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News Alert: Public Consultation on the EU’s Tobacco Products Legislation: Comment Period Open Until May 16, 2023

By Azim Chowdhury, Ales Bartl & David J. Ettinger on April 6, 2023
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Banner to advertise Keller and Heckman's series of articles on tobacco regulation in the European Union, with imagery of an e-vapor device, cigarettes, and a European Union flag.

On February 21, 2023, the European Commission opened a public consultation[1] seeking feedback on the performance of the current legislative framework for tobacco products, and ways that the legislation could be improved. All interested stakeholders can submit comments until May 16, 2023.

I. Background

In May 2008, the European Commission issued a report[2] on the implementation of Directive 2003/33/EC[3], i.e., the Tobacco Advertisement Directive. The report stressed the margin of discretion given to the EU Member States on cross-border tobacco advertising and sponsorship, noting the risk of inconsistent interpretation and application of the Directive in different Member States, as well as the challenges posed by the growing use of e-commerce/online sales and Internet advertising.

In May 2021, the European Commission issued a report[4] on the application of Directive 2014/40/EU[5], i.e., the Tobacco Products Directive. As mentioned in our previous article[6], the report highlighted the need to address, in a revision of the Tobacco Products Directive, issues such as further enforcement of the current regime for cross-border distance sales, emerging novel tobacco products[7], regulatory challenges posed by heated tobacco products and electronic cigarettes[8], new herbal products entering the market[9], and options to increase tobacco manufacturers’ liability.

In May 2022, the European Commission opened a call for evidence for the evaluation of the legislative framework for tobacco products[10]. The call for evidence stressed the need to keep up with the rapid rise in emerging products, new technologies and markets under constant development changes[11], and the need to assess how the legislation is functioning in relation to product toxicity, addiction, and attractiveness. The Commission also emphasized the importance of appraising how tobacco products are being presented and promoted to the public[12]. The evaluation aims to assess the implementation of the Tobacco Products Directive and the Tobacco Advertising Directive in the context of the implementation of other related tobacco control policies[13].

II. The Public Consultation

The public consultation, as noted above, is open until May 16, 2023, and seeks comments on whether the current EU legislation is effectively protecting public health in light of the emergence of heated tobacco products, e-cigarettes and refill containers[14], nicotine pouches[15], and heated herbal products[16].

Part I of the consultation is focused on the Tobacco Products Directive. Opinions are sought on the EU’s contributions to reducing health risks from tobacco and related products, in reference to steps taken on establishing limits on tar, nicotine, and carbon monoxide, and bans on characterizing flavors. The Commission also wants to learn about the increasing use of emerging products among youth and the health risks associated with these products.

Part II of the consultation addresses the Tobacco Advertisement Directive, the provisions on advertising of electronic cigarettes set forth by the Tobacco Products Directive[17], and specifically whether these legislative acts are effectively protecting public health.

Finally, Part III includes questions on other relevant policies, notably on the legal age limit verification for the purchasing of tobacco products (the age limit is currently set at 18 years old in the EU Member States[18]), tobacco and related product sales channels (including emerging products) and possible restrictions on the same, public awareness campaigns and tobacco control actions, and the availability of smoking cessation programs.

III. Next steps

After the end of the public consultation, targeted stakeholder consultations also will take place[19]. The European Commission plans to issue its evaluation report in the second quarter of 2023[20]. According to the European Commission’s Implementation Roadmap[21] of Europe’s Beating Cancer Plan, the Commission is expected to adopt a proposal for the revision of the Tobacco Products Directive in 2024, although it is not clear yet whether this proposal also will include a revision of the Tobacco Advertisement Directive or other legislative provisions on tobacco and related products.

Should you need further details or any assistance, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Azim Chowdhury (chowdhury@khlaw.com), Ales Bartl (bartl@khlaw.com), or your existing contact at Keller and Heckman LLP.


[1] Have your say: Evaluation of the legislative framework for tobacco control

[2] Report from the Commission to the Council, the European Parliament and the European Economic and Social Committee – Report on the implementation of the tobacco advertising directive 

[3] Directive 2003/33/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products

[4] 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 of May 20, 2021

[5] Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products

[6] The EU’s Tobacco Products Directive: Revisiting the Requirements and Updates on Heated Tobacco Products

[7] As per the report, new products not containing tobacco, such as oral nicotine pouches

[8] The report highlighted that it should be explored whether some provisions could be further developed or clarified, such as tank size or labeling requirements; use of flavors; use of nicotine-free liquids; and advertising provisions.

[9] Specifically, the report pointed out CBD containing cannabis extracts and oils, used particularly in e-cigarettes (with or without nicotine), and stressed the lack of clarity of the regulation on cannabis extracts or synthetic CBD in e-liquids under the Tobacco Products Directive.

[10] The call for evidence was opened from May 20, 2022 until June 17, 2022 (see Have your say: Evaluation of the legislative framework for tobacco control).

[11] Specifically, according to the Call for evidence for the evaluation of the legislative framework for tobacco control (available on the web page of Have your say: Evaluation of the legislative framework for tobacco control), a big variety of emerging products (e.g., heated tobacco products, nicotine-free e-cigarettes, and nicotine pouches) has entered the EU market, new virtual environments (including web shops and information society services such as social media) have surfaced, and new public health interference strategies of tobacco and related industries have emerged.

[12] See Call for evidence for the evaluation of the legislative framework for tobacco control

[13] These policies concern sales arrangements and policies such as education, communication, training and public awareness, tobacco advertising, promotion and sponsorship, demand reduction measures concerning tobacco dependence, protection of the environment and the health of persons and research, surveillance and exchange of information. The Tobacco Taxation Directive 2011/64/EU and the Council Recommendation on Smoke-Free Environments 2003/54/EC are not evaluated in the present process (see Call for evidence for the evaluation of the legislative framework for tobacco control).

[14] They include both nicotine-containing and nicotine-free e-cigarettes (see Call for evidence for the evaluation of the legislative framework for tobacco control).

[15] Products that contain tobacco-derivated or synthetic nicotine and other flavoring agents. They are placed in the mouth next to the gums, usually behind the lip (see Call for evidence for the evaluation of the legislative framework for tobacco control).

[16] Heated herbal sticks, i.e., tobacco-free, nicotine-free, and tar-free herbal cigarettes coming with vape pens which resemble those used for heated tobacco products (see Call for evidence for the evaluation of the legislative framework for tobacco control).

[17] Article 20 par. 5 of the Tobacco Products Directive

[18] The legal age limit for the purchasing of tobacco products is not harmonized by the Tobacco Products Directive and is established by the legislation of the EU Member States.

[19] See Call for evidence for the evaluation of the legislative framework for tobacco control

[20] See Have your say: Evaluation of the legislative framework for tobacco control

[21] See Europe’s Beating Cancer Plan: Implementation Roadmap

Photo of Azim Chowdhury Azim Chowdhury

Azim Chowdhury is a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation. He is a Partner in Keller and Heckman’s nationally-ranked food and drug law practice.

Mr. Chowdhury advises domestic and foreign corporations in matters of…

Azim Chowdhury is a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation. He is a Partner in Keller and Heckman’s nationally-ranked food and drug law practice.

Mr. Chowdhury advises domestic and foreign corporations in matters of Food and Drug Administration (FDA) and international regulatory compliance. In particular, he has developed expertise in tobacco and vapor product regulation relating to the implementation of the Family Smoking Prevention and Tobacco Control Act, and spearheaded the Tobacco and E-Vapor practice at Keller and Heckman. Specifically, Mr. Chowdhury has experience representing tobacco, e-cigarette and e-liquid manufacturers, distributors, retailers, suppliers and trade associations in matters of FDA, state and global regulatory compliance. He also assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and European Union, with an emphasis on indirect additives used in food-contact materials.

Mr. Chowdhury has authored and edited numerous articles and publications, including Tobacco Regulation and Compliance: An Essential Resource, FDA Regulation of Tobacco: A Comprehensive Guide – An FDLI Primer and Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition. He is a frequent contributor to the Food and Drug Law Institute’s (FDLI) Update Magazine and has served on the Editorial Advisory Board of the Food and Drug Law Journal.  In addition, he has been interviewed in the U.S. News and World Reports Best Lawyers Edition (2016) and was named one of “10 Names to Know in the Vape World” in the October 2015 issue of Vape Magazine. Mr. Chowdhury received the 2018 National Law Review Go-To Thought Leadership Award for his consistent coverage of the emerging issues surrounding vaping and e-cigarettes on Keller and Heckman’s law blog, The Continuum of Risk.  As an industry leader, Mr. Chowdhury frequently speaks at industry conferences and events.

Mr. Chowdhury also has an active pro bono practice through Keller and Heckman’s Pro Bono Program, and has been featured in the Baltimore Sun for successfully obtaining asylum in the United States for a family who fled their home country of El Salvador because of violence they faced from an international gang.

Prior to entering private practice, he served as a judicial law clerk on the Court of Special Appeals of Maryland. Mr. Chowdhury received a B.A. and B.S. from Johns Hopkins University, a MBA from the University of Maryland Robert H. Smith School of Business, and a JD, cum laude, from the University of Maryland School of Law.

Education: Johns Hopkins University (B.A., B.S., 2003); University of Maryland Robert H. Smith School of Business (M.B.A., 2006); University of Maryland School of Law (J.D., 2006, cum laude).

Admissions: District of Columbia; Maryland

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Photo of Ales Bartl Ales Bartl

Ales Bartl has a broad experience in European Union (EU) product regulatory law, including Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, the Classification, Labelling, and Packaging (CLP) regulation, Biocidal Products Regulation (BPR), medical devices, electronic products, and general product compliance and…

Ales Bartl has a broad experience in European Union (EU) product regulatory law, including Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, the Classification, Labelling, and Packaging (CLP) regulation, Biocidal Products Regulation (BPR), medical devices, electronic products, and general product compliance and product safety. He advises on regulatory compliance of a broad range of products marketed in the EU and represents clients before EU and national competent authorities on compliance and enforcement issues, including product withdrawals and recalls.

Ales also represents clients before the Court of Justice of the European Union and the Board of Appeal of European Chemicals Agency.

Prior to joining Keller and Heckman, Ales interned at the European Commission (EC) and worked for almost ten years as an EU regulatory associate at two international law firms in Brussels.

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Photo of David J. Ettinger David J. Ettinger
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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    The Continuum of Risk
  • Organization:
    Keller Heckman
  • Article: View Original Source

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