Novel nicotine and tobacco products in pediatric age: a joint position paper | Italian Journal of Pediatrics

In the United States, the federal “Tobacco 21” law (2019, strengthened in 2024) forbids the sale of all tobacco and nicotine products, including e-cigarettes, HTPs, and nicotine pouches, to individuals under the age of 21. E-cigarettes and heated tobacco products are regulated under Tobacco 21 but are not approved as smoking cessation aids [47]. In August 2024, the Food and Drug Administration (FDA) further strengthened these regulations, focusing on unlawful items and sales to minors, especially flavored e-cigarettes and nicotine pouches [48]. Supplementary state and local regulations include taxation (Illinois), flavor bans (New York), restrictions on online sales (Vermont), and “Nicotine-Free Generation” statutes (Massachusetts). The FDA is currently proposing a tobacco product standard to regulate nicotine yield in cigarettes and other combusted tobacco products by September 15, 2025. This initiative aims to reduce addictiveness and support individuals in their efforts to quit smoking [47].

Australia strictly regulates nicotine containers and e-cigarettes, with vaping products exclusively available at pharmacies for smoking cessation purposes [49]. Nicotine pouches are unlawful without prescription and have not been approved for safety and efficacy [50]. New Zealand regulates e-cigarettes, HTPs, and nicotine pouches, focusing on flavors, nicotine levels, and age of sale to reduce appeal to young people. The Act includes restrictions on flavors, nicotine levels, and age of sale, with the aim of reducing the appeal of these products, especially among young people [51]. The retail sale of nicotine pouches is prohibited without specific medical approval.

In the United Kingdom, the Tobacco and Related Products Regulations regulate e-cigarettes by establishing restrictions on nicotine concentration, refill volumes, packaging, labeling, and advertising [52]. HTP are subject to the generic tobacco framework, which lacks any specific provisions. In contrast, nicotine pouches are currently regulated solely as general consumer products, with no restrictions on the age of sale, nicotine content, flavors, or marketing. Since June 1st, 2025, a ban on disposable vapes has come into force as the British government aims to stem their use and reduce health risks and litter, preventing the leaking of harmful chemicals into the environment. It is estimated that up to 5 million disposable vapes are discarded each week in the United Kingdom rather than being recycled [53]. In February 2025, France proposed to EU Commission to ban also nicotine pouches, classifying them as poisonous substances. (2025). The European Commission issued this notification, but its implementation was suspended until August 2025 following formal objections from several EU member states [54].

Germany regulates e-cigarettes and refill containers, with sales to minors under 18 prohibited under the Protection of Young Persons Act, which explicitly covers e-cigarettes and refill containers, with penalties for violations. HTPs are treated as conventional tobacco products [55]. Nicotine pouches are classified as unauthorized “novel foods” and commercial sale is prohibited unless specifically authorized under EU novel food regulation.

The regulation of e-cigarettes poses a significant challenge for global health authorities due to the rapid evolution of ENDS and their growing popularity, particularly among youth. Initially introduced as smoking cessation aids, e-cigarettes have evolved into recreational products, often marketed through channels attractive to adolescents [56]. Regulatory efforts vary widely across countries. Formally, all countries ban sales of nicotine products to minors, but enforcement varies. In most of the EU, legislation remains relatively lenient, indirectly, while in Australia, stricter controls have been implemented, allowing ENDS sale only via prescription. The U.S. has raised the minimum age for purchase to 21 years [57, 58]. In particular, the Australian policy seems quite effective in reducing vaping among youth. A comparative study between found that although New Zealand’s less restrictive policies, contributed to faster declines in adult smoking, they may also have increased youth vaping [59].

Despite such efforts, regulatory loopholes persist. For instance, nicotine-free vapes remain accessible to minors, and social media marketing continues to evade age-gating protocols. Many regulations impose product safety standards but do not formally approve e-cigarettes as smoking cessation tools [60, 61]. Also, the online market usually has weak control and less strict regulations, allowing people to escape from the bans. For instance, a study conducted in California [62] showed a rise in online shopping queries following the introduction of flavor restriction, showing that on-line market rules must be enforced in order to prevent irregular selling.

In Italy, the regulation of e-cigarettes falls under a combination of national and European Union laws. The main primary legislative framework comes from the European Tobacco Products Directive 2014/40, which Italy has implemented in 2016 [63, 64]. Italy regulates e-cigarettes as tobacco products, prohibiting sales to individuals aged 18 and over, banning online and distance sales, and restricting use in government buildings [65]. HTPs have lighter regulatory requirements and preferential taxation. Nicotine pouches, initially unregulated, have been subject to control since 2022, but are not covered by the tobacco regulations. This law regulates the manufacture, presentation, and sale of ENDS and refill containers. E-cigarette products must comply with rules on ingredient disclosure, health warnings, packaging, and advertising restrictions. Nicotine-containing e-liquids must not exceed a concentration of 20 mg/mL, and their packaging must include child-resistant mechanisms and warnings about addiction [66]. Italy prohibits the sale of e-cigarettes and HTPs to individuals under 18 years of age. Retailers must verify age both in physical stores and online, although enforcement of these rules has been inconsistently applied [67]. Moreover, in Italy, advertising is tightly restricted: promotional content for e-cigarettes is banned on TV, radio, newspapers, and magazines. However, on social media, youth-targeted content may still appear. To counteract this, the Italian Ministry of Health periodically issues public health warnings and campaigns highlighting the risks of youth vaping and nicotine addiction. Italy also imposes a tax on e-liquids, both with and without nicotine. This tax was initially high, leading to the growth of an illicit market and consumer pushback. In response, the government revised the tax structure in 2019 to make legal products more accessible while maintaining revenue and public health goals. Nonetheless, in 2022, 15% of 13-to 15-year-olds reported buying e-cigarettes directly from retailers, with nearly half getting them from a relative or friend. Furthermore, according to the Global Youth Tobacco Survey, more than 70% of current vapers who attempted to buy e-cigarettes or HTPs from tobacconists reported not being refused by the retailer because they were underage [21].

United Kingdom is another example that legislative intervention can actually determine a fast response in tackling vaping addiction. In 2024, the British government announced plans to introduce new vaping policies, including a ban on disposable vapes, in order to prevent youth vaping [68]. A recent study which uses data from the Smoking Toolkit Study, an ongoing monthly cross-sectional survey on young people from 16 years of age, the prevalence of young “vapers” stabilized rather than increasing [69]. With the disposable vape ban introduced in June 2025, its long-term impact on future generations will warrant close monitoring [53]. In the US, seven states have policies restricting the sale of flavored e-cigarettes. A recent cross-sectional study has shown some reduction in e-cigarette use among young adults but has caused an unintended increase in traditional cigarettes consumption [70]. This shows that one policy is not sufficient, and multiple legislations are needed to prevent youth vaping. Table 1 summarizes an overview of different regulations on ENDS.

Table 1 A comparative overview of different regulations

As evidenced in a systematic review assessing the effectiveness of regulatory strategies aimed at preventing or reducing e-cigarette use among youth (ages 12–21) in high-income countries [71], the most promising strategies include flavor bans, sales licenses, warning labels, and taxation, while age restriction, although the most widely adopted, demonstrated variable results.

Calls for comprehensive reform include aligning vaping laws with those regulating tobacco products: banning flavored e-liquids, enforcing plain packaging, and restricting use in public areas. Stronger surveillance, tax policies, and educational campaigns are also vital. Given the increasing health evidence and the risk of creating a new generation of nicotine users, regulatory frameworks must evolve rapidly to prioritize youth protection while supporting harm reduction strategies for adult smokers.

Evidence indicates that combined regulations, particularly when implemented early and in coordination, are more effective than isolated measures. A comprehensive strategy, including flavor and marketing bans, taxation, strict age-verification, restrictions on use in public places to limit both direct use and secondhand exposure, plain packaging, and sales licensing, will reduce product appeal, accessibility, and involuntary inhalation. Such an integrated approach targeting price, availability, and desirability is essential to protect adolescents from nicotine initiation and to safeguard public health [72].

Taxation of e‑liquids, enforcement of minimum‑price policies, and mandatory special licenses for vaping retailers have proven highly effective at curbing youth access by making products less affordable and more difficult for minors to obtain [71]. Moreover, revenue generated from these measures can be reinvested in prevention programs, creating a sustainable funding stream to support educational and cessation initiatives.

Ongoing surveillance of adolescent nicotine uses and robust research into the long‑term health effects of ENDS, heated‑tobacco products, and oral pouches remains essential. Public‑health agencies across Europe should systematically collect age‑specific data on single and dual‑use patterns and allocate funding to studies examining neurodevelopmental impact, respiratory outcomes, and addiction trajectories in youth, where current evidence is still limited.

Table 2 summarizes key policy recommendations and their intended targets for preventing youth nicotine use and safeguarding adolescent health.

Table 2 Key recommendations

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