Nicotine pouches are no longer considered to be a medicinal product

Nicotine pouches are no longer considered to be a medicinal product

During the last session of the Joint Commission in September 2021, the nature of nicotine pouches was again questioned. It was concluded that they are no longer part of the medicinal products’ family. Despite the standard 10mg dose being considered safe to avoid the risk of poisoning, manufacturers should consider specific recommendations concerning the nicotine yield and the maximum daily dose, use by children, and therapeutic claims.

What are nicotine pouches?

Nicotine pouches are manufactured using a form of dehydrated nicotine with added flavors, and they usually contain plant fibers, flavorings, and sweeteners. They are consumed by being placed between the lip and gum and they are not supposed to be spitted. Nicotine is absorbed into the bloodstream via the mucous membranes in the mouth. They differ from the snus pouches, which are made of tobacco leaf.

New advice with recommendations for manufacturers


According to the Joint Commission’s latest opinion, nicotine pouches are no longer considered medicinal products, since it has been proved that the usual doses used by adult consumers do not cause any adverse effects, such as the controversial intoxication risk.

However, nicotine pouches can still be harmful, since they remain a nicotine-based product. For this reason, manufacturers shall produce pouches containing no more than 20 mg, indicating the recommended numbers of pouches to be consumed per day on the packaging.

Children Safety and therapeutical claims

Nicotine pouches cannot be sold or offered to minors, considering that their different body structure increases the risk of side effects.

Finally, these products may not bear therapeutic claims. Claims like 'Helps to quit smoking' would make the product a medicinal product, even if the claim is only mentioned on the website and not on the product’s packaging.

The Joint Commission has submitted its recent opinion to the FPS Health, Food Chain Safety and Environment to evaluate whether nicotine pouches could be considered as a 'similar product', as stated in the law of January 24, 1977, governing foodstuffs and other products. Additionally, an opinion from the Superior Health Council on the matter is still pending (FAMHP, 2021).

What are the current Regulations of Nicotine Pouches?

  • Europe – EU: The European Union has put a ban on tobacco snus, while nicotine pouches are not regulated under the current tobacco regulations. The EU Commission has defined Nicotine Pouches as a consumer product with non-pharmaceutical nature which resemble tobacco for oral use subject to the TPD bans under Article 17.
  • Europe – UK: Since Nicotine pouches are tobacco-free products and they do not have medicinal claims, they are not regulated neither by Tobacco and Related Products Regulations (TRPR) neither by the MHRA . The most applicable regulation is the General Product Safety Regulations (GPSR). Recently the COT Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment has published a preliminary paper to discuss the bioavailability of nicotine and other ingredients from the use of oral nicotine pouches and assessment of risk to users.
  • Europe – Scandinavia: The EU ban on snus is not applying in Sweden. In 2019, the Swedish National Food Administration advised that, since nicotine pouches are mostly absorbed through the mouth and not the stomach, they should not be regulated as food. In Norway it is legal to buy snus, but not possible to buy nicotine pouches;
  • Europe – Germany: In 2021, nicotine pouches introduced on the German market were removed, as the German Office of Consumer Protection and Food Safety (BVL) declared that nicotine pouches cannot be sold legally since they are not regulated under either the tobacco nor the food legislation;
  • USA: The US Food and Drug Administration (FDA) has regulated nicotine pouches by stating an age restriction, a nicotine health warning and pre-market assessment;
  • Australia: Nicotine pouches, e-cigarettes and heated tobacco products are banned from sale;
  • New Zealand: In 2017, the authorities reviewed their tobacco policy and adopted a harm reduction strategy, intending to make New Zealand smoke-free by 2025, stating that non-smoking tobacco products and new nicotine products must be given prior approval to be sold in the country.
  • Canada: From November 2020, it is possible to buy nicotine pouches, however, the Canadian government warns of its harmful effect on health.
Get in touch

Maria Giulia Sardone

26.10.2021

Regulatory Affairs Department


References:

- FAMHP. (2021). Nicotine pouches are no longer considered to be a medicinal product. Retrieved on 26/10/2021 from https://www.famhp.be/en/news/nicotine_pouches_are_no_longer_considered_to_be_a_medicinal_product

- Federal Office of Consumer Protection and Food Safety (2020) Inclusion of nicotine-free e-cigarettes and refillable containers in the scope of application of the German tobacco products act from January 1, 2021. Retrieved on 02/12/2021 from   https://www.bvl.bund.de/SharedDocs/Fachmeldungen/03_verbraucherprodukte/EN/2020/2020_11_16_Fa_Aenderung_Tabak_engl.html;jsessionid=49BEDFFF5B6CA1EB6DCBFD3B08E49E29.1_cid290

- European Commission. (2021). Report From The Commission To The European Parliament, The Council, The European Economic And Social Committee And The Committee Of The Regions

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0249&from=EN

- Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment. (2021). A summary of data on the bioavailability of nicotine and other ingredients from the use of oral nicotine pouches and assessment of risk to users. Retrieved on 02/12/2021 from

https://cot.food.gov.uk/sites/default/files/2021-05/TOX-2021-22%20Nicotine%20pouches.pdf

- Christofer Fjellner. (2020). Innovation and Less Harmful Alternatives to Tobacco: The Case of Nicotine Pouches Regulation. Retrieved on 02/12/2021 from https://ecipe.org/publications/less-harmful-tobacco/#_ftn4

- Australian Government Department of Health. (2021). Smoking and tobacco laws in Australia. Retrieved on 02/12/2021 from https://www.health.gov.au/health-topics/smoking-and-tobacco/about-smoking-and-tobacco/smoking-and-tobacco-laws-in-australia

- New Zealand Ministry of Health. (2021). Regulation of vaping and smokeless tobacco products. Retrieved on 02/12/2021 from https://www.health.govt.nz/our-work/regulation-health-and-disability-system/regulation-vaping-and-smokeless-tobacco-products

- Government of Canada. (2021). Vaping Products – New limits on nicotine concentration and consultation on flavour restrictions. Retrieved on 02/12/2021 from https://www.canada.ca/en/health-canada/news/2021/06/backgrounder-vaping-products--new-limits-on-nicotine-concentration-and-consultation-on-flavour-restrictions.html

- US Food and drugs Administration (2021), FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products. Retrieved on 02/12/2021 from https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products

- Tobacco Tactics. (2021). Nicotine Pouches. Retrieved on 26/10/2021 from https://tobaccotactics.org/wiki/nicotine-pouches/