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Category: Global Regulation

  • Philippines Flagged ‘Elevated Risk’ for Illicit Cigarettes as Price Gaps Grow

    Philippines Flagged ‘Elevated Risk’ for Illicit Cigarettes as Price Gaps Grow

    The Philippines has been identified as an “elevated risk” market for illicit cigarettes, with illegal products accounting for 25.3% of total sales last year and projected to rise to 28.9% by 2028, according to a Euromonitor International study commissioned by the EU-ASEAN Business Council. The report estimates the government lost nearly $980 million in 2024 and about $1.1 billion last year due to the illicit cigarette trade, while illegal e-vapes, which make up 86% of the market, caused an additional P23 billion ($400 million) in losses from 2024 to 2025.

    Researchers cited price-sensitive consumers, porous maritime borders, established regional smuggling routes, annual excise tax hikes of 5%, and enforcement challenges as key drivers, with illicit products increasingly imported from neighboring ASEAN states and China. The study also highlighted the growing role of digital platforms such as Telegram, WhatsApp, and Facebook Marketplace in distributing illegal tobacco, alongside traditional sari-sari stores and street vendors, and warned that paper-based tax stamps are easily counterfeited, recommending a shift toward digital tax verification systems to better protect revenues and track the trade.

  • Maldives Customs Seizes 2.3M Smuggled Cigarettes

    Maldives Customs Seizes 2.3M Smuggled Cigarettes

    Authorities at the Maldives Customs Service intercepted more than 2.3 million smuggled cigarette sticks during an operation at the Malé Commercial Harbor last week, uncovering over 230 cases of illicit tobacco products with an estimated street value exceeding MVR 32 million ($2.1 million). Officials did not disclose further operational details, but the seizure comes amid a noted surge in cigarette smuggling following recent hikes in tobacco import duties. The case also follows earlier incidents involving charges over the theft of a container holding previously confiscated cigarettes, underscoring growing enforcement challenges tied to the expanding black market for tobacco in the Maldives.

  • MALAYSIA VAPE INDUSTRY WARNS OF $150 MILLION ANNUAL TAX REVENUE LOSS IF 15ML PRODUCTS ARE HASTILY BANNED

    MALAYSIA VAPE INDUSTRY WARNS OF $150 MILLION ANNUAL TAX REVENUE LOSS IF 15ML PRODUCTS ARE HASTILY BANNED

    Malaysia’s local vape industry has warned that any abrupt move to ban 15ml vape products under the Control of Smoking Products for Public Health Act 2024 (Act 852) could cost the country more than RM600 million ($150 million) in annual tax revenue, while putting thousands of Malaysian jobs at risk.

    Local vape companies have collectively invested tens of millions of ringgit since Act 852 was introduced, including product registration with the Ministry of Health Malaysia (MOH), SIRIM certification, excise duty payments, establishment of local manufacturing facilities, laboratory testing, and compliance with safety and labelling standards.

    Mohamad Nizam Talib, President of the Malaysian E-Vaporizers and Tobacco Alternatives Association (MEVTA), stressed that the industry had taken significant steps to comply with every regulatory requirement since Act 852 came into force.

    “We have followed the law and made substantial investments to ensure our products meet government standards. Now, out of nowhere, there are proposals to eliminate the 15ml product category, without any reasonable transition period. This does not just affect the industry. It affects national revenue and the livelihoods of Malaysians,” he said.

    Based on current estimates, there are approximately 1.5 million vape users in Malaysia, with around 70% using liquid-based vape systems. Average consumption is estimated at roughly eight bottles per month.

    At a tax rate of RM6 per 15ml bottle, the government is estimated to collect approximately RM50 million ($12.5 million) in tax revenue each month or more than RM600 million annually from this product category alone.

    A hasty ban on 15ml products would not only risk crippling the legitimate local industry, but could also fuel a surge in smuggling, accelerate black market growth, undermine regulatory control, and open the door to untaxed and unregulated products flooding the market.

    “Consumer demand does not simply disappear when legal products are taken off the shelf. Users will turn to the black market for unregulated and untaxed alternatives that fall entirely outside the government’s oversight,” Nizam added.

    The industry also raised concerns about the patchy enforcement of Act 852, noting that online sales remain rampant, unregistered products are still readily available, and the misuse of vape products containing prohibited substances, including synthetic drugs, is on the rise.

    The real driver of vape misuse, the industry argued, is the illegal market and underground products that sit completely outside any regulatory framework, not the legitimate, registered products currently being targeted.

    At the same time, the industry highlighted what it described as a glaring policy inconsistency: open system devices remain permitted, taxes continue to be collected, and SIRIM certifications are still being approved, yet the legally manufactured vape liquids designed for use with these very devices are now being proposed for elimination.

    “If the devices are still legal, why are legitimate vape liquids being singled out for a ban? This sends deeply mixed signals to investors and the industry,particularly given the significant investments that have been made to meet all government requirements,” Nizam said.

    Malaysia’s local vape industry is estimated to employ more than 8,000 workers in manufacturing and over 15,000 in retail, with thousands more supporting jobs throughout the broader supply chain.

    A significant portion of industry players are young entrepreneurs and Bumiputera business owners who have built their businesses through legal channels over the past few years.

    Against a backdrop of economic uncertainty and rising retrenchment cases across multiple sectors, any drastic action against the vape industry would further strain employment opportunities for Malaysians.

    The industry also claimed that no meaningful consultation had been conducted with the relevant economic ministries and agencies, including the Ministry of Finance, the Royal Malaysian Customs Department, the Ministry of Domestic Trade and Cost of Living (KPDN), and the Ministry of Investment, Trade and Industry (MITI), before the proposal to eliminate 15ml products was tabled.

    In light of this, the industry is calling on the Prime Minister to intervene directly to ensure that any policy changes properly account for the economic implications, national revenue, investment stability, and the risk of a growing black market that will become increasingly difficult to rein in.

  • CTP Director Touts Progress, Future in Statement

    CTP Director Touts Progress, Future in Statement

    The FDA’s Center for Tobacco Products says it has made significant progress in streamlining the review of premarket tobacco product applications (PMTAs), reducing its backlog by approximately 70% in 2025 and eliminating the queue for initial acceptance review. In a statement dated May 7 and released today (May 13), acting Director Bret Koplow said new efficiencies are allowing applications to move into review almost immediately, while accelerated filing and scientific review processes—particularly for nicotine pouches and electronic nicotine delivery systems—are helping bring compliant products to market more quickly.

    Koplow also highlighted the success of a pilot program for nicotine pouch applications, which led to authorizations for six products within three months, a record pace for the agency. The FDA plans to apply lessons from the pilot more broadly, including expedited review for product modifications and increased real-time communication with applicants, signaling a shift toward faster but still science-based regulatory decision-making in the nicotine category.

    Read the full release here.

  • Maryland Adds Two Tobacco-Related Laws

    Maryland Adds Two Tobacco-Related Laws

    Maryland Governor Wes Moore signed two tobacco-related bills aimed at expanding regulatory oversight and tightening control of vaping products, both set to take effect on October 1. Senate Bill 279 grants Baltimore City new authority to enact and enforce local regulations on cigarettes, tobacco products, and electronic smoking devices that are at least as stringent as state law, marking a shift toward greater local control and potentially creating stricter rules at the city level. The measure also introduces local licensing requirements, with partial fee sharing with the state, and has drawn mixed reactions from public health advocates and industry groups concerned about regulatory fragmentation.

    Senate Bill 249 introduces additional licensure requirements for businesses that manufacture, distribute, or sell electronic smoking devices, aiming to improve oversight and tax compliance in the vape market. The legislation targets gaps in enforcement, with officials noting that a significant portion of retailers have been improperly taxing these products.

  • Germany Plans to Ban Disposable E-Cigs

    Germany Plans to Ban Disposable E-Cigs

    Germany is preparing legislation to ban disposable e-cigarettes, with Environment Minister Carsten Schneider last week citing safety and environmental concerns as the primary drivers. The government plans to introduce a draft bill in the coming months that would effectively end sales of single-use vapes, following reports of increased fires at waste facilities linked to improperly discarded devices.

    Officials said the lithium-ion batteries in disposable e-cigarettes pose a risk when crushed during waste processing, endangering workers and infrastructure. The proposed ban also aligns with broader environmental goals, as authorities seek to address the growing impact of electronic waste and improve recycling outcomes.

  • Finland’s Kokoomus Plans Generational Tobacco Ban

    Finland’s Kokoomus Plans Generational Tobacco Ban

    Finland’s National Coalition Party (Kokoomus) proposed a generational tobacco ban as part of its long-term policy platform, aiming to prohibit tobacco sales from 2030 to individuals born in 2015 or later. The proposal, included in a broader program outlining policy goals through 2040, will be voted on at the party’s congress in June.

  • Philippines’ Health Renews Total Vape Ban Push

    Philippines’ Health Renews Total Vape Ban Push

    The Philippine Department of Health renewed its call for a total ban on vaping products, citing public health risks and positioning prohibition as the most straightforward and cost-effective solution. While a full ban is not yet in place, the agency is urging stricter enforcement of existing regulations under the Vape Regulation Act, particularly provisions restricting flavored products that may appeal to minors.

    The DOH pointed to regional precedents, noting that several neighboring Asian countries have already implemented comprehensive vape bans. In the interim, officials are prioritizing the removal of flavored vape products from the market, emphasizing that flavor descriptors linked to fruits, candy, desserts, or cartoon imagery are considered to disproportionately attract youth.

  • Indonesia Stepping Up Vape Surveillance

    Indonesia Stepping Up Vape Surveillance

    Indonesia’s National Food and Drug Monitoring Agency (BPOM) is set to gain oversight of vape distribution nationwide, working alongside the National Narcotics Agency (BNN) following reports of drug-laced e-liquids in the market. BPOM said it will develop technical regulations under the country’s recent health laws to determine which vape products are permitted and which will face sanctions, with decisions guided by scientific assessment.

    While BNN has proposed a total ban on e-cigarettes to combat narcotics risks, BPOM signaled a more targeted approach, focusing on stricter control of illegal products lacking excise stamps rather than blanket prohibition. Authorities noted that illicit vapes are the primary source of drug contamination.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”