Category: Regulation

  • ‘Endgame’ Revised to Those Born After 2007

    ‘Endgame’ Revised to Those Born After 2007

    Photo: matka_Wariatka

    After considering the views of stakeholders, the government of Malaysia has pushed the year limit of its tobacco generational endgame law to 2007 from 2005, reports New Straits Times.

    Earlier this year, Health Minister Khairy Jamaluddin tabled a new Tobacco and Smoking Control bill to replace the current tobacco product control legislation under the Food Act 1983. Modeled on similar legislation in New Zealand, the proposal included a provision to ban smoking and prohibit the ownership of tobacco and vape products by those born after 2005.

    Postponing the year limit will allow more time for community education, a robust implementation plan and to ramp up enforcement, according to Khairy.

    The health minister has been pushing for the Tobacco and Smoking Control Bill in line with efforts to make Malaysia a tobacco-free country by 2040.

    He said cigarette smoking would cost the government MYR8 billion ($1.8 billion) to treat lung cancer, heart problems and chronic obstructive pulmonary disease by 2030.

    The cabinet gave the green light for the bill on July 14, and it will be tabled and put to a vote in the Parliament’s Lower House this week.

    BAT Malaysia said the proposed generational smoking ban is a prohibitive way to reduce the health impact of smoking and will only fuel the illicit tobacco market, which already accounts for almost 60 percent of tobacco sold in Malaysia.

    “It has never been tested in the real world, lacks any scientific evidence of effectiveness and is likely to be detrimental to our country’s health agenda,” BAT Malaysia Managing Director Nedal Salem was quoted as saying by The Edge Markets.

    He said the Ministry of Health (MOH) should pursue a science-based regulatory framework, informed by the positions of countries such as the U.K., where vaping is acknowledged as significantly less harmful and a viable alternative to reduce smoking prevalence.

    BAT Malaysia called on the MOH to include industry players in the overall consultation process in developing appropriate regulations for vapor products.

  • Kiwi Generational Ban Gets First Reading

    Kiwi Generational Ban Gets First Reading

    Photo: Tom

    A historic smokefree bill to ban smoking for next generation up for first reading in New Zealand, reports the NZ Herald.

    Announced last year, the proposed legislation prohibits people born after Jan. 1, 2009, from purchasing tobacco products.

    The plan is part of a push to drop daily smoking rates in New Zealand to less than 5 percent across all population groups by 2025. In 2019–2020, it sat at 13.4 percent.

    Introduced by the labor party, the legislation already enjoys broad support in Parliament.

    The sole voice opposing it outright is the ACT party, with health spokeswoman Brooke Van Velden saying prohibition will only fuel a black market.

    Critics say the measure will likely fuel an already growing black market for cigarettes and that more support is needed for people to transition to vaping.

    The Ministry of Health acknowledges as much. Its regulatory impact statement says there is already a growing illicit market and that the policy changes were “likely to exacerbate this.”

    The government aims to pass the bill by December, meaning that, all going to plan, those aged 14 in 2023 will be banned from purchasing tobacco.

  • Court Refuses to Suspend Fontem MDO

    Court Refuses to Suspend Fontem MDO

    A U.S. appeals court denied Fontem US’ request to suspend the Food and Drug Administration’s marketing denial orders (MDO) for certain Myblu products.

    On April 8, the FDA rejected several of the company’s premarket tobacco product applications on the basis that they lacked sufficient evidence to show that permitting the marketing of those products would be appropriate for the protection of public health.

    The court rejected Fontem’s July 12 request for a stay, saying that the e-cigarette company had waited too long to file the motion.

    “Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote.

    The court also stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO on merits.

    “The court ruling does not affect our progress through the FDA’s administrative appeals process, through which we intend to convince the agency that approval should be granted for Myblu products,” said a spokesperson for Fontem US.

    “In the meantime we continue to supply Myblu to the majority of retailers. The MDO does not apply to Blu disposables which constitute 50 percent of Blu share in the U.S. market.”

  • RLX Obtains Chinese Manufacturing License

    RLX Obtains Chinese Manufacturing License

    Photo: RLX Technology

    China’s State Tobacco Monopoly Administration (STMA) has licensed RLX Technology to operate in the vapor business.

    On Nov. 26, 2021, China’s State Council amended the country’s tobacco monopoly law to include vapor products, giving the STMA authority to regulate the sector.

    The STMA license, which is valid until July 31, 2023, allows RLX Technology to manufacture 15.05 million rechargeable vaping devices, 328.7 million cartridges and 6.1 million disposable e-cigarettes per year.

    Since the first quarter of 2022, Chinese authorities have issued a series of implementing rules and guiding opinions to strengthen oversight of e-cigarette products and regulate the e-cigarette industry. These rules and opinions set forth that all e-cigarette manufacturing enterprises must obtain a license from the STMA.

    “This license represents an important milestone in our strategic roadmap as we strive to comply with the new regulatory requirements in a timely manner,” said Ying (Kate) Wang, co-founder, chairperson of the board of directors and CEO of RLX Technology, in a statement.

    “We believe that we are well-positioned to achieve compliance in our operations according to schedule. To adapt to the new market dynamics and ensure business development, we will, and will urge our business partners to, continue making efforts to comply with all applicable regulatory requirements, including, but not limited to, obtaining requisite licenses and regulatory approvals, developing products that meet the mandatory national standards, and processing all transactions via the National E-cigarette Transaction Platform when it is implemented.

    “We will remain committed to providing high-quality products that deliver superior performance and safety in strict compliance with legal and regulatory requirements, while exploring new growth opportunities in the industry.”

  • Michigan Raises Tobacco Purchase Age

    Michigan Raises Tobacco Purchase Age

    Credit: Vitalii Vodolazskyi

    Michigan has raised the age to purchase tobacco and other products containing nicotine from 18 to 21. 

    “This legislative package brings Michigan in line with the federal Tobacco 21 legislation, raising the state age for tobacco sales from 18 to 21. The package amends several acts to raise the age of sale for retailers, prohibit anyone under 21 from entering a tobacco retail store, and prohibit tobacco sales through the mail to anyone under 21,” Gov. Gretchen Whitmer stated after signing the bill into law.

    The package also revises the disbursement of proceeds from the tax on cigarettes and other tobacco products. Senate Bill 576 also amends a portion of the Michigan penal code to require agents who distribute tobacco through the mail to verify that the recipient is 21 years of age, revising the previous age limit of 18.

    The legislation states that the act will not apply to the Youth Tobacco Act, which now prohibits tobacco use for those under 21, rather than 18.

    “The Tobacco 21 package aligns Michigan with progress at the federal level, and is an important step in keeping tobacco products out of the wrong hands,” said Senator Paul Wojno. “Kudos to Governor Whitmer for working with the me and my colleagues in the legislature to protect our communities and public health across the state.”

  • Many Comments on EU Tobacco Changes

    Many Comments on EU Tobacco Changes

    Credit: Savvapanf Photo

    An overwhelming majority of EU citizens who responded to a European Commission initiative say they support tobacco harm reduction products.

    The Commission’s “Call for Evidence” on the legislative framework for tobacco control received an unprecedented level of feedback, with consumers of alternatives to tobacco products – vaping, heated tobacco and oral nicotine pouches – making their voices heard in huge numbers, according to EU Political Report.

    More than 24,000 EU citizens responded to the call, launched by the Commission as part of its ongoing evaluation of what future EU tobacco laws will look like through revision of the Tobacco Products Directive.

    The massive interest in the issue may surprise some and may put the European Commission on the back foot as has been seen by some as having previously failed to support ‘tobacco harm reduction’.

    The 4-week public consultation, from May 20 May to June 17, had one of the biggest ever responses to a consultation. On average, calls of this length receive around 354 submissions. In recent years, only the “call for evidence” for a digital euro for Europe received a similar scale of a response, but still fell short of the 20,000 submission mark despite taking place over a longer period of time (10 weeks).

    Of the 24.000 submissions, more than 90 percent came from individual EU citizens, suggesting the extent to which this issue is a priority for the European public at large. Many submissions came from citizens in Germany, Italy and Romania.

    It showed that the biggest issue for citizens across all member states is the regulation of reduced-risk products such as e-cigarettes. On this, it has been argued that the Commission it out of sync with public opinion.

    The Commission has favored the introduction of new restrictions on reduced risk products, including flavor bans and sale restrictions but some in the industry hope the public response could now force it to reconsider these plans.

    In June, the Commission announced plans to prohibit the sale of flavored heated tobacco products in the EU. The proposal came, it said, in response to the “significant increase” in the volumes of heated tobacco products sold across the EU.

    A Commission report showed a 10 percent pick up in the sales volumes of heated tobacco products in more than five Member States and overall in the EU, heated tobacco products exceeded 2.5 % of total sales of tobacco products.

    An overwhelming majority of submissions supported tobacco harm reduction products, including vaping and nicotine pouches, as “critical tools” that have helped smokers to quit. Respondents were nearly unanimous in opposing any plans to restrict access to such products for adults over the age of 18.

  • Joytech Parent Submits PMTA to FDA

    Joytech Parent Submits PMTA to FDA

    China-based JWEI has announced today that they have successfully submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for a device created with “new innovative technology” that focuses on safety, harm reduction and is designed to curb underage use.

    “JWEI has been a leader in this industry from the start and this milestone again reiterates our commitment to the industry and public health: ensuring our adult customers continued access to less harmful alternatives to traditional tobacco products, while setting a new standard preventing underage youth access.” said VP of JWEI Group Jason Yao.

    JWEI is the parent to the brands Joytech, Eleaf, Wismec and Joyevita. The company did not offer additional information on the specific device submitted for the PMTA.

    JWEI developed a set of principles to guide through every step of its new product development, led by safety and effectiveness studies in early 2019. “The design philosophy is the foundation and guide rails for designing, manufacturing, verifying, validating, and continuously improving innovative, responsible, reliable, and high-quality products,” the release states.

    The limited product debut in the UK has received overwhelming recognition from users and commercial partners after a few months’ actual use, according to JWEI

    “As one of the world-leading device manufacturers and innovators of e-cigarette and vaping products, JWEI has over 3,600 granted patents and multiple internationally recognized manufacturing and quality certifications (GMP, HACCP, ISO9001, ISO13485, EHS, and ERP),” according to a press release.

  • FDA Reviewing Oversight Rules After Botched Juul PMTA

    FDA Reviewing Oversight Rules After Botched Juul PMTA

    The head of the U.S. Food and Drug Administration Tuesday said he has commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews, according to AP.

    The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order and placing Juul’s premarket tobacco product application (PMTA) back under review.

    “Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s programs, Califf said in a statement. The agency’s Center for Tobacco Products (CTP) is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health … CTP will continue its important work during the evaluation, including review pending applications and take enforcement actions as needed.”

    Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.

    “It may take some time to implement any recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner,” Califf stated. “It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues we are facing, while preparing for the many scientific challenges and fascinating opportunities of the future.”

  • Malaysia’s Generational Tobacco Ban Clears Cabinet

    Malaysia’s Generational Tobacco Ban Clears Cabinet

    Photo: PX Media

    Malaysia’s Cabinet has approved the Tobacco and Smoking Control Bill, reports The Star.

    “I will be sending [the Bill] to Parliament for this session,” Health Minister Khairy Jamaluddin told reporters during the presentation of a new drug perception study report on July 14.

    Among other provisions, the bill calls for a ban on sales of cigarettes, tobacco and vapor products to those born after 2005.

    The proposed law is modeled on legislation in New Zealand, which in December 2021 revealed a plan to phase out smoking by gradually raising the smoking age until it covers the entire population.

    Presently, some 40.5 percent of men and 20 percent of women smoke in Malaysia.

  • Malaysia: Cabinet to Consider Generational Smoking Ban

    Malaysia: Cabinet to Consider Generational Smoking Ban

    Photo: sezerozger

    Malaysia’s Cabinet will review a bill this week that would ban smoking for those born after 2005, reports The Edge.

    According to Health Minister Khairy Jamaluddin, the bill’s “implementation of the generational endgame” provision aims to prevent Malaysia’s younger generations from picking up the smoking habit and getting addicted to tobacco products when they grow older, as well as to reduce the number of smokers in Malaysia to less than 5 percent by 2040.

    “This will be able to reduce the risk of premature deaths, chronic diseases and treatment costs that have to be borne by the government due to smoking complications among the community,” Jamaluddin said.

    Presently, some 40.5 percent of men and 20 percent of women smoke in Malaysia.

    Anticipating resistance to the bill from cabinet members worried about tax revenues and tourist spending, Khairy said that without the legislation, the government would have to bear treatment costs of about MYR8 billion ($1.81 billion) to treat health problems linked to smoking.

    Malaysia’s bill, which would also regulate vapor products, is modeled on legislation in New Zealand, which in December 2021 revealed a plan to phase out smoking by gradually raising the smoking age until it covers the entire population.