging and technical design characteristics in nine European member states. Tobacco Control, 29(5), 531-536. https://doi.org/10.1136/tobaccocontrol-2019-055061
Girvalaki C, et al. Compliance of E-cigarette Refill Liquids With Regulations On Labelling, Packaging and Technical Design Characteristics in Nine European Member States. Tob Control. 2020;29(5):531-536. PubMed PMID: 31519795.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Compliance of e-cigarette refill liquids with regulations on labelling, packaging and technical design characteristics in nine European member states. AU - Girvalaki,Charis, AU - Vardavas,Alexander, AU - Tzatzarakis,Manolis, AU - Kyriakos,Christina N, AU - Nikitara,Katerina, AU - Tsatsakis,Aristidis M, AU - Vardavas,Constantine I, Y1 - 2019/09/13/ PY - 2019/03/18/received PY - 2019/08/07/revised PY - 2019/08/07/accepted PY - 2019/9/15/pubmed PY - 2021/6/10/medline PY - 2019/9/15/entrez KW - electronic nicotine delivery devices KW - packaging and Labelling KW - public policy SP - 531 EP - 536 JF - Tobacco control JO - Tob Control VL - 29 IS - 5 N2 - OBJECTIVE: To evaluate electronic cigarette (e-cigarette) product compliance with European regulations (Tobacco Products Directive (TPD), Implementing Decisions), with a focus on labelling/packaging practices and technical design/safety features. METHODS: Before the implementation of the TPD, in early 2016, we randomly selected e-cigarette refill liquids from the five top-selling companies in France, Poland, Germany, Netherlands, UK, Spain, Romania, Hungary and Greece. Identical products were purchased after the implementation of the TPD (early 2018) and assessment of compliance was performed on self-matched samples (n=107) using a prospective cohort design. Compliance with the Classification, Labelling and Packaging (CLP) regulations was also evaluated. RESULTS: Following the implementation of the TPD, improvements were noted with regards to the existence of text-only warnings (32.7% pre vs 86.0% post, p<0.001), child-resistant fastenings (93.3% pre vs 100.0% post, p=0.016), tamper-proof vials (58.9% pre vs 86.9%, post p<0.001) and maximum refill volume ≤10 mL in vials (86.9% pre vs 94.4% post, p=0.008). Lower compliance was noted with regards to the inclusion of a leaflet (26.2% pre vs 53.3% post, p<0.001), refilling instructions (28.0% pre vs 51.4% post, p<0.001) and health warnings on the box, vial or leaflet (32.7% pre vs 86.0%, p<0.001). Overall, 86.0% of products had a warning label in the post-TPD phase in comparison to 32.7% of products before the implementation of the TPD (p<0.001). Compliance with the CLP regulations, also increased in the post TPD follow-up phase. CONCLUSIONS: This is the first study to evaluate the level of implementation of the e-cigarette regulations in nine EU member states. Our results indicate that refill liquids had substantial but not full compliance in most of the characteristics evaluated. Further effort is needed to ensure complete compliance. SN - 1468-3318 UR - https://www.unboundmedicine.com/medline/citation/31519795/Compliance_of_e_cigarette_refill_liquids_with_regulations_on_labelling_packaging_and_technical_design_characteristics_in_nine_European_member_states_ DB - PRIME DP - Unbound Medicine ER -