Atti del XXIV Convegno Nazionale Tabagismo e Servizio Sanitario Nazionale
Pubblicato: 2022-09-21

Update on new tobacco and nicotine products

Ufficio 8 - Promozione della salute e prevenzione e controllo delle malattie cronico-degenerative Direzione generale della prevenzione sanitaria Ministero della Salute, Roma
Ufficio 8 - Promozione della salute e prevenzione e controllo delle malattie cronico-degenerative Direzione generale della prevenzione sanitaria Ministero della Salute, Roma

Article

In the field of tobacco control, we discuss almost exclusively of cigarettes and cut tobacco. Only recently, attention was also expanded to two other products, electronic cigarettes and heated tobacco products, often confusing them with each other.

However, very little attention is paid to other tobacco products, including some of them very old, and to the very recent nicotine salts. We will therefore make a brief examination of the “other” tobacco products containing nicotine available in Italy that have their own specific diffusion (measured by market share) and their attractiveness that could suddenly spread as has already happened for Roll Your Own (RYO) tobacco, heated tobacco products and e-cigarettes.

For some of these products there is a definition within the legislative provisions that serve to regulate tobacco products, mainly the Directive 2014/40/EU (called Tobacco Products Directive, TPD) and the Legislative Decree No. 6/2016 which has ratified it in Italy. The presence of a definition within these laws is essential so that all the rules contained can be applied. On the contrary, the absence of a definition (or a definition that is too general) for a specific product result in an increased difficulty in controlling such product.

Cigars: they are defined in Article 2 paragraph 11 of the TPD as “a roll of tobacco that can be consumed through a combustion process”. They are probably the oldest of the tobacco products and they are considered a niche product even if on the Italian market, almost 2,000 different types of cigars are registered. The sale of this product in Italy is slightly increasing, passing from 600,000 kg sold in 2004 to almost 1,000,000 in 2021 with a market share rising from 0.8% to 1.2%. Excise taxes represent for this product 23.5% of the final price.

Cigarillos: are defined in Article 2 paragraph 12 of the TPD as “a type of small cigar (max 3.5 g), Rolls of tobacco filled with a mixture of beaten tobacco and equipped with an outer band of the typical color of cigars, of reconstituted tobacco, covering the product, including any filter”. About 50 products of this type are registered on the Italian market, taxation is equal to 24% of the final price and currently produce over 200 million euros in revenues and around 50 million euros in excise duties.

Given such definition of cigarillos, some manufacturers were able to use cigarillos to circumvent restrictions placed on traditional cigarettes (ban on 10 packs, images and warnings on 60% of the pack, restrictions on ingredients, etc.), creating a product very similar to conventional cigarettes but wrapped in a “leaf” of tobacco. This led to a substantial increase in sales which went from 400,000 kg in 2004 to 1,800,000 kg in 2019 with a market share growing from 0.6% to 2.5%.

Snuff, chewing and oral tobacco: three tobacco types defined in Article 2, paragraphs 6, 7 and 8 of the TPD as “smokeless tobacco products that can be consumed nasally; all tobacco products intended for oral use, consisting totally or partially of tobacco, in the form of powder, fine particles or any combination of these forms, especially those presented in pouches-portions or porous pouches”. These products represent a very small but rapidly growing niche in the market, they went from 10,000 kg sold in 2004 to 45,000 kg sold in 2021 where they represent only 0.05% of the Italian market share. There are only 13 products registered with a tax of 25.3% of the final price for a turnover of about 13 million euros and 4 million in excise duties. In 2020, the Ministry of Health, in collaboration with the Customs Agency and the Nuclei Antisofisticazioni e Sanità (NAS), removed one of these products from the market because it was considered too similar to the Swedish snus whose sale is prohibited in the rest of the EU.

Tobacco for water pipes (Hookahs). It is defined in Article 2 paragraph 13 of the TPD as “tobacco product that can be consumed with a water pipe. For the purposes of this Directive, water pipe tobacco is considered a smoking tobacco product”. The fact that it is considered as smoking products means that higher excise duties are imposed (56.5% of the final price) and that it is covered by the same regulations of conventional cigarettes such as the obligation of combined warnings and the prohibition of use in public places. There are no data on sales but during some checks carried out by the NAS and the Guardia di Finanza during the month of April 2022, 37 (64%) out of 58 controlled rooms did not have a smoking room or were irregular and in 17 (29%) of the premises, more than 70 kg of smuggled products were also seized.

Herbal products: are defined in Article 2 paragraph 15 of the TPD as “a product based on plants, herbs or fruit that does not contain tobacco and which can be consumed through a combustion process”. These products are regulated in articles 21 and 22 always of the TPD. Also, for these products, the fact of being considered as smoking means that higher excise duties are imposed (56.5% of the final price) and that they are covered by the same regulations of conventional cigarettes such as the obligation of combined warnings and the prohibition of use in public places. There is no official sales data, some brands are sold in pharmacies as smoking cessation products.

Chopped tobacco for pipes: it is defined in Article 2, paragraph 2 as “tobacco that can be consumed through a combustion process and intended exclusively for use in a pipe”. It is also a very “ancient” product. In 2004, 150,000 kg were sold and in 2021 almost 300,000 kg with a market share of 0.40%, which has doubled since 2004. They have a tax rate of 56.5% of the final price and there are over 300 registered products on the market Italian.

Heated tobacco products: they do not have a definition in the TPD and they can be traced back to the new generation tobacco products defined in Article 2 paragraph 14 as a tobacco product that: a) does not fall into the following categories: cigarettes, rolling tobacco, tobacco pipe tobacco, water pipe tobacco, cigars, cigarillos, chewing tobacco, snuff or oral tobacco; and b) is placed on the market after May 19, 2014”. These products are a prime example of how the absence of a definition in the TPD can hinder regulation and facilitate the spread of tobacco products. Since they were introduced on the Italian market at the end of 2014, sales have gone from a few thousand kg to over 9 million kg in 2021, making them the second best-selling product after cigarettes, with a market share of over 12. 0%. Also complicit are the tax breaks received by the Ministry of Economy which first taxed them with an excise duty equal to 50% of that of cigarettes and reducing it again in 2019 to 25%.

The current taxation system, as seen in Figure 1, makes it the least taxed product with a loss for the Italian State (and profit for the producer) of over 100 euros per every kg of product sold.

Bags with nicotine salts: they do not have a definition within the TPD. They are bags that are placed under the lips, those who use them ingest nicotine through the oral mucosa and saliva. They contain nicotine in varying quantities and concentrations (from 3 to 50 mg / g), along with other additives including sweeteners and flavors (mainly menthol and fruit). Since they have not been included in the TPD, they are not subject to any obligation relating to warnings, no limits on nicotine concentration, no obligation to open anti-children, no obligation to notify ingredients and no prohibition of advertising.

Of particular interest are the events related to these products that occurred in the period December 2020 February 2022. The Ministry of Health in collaboration with the National Chemical Substances Center of the Italian National Institute of Health ordered in May 2021 the ban on the sale of Swedish Match ZYN nicotine sachets because they were considered dangerous to health. In November 2021 the placing on the market of the similar VELO product of British American Tobacco was also prohibited for the same reasons but in February 2022, article 3-novies of law No.15 of 25 February 2022 (conversion of the Milleproroghe decree), defining the provisions on the consumption tax, it has in fact admitted to the marketing a new category of products, other than manufactured tobaccos, containing nicotine and preparations in order to allow the absorption of this substance, without combustion or inhalation, also through functional envelopes to their consumption. The rule does not provide for the classification of such articles as tobacco products under the TPD and authorizes the marketing in Italy of a type of article on which the Health Prevention Directorate General (DGPRE) had already expressed its opposition, as it is dangerous to health.

At the end of this discussion there are the following messages to keep in mind:

  1. among the tobacco products there are not only cigarettes;
  2. regulation almost always finds itself chasing the market. The TPD itself was developed in 2012 and is no longer able to take into account the new products that have entered the market over the last 10 years;
  3. there is a need for better regulation that is able to anticipate the introduction of future products.

Figures and tables

Figure 1.Excise taxation (euro) for each kilogram of product sold in Italy [1].

Figure 2.Risks associated with the entry into the market of nicotine salts according to the Dutch Institute for Health and the Environment (RIVM).

References

  1. Agenzia delle Accise, Dogane e Monopoli. Libro blu. 2020. Publisher Full Text

Affiliazioni

Lorenzo Spizzichino

Ufficio 8 - Promozione della salute e prevenzione e controllo delle malattie cronico-degenerative Direzione generale della prevenzione sanitaria Ministero della Salute, Roma

Daniela Galeone

Ufficio 8 - Promozione della salute e prevenzione e controllo delle malattie cronico-degenerative Direzione generale della prevenzione sanitaria Ministero della Salute, Roma

Copyright

© Sintex Servizi S.r.l. , 2022

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