TobaccoReporter logo

Blog

  • FDA Rule on Nicotine Content Clears OMB

    FDA Rule on Nicotine Content Clears OMB

    The Biden administration has moved closer to implementing a rule that would limit nicotine levels in cigarettes, with the proposal clearing an Office of Management and Budget review on Friday.

    Public health experts are optimistic about the potential impact. Studies suggest significantly reducing nicotine—by as much as 95%—could render cigarettes non-addictive, prompting many smokers to quit or transition to less harmful alternatives like e-cigarettes or nicotine pouches. Dorothy Hatsukami, a tobacco policy researcher, noted that minimally addictive cigarettes have shown promise in helping people quit smoking.

    However, critics warn of unintended consequences. Guy Bentley of the libertarian Reason Foundation argued that restricting nicotine levels could effectively ban cigarettes, fueling a black market and benefiting foreign entities.  “Biden’s ban is a gift with a bow and balloons to organized crime cartels with it, whether it’s cartels, Chinese organized crime, or Russian mafia. It’s going to keep America smoking, and it’s going to make the streets more violent,” said Rich Marianos, former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and the current chair of the Tobacco Law Enforcement Network.

    The future of the rule remains uncertain given the upcoming change of administration and the likelihood of litigation by industry.

  • Morocco Launches Next Phase to Curb Smoking

    Morocco Launches Next Phase to Curb Smoking

    Calling tobacco use one of Moracco’s most serious health concerns, Health Minister Amine Tahraoui announced the second phase of a national plan to address it. Speaking at the House of Representatives earlier this week, Tahraoui outlined the plan scheduled to run through 2029, part of a strategy to address non-communicable diseases and ultimately reduce smoking by 20% in the nation. Combating tobacco use was a priority under the first phase, the National Plan for Cancer Prevention and Control, which ran from 2010-2019.

    The second phase will have several new measures, mostly centered around raising public awareness and launching campaigns focused on educating citizens.

    “Every year, nearly 8 million lives are lost to tobacco worldwide,” Tahraoui said. “Morocco must take stronger steps to safeguard its population from this tragic reality.” The minister said 8% of Moroccan deaths are attributed to tobacco use, costing the nation $500 million each year, which represents 8.5% of total healthcare expenditures and 0.45% of the national GDP.

  • Dangerous Metals Found in Illegal Vape Devices

    Dangerous Metals Found in Illegal Vape Devices

    British scientists say they found “alarming levels of dangerous metals” and “dangerously high levels of nicotine” in a batch of illegal vapes seized during a raid in Derby, England in 2023. During the 18-month joint study by the University of Derby and public health and trading standards officers, toxicologists tested 10 illegal products and found “huge and often alarming levels of dangerous metals”, including cadmium, copper, nickel, and lead.

    “Lead is harmful to everyone and every organ,” said Dr. Ali Kermanizadeh, a senior lecturer in toxicology at the University of Derby. “It’s a neurotoxin. It can cause anemia, and it can cause severe conditions such as heart disease and strokes.

    “In some of the products, we found the nicotine content equivalent to smoking 200 traditional cigarettes.”

    The study concluded that using unregulated vapes, based on the chemicals found, could lead to severe long-term health conditions.

    “The toxicity varies from product to product,” Kermanizadeh said. “We’ve found these products cause cell death, they cause huge amounts of inflammation, they can change normal cell function, and they can also cause DNA damage. Long-term they can result in the development of cancers.”

    “The market is flooded with illegal vapes,” said Donna Dowse, service manager at Derby Trading Standards. “It’s important to get the message out that illegal vapes contain high levels of toxic chemicals, which are extremely harmful.”

  • Oliva Cigars See Price Increase

    Oliva Cigars See Price Increase

    Oliva Cigars announced its wholesale prices will increase either 3% or 5% beginning January 15. The company said it would honor its previous 2024 prices on any orders placed before January 15, and cited inflation as the main reason for the increase. The vast majority of Oliva’s cigars will increase by 3%, however, Oliva Serie V Melanio and Oliva Serie V Melanio Maduro will increase by 5%.

  • BAT Expands VUSE Presence in Korea

    BAT Expands VUSE Presence in Korea

    BAT Rothmans, the Korean subsidiary of British American Tobacco, announced plans today to accelerate its growth in the country’s vaping market by broadening its product offerings and distribution network.

    The flagship VUSE Go Slim 2ml, initially available in limited districts within Seoul, will now be distributed across all of Seoul, Incheon, and Busan. The device features a transparent mouthpiece for checking liquid levels and a removable battery. To cater to varying preferences, six new flavors have been introduced: Cool Fresh, Pearl Spark, Forest Mix, Dark Smooth, Purple Smooth, and Blossom Smooth.

    The VUSE Go Box 6ml, launched last year, has become popular among adult users transitioning to vapor products. With three times the liquid volume of the VUSE Go Slim and additional features like a boost control button for enhanced flavor, the device is priced competitively at 25,000 won ($17.15).

    The company entered the Korean market 18 months ago, introducing the VUSE Go lineup as the first of its kind in Asia. The brand has gained recognition for its use of high-quality natural nicotine and odor-free technology. “VUSE is dedicated to meeting the diverse needs of consumers by supporting the transition to non-combustible alternatives,” a BAT Rothmans official said. The company aims to strengthen VUSE’s position as a leading vapor brand in Korea by continuing to expand product options and accessibility.

  • PanelCompliance to Host Webinar on 21 CFR Part 11

    PanelCompliance to Host Webinar on 21 CFR Part 11

    The January 8th webinar will explore the significance of 21 CFR Part 11, a regulation critical for FDA-regulated companies transitioning to electronic records. The session will clarify how Part 11 extends beyond standard IT security by integrating specific measures for controlling electronic signatures and maintaining the integrity of electronic records, as outlined in FDA guidance. The regulation aims to balance the efficiency of electronic records with FDA’s priority on ensuring patient safety and preventing data compromise.

    Participants will gain insights into the regulatory framework, including the differences between open, closed, and hybrid systems, as well as the technical and procedural validation requirements for Part 11 compliance. The webinar will also address confusion stemming from the FDA’s initial regulation and its selective enforcement policy. By understanding these guidelines, companies can better navigate the intersection of data security and patient safety in FDA-regulated environments.

  • FDA Issues Final Guidance on Testing Methods

    FDA Issues Final Guidance on Testing Methods

    The FDA has published final guidance for the tobacco industry on the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides recommendations for tobacco manufacturers on how to generate validation and verification data for analytical methods supporting regulatory submissions, including Substantial Equivalence (SE) reports, Premarket Tobacco Product Applications (PMTA), and Modified Risk Tobacco Product Applications (MRTPA). It also applies to testing and reporting harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

    The updated guidance finalizes the draft issued in December 2021, incorporating comments received from stakeholders. Key changes include updates reflecting recent statutory revisions, such as the inclusion of synthetic nicotine under the definition of tobacco products, and clarifications on alternative validation procedures. The guidance also supports the use of national and international standard test methods and provides detailed recommendations on laboratory accreditation, statistical methods, and analytical test method validation, helping the industry produce more reliable and consistent data for regulatory purposes.

  • FDA Tightens Oversight on Vape, Pouch Imports

    FDA Tightens Oversight on Vape, Pouch Imports

    The FDA has updated import alerts 98-07 and 98-06 to strengthen the regulation of unauthorized e-cigarettes and other tobacco products entering the country. The changes clarify that all new vapor products must have FDA authorization to be marketed legally in the U.S. Under Import Alert 98-07, unauthorized vapor imports may face detention or refusal of entry without physical examination. The update also provides clearer guidance for importers, customs brokers, and federal partners, including links to the FDA’s searchable database of authorized tobacco products.

    Import Alert 98-06 focuses on non-e-cigarette tobacco products, including smokeless tobacco and nicotine pouches such as NOIS, LYFT, and SKRUF. These products, like vapor products, may also be detained if unauthorized. The FDA emphasized that mis-declared products remain a key focus, citing the seizure of three million units of unauthorized vapor products worth $76 million in collaboration with U.S. Customs and Border Protection. To date, the FDA has authorized only 34 vapor products and devices, underscoring its commitment to enforcing compliance and preventing illegal products from entering the market.

  • Optimism High as Zimbabwe Tobacco Harvest Begins Despite Weather Challenges

    Optimism High as Zimbabwe Tobacco Harvest Begins Despite Weather Challenges

    The early harvesting of Zimbabwe’s tobacco crop is underway, with farmers optimistic about achieving the annual target of 300 million kilograms despite earlier setbacks. Edward Dune, president of the Tobacco Farmers Union Trust, reported that most irrigated farms have started reaping, although recent heatwaves have compromised leaf weight in some areas. Encouraged by the December rains, small-scale farmers are still planting, and Dune anticipates an early start to the marketing season if favorable weather continues. The influx of labor to tobacco farms, particularly in arid regions like Binga and Muzarabani, reflects the sector’s importance for local livelihoods.

    To support farmers, the government has extended the deadline for seedbed destruction to January 15, 2025, following a recommendation by the Tobacco Industry and Marketing Board (TIMB). The extension, prompted by delayed rains and transplanting, allows growers to maximize their efforts amidst challenging conditions. With 84,661 hectares transplanted as of late December—exceeding last year’s figure—TIMB is optimistic about the industry’s growth and resilience. Efforts to ensure high-quality tobacco, proper handling, and competitive pricing remain priorities as TIMB prepares for a crop assessment exercise in January to evaluate the main dryland crop’s progress.

  • Queensland Cracks Down on Illicit Trade

    The Queensland government is intensifying efforts to combat the illegal trade of tobacco and vapes, which it claims is being exploited by criminal gangs. Health Minister Tim Nicholls revealed that 350-400 stores, including repeat offenders, are under surveillance, with recent raids seizing millions of illicit cigarettes, tons of loose tobacco, and tens of thousands of illegal vapes. Nicholls emphasized the need for stricter financial penalties, arguing that current fines, capped at $3,200 for individuals and $10,000 for corporations, are insufficient to deter the lucrative trade. Discussions are underway with the attorney-general to introduce harsher penalties.

    Meanwhile, the government faces mounting pressure to release the delayed Mid-Year Fiscal and Economic Review (MYFER). Labor’s Shannon Fentiman criticized the delay, suggesting the government is buying time to address fiscal mismanagement and accusing the LNP of stalling after their October election victory. Nicholls defended the postponement, citing efforts to uncover past Labor overspending and ensure an accurate portrayal of state finances. He dismissed opposition criticism as desperation, maintaining that the government is prioritizing transparency and accountability in its economic reporting.