A. LEGAL CLASSIFICATION AS FOOD
Nicotine pouches are considered food under case law and are measured against food regulations.
“Nicotine pouches’ (tobacco-free nicotine pouches for oral use) are likely to be ‘foodstuffs‘ within the meaning of Article 2(1) of Regulation (EC) 178/2002. Their essential ingredients, which in addition to nicotine also include sweeteners and flavorings, are likely to (also) enter the gastrointestinal tract to a not merely insignificant extent in the course of consumption lasting up to thirty minutes through the unavoidable formation of saliva. The term “food” in Article 2 (1) of Regulation (EC) 178/2002 may also include those products that are not consumed as such, but whose substances are ingested by humans when used as intended, because they regularly (also) enter the gastrointestinal tract via saliva to a not merely insignificant extent. Insofar as the legislator has stipulated in Article 2 (2) of Regulation (EC) 178/2002 that “foodstuffs” also include chewing gum, this is probably an exemplary clarification for the latter type of product and not a conclusive clarification in the narrow sense. (OVG Hamburg, decision of 19.8.2021, Az. 5 Bs 56/21, Leitsatz, LMuR 2022, 43, beck-online).
“Nicotine pouches, which contain nicotine and flavorings in a permeable casing in addition to a carrier for release in the oral cavity and for absorption via the oral mucosa, are foods within the meaning of Art. 2 of the Basic Food Regulation, which, depending on the amount of nicotine, may be harmful to health within the meaning of Art. 14(2)(a) of the Basic Food Regulation [Note: Regulation (EC) 178/2002]” (OVG Lüneburg, decision of 9.2.2021, Az. 13 ME 580/20, LMuR 2021, 203, beck-online).
“The tobacco-free nicotine pouches (Nicotine Pouches) distributed by the applicant are in all likelihood to be classified as foodstuffs within the meaning of Art. 2 VO (EC) 178/2002.” (VG München Beschl. v. 20.5.2021 – M 26b S 20.6309, BeckRS 2021, 12923 Rn. 44, beck-online).
This is partly criticized in the literature. Reinhart, comment on OVG Hamburg, decision of 19.8.2021, Az. 5 Bs 56/21, LMuR 2022, 43, beck-online). Reinhardt would like to see the product safety regulations (ProdSG) applied:
“According to the general regulations of the product safety law, the safety and health of persons must not be endangered when used as intended or in a foreseeable manner (§ 3 para. 1 no. 2 ProdSG). Since tobacco-free nicotine pouches are made available as a product on the market as part of a business activity, the scope of application of the Product Safety Act is in any case fundamentally open (Section 1 (1) ProdSG). The nicotine pouches are also consumer products in the sense of § 2 No. 25 ProdSG, which may only be made available on the market if they are safe (§ 6 ProdSG). As far as a – under consideration of given application and warning instructions – intended use of an in itself defect-free product is given, a health hazard resulting from the nature of the product is no subject of the ProdSG, however, if necessary, chemical-legal specifications can be additionally considered” (Reinhart, comment on OVG Hamburg, decision of 19.8.2021, Az. 5 Bs 56/21, LMuR 2022, 43, beck-online).
B. HEALTH HAZARD WITHIN THE MEANING OF ARTICLE 14(2)(A) OF REGULATION (EC) 178/2002
Depending on the amount of nicotine, it is assumed that there is a health hazard within the meaning of Article 14 (2) (a) of Regulation (EC) 178/2002:
“The initial decision is based on a food technical analysis, namely the toxicological risk assessment of tobacco-free nicotine pouches by the Bavarian State Office for Health and Food – LGL – dated 23. 4. 2020. According to this, the oral intake of a nicotine pouch exceeds the limit value announced by the European Food Safety Authority EFSA by a factor of 36 to 175 and the tested nicotine pouch is judged to be harmful to health and thus not safe according to Article 14 (2) (a) of the Basic Regulation” (OVG Lüneburg, decision of 9.2.2021, Ref. 13 ME 580/20, LMuR 2021, 203 Rn. 21, 22, beck-online).
“The nicotine pouches are likely to be classified as harmful to health within the meaning of Article 14 (2) (a) of Regulation (EC) 178/2002. Nicotine is a substance which in itself is likely to be highly unhealthy even if it is not ingested by way of tobacco smoking, but rather without tobacco or smoke (aaa). The reference values for nicotine levels in foodstuffs that are harmful to health, which were used by the respondent on the basis of the CVUA expert opinion of 17.9.2020, are not objectionable in the context of the present summary proceedings (bbb). The other objections raised by the applicant in this context are not valid (ccc)“. (OVG Hamburg, decision of 19.8.2021, ref. 5 Bs 56/21, LMuR 2022, 43, beck-online).
“In an expert opinion dated November 5, 2020, the Bavarian State Office for Health and Food Safety (LGL) judged several Nicotine Pouches to be harmful to health due to their nicotine content and therefore not marketable. These included the products “ZYN CITRUS MINI NICOTINE POUCHES STRENGTH 4” (ZYN) and “VELO Berry Frost Nicotine Pouches EASY” (VELO). (…) In the toxicological risk assessment in the expert reports, a significant exceedance of the ARfD value derived by the European Food Safety Authority (EFSA) from the results of a human study (value of the acute reference dose, i.e. the amount of substance per kg body weight that can be ingested in the diet with one meal or within one day without any apparent risk to the consumer; originally developed for pesticide residues in fruit, cf. https://www.lgl.bayern.de/ was found to be 20-, 51-, and 101-fold, respectively, depending on the release of 20%, 50%, or 100% of the nicotine contained in a pouch. For the product VELO, a significant exceeding of the ARfD value, namely by a factor of 11, 29 or 58 – depending on the release of 20%, 50% or 100% of the nicotine contained in a pouch – was also determined in the case of oral consumption of a portion pouch” (VG Ansbach judgment of July 27, 2022, Az. AN 14 K 20.02641, BeckRS 2022, 23337 Rn. 3, beck-online).
There is talk of withdrawing products from the market if the ARfD value of 0.0008mg/kg body weight is applied and the products exceed this value (Deutscher Bundestag, Wissenschaftliche Dienste, Zulässigkeit des Verkaufs von tabakfreien Nikotinbeuteln (“Nicotine Pouches”) und Lutschtabakprodukten (“Snus”) in Deutschland, p. 5, https://doi.org/10.17590/20211221-131258).
“Currently, nicotine in pouches is classified as a novel food by regulatory agencies. If the ARfD value of 0.0008 mg/kg bw is applied, nicotine pouches containing nicotine levels presented in this report will be withdrawn from the market,” Health Evaluation of Nicotine Pouches, 7 Oct. 2022, p. 16, https://www.bfr.bund.de/).
Conclusion:
In view of the aforementioned case law, it must be assumed that “Nicotine Pouches” that exceed the permissible limit of nicotine in food (significantly exceeding the ARfD value) are not marketable.
There is uncertainty regarding the future legal assessment. The legal evaluation may not yet be completed, as this is a relatively new topic.
Legal Policy:
The legislator has refused to create a statutory regulation. It refers to the fact that such a regulation can only be uniform across the EU (Deutscher Bundestag, Wissenschaftliche Dienste, Zulässigkeit des Verkaufs von tabakfreien Nikotinbeuteln (“Nicotine Pouches”) und Lutschtabakprodukten (“Snus”) in Deutschland, p. 5, https://www.bundestag.de/).
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