Products Regulation
Products Regulation
Considering the EU legislation’s focus preventing young people from tobacco addictive behaviour, cigars and cigarillos, have been granted exemptions from certain requirements relating to ingredients, flavours, labelling and reporting, as products mainly consumed by mature and conscious consumers representing small groups of the population (1).
This fact has once again recently been confirmed in the European Commission’s Support Study to the report on the application of Directive 2014/40/EU and the 2024 Eurobarometer, which found practically no use of cigars and cigarillos in the under-25 age group in the EU (2).
This approach is widely understood and shared across the globe – from the exclusion of cigars to the US Food and Drug Administration’s Final Deeming Rule (3) to the labelling exemption granted for cigars and cigarillos in the vast majority of EU countries which have implemented plain packaging for cigarettes.
In the absence of clear change of circumstances in terms of sales volumes or consumption patterns of young people, as recently confirmed by the European Commission in November 2025 (4), ECMA firmly believes that cigars and cigarillos should continue to be treated differently from mass-consumed tobacco and nicotine products.
This position is further supported by the recent ruling of the Court of Justice of the European Union (CJEU), which confirmed in its judgment that the “substantial change of circumstances” clause is lawful, proportionate and appropriate within EU legislation (5).
As the European Commission is preparing to publish its Evaluation of the Legislative Framework for Tobacco Control, you can find here ECMA’s contribution.
(1) Recital 26 of Directive 2014/40/EU.
(2) European Commission, Final Report: Support Study to the report on the application of Directive 2014/40/EU, May 2021, p. 290; and Special Eurobarometer report on ‘Attitudes of Europeans towards tobacco and electronic cigarettes’, published in June 2024, p. 26
(3) United States Court of Appeals for the District of Columbia Circuit, CIGAR ASSOCIATION OF AMERICA vs US FDA, No. 18-5195, 7 July 2020 and confirmed in the Food & Drug Administration (FDA) and the Center for Tobacco Products (CTP), Final Substantial Equivalence and Premarket Tobacco Product Application Rules to address deemed product, 19 January 2021.
(4) European Commission, Answer given by Mr Várhelyi on behalf of the European Commission to Priority question for written answer P-004058/2025, 19 November 2025.
(5) European Court of Justice, Judgement of the Court (Second Chamber) In Case C759/23, PJ Carroll & Company Ltd vs Irish Minister of Health, 26 June 2025, ECLI:EU:C:2025:477