Category: Featured

New Tobacco Health Warnings in India

Photo: Tobacco Reporter archive
Tobacco manufacturers selling in India will have to print a new health warning on their products starting Dec. 1, reports Mint.
The Union Health Ministry has specified two sets of warning messages and images to be used on both sides of the pack. The first, “Tobacco causes painful death,” must be printed with an image on one side of a pack, and the message “Tobacco users die young” must be displayed with an image on the other side of a pack.
The packs must also display a toll-free helpline for smokers wishing to quit.
Health activists welcomed the new warnings.
“It’s a proven fact that the lives of tobacco users are shortened by up to 10 years as compared to nontobacco users,” said S.K. Arora, medical superintendent of the Sanjay Gandhi Memorial Hospital and renowned tobacco control expert. “The warnings play a significant role in helping tobacco users quit the habit.”
In the second round of the Global Adult Tobacco Survey, 61.9 percent of cigarette smokers, 53.8 percent of bidi smokers and 46.2 percent of smokeless tobacco users were considering quitting due to the warning label on packets. The number is significantly higher compared to the 2009–2010 figures.
According to government data, tobacco use causes more than 1.3 million deaths every year
July 27, 2022
CTP’s Matt Holman Joins PMI
Matt Holman
Matt Holman, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) Office of Science, is leaving the agency to join Philip Morris International effective immediately, reports The Hill, citing a memo from CTP Director Brian King. Holman has been director since 2017.
“I know that he led the Office through a critical time, including preparing for and overseeing review for the bolus of PMTA [premarket tobacco product application] applications,” King said in the memo. “I’m grateful to Matt for his contributions to the Center and unwavering commitment to you all over the years, and I wish him well in his next chapter.”
Holman’s departure comes after Mitch Zeller, the longtime CTP head, retired in April. King was appointed director earlier this month.
According to King’s memo, Holman has been on leave and has recused himself from all CTP and FDA work while exploring career opportunities outside government.
While free to pursue employment outside of the government, FDA employees are required to immediately disclose that they are exploring opportunities outside the government.
In March, the FDA signed off on a third-generation version of PMI’s IQOS heat-not-burn product, which was first authorized for sale in 2019. In 2020, FDA authorized it as a Modified Risk Tobacco Product, allowing the company to legally claim that fully switching from regular cigarettes to IQOS can reduce a person’s exposure to harmful chemicals.
Holman leaves the CTP as the agency faces series of major tobacco-related decisions, including a potential ban on menthol cigarettes, lowering nicotine levels, and the next step in its ongoing attempt to regulate Juul and other electronic cigarettes.
A spokesperson for Philip Morris said Holman “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives while protecting youth. We are looking forward to him joining our team as we continue to pursue a smoke free future.”
July 26, 2022
‘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.
July 26, 2022
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.
July 26, 2022
RAI Transitioning to Electric/Hybrid Vehicles

Photo: unlimit3d
Reynolds American Inc. (RAI) is transitioning its vehicle fleet to hybrid and electric models. The move will replace aging vehicles on a rolling basis over the next three years, resulting in a projected annual reduction in carbon emissions of more than 1,000 tons.
“Our sales and trade marketing representatives average nearly 27,000 miles a year in their territories across the 50 states—that’s a lot of time on the road,” said Ed Mirana, senior vice president of national sales and strategic accounts at RAI, in a statement. “With this move to hybrid vehicles, our sales and operations teams are driving progress on our sustainability ambitions.”
RAI is collaborating with Ford Pro to transition its current fleet to a mix of vehicle models, including the Escape SEL Hybrid, Explorer Limited Hybrid, Ford E-Transit and Ford-150 Lightning.
Included in the fleet of more than 1,800 vehicles are nearly 50 light-duty operations vehicles used across RAI’s North Carolina and Tennessee facilities, which will be transitioned to a combination of hybrid and electric models as part of this initiative.
“We continue to push for new ways to reduce our use of resources and environmental impact. We have a bold global ambition for carbon neutral operations by 2030, and reducing carbon emissions in our fleet is an important step on this journey. In addition, by 2024, more than 95 percent of all industrial vehicles used in operations will be electric,” said Bernd Meyer, executive vice president of operations at RAI. “With these significant changes and investments over the next few years, we are currently on track to meet a fleet carbon emission reduction of 50 percent by 2025.”
In 2022, approximately 650 hybrid and electric vehicles will replace internal combustible engine vehicles organization-wide.
RAI joins BAT Group’s growing list of markets across the globe, including Australia, Colombia, Germany, Mexico and the Netherlands, where trade and operations fleet transitions to hybrid and electric vehicles are well underway.
July 26, 2022
Kaival Launches PMI’s Veeba in Canada
Kaival Brands Innovations Group (KBI) announced the launch of Philip Morris International’s Veeba disposable e-cigarette in Canada.
In June, Kaival and PMI signed an agreement for the development and distribution of electronic nicotine-delivery system products in markets outside of the U.S.
“The agreement with Philip Morris Products was a remarkable accomplishment for the company, and now we have advanced to the next phase of international distribution with the actual launch of their custom branded product, Veeba,” said Eric Mosser, president and chief operating officer of Kaival Brands, in a statement.
“We are excited to support PMI’s efforts to provide a range of alternatives compared to cigarettes. The commercialization of Veeba complements PMI’s already strong smoke-free portfolio, providing adult smokers with an even broader range of usage, taste, price and technology options.”
The agreement licenses PMI to manufacture, promote, sell and distribute the Bidi Stick and any newly developed devices in certain markets outside of the United States, with potential royalties owed to KBI.
July 26, 2022
Smoore Opens PMTA Testing Lab in China

Photo: Smoore
Smoore has opened China’s first non-clinical full-scale testing laboratory for U.S. premarket tobacco product applications (PMTA).
Operated by Smoore’s Analysis, Testing and Safety Assessment Center, the laboratory provides all non-clinical evidence required to bring a new nicotine product to market, including material safety, hazardous components and potentially hazardous components (HPHC’s), and toxicology testing.
This is the first PMTA testing laboratory to open in China, and will allow Smoore to further improve the safety of its products, and help the brands they work with to successfully pass PMTA certification.
Prior to Smoore opening its new laboratory, vaping companies wanting to enter the U.S. would need to use third-party partners to complete their PMTA testing, which can be a costly and time-consuming process. With the new China facility, Smoore’s brand partners can more easily complete their PMTA certification and improve their accessibility to the US market.
“The FDA is very concerned about HPHCs and has set out a list of 33 substances which must be tested for,” said Dr Long, the director of Smoore’s new Safety Assessment Center, in a statement. “Our new laboratory can do all this and more, and has the capacity to test for 37 substances; we are the only facility in China whose testing capabilities covers the full range of HPHCs substances.”
According to Smoore, the laboratory tests against a world-leading new database of HPHCs, developed by Smoore and derived from international toxicity databases including those maintained by the U.S. Environmental Protection Agency (EPA).
Advanced computational toxicology software is also used to predict for unknown and potentially hazardous ingredients not included in these databases, further increasing Smoore’s safety assessments.
Since establishing its first research institute in 2017, Smoore has continued to lead the industry in evidence-based research. Its Safety Assessment Center has raised safety standards to medical grade, and works to constantly review product safety.
A total of eight products have been approved for marketing by the FDA, many of which are manufactured by Smoore.
July 26, 2022
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.”
July 25, 2022
Ex-President Scrutinized Over Cigarette Shipment

Photo: Taco Tuinstra
The U.S. government has blacklisted former Paraguayan President Horacio Cartes for his role in “significant corruption,” a move that prevents Cartes from entering the United States, reports The Wall Street Journal.
The decision follows revelations that an aircraft formerly owned by an Iranian carrier that is blacklisted by the U.S. Treasury for alleged arms trafficking transported cigarettes from a company owned by the former president.
Earlier this year, Paraguay’s then interior minister, Arnaldo Giuzzio, accused Cartes of laundering money and illicit enrichment tied to the alleged sale of contraband cigarettes from the former president’s tobacco company, Tabacalera del Este, known as Tabesa. The assertions didn’t lead to charges.
Last month, Paraguay’s top anti-corruption official, Rene Fernandez, called for a probe into allegations that Tabesa was linked to a group of Venezuelan and Iranian men who traveled through Paraguay in May. Paraguayan prosecutors are now investigating the men for alleged links to terrorism, though they have not been charged, government documents show.
The plane and its crew were grounded in Argentina last month, with authorities there saying they are investigating alleged terrorism ties.
Flight logs show that the jet reported carrying $754,000 worth of cigarettes sourced from Tabesa when it flew out from Paraguay to Aruba on May 16, according to the anti-corruption office. Listed as the recipient of the cargo was Tabacos USA, a Pennsylvania-registered company also owned by Cartes.
Paraguay, which borders Brazil and Argentina, has long been at the center of the illegal trade of contraband goods and drugs, according to security experts in the U.S. and Latin America.
July 25, 2022
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.”
July 24, 2022