Daily news alerts / BULGARIA

Switzerland: In a joint campaign with five other cantons, the Basel cantonal laboratory examined e-liquids for their nicotine content, prohibited ingredients and health warnings. After it was found that two thirds of the samples were not legally compliant, 44% were subjected to a sales ban for failings such as the nicotine content not being declared in the official language or chemicals being incorrectly classified. According to the health department, the high rate of non-compliance demonstrates that manufacturers and importers are not aware that the products come under the Federal Food Safety Act and the Chemicals Ordinance.

Jordan: The House of Representatives has referred a government-drafted bill of child rights to a joint committee of the Women and Family Affairs Committee and the Legal Committee. The bill proposes fines ranging from JOD 100 ($140) to JOD 300 ($420) for smoking or vaping in front of children, including by parents or family members. Vaping is considered to be smoking under Public Health Law No. 47/2008 and the Standards for tobacco and nicotine products, including electronic ones.

US - federal: US Food and Drug Administration (FDA) commissioner Robert Califf has ordered an external review of the Center for Tobacco Products (CTP), citing a “series of challenges that have tested our regulatory frameworks and stressed the agency’s operations”.

US - general: Myblu vaping products will not be allowed to be sold in the US market while the court reviews a marketing denial order (MDO), as an appellate court has declined to issue an emergency stay for Fontem US in its challenge against an MDO handed down by the US Food and Drug Administration (FDA).

Israel: Health minister Nitzan Horowitz is considering further restricting the marketing of disposable e-cigarettes and raising the excise duty on them, due to their growing popularity among young people, press reports. He is reportedly considering requiring disturbing and impactful images on packaging to discourage purchase.

Malaysia: A poll of 40 members of Malaysia’s lower parliamentary chamber the Dewan Rakyat found only 12 said they would vote in favour of a bill banning the sale of vaping products to anyone born after 2005. Another 26 said they would decide how they would vote after the publication of the draft bill. The report by CodeBlue, a newspaper specialising in health matters, says most of those as yet uncommitted “appeared to lean towards opposing the tobacco bill in its current form, as they expressed various concerns with the proposed generational ban on tobacco and vape”.

Russia: The bill setting future tax rates has been adopted and published, increasing excise rates for e-liquids and e-cigarette devices in 2025 by 4%. Devices will be taxed at RUB 70 (€1.20), and e-liquids at RUB 20 (€0.34) per ml. 

Czech Republic: The Ministry of Health has updated the publicly available list of notified herbal products for smoking, e-cigarettes and refill containers.

US - California: Attorney general Rob Bonta yesterday announced $22m in state funding for local government agencies to tackle the illegal sale of tobacco products, including e-cigarettes, especially to minors. He said the Department of Justice’s Tobacco Grant Program would give local agencies “the funding they need to keep our children healthy and hold tobacco retailers accountable”. Any local agencies with authority to enforce tobacco-related state laws or local ordinances are eligible to apply.

US - general: Triton Distribution and Vapetasia, two manufacturers of flavoured e-liquids, were denied a review of the FDA’s marketing denial order (MDO) in the Fifth Circuit Court of Appeals yesterday, Bloomberg reports. Triton was granted a stay of execution last October, allowing the company to continue selling its flavoured e-cigarettes after receiving an MDO from the FDA in September, pending the resolution of the case. Earlier this year, when the court heard oral arguments, the questions put by the three-judge panel seemed to suggest one judge would be in favour of Triton’s case, while the other two questioned it.

EU: Tomorrow, 20th July, is the last day to submit feedback on the initiative to review the Council of the European Union’s 2009 recommendation on smoke-free environments. The initiative seeks to extend the recommendation to cover emerging products and to increase its scope to include additional outdoor spaces such as schools and playgrounds.

US - General: The anti-tobacco, anti-vaping Truth Initiative is calling on the FDA “to immediately remove all synthetic nicotine products now on the market illegally like Puff Bar, a top youth brand, and to only allow e-cigarettes that have been reviewed and meet the rigorous public health standards to remain on the market”. The group says the FDA should prioritise the review of tobacco-derived and synthetic nicotine e-cigarettes, as they are “most popular among youth”.

US - California: Millbrae City Council intends to prepare an ordinance that would prohibit the sale of flavoured tobacco products within the city, which lies in the San Francisco Bay Area and has a population of just over 23,000. Millbrae is in San Mateo County, where sales of flavoured tobacco products and e-cigarettes have been banned in unincorporated areas since 2018. The county intends to update its Tobacco Retailer Permit Ordinance to specifically include synthetic nicotine products and non-nicotine e-cigarettes and to place stipulations on where new retailers can be located. A Californian referendum over a state-wide flavour ban is still pending.

US - general: The Campaign for Tobacco-Free Kids has urged the Food and Drug Administration (FDA) to enforce the congressionally mandated deadline and clear the market of any synthetic nicotine products, including e-cigarettes, that had not obtained FDA authorisation by yesterday, 13th July. It emphasised that a growing number of e-cigarette manufacturers have increasingly switched to using synthetic nicotine since the FDA acted against flavoured products made with tobacco-derived nicotine. The statement by campaign president Matthew Myers singled out Puff Bar as “the most popular e-cigarette brand among kids” and said it “sells synthetic nicotine products with kid-friendly flavors like Banana Ice and Cool Mint”.

Malaysia: The Cabinet yesterday approved the Tobacco and Smoking Control Bill that sets out to ban the sale of vaping products to anyone born in or after 2005, press reports. The Cabinet’s approval allows health minister Khairy Jamaluddin to table the bill in Parliament, which he intends to do during the upcoming session, which begins on Monday, 18th July.

US- general: Today, 13th July, is the final date for synthetic nicotine products to be marketed in the US without a premarket tobacco product application (PMTA) having been submitted by 14th May. The Food and Drug Administration (FDA) has been criticised for its statement that it could not say how many companies selling such products had submitted an application – making it impossible to estimate the real number of illegal products on the market, media reports. Senator Dick Durbin said: “It seems that the FDA is unable to implement processes for monitoring the market and neglects its duty to ensure compliance with the law.” Matt Myers, president of the Campaign for Tobacco-Free Kids, said: “If FDA allowed products to remain on the market that didn’t file an application, it is both directly contrary to the law and puts America’s kids at risk.” Lawyer Azim Chowdhury said he expected the FDA “to go after big companies known for marketing to kids, and hopes the agency does not try to put small vape shops out of business”.

US - federal: The American Vapor Manufacturers Association has formally asked the inspector general of the US Department of Health and Human Services to investigate “unethical political interference between Congress and FDA”. Specifically it queries whether the commissioner was aware that the FDA’s Juul decision was based on incomplete information; calls for all correspondence between the commissioner and members of Congress (including senator Dick Durbin and representative Raja Krishnamoorthi) to be made public; and also for other communications between the commissioner and a Wall Street Journal reporter, between him and his immediate predecessor, and between any FDA officials and the Campaign for Tobacco-Free Kids and Parents Against Vaping to be made public.

Spain: The National Committee for Smoking Prevention (CNPT) has published a statement expressing concern about the widely reported decision of the Ministry of Health to stop work on an amendment of the Tobacco Act. The CNPT, which is the leading anti-tobacco organisation in Spain and is associated with medical and health organisations, is urging the ministry to confirm whether or not it will indeed abandon its legislative plans. It also insists on the need to approve laws that reduce nicotine and tobacco consumption and asks the ministry about the Comprehensive Plan for the Prevention and Control of Smoking 2021-2025, which was meant to have been approved already. Both the Tobacco Act amendment and the prevention and control plan were intended to impose further restrictions on both tobacco and vaping products.

Mexico: The Federal Commission for Protection Against Public Health Risks (Cofepris) has closed down more than 179 shops and vending machines and seized almost 65,000 e-cigarettes since January 2021, press reports. The Cofepris action comes after e-cig sales were banned by the government, an order that has been contested in court multiple times.

Uruguay: The Ministry of Education and Culture has approved the setting-up of the Association of Vapers of Uruguay (Asovape), which seeks to reduce smoking and regulate the consumption of e-cigarettes, press reports. The ministry said the association would “promote through education...the ways of reducing the harm associated with smoking”. The sale of e-cigarettes has been banned in Uruguay since 2009.

Spain: The Ministry of Health has decided not to continue with its planned amendment to the Tobacco Act, press reports. The government has decided there is not enough time before its term ends at the end of 2023 to undertake the reform, which would have banned smoking on open-air terraces, in cars with children or pregnant women present, and in open-air stadiums. It would also have established neutral packaging and further restricted the advertising of tobacco and vaping products. The amendment was framed within the Comprehensive Plan for the Prevention and Control of Smoking 2021-2025, which was meant to be approved by June 2022 and now presumably will not be approved.

US - federal: Tomorrow, 13th July, is the last day synthetic nicotine products can be marketed in the US without a premarket tobacco product application (PMTA) having been submitted by 14th May. While the Food and Drug Administration (FDA) will maintain enforcement discretion, it will be illegal after tomorrow to distribute such products without a PMTA.

Philippines: The Presidential Office has confirmed to ECigIntelligence that it received the Vaporized Nicotine Products Regulation Bill, which will further regulate vaping products, on 24th June, six days before president Bongbong Marcos took office. If the president does not act on a bill submitted by Congress, it lapses into law after 30 days of receipt.

Hungary: The Supervisory Authority for Regulatory Activities (SZFTH) has provided ECigIntelligence with figures showing that sales of e-liquids grew steadily in 2017, 2018 and 2019 but began to fall with the introduction of a flavour ban in May 2020. Sales slid from 16,000 l in 2019 to 12,400 l in 2020, 9,500 l in 2021 and 4,200 liters in the five-month period from 1st January to 31st May 2022.

Kazakhstan: President Kassym-Jomart Tokayev has signed a bill to introduce changes to the Tax Code, media reports. The tax rate for nicotine e-liquids will rise to KZT53 ($0.11) per ml on1st January 2023 and to KZT55 ($0.12) on 1st January 2024.

Saudi Arabia: The National Committee for Tobacco Control has tweeted that the Islamic pilgrimage season, the Hajj, is an opportunity to quit smoking, and stressed that under the Anti-Smoking Law Royal Decree No. (M/56)/2015 it is prohibited to consume any tobacco product in religious areas, including squares and places surrounding mosques. Saudi Arabia’s anti-smoking regulations also apply to e-cigarettes.

France: Senator Françoise Férat of the Centrist Union Group has submitted a parliamentary question to the minister for ecological transition asking whether he is considering banning disposable e-cigarettes. Férat said disposables encouraged consumption and increased the volume of waste, amounting to an “ecological disaster”.

Iceland: A bill amending Law 87/2018 on electronic cigarettes and refills has today come into force. It makes the sale of vaping products subject to licensing by the Housing and Civil Engineering Institute and explicitly prohibits the advertising of e-cigarettes on social media.

Saudi Arabia: The Zakat, Tax and Customs Authority  has introduced an initial draft through the Public Consultation Platform, proposing amendments to the executive bylaw on excise tax. It suggests that a warehouse should be eligible for licensing as a tax warehouse if it acquires an average of 500,000 vaping devices a year rather than 1m devices as at present, and 125,000 l of e-liquid rather than 500,000. The authority has until 30th July to discuss the amendments before accepting them.

US - Federal: The Food and Drug Administration (FDA) has issued another batch of warning letters to manufacturers and distributors of e-liquid products that it regards as “new tobacco products” lacking the required FDA marketing authorisation.

Brazil: The board of the National Public Health Surveillance Agency (Anvisa) decided unanimously at an extraordinary meeting yesterday, 6th July, to maintain the existing ban on e-cigarettes and heated tobacco. The agency will now prepare a regulatory draft that will be sent to the body’s governing body, the college, for deliberation. The college will later decide whether or not to open the draft for a public consultation.

Sweden: The Public Health Agency has updated the public list of notified e-cigarettes and refill containers, containing 12,054 vapour products.

Italy: The Custom and Monopoly Agency (ADM) has updated the lists of notified nicotine-containing and nicotine-free e-cigarette products, now containing a total of 21,341 products.

Philippines: Presidential spokesperson Trixie Cruz-Angeles has told reporters that the new president, Ferdinand Marcos Jr, has given no indication of whether or not he supports the Vaporized Nicotine Products Regulation Bill, which would change regulations on vaping products. Bills approved by the former Congress lapse into law if the president fails to act on it within 30 days of receiving it. The presidential office has not confirmed to ECigIntelligence when the bill was received.

Romania: The Ministry of Finance has introduced a bill to progressively increase the excise duty on e-cigarettes and e-liquids. It proposes duty on e-liquids at RON0.62 (€0.13) for 2022; RON0.72 (€0.15) in 2023; RON0.81 (€0.16) in 2024; RON0.91 (€0.18) in 2025 and RON1.03 (€0.21) in 2026. If the bill is approved, the new rate will come into force on 1st August and be updated on that date every year.

US - Federal: The US Food and Drug Administration (FDA) has administratively stayed its marketing denial order (MDO) against Juul Labs, says “there are scientific issues unique to the Juul application that warrant additional review”. This only suspends the MDO but does not rescind it -- all e-cigarette products need FDA authorisation in order to be legally marketed.

Brazil: The National Public Health Surveillance Agency (Anvisa) was to discuss the regulation of e-cigarettes and heated tobacco in an extraordinary meeting today, 6th July. The public meeting was called to consider information and comments received during a public consultation, which closed on 10th June. In its preliminary report, published in April, the agency suggested that the existing ban should be maintained. No final decision is expected yet.

France: The National Agency for Food, Environmental, and Occupational Health Safety (ANSES) has published an updated list of notified e-cigarettes, which includes 81,809 products.

US - Michigan: Senate Bill 1109 has been introduced. This bill would prohibit the sale of vapour products with any heating element not made of or encased in glass and/or ceramic.

Luxembourg: In answer to a parliamentary question about whether the increased use by teenagers of flavoured disposable e-cigarettes, as seen in France, was also occurring in Luxembourg, health minister Paulette Lenert said yesterday that as none of the notification fees for disposables had been paid, their presence on the market was illegal. She added that while it did not currently have usage data on these products, “the Ministry of Health takes the emergence of this type of product very seriously [as] the electronic cigarette in all its forms or variants constitutes a potential health risk”.

US - general: The Smoke-Free Alternatives Trade Association (SFATA) met up with the FDA Center for Tobacco Products (CTP) to discuss the future of the vapour industry and what the association called the “pending illicit sales epidemic”. In a meeting well attended by FDA and CTP representatives, the SFATA challenged the mass issuing of marketing denial orders (MDOs) by the FDA, saying it presented the threat of an unregulated illicit market developing. It said that in the cause of reducing youth vaping, the FDA had spread the belief that vapour products are at least as harmful as combustible tobacco. The SFATA, whose presentation used data provided by ECigIntelligence, called on all interested parties to join it in its work of “advocating for a reasonably regulated marketplace”.

EU: EU law requires certain large companies to disclose information on the way they operate and manage social and environmental challenges. The European Council and Parliament have reached an agreement on the rules of the Corporate Sustainability Reporting Directive, which will impact listed EU and non-EU companies operating in the region, with a turnover of more than €150m. Among more detailed reporting requirements, it requires large companies to report on sustainability issues such as environmental, social and human rights and governance factors, and to have their reported sustainability information independently audited.

Portugal: The Directorate-General for Health has launched its 2030 National Strategy for the Fight against Cancer. Among measures proposed are an increase in e-cigarette and tobacco product prices, regulation of ingredients and packaging, and raising the minimum legal purchase age. The document is under public consultation until 29th July.