LATEST ALERTSVietnam: At a workshop held on 23rd December 2022, representatives from the Ministry of Trade and Industry said they were gathering opinions from different ministries on the amendment of Decree 67, which will regulate e-cigarettes and heated tobacco products, press reports. The deputy director of the legal department of the Ministry of Health supports banning the products, because if allowed, “the rate of smuggling is still at risk of increasing”.
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Italy: The anti-corruption non-governmental organisation (NGO) Organised Crime and Corruption Reporting Project (OCCRP) and its partners revealed last year that cigarette brands were introduced onto the market which contained “more menthol flavoring than legally allowed”, and accused a tobacco company of deliberately introducing new brands of cigarettes with menthol in them but hiding this fact from the authorities. In March 2022, Italy’s customs agency banned two brands, but their manufacturer appealed against the decision and the courts allowed for their reintroduction – although the company subsequently opted not to reintroduce them. An appeal by customs authorities is under consideration by a court in Rome.
Italy: If Parliament fails to approve the 2023 Budget Bill by 31st December 2022, the excise duty increase introduced by the 2021 Budget would apply at least for January 2023. Heated tobacco products would be taxed at 40% of the duty on the equivalent quantity of cigarettes, instead of the 36.5% proposed by the 2023 Budget Bill.
US - Maine: Yesterday, 20th December, the South Portland City Council approved a ban on the sale of flavoured tobacco products including e-cigarettes and menthol-flavoured products. The ban will become effective on 1st April 2023, making South Portland the fourth community in Maine to ban flavoured tobacco.
21st December 2022 - Europe |
EU: Organisers of the European Citizens’ Initiative (ECI) “Call to achieve a tobacco-free environment and the first European tobacco-free generation by 2030” have set 16th January 2023 as the date to start collecting signatures. As we previously reported, among other things the initiative seeks to end the sale of nicotine products to people born after 2010, to extend outdoor non-smoking and non-vaping spaces, and to eliminate tobacco advertising and social media presence. The ECI needs to collect a total of 1m signatures in seven different EU member states in one year before the European Commission considers proposing any related legislation.
EU: Sara Skyttedal, Swedish member of the European Parliament (MEP) for the European People’s Party, yesterday submitted a priority parliamentary question asking the European Commission whether it considers different regulations on nicotine pouches enacted by member states to be a problem for the European single market, referring to the recent Belgian proposal to ban these products. Skyttedal also asked the Commission what member states should take into consideration when issuing new regulations on nicotine pouches. A detailed analysis on the clashes between a nicotine pouch ban and the European single market is available in our regulatory report.
21st December 2022 - Europe |
EU: Yesterday, 20th December, we published an alert about the delegated regulation amending Regulation (EC) 1272/2008 (CLP regulation) adopted by the European Commission (EC) on 19th December, which aimed to include certain amendments to the Annexes of the current CLP regulation. Also on 19th December, the EC submitted a draft proposal to change the current CLP regulation, which is to be a targeted revision of the enacting terms and, where relevant, the related Annexes. The amendment seeks, among other things, to improve harmonised classification of chemicals and clarify rules on hazard labelling. This could impose further obligations on producers of nicotine products regarding additional chemicals that may be contained in a device or delivery mechanism. The feedback period for the proposal, which is to follow regular legislative procedure, is until 15th February 2023.
21st December 2022 - Europe, Netherlands |
Netherlands: The Ministry of Health, Welfare and Sport has announced a public consultation to ban tobacco-free nicotine products for oral use, such as nicotine pouches. The consultation will be active until 16th January 2023.
21st December 2022 - Paraguay, South America |
Paraguay: The Ministry of Health warned yesterday (20th December) about the health risks associated with heated tobacco and chewing tobacco products. The ministry considers that “heated tobacco products are equally harmful as traditional cigarettes”, and calls for the enactment of a law that regulates heated tobacco products given their increasingly widespread use among the population. Paraguay’s broad tobacco framework currently covers heated tobacco products.
20th December 2022 - North America, United States |
US - General: The Reagan-Udall Foundation has submitted its recommendations to US Food and Drug Administration (FDA) commissioner Robert Califf. The recommendations focused on four programme areas: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. The report stated that the Center for Tobacco Products (CTP) should “make process improvements and identify and address the policy and scientific questions that underpin its regulatory framework”. It also concluded that vaping industry insiders observed a lack of “consistent implementation” of CTP policies, particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process. The Reagan-Udall Foundation is a private nonprofit organisation created by Congress to support the mission of the FDA.
20th December 2022 - Europe |
EU: Yesterday, 19th December, the European Commission (EC) adopted a draft delegated regulation amending Regulation (EC) 1272/2008 on hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (CLP regulation). The amendment seeks to “insert new hazard classes and their criteria into the CLP regulation for its adaptation to technical and scientific progress”. This may impose additional obligations on producers of nicotine products in relation to additional chemicals that may be contained in a device or delivery mechanism. A delegated act is a non-legislative act adopted by the EC to add non-essential elements to the act or amend them. It is to enter into force on the 20th day following its publication in the Official Journal of the European Union if no objection is raised by the Council or Parliament.
US - General: The Clinton Foundation announced a funding plan for Tobacco Free Portfolios (TFP), with a total value of $5.5m over approximately five years. The foundation has partnered with the state of California, Truth Initiative, BNP Paribas, and Ing Bank Slaski, among others. The primary goals of the funding plan to be reached by December 2023 are to increase the committed assets by at least $3tn and engage with at least 20% of the leading US financial institutions. TFP is a nonprofit organisation with a mission to promote tobacco-free finance across financial institutions.
Hungary: Provisions to include tobacco- and nicotine-free herbal sticks compatible with heating devices in tobacco legislation were published yesterday, 19th December, in the Official Gazette. As we previously reported, the parliament adopted these provisions on 7th December. These sticks will be allowed to be sold only in national tobacco shops, and will be taxed at HUF35 ($0.092) per stick starting 1st February 2023. These provisions also include more requirements for tobacco retailers and product display.
20th December 2022 - North America, United States |
US - Federal: The US Office of Special Counsel (OSC) has written to the president and Congress advising them that the US Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) had “relaxed its standards of review for certain tobacco products”. A CTP toxicologist-turned-whistleblower disclosed that a 2019 memo to CTP scientists on how to evaluate potentially harmful ingredients in substantial equivalence applications directed them to stop using objective, quantitative data to evaluate applications and to use instead an “eyeballing it” approach, which resulted in unclear review standards. The FDA appointed an independent panel of specialists to evaluate the allegations, and subsequenly implemented its six recommendations. While supportive of these steps, the whistleblower said FDA scientists will still need courage to challenge a system that “discourages dissenting voices”.
US - Ohio: Governor Mike DeWine has hinted that he may veto House Bill 513, which would prevent political subdivisions such as cities from banning or regulating the sale of flavoured cigarettes and flavoured e-cigarettes. Specifically, the bill states that the regulation of tobacco products and alternative nicotine products is a matter of general statewide concern that requires statewide regulation.
Portugal: Parliament has published the final text of the State Budget 2023, which increases the specific heated tobacco tax from €0.0845 to €0.0896 per g. It also stipulates that the total tax on heated tobacco cannot amount to less than €0.193 per g. It comes into force on 1st January 2023.
Indonesia: The Ministry of Finance has recently issued Regulation 192/PMK.010/2022, amending Regulation 193/PMK.010/2021 to set the new applicable excise duties for tobacco products for 2023 and 2024. Starting 1st January 2023, heated tobacco products, classified as "solid e-cigarettes'' ("rokok elektrik padat"), will be taxed at IDR2,886 ($0.19) per g of tobacco and, from 1st January 2024, the tax will increase to IDR3,074 ($0.20) per g. Chewing tobacco products will be taxed at IDR127 ($0.0082) per g of tobacco from 1st January 2023, and at IDR135 ($0.0087) from 1st January 2024. The new levies represent increases of 6.5% and 6% over the prior year's for heated tobacco and chewing tobacco products, respectively.
Japan: On 14th December, the prime minister proposed raising the tax rate on tobacco, including heated tobacco, among other commodities in order to offset defence spending. Media reports that taxes should be raised by JPY1 ($0.0073) per cigarette in the first year and then JPY0.5 ($0.0037) each year onwards. The proposal was criticised by some members of the ruling Liberal Democratic Party, suggesting that he should face a no-confidence vote.
16th December 2022 - Asia, Bangladesh |
Bangladesh: The Ministry of Health intends to ban vaping products and heated tobacco by amending the Smoking and Use of Tobacco Products (Control) Act, press reports. According to our understanding, no bill has been published yet.
Italy: The Revenue Agency has introduced a tax code for nicotine pouches to remit the excise duties through the F-24 excise form. Nicotine pouches were regulated in February 2022 by Law 15/2022, which created a new tax category for nicotine pouches in the Consolidated Law on Excise Duties, bringing them under the control of the Customs and Monopoly Agency (ADM). Nicotine pouch excise duty amounts to €22/kg and tax stamps will be mandatory starting 1st January 2023. The law does not feature any restrictions on pouch ingredients, packaging or advertising.
16th December 2022 - Central America, Dominican Republic |
Dominican Republic: The special commission of the Chamber of Deputies working on the bill regulating heated tobacco and electronic cigarettes held a meeting yesterday with doctors and medical organisations from different specialisms in order to discuss their views in relation to these products, press reports. The president of the Dominican Society of Neurology, Santiago Valenzuela, said that heated tobacco products help those who are addicted to combustible cigarettes, due to the fact that they are less harmful.
16th December 2022 - Peru, South America |
Peru: The Ministry of Health has published an information note about the negative impact of e-cigarettes and heated tobacco products on the environment. It claims that these devices have batteries that require special disposal and that the products are made of non-biodegradable materials.
Belgium: The 2022-2028 Strategy for a Tobacco-Free Generation has been agreed by a joint group of federal and regional health ministers. The plan sets several objectives, including banning nicotine pouches and cannabinoid-containing pouches; reducing the price differential between different tobacco products; improving health promotion; banning vending-machine sales; tighter restrictions on long-distance sales and advertising; and keeping the tobacco industry out of the preparation and implementation of public health policy.
Austria: Health minister Johannes Rauch is working on an amendment to the Tobacco and Non-Smoker Protection Law to extend the range of public outdoor spaces where smoking is banned and to apply restrictions to nicotine pouches, press reports. Rauch says the amendment is to be reviewed at the start of 2023.
Ukraine: The Ministry of Finance plans to increase the fee for excise stamps on heated tobacco products and e-liquids from UAH0.091 (€0.0023) to UAH0.1484 (€0.0038), media reports. If approved, the new rate is expected to come into force the day after the regulation is published.
Sweden: Bill 2021/22:245, presented in May by the previous government, has been adopted by the Riksdag (parliament) together with the 2023 Budget Bill. It will mean a 3% increase in excise duty on tobacco products in 2023; however, the exact rates are not mentioned in the bill. Starting in 2024, snus will be taxed at SEK508 (€47) per kg, nicotine pouches at SEK202 (€19) per kg, and chewing tobacco at SEK560 (€52) per kg. The Swedish Tax Agency told TobaccoIntelligence that depending on the authorities’ interpretation, there are two possible rates that may apply to heated tobacco consumables, either those on cigarettes or those on “other tobacco products”. Cigarettes will be taxed at SEK1.78 (€0.16) per stick in 2024, while other tobacco products will be taxed at SEK2,166 (€200) per kg.
US - Ohio: Columbus City Council has unanimously approved an ordinance banning the sale of flavoured tobacco products, including e-cigarettes and menthol tobacco. The ban will come into effect on 1st January 2024, allowing businesses a year to clear existing stock. The ordinance does not apply to the sale of flavoured shisha. Columbus is the Ohio state capital, with a population of over 900,000.
14th December 2022 - Australasia, New Zealand |
New Zealand: Most provisions of the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill, which will ban the sale of smokable tobacco products to anyone born after 1st January 2009, will come into force on 1st January, having received final royal assent.
14th December 2022 - Africa, South Africa |
South Africa: The government has tabled the Tobacco Products and Electronic Delivery System Control Bill in Parliament. The latest version of the bill proposes a total ban on the use of heated tobacco in indoor public places and certain outdoor areas, and strengthens the rules on packaging and health warnings.
Georgia: Amendments to the Law on Tobacco Control came into effect yesterday, postponing the requirement for standardised plain packaging of tobacco products to 31st July 2024. The regulation was reportedly originally supposed to come into force in 2018, but was then put back until 31st December 2022.
Slovakia: The government has approved the National Action Plan for the control of tobacco and related products, seeking to improve smoking prevention among young people compliance with the law on the protection of non-smokers. The Slovak Pneumology Society has praised the plan for advocating a harm reduction approach, media reports.
Belarus: Temporary licensing of imports of heated tobacco consumables has been introduced by Resolution of the Council of Ministers, media reports. Tobacco sticks may be imported from other members of the Eurasian Economic Union (EAEU) – Russia, Kazakhstan, Kyrgyzstan and Armenia – and from other states only under licences issued by the Ministry of Antimonopoly Regulation and Trade. The resolution came into force on 11th December and is valid for six months.
US - California: A motion filed by RJ Reynolds and other tobacco companies, seeking an emergency order to stop California from enforcing the flavour ban approved in the November ballot, has been denied by the US Supreme Court. The ban will come into effect next week.
13th December 2022 - Australasia, New Zealand |
New Zealand: The Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill, which will set a limit on the number of e-cigarette retailers and ban the sale of smokable tobacco products to anyone born after 1st January 2009, was approved by Parliament at its third and final reading. The bill will now be signed by the governor-general before becoming law.
Malaysia: New health minister Zaliha Mustafa has said she plans to reintroduce the Tobacco and Smoking Control Bill 2022 in the first sitting of Parliament next year, press reports. The bill proposes a ban on the sale and use of tobacco products to those born on or after 1st January 2007. Mustafa has also said she needs to review certain aspects of the bill, such as its implementation and timeline.
Hungary: Parliament last week adopted a law closing a legal loophole that allowed nicotine-free herbal sticks compatible with heating devices to be sold in places other than national tobacco shops, press reports. From February 2023, these sticks will also be subject to excise duty.
Slovenia: A regulation setting new excise duties on heated tobacco products has been published in the Official Gazette. The tax will be set at €110 per kg of tobacco from 1st January, €116 per kg from 1st May, and rise again to €122 per kg on 1st November 2023.
13th December 2022 - Europe |
EU: Swedish MEP Johan Nissinen, of the European Conservatives and Reformists Group, has submitted a parliamentary question, asking whether the European Commission has any plans to promote alternatives to cigarettes, such as nicotine pouches, with a view to curbing tobacco use in Europe, and whether it has considered the risk of the number of smokers in Europe increasing if the tax on pouches is increased. Nissinen also asked whether the Commission had studied developments in Sweden, where “nicotine pouches are popular, and, together with snus, they have led to a marked reduction in the number of smokers”.
Iceland: A bill to amend the Tobacco Control Act No. 6/2022 by transposing the EU Tobacco Products Directive (TPD) into the Icelandic legal framework has been submitted to the Althingi (parliament) by the Ministry of Health. It would place heated tobacco products under new restrictions, including product restrictions and the common notification system currently in place across the EU.
Iceland: An amendment to Regulation 991/2022 on the packaging of nicotine products has been published in the Official Gazette, deferring the entry into force of certain labelling requirements for nicotine pouches to 1st March 2023. At the same time, an amendment to Regulation 992/2022 on marketing notifications, licensing, and ingredients of nicotine products has also been published, lowering the fee for licence applications to sell nicotine pouches from ISK72,864 (€482) to ISK27,224 (€180).
Belarus: Finance minister Yury Seliverstov has announced planned increases in 2023 in excise duties on tobacco products, bringing them level with Russian rates, media reports. It is also planned to introduce a tax on heated tobacco devices at the same rate as in Russia.
Austria: The Austrian government has notified a bill to the European Commission's TRIS database to amend the Children and Young People Act. The bill bans the sale, possession and consumption of tobacco products and their devices for children and young people (under-18s). The ban includes heated tobacco and nicotine pouches, as specifically mentioned in the bill's impact assessment.
12th December 2022 - North America, United States |
US - Federal: A group of senators are reintroducing the No Tax Subsidies for E-Cigarette and Tobacco Ads Act, "which would crack down on e-cigarette companies and close a tax loophole that allows manufacturers to claim federal tax deductions for the cost of advertising for e-cigarettes and tobacco products".
Egypt: On 11th December the Ministry of Local Development announced the entry into force of Law No. 154/2019 on Licensing Stores and Premises. The new law sets a licence fee for premises that serve and sell tobacco at a minimum of EGP800 ($32.42) and a maximum of EGP10,000 ($405.21). In addition, the law simplifies the licensing procedure, as applicants will only have to deal with one competent authority – "The Local Licensing Centres" – which will resolve applications in 90 days.
Russia: The Ministry of Finance is proposing to gradually bring excise rates on nicotine-containing e-liquids and heated tobacco consumables to the same level as those on cigarettes, media reports. This was stated by deputy finance minister Alexei Sazanov, who said that this proposal is currently being discussed by the government.
Slovakia: The government approved the National Action Plan for the control of tobacco and related products, media reports. With the plan, the ministry seeks to improve conditions in the field of smoking prevention among young people as well as to improve control of compliance with the law on the protection of non-smokers.
12th December 2022 - Europe |
EU: On 9th December, the Council and the European Parliament reached a provisional political agreement on the new battery regulation. The new regulation seeks to regulate the whole life cycle of batteries, from design to disposal, repealing the current EU Batteries Directive. It would cover a wide range of batteries, including industrial and portable ones, potentially affecting batteries contained in heated tobacco devices. It is still unclear to what extent device batteries would be touched, as the regulation would only provide a general framework, whereas the regulatory details would be provided in a secondary EU legislation, such as delegated and implementing acts. Reportedly, it is expected that around 32 delegated and implementing acts will complement the EU’s battery regulation.
9th December 2022 - North America, United States |
US - Federal: The implementation of graphic cigarette warnings ordered by the Food and Drug Administration (FDA)'s rule has been vacated by a federal judge, based on a First Amendment claim with an in-depth analysis in the decision. This means that it nullifies and revokes the agency rule, rendering it devoid of legal effect. Truth Initiative has issued a statement urging the Justice Department to appeal this decision, stating that "Courts have long held that mandatory health warnings conveying truthful information about the risks of dangerous products do not violate the First Amendment".
Germany: According to a survey held by the Cancer Research Center (DKFZ), the largest biomedical research institute in Germany, more than three quarters of participants would like neither e-cigarettes nor heated tobacco to be used in non-smoking areas. The research centre is demanding that federal and state governments include both products in their non-smoker protection laws.
US - Maine: South Portland City Council is considering a ban on the sale of flavoured tobacco products, including e-cigarettes. Councillors voted 5-2 yesterday in favour of the ban, which will include menthol products, press reports. South Portland, which has a population of 27,000, could become the fourth Maine community to ban flavoured tobacco, a previous attempt having failed in 2019.
