Are Nicotine Pouches Legal in Italy

What it means: The new legal framework for nicotine bags will bring clarity to the market for these products in Italy, whereas until now they were considered consumer goods and fell into a legal grey area. Health officials in Rome are considering regulating nicotine bags in Italy after seizing and banning the sale of a brand of such products, according to a laboratory analysis by the Higher Institute of Health (ISS). – Federal Office for Consumer Protection and Food Safety (2020) Inclusion of nicotine-free electronic cigarettes and reusable containers in the scope of the Tobacco Products Act from 1 January 2021. Accessed on 02/12/2021 by www.bvl.bund.de/SharedDocs/Fachmeldungen/03_verbraucherprodukte/EN/2020/2020_11_16_Fa_Aenderung_Tabak_engl.html;jsessionid=49BEDFFF5B6CA1EB6DCBFD3B08E49E29.1_cid290 In some countries, legislation is uncertain. Non-tobacco nicotine sachets have been banned in the state of Bavaria, while the Federal Office for Consumer Protection and Food Safety (BVL) has recognised that the products are not regulated by the Tobacco Act and should not be placed on the market. The BVL has determined that nicotine bags are a food that contains a new unauthorized food ingredient (nicotine) and is therefore illegal to sell. Source: Euromonitor International Passport, Tobacco Control System, published in May 2022. Brands ranked top-down based on global sales volume (millions of units in 2021). 1 unit = 1 sachet of nicotine* Since 2020, British American Tobacco (BAT) has been consolidating its product portfolio under the Velo brand. Lyft has been rebranded as Velo, which explains its negative volume growth rate in 2021.

The countries listed in “Presence in the main country” are ranked high to low for volume sales of at least 10 million units based on the brand`s sales volume in 2021. In July 2021, PMI announced that it had acquired Fertin Pharma, a company specializing in nicotine replacement therapy (NRT) products.32 At that time, PMI also began referring to nicotine gums and bags as “modern oral” products, as BAT does.32 The company told TobaccoIntelligence in June 2021 that it does not sell nicotine bags in Italy. but might be interested if clear rules were introduced. This followed the seizure of a number of Swedish bags from the Match Zyn brand, which went on sale in Rome. – Commission on the Toxicity of Chemicals in Foodstuffs, Consumer Products and the Environment. (2021). A summary of data on the bioavailability of nicotine and other ingredients from the use of oral nicotine bags and the assessment of the risk to users. Retrieved on 02/12/2021 from It is legal to buy nicotine replacement therapy (NRT) products in pharmacies without a prescription and it can be marketed. The NRT market in Italy represents €12.9 million. In 2019, BAT introduced nicotine bags into its wallet and marketed them as Lyft in the UK and Velo in the US.789 A July 2019 report suggested that BAT`s nicotine bags were also available for sale in Sweden, Italy and Tanzania.10 BAT began promoting Lyft/Velo in “emerging markets” in low- and middle-income countries (see below). Nicotine bags are subject to a variety of regulations around the world depending on how they are defined and classified, and in many cases there are no regulations.

All of the “Big Four” TTC (PMI, BAT, JTI, Imperial Brands) invested in Swedish snus and related products called nicotine bags, which they promoted as part of their harm reduction strategies. In other countries, nicotine bags are explicitly banned, such as in Kenya, which banned nicotine bags in February 2022. BAT launched Lyft in Kenya and then pulled it out. In Europe, it remains to be seen whether the EU`s Tobacco Products Directive 3 (which is unlikely to come into force until 2025) will provide more guidance on the regulation of nicotine bags. In Italy, where sales of nicotine sachets are currently relatively low, nicotine sachets will officially fall under tobacco law from 1 January 2023 and will be taxed at €22 per kg for the first time. As for the 36 countries covered by the Tobacco Processing Index, nicotine bags are allowed in 24 countries (often considered consumer goods by regulators). Of the 24 markets in 2021, there was a remarkable market size (more than 10 million units) in seven: United States, Sweden, United Kingdom, Germany, Ukraine, Switzerland and Poland [4]. Nicotine bags are sold as consumer goods, unlike nicotine replacement therapy (NRT) products, which require a pharmaceutical license and are traditionally beyond the capabilities of tobacco companies.

Of the 15 companies ranked by the Tobacco Transformation Index®, seven offer nicotine bags so far. Nicotine bags are a fast-growing but relatively small category, accounting for 0.3% of the global tobacco market in terms of value in 2021. Italy complies with the European Tobacco Products Directive (TPD) (2014). The Italian law implementing the TPD is Legislative Decree No. 6 of 12 January 2016. Therefore, e-cigarettes are regulated as tobacco products. Indoor vaping bans apply to government buildings. Recent legislative changes (2018) have made distance selling and online sales illegal. Some online commentators are concerned that a recent tax increase that applies to e-cigarettes, but not heated tobacco products, is preventing safer nicotine consumption.

On 13 December 2018, the Chamber of Deputies adopted a tax decree that will reduce by 80% the current taxation of e-liquids containing nicotine for electronic cigarettes. This would reduce the current high tax from almost 4 euros for a 10 ml bottle to a slight tax of 80 cents (for e-liquids containing nicotine). Table 1 does not include Philip Morris International, which acquired AG Snus and its Shiro brand in May 2021. The brand has a limited presence in the Swedish market. Small businesses are entering the niche market. For example, next-generation British nicotine and CBD maker V&YOU launched a new nicotine &Boost+ bag in September 2021. Nicotine bags are made using a dehydrated form of nicotine with added flavors and usually contain plant fibers, flavorings, and sweeteners. They are consumed by placing them between the lip and the chewing gum, and they are not meant to be spat out.

Nicotine is absorbed into the bloodstream through the mucous membranes of the mouth. They are different from snus bags, which consist of tobacco leaves. Nicotine vapers (e-cigarettes) are legal in Italy and there are 721,900 vapers in the country, which equates to a vaping prevalence of 1.37% among adults. Vaping devices can only be sold to people over the age of 18, the package must include a health notice, and there are restrictions on the nicotine content they can contain. Heated tobacco products are legal, but the situation is a little more complicated for snus. Although it is illegal to import snus for trade or buy the product online, it is possible to import it for personal use. An important finding of the SmPC is that “nicotine replacement therapy (NRT) is more effective in helping people quit smoking when used with the input and support of healthcare professionals, but much less so when used alone.” 70 If nicotine sachets were sold as consumer goods, that would not be the case. However, she did not mention whether the new law should also establish rules for nicotine bags.

BAT`s website for its “modern and traditional oral products” states that it markets Niconovum NRT products in the United States and Sweden under the Zonnic brand. It also states that “in Sweden, Zonnic products include tobacco-free nicotine bags.” 6667 Bat (renamed R.J. Reynolds Vapor Company) converted its Revel nicotine street into Velo and submitted it for pre-market approval in the United States.6869 In May 2021, PMI acquired Danish snus manufacturer AG Snus, which makes nicotine bags.3031 This acquisition was not widely used at the time. For more information, see Cigarette companies that invest in snus. Elsewhere, nicotine bags may not have been formally regulated by law under tobacco legislation, as in Mexico. In these cases, there is no legislation for the introduction of the product on the market and there is a lack of legislation on the advertising of nicotine bags. Nicotine bags are officially regulated on the Italian market after a bill was approved by the country`s Senate. The Chamber of Deputies had already approved the text. cot.food.gov.uk/sites/default/files/2021-05/TOX-2021-22%20Nicotine%20pouches.pdf nicotine bags are similar to snus bags in that they can be placed between the lip and chewing gum and do not need to be spat out. However, they do not contain a tobacco leaf, but a form of dehydrated nicotine (with additional flavors) and do not need to be kept cold.2 Nicotine is absorbed into the bloodstream through the mucous membranes of the mouth.23 Bags usually also contain vegetable fibers, flavors, and sweeteners.3 These are not new products, and similar mouth sacs with a different nicotine content have been available in Sweden for many years.

Regulated as a food.3 In response to concerns about the potential impact on tobacco producers, Business Daily Africa reported that BAT`s head of legal and external affairs said the company “uses the proceeds of the tobacco portfolio to invest in new categories. When the time comes, we will help them (farmers) switch to sustainable crops,” although this “is not a change that can happen overnight.” 50 Spencer-Obatyoinbo confirmed that the switch from BAT to “non-combustible materials” was “not an immediate thing”.50 Nevertheless, it was reported that BAT lobbied the Kenya Revenue Authority (KRA) for tax relief on the product in September 2020. citing its high investments and potential exports.51 (According to bat, nicotine for its bags is currently produced in Switzerland.) 51 The Executive Director of the International Institute of Legislative Affairs argued that this would be a “major setback for tobacco control interventions in Kenya”.52 For more information, see the country`s profile page in Kenya.