{"id":6320,"date":"2022-05-11T08:04:05","date_gmt":"2022-05-11T06:04:05","guid":{"rendered":"https:\/\/snusforumet.se\/?p=6320"},"modified":"2022-05-16T11:14:33","modified_gmt":"2022-05-16T09:14:33","slug":"docs-expose-dg-sante-duplicity-on-nicotine-pouch-regulation","status":"publish","type":"post","link":"https:\/\/snusforumet.se\/en\/docs-expose-dg-sante-duplicity-on-nicotine-pouch-regulation\/","title":{"rendered":"Docs expose DG SANTE \u2018duplicity\u2019 on nicotine pouch regulation"},"content":{"rendered":"\n

Previously unreleased EU documents obtained by Snusforumet reveal the European Commission’s DG SANTE exaggerated claims about member states\u2019 desire for EU-wide regulation and calls to ban tobacco-free nicotine pouches.<\/strong> UPDATE 12 May: DG SANTE comments added below the story. <\/em><\/strong><\/p>\n\n\n\n

According to Patrik Str\u00f6mer, Secretary General of the Association of Swedish Snus Manufacturers, the documents raise questions about whether DG SANTE<\/a>, the EU body responsible for regulating health and food safety and which is actively examining a possible EU-wide regulation of nicotine pouches, is “putting words in the mouths of member states”.<\/p>\n\n\n\n

\u201cIt\u2019s hard to see these documents and not see DG SANTE\u2019s biased exaggeration as anything other than evidence of a prejudice against nicotine pouches,\u201d he adds.<\/p>\n\n\n\n

The documents \u2013 obtained via a Freedom of Information request filed by BAT and reviewed by Snusforumet \u2013 originate from the Commission\u2019s Health and Food Safety Directorate General<\/a>, commonly referred to as DG SANTE by Brussels insiders.<\/p>\n\n\n\n

They include email correspondence sent to and from DG SANTE between August and November 2021 ahead of the 17th meeting of the directorate\u2019s Group of Experts on Tobacco Policy, held on December 2nd, 2021<\/a>.<\/p>\n\n\n\n

DG SANTE ‘informal’ survey<\/h2>\n\n\n\n

Founded in 2014, the group<\/a> aims to \u201cassist the Commission in the preparation of policy initiatives for incentive measures in the area of tobacco control\u201d. The expert body also facilitates cooperation and consultation among member states regarding legislative proposals under the Tobacco Products Directive.<\/p>\n\n\n\n

Among other items discussed<\/a> at the December 2021 meeting were the results of an \u201cinformal\u201d survey sent to member states related to nicotine pouches \u201cin the context of medicinal products legislation\u201d.<\/p>\n\n\n\n

The presentation<\/a>, available to the public along with the minutes of the meeting<\/a>, reveals the survey elicited responses from only nine member states, with nicotine pouches legally available as consumer products in six.<\/p>\n\n\n\n

Two member states regulated pouches with medicinal products legislation, while four were considering regulating pouches under such legislation. Finland, the only one of the survey respondents to be identified publicly, was also the only member state that had specific regulations for nicotine pouches.<\/p>\n\n\n\n

\u201cMost Member States have called for a EU level legislation that regulates these products (including banning nicotine pouches),\u201d the presentation states<\/a> at the conclusion of the survey results presentation – a claim repeated in the minutes of the meeting, which are also available to the public.<\/p>\n\n\n\n

\"\"<\/figure><\/div>\n\n\n\n

Missed deadlines, few responses<\/h2>\n\n\n\n

However, a review of emails and actual survey results obtained by Snusforumet paints a vastly different picture. What emerges is an image of an agency desperate to manufacture a position from member states despite lukewarm interest in the issue.<\/p>\n\n\n\n

DG SANTE even enlisted assistance from the European Medicines Agencies Co-operation of Legal and Legislative Issues<\/a> (EMACOLEX) to help disseminate the survey<\/a>.<\/strong><\/p>\n\n\n\n

But emails indicate the deadline for the survey was pushed back repeatedly due to a lack of responses ahead of the original September 15th deadline.<\/p>\n\n\n\n

\u201cI am glad that you received more replies, although the number is still quite low. Maybe presentation and discussion will encourage additional member states to share their views on this topic,\u201d a representative from JAZMP<\/a>, the Slovenian medical products agency and acting chair of EMACOLEX writes to DG SANTE on November 17, 2021<\/a>, upon learning a total of eight responses had been collected.<\/p>\n\n\n\n

\"\"<\/figure><\/div>\n\n\n\n

Emails also indicate the survey remained open till at least December 8th,<\/a> a full week after the December 2nd meeting where the results were presented.<\/p>\n\n\n\n

\u201cInstead of accepting that member states perhaps didn\u2019t have a position on the issue or weren\u2019t interested in responding, DG SANTE decided it could simply put the words it wanted to hear into the mouths of member states,\u201d says Str\u00f6mer.<\/p>\n\n\n\n

How does DG SANTE define ‘most’?<\/h2>\n\n\n\n

Furthermore, a review of the actual survey responses<\/a> – and the countries that submitted them \u2013 cast doubt on DG SANTE\u2019s claim that \u201cmost\u201d member states want EU-level regulation of nicotine pouches, including an outright ban.<\/p>\n\n\n\n

The survey consisted of five questions<\/a> focusing on the presence and current regulation of nicotine products in member states. Two of the questions specifically addressed member states’ views on whether nicotine pouches should be regulated as a medicinal product.<\/p>\n\n\n\n

The final question asked member states to provide comments on the possible role of nicotine pouches in national tobacco cessation policies and their \u201cinterference\u201d with other nicotine replacement therapies.<\/p>\n\n\n\n

In addition to Finland, respondents to the survey include the Czech Republic, Spain, Ireland, Hungary, Latvia, the Netherlands, Portugal, and Slovenia – one-third of EU member states representing roughly a quarter of the total EU population.<\/p>\n\n\n\n

Contrary to the impression given by the DG SANTE\u2019s claims, only one member state – the Netherlands – indicated it was in favour of banning nicotine pouches.<\/p>\n\n\n\n

\u201cOur government is of the opinion that there is no room for these products in tobacco cessation policy,\u201d the Dutch response reads<\/a>.<\/p>\n\n\n\n

DG SANTE: prejudiced on pouches?<\/h2>\n\n\n\n

Five of the respondents indicated they were in favour of regulating nicotine pouches at the EU level. Ireland, Slovenia, Hungary, and Latvia saw the EU\u2019s TPD as the most logical way forward, while the Czech Republic and Finland expressed an interest in a common EU-wide approach without specifying any further.<\/p>\n\n\n\n

Spain, meanwhile, had no comment on the question of EU-wide regulation, stating that \u201cwe understand nicotine pouches will be used for smoking cessation\u201d and thus should be regulated as medicinal products.<\/p>\n\n\n\n

Even though five of the nine survey respondents favoured EU-level regulations for nicotine pouches, that\u2019s a long way from claiming that \u201cmost\u201d support that position, Str\u00f6mer points out.<\/p>\n\n\n\n

\u201cThis is a frightening example of an EU body playing fast and loose with the numbers in order to find support – however tenuous – for their pre-determined position on nicotine pouches,\u201d he explains.<\/p>\n\n\n\n

‘Look at science and Sweden’<\/h2>\n\n\n\n

Str\u00f6mer emphasizes that manufacturers welcome nicotine pouch regulation<\/a>, as long as rules are based on available science<\/a> and take the harm reduction potential of nicotine pouches into account.<\/p>\n\n\n\n

\u201cWhat\u2019s missing from this discussion entirely is a proper look at the science and the public health impact<\/a> that the availability of smokeless products like snus and nicotine pouches has had in Sweden,\u201d he says.<\/p>\n\n\n\n

Following the publication of this article, a spokesperson for DG SANTE responded to Snusforumet’s requests for comment with the following statement:<\/p>\n\n\n\n

“The survey referred to in the minutes was a tool to collect feedback from the members of the EMACOLEX group on a topic of interest to the Union and its citizens. Similar exercises have been conducted in the Expert Group on Tobacco Policy meetings (recorded in the previous minutes published on the website, for example please see: Summary Record – 13th Meeting (21 March 2019)<\/a>). The main objective of these exercises was to better understand the regulatory approaches of the different Member States to nicotine pouches, while raising awareness for the presence of these products in the EU market and potential regulatory gaps. All replies were collected on a voluntary basis and regarded as adding progressive clarity to the topic. More so, the replies focused on information of individual national contexts.<\/em><\/p>\n\n\n\n

“One of the several findings presented in the meeting of 2 December 2021 was that among the survey respondents most \u201chave called for a legislative initiative at EU level that would regulate these products (including banning nicotine pouches)\u201d, which is derived from the replies of Member States to the survey questions. The need for a EU level approach\/guidance has also been a recurring finding from the other similar exercises. The published summary record reflects the collective recollection of the discussion on this point approved by all the participants.”<\/em><\/p>\n\n\n\n

\n\n\n\n

DG SANTE documents obtained by Snusforumet<\/h2>\n\n\n\n

<\/p>\n\n\n\n

DG SANTE nicotine pouch survey results<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex 5.08.2021 (DG SANTE)<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex 6.08.2021 (EMACOLEX Chair)<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex 6.08.2021 (DG SANTE)<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex 9.12.2021 (EMACOLEX Chair)<\/a><\/p>\n\n\n\n

Follow-up nicotine pouches survey 8.12.2021 (DG SANTE)<\/a><\/p>\n\n\n\n

Follow-up nicotine pouches survey 27.10.2021 (DG SANTE)<\/a><\/p>\n\n\n\n

Follow-up nicotine pouches survey 6.10.2021 (DG SANTE)<\/a><\/p>\n\n\n\n

Follow-up nicotine pouches survey 7.10.2021 (EMACOLEX Chair)<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex 27.10.2021 (INFARMED – National Authority of Medicines and Health Products, I.P)<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex (NL) 27.10.2021 (CBG-MEB)<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex (HU) 25.11.2021 (National Institute of Pharmacy and Nutrition)<\/a><\/p>\n\n\n\n

Nicotine pouches follow up – Emacolex (ES) 8.11.2021 (Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios – AEMPS)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Previously unreleased EU documents obtained by Snusforumet reveal the European Commission’s DG SANTE exaggerated claims about member states\u2019 desire for EU-wide regulation and calls to…<\/p>\n","protected":false},"author":3,"featured_media":6339,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[218],"tags":[418,481,258,349,273,248],"class_list":["post-6320","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulations","tag-bat","tag-dg-sante","tag-eu-2","tag-european-commission","tag-nicotine-pouches","tag-patrik-stromer-en"],"acf":[],"yoast_head":"\nDocs expose DG SANTE \u2018duplicity\u2019 on nicotine pouch regulation - Snusforumet<\/title>\n<meta name=\"description\" content=\"DG SANTE has exaggerated claims about EU member states\u2019 desire to ban nicotine pouches, previously unreleased documents show.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/snusforumet.se\/en\/docs-expose-dg-sante-duplicity-on-nicotine-pouch-regulation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Docs expose DG SANTE \u2018duplicity\u2019 on nicotine pouch regulation - 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