(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.
(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, Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products, COM(2021) 249 final, May 2021, See Section ‘Substantial change of circumstance clause (Articles 2(28), 7(12), 11(6))’, p. 16.