Category: News This Week

FDA Issues Guidance on User Fees

Photo: Grandbrothers
The U.S. Food and Drug Administration has issued a draft guidance that helps answer frequently asked questions around tobacco product user fees.
The draft guidance provides information regarding the submission of information needed to assess user fees owed by each domestic manufacturer or importer of tobacco products and how FDA determines whether a company owes user fees in each quarterly assessment. Starting May 27, public comments related to this draft guidance may be submitted through July 26, 2021.
The Federal Food, Drug & Cosmetic (FD&C) Act requires FDA to “assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products subject to” the tobacco product provisions of the FD&C Act. Under the calculations required by the FD&C Act, the tobacco products that are subject to user fee assessments are cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigars and pipe tobacco.
The FD&C Act provides for the total quarterly assessment to be allocated among specified classes of tobacco products. The class allocation is based on each tobacco product class’ volume of tobacco products removed into commerce. Within each class of tobacco products, an individual domestic manufacturer or importer is assessed a user fee based on its market share for that tobacco product class.
May 27, 2021
‘Reforestation Efforts Paying off in Brazil’

Photo: Joao Bispo
Tobacco industry reforestation efforts are paying off in southern Brazil, reports industry association SindiTabaco on National Atlantic Forest Day. Over the past 40 years, the tobacco sector has been working to eradicate the consumption of wood from native trees for curing. As a result, Forest cover on small-scale tobacco farms has now reached 24 percent, split into 15 percent native forests and 9 percent planted forests, according to data released by the Tobacco Growers’ Association of Brazil.
“For some decades now, the sector has been self-sufficient in fuel wood for curing tobacco, and thus native forests are preserved,” said SindiTabaco president Iro Schunke. “Incentives provided by the industries, which started in the mid-1970s, and the farmers’ willingness to plant eucalyptus trees played a fundamental role in the present enviable forest cover rates.”
In 2019, SindiTabaco partnered with the Federal University of Santa Maria to preserve forests while providing farmers with a sustainable source of energy.
“Tobacco is a centuries-old crop, and when it was brought to our region, it was strongly dependent on natural forests as a source of fuel wood, particularly because back then there were no planted forests,” says research coordinator Jorge Antonio de Farias.

For some decades now, the sector has been self-sufficient in fuel wood for curing tobacco, and thus native forests are preserved.
Iro Schunke, president, SindiTabaco
“Such common tree species as eucalyptus and acacia were rare at that time and little known, and, on the other hand, native forests were in great abundance. As of the 1970s, when the sector set targets to eradicate the consumption of wood from native trees, the farmers began to use wood from planted forests.
“Within this context, the target of the project consists in strengthening the conquests achieved so far—that is to say, the maintenance of the existing native forests—and at the same time come up with new elements and technologies capable of increasing the productivity rates of existing reforested plots whilst establishing new reforestation areas.
“To this end, we are creating reference units in tens of tobacco farms, testing new technologies and techniques, like spacing—distance between trees—new genetic materials and forest species that lead to higher productivity and energy performance.”
The results of the research will be shared through social media channels with tobacco farmers.
May 26, 2021
Vapor Stocks Plunge on China Health Warning

Photo: Kenishirotie
Vapor company stocks listed on the Hong Kong Stock Exchange plunged following an official warning that e-cigarettes can damage health, reports the Global Times. Smoore International saw its shares slump nearly 20 percent near the end of the May 26 trading session before finishing the day down 17.1 percent. China Boton Group lost 17.94 percent while Huabao International Holdings shed 7.69 percent. By comparison, the benchmark Hang Seng Index gained 0.88 percent.
The rout was triggered after the National Health Commission and the World Health Organization’s China office unveiled a joint report stating that there’s sufficient proof that e-cigarettes are unsafe and harmful to health.
According to the report, China’s smoking population tops 300 million, with the smoking rate for those aged 15 and above standing at 26.6 percent and the percentage of male smokers hitting 50.5 percent. Cigarettes claim the lives of more than 1 million people in the country per year, the authors wrote. The annual number is estimated to rise to 2 million by 2030 and then to 3 million by 2050, assuming the absence of effective actions.
The recent report contradicts a report by the U.K. Royal College of Physicians, which in 2016 concluded e-cigarettes are 95 percent safer than regular cigarettes and are likely to be hugely beneficial to public health.
One vapor company defied the panic selling on May 26: In the final hour of Hong Kong trading, BYD Electronic soared 22.91 percent on reports that the company has finalized patenting its e-cigarette business, which is expected to begin mass production in June.
May 26, 2021
RJR Ordered to Pay $3 Million to Sick Smoker

Photo: Alex
A Florida jury on May 24 ordered R.J. Reynolds Tobacco Co. (RJR) to pay roughly $3 million to a man suffering from chronic lung disease after decades of smoking, reports Courtroom View Network.
Plaintiff Roosevelt Gordon, who suffers from emphysema and chronic obstructive pulmonary disease, will receive $447,000 for medical expenses and $2,522,880 for past and future pain and suffering.
Gordon blames his illness on the Winston cigarettes he began smoking as a teenager. RJR countered that Gordon chose to smoke despite knowing the risks to his health.
The plaintiff’s attorney argued that Gordon never saw the messages RJR put out about the health risks associated with smoking and that consumer expectations in decades past were very different than today.
The case, which is unrelated to the historic Engle class action, relied on only two claims—defective product and negligence—and demanded no punitive damages, which allowed it to reach a conclusion relatively quickly.
These two trials come on the heels of an April trial in Miami, where a jury cleared Philip Morris of any liability for a longtime smoker’s stroke.
In February, an Oregon jury returned a defense verdict for RJR over responsibility for a smoker’s fatal lung cancer.
May 26, 2021
Poda Patents Closed-Ended HnB Cigarette

Photo: Poda Lifestyle and Wellness
Poda Lifestyle and Wellness expects to receive patent protection for its Poda zero-cleaning heat-not-burn (HnB) technology in Europe and the United States soon.
The Poda system uses proprietary biodegradable single-use pods. The design prevents cross-contamination between the heating devices and the pods, eliminating cleaning requirements and providing users with a convenient and enjoyable potentially reduced-risk smoking experience.
The company says its pods are the first and only cigarettes to have a completely closed end. A closed-ended cigarette utilizing HnB heating technology allows for an ashless experience and provides for consistent quality each time a new pod is inserted into the heating device.
Poda Lifestyle and Wellness’ research and development commenced in January 2015. The Poda zero-cleaning technology was granted a Canadian patent in 2018 with patent entries filed in more than 65 additional countries.
“We have spent years of research and development with regards to our invention and are very pleased to see that our invention has been granted a patent in Canada,” said Poda CEO Ryan Selby in a statement.
“We have filed for patents in 65 other countries and expect USA and European patents to follow in short order now that we have received the Canadian patent.”
We have spent years of R&D and are very pleased to see that our invention has been granted a patent in Canada.
Ryan Selby , CEO, Poda
“This will protect our company for many years ahead as we launch Poda into the global marketplace as the first heat-not-burn system that allows users to experience maintenance-free heating of substrates such as tobacco or dried plant material with zero cross-contamination when switching from one substrate to another.”
May 26, 2021
Farmers Targeted by Dishonest Middlemen

Photo: Taco Tuinstra
Many small-scale farmers in Zimbabwe complain they are being impoverished by merchants who are luring them into a debt trap.
According to an article by AP, unscrupulous middlemen offer farmers loans to pay for fertilizer, seed and firewood for curing. In addition to repaying the loans with interest, farmers must sell the crop at a price set by the merchant, who then sells it to the highest bidder at auction.
Farmers end up earning only a fraction of what the tobacco fetched at the sales floor.
For more than 60 years, tobacco was a lucrative export crop from which white farmers profited. But after the year 2000 when President Robert Mugabe’s supporters began seizing white-owned farms, often violently, tobacco production plummeted. The flue-cured tobacco crop dropped from a 1998 peak of 260 million kg to just 50 million kg in 2008.
Since then, tobacco production by Black farmers has grown. Before Mugabe’s land reforms, the bulk of the tobacco crop was grown on a few thousand white-owned commercial plantations. Today, it is grown by more than 145,000 small-scale Black growers. Zimbabwe’s tobacco crop is estimated to be 200 million kg this year, up from 180 million kg last year.

At the heart of the problem is the inability of resettled farmers to raise their own finance through banks. Banks fear that they will be left holding a piece of paper if a farmer fails to repay.
John Robertson, economist
Before the land reforms, Zimbabwe’s commercial banks gave loans to white farmers so they could purchase inputs for their crops. But the banks pulled out years ago because the government has not issued transferable ownership deeds to the Black farmers resettled on the formerly white-owned land. This means they have no collateral to secure commercial bank loans.
At the heart of the problem is the inability of resettled farmers to raise their own finance through banks, said economist and analyst John Robertson.
“Banks fear that they will be left holding a piece of paper if a farmer fails to repay. They can’t touch the land,” said Robertson.
While many farmers are contracting with reputable leaf merchants who buy tobacco directly for their customers, the difficulty of securing bank loans leaves others vulnerable to predatory middlemen.
The government says the solution lies with a state-owned Land Bank launched in April, which would loan farmers money for their tobacco crops at reasonable rates.
May 25, 2021
Demand for Menthol Liquid up After Ban

Photo: Max
A year to the day since menthol cigarettes were banned in the U.K., more than two-thirds of vapor retailers are reporting a rise in sales of menthol-flavored e-liquids, according to a study by the U.K. Vaping Industry Association (UKVIA).
The ban last year, which also prevented menthol filters, papers and skinny cigarettes from being produced or sold in the U.K., followed a four-year phasing-out period, which saw smaller packs of rolling tobacco and 10-packs of cigarettes banned in 2017.
The study revealed that more than 70 percent of owners of brick-and-mortar stores and online retail operations said they had seen an uptake in demand for menthol vape products.
And, while fruit e-liquids remained the customer favorite, menthol was the second most popular flavor, according to the survey.
“What we have witnessed in the U.K. is that menthol as an ingredient in vape e-liquids has continued to increase following the combustible menthol ban and is now one of the most important components of all e-liquids,” said Tim Phillips, independent analyst at ECigIntelligence.

Menthol as an ingredient in vape e-liquids has continued to increase following the combustible menthol ban and is now one of the most important components of all e-liquids.
Tim Phillips, analyst, ECigIntelligence
UKVIA Director-General John Dunne said the survey results were a clear indication of the importance e-cigarettes have in helping smokers to quit their habits in favor of vaping, which Public Health England acknowledges is far less harmful than combustible tobacco.
“Our survey of retailers clearly shows that, as menthol cigarettes were removed from sale, vape stores witnessed an increase in sales of the same flavor in e-liquid form,” he said.
“It is not unreasonable to surmise that the majority of menthol e-liquid sales above retailers’ baseline pre-ban were to those who would have previously smoked cigarettes.”
May 25, 2021
Governments Urged to End Cigarette Sales

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More than 140 organizations released a letter on May 24 calling on governments to begin plans to phase out the sale of all cigarettes. Signatories include the Association of American Cancer Institutes and schools such as the Johns Hopkins Bloomberg School of Public Health.
“For decades, tobacco companies have falsely claimed they’d stop selling cigarettes if proven deadly,” said Action on Smoking and Health (ASH) Executive Director Laurent Huber. “Clearly, they didn’t mean it and will continue as long as it is profitable. It’s up to governments to protect their citizens from tobacco products and from the tobacco industry by planning to phase out the sale of combustible tobacco.”
The joint letter released is part of “Project Sunset,” an umbrella program that seeks to phase out the commercial sales of cigarettes.
According to ASH, the idea of phasing out tobacco sales is neither radical nor theoretical.
“Society has banned the sale of products that are far less harmful and even useful, like lead gasoline, chlorofluorocarbons and asbestos,” the organization wrote in a press note. “What is radical is allowing an addictive product that kills when used as intended to be more readily available than milk.”
ASH insists that Project Sunset is not prohibition. “It is about phasing out the sale of commercial tobacco products, not possession or use,” the organization wrote. “Some opponents (some funded by the tobacco industry) have warned that banning tobacco sales would give law enforcement new rationales to abuse their power, especially in communities of color. But it will never be illegal to hold a cigarette, or to grow tobacco, or even to buy it.”
ASH contends that marketing and selling tobacco also violates basic human rights. “Tobacco addiction compounds health inequities, especially among minority communities, who are preferentially targeted by tobacco industry marketing,” the group wrote.
“And there is growing agreement that what the tobacco industry does every day is not only immoral but criminal. Marketing and selling a product known to be addictive and deadly easily meets most definitions of murder.”
May 25, 2021
Countries Recognized for Anti-Smoking Efforts

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The World Health Organization (WHO) bestowed its World No-Tobacco Day Awards for 2021 in the Americas to three Costa Rican institutions, the ministries of health in Saint Lucia and Paraguay, the Uruguayan National Resource Fund, two California cities and a Brazilian doctor, according to the Pan American Health Organization.
The winners, selected from nominations received in response to a public call, achieved key advances in tobacco control in their countries, according to the global health body. The awards are part of global tobacco control efforts recognized on World No-Tobacco Day every year.
A shared award was given to Costa Rica’s mSalud Institutional Team, which comprises three institutions formed by the Ministry of Health, the Costa Rican Social Security Fund and the Institute on Alcoholism and Drug Dependence. The mSalud Team received the award for their role in expanding quit-tobacco services through development of online tools.
Uruguay’s National Resource Fund received the award for its role in the National Network of Smoking Cessation Units. The network arose out of the Tobacco Treatment Program, which the Resource Fund created in 2004. The Resource Fund is now responsible for coordinating, evaluating and supporting the network, which has played a key role in increasing access to quit-tobacco services throughout the country.
The award was given to Tania Cavalcante, an oncologist at Brazil’s National Cancer Institute and Executive Secretary of the National Committee for the Implementation of the Framework Convention on Tobacco Control in Brazil. She received it for her lifelong contribution to effective tobacco control policy in Brazil and for her globally impactful work on implementation of the WHO Framework Convention on Tobacco Control (FCTC). Cavalcante also has been instrumental in facilitating countries’ exchanges of experiences in tobacco control in Latin America and among Portuguese-speaking countries.
Saint Lucia’s Ministry of Health and Wellness received the award for its role in adoption in June 2020 of the Public Health (Smoking Control) Regulations, Statutory Instrument, 2020, No. 81. The regulation establishes a smoking ban in enclosed public and working places and on public transport. The regulation covers electronic cigarettes and prohibition of the sale of tobacco products in places such as health, sport, government, childcare, educational and religious facilities. With the adoption, St. Lucia became the eighth country in the Caribbean and the 22nd in the Americas to adopt regulation in keeping with Article 8 of the FCTC, which asserts that people should be protected against tobacco smoke in indoor public places, indoor workplaces and public transportation.
Paraguay’s Ministry of Public Health and Social Welfare received the award for its role in Decree No. 4624, which establishes that cigarettes, heated-tobacco products or electronic cigarettes can only be consumed in open-air spaces without crowds. With the decree, Paraguay joins the rest of South American countries in following Article 8 of the FCTC to create a smoke-free region.
The California cities of Beverly Hills and Manhattan Beach shared the award for their ban on the sale of tobacco products. According to the WHO, their actions serve as proof of concept for Project Sunset, a global effort to phase out sale of commercial combustible tobacco products, including alternative nicotine-delivery systems. California has since set a goal of eliminating tobacco use by 2035. Through this initiative, Beverly Hills and Manhattan Beach are going one step beyond established measures to mitigate and reduce consumption of tobacco, the global health body said.
May 25, 2021
Study: Does Nicotine Protect Against Covid?

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Researchers at the Pitie-Salpetriere hospital in Paris are investigating whether Covid-19 can be treated with nicotine, reports RFI.
The project is in response to an observation made by doctors in the first months of the pandemic that there were fewer smokers among their most serious Covid cases. The “smokers’ paradox” was observed in China and in peer-reviewed studies around the world. A French study found that out of 11,000 hospitalized patients, only 8.5 percent were smokers compared to 25.4 percent of the general population.
Some suggest the nicotine in cigarettes could be slowing the virus. Many Covid-19 deaths are caused by an overreaction of the immune system. Scientists speculate that nicotine helps moderate such overreactions because it lowers the immune system’s activity.
Last year, French researchers analyzed public health data of people who used nicotine substitutes, like patches or gum. They noticed that those people had fewer Covid cases than those who did not use nicotine substitutes.
To test the hypotheses, Paris hospitals launched three clinical studies using nicotine patches. One of the studies, concluded in April, involved 220 patients in intensive care units for severe Covid infections. Half were given nicotine patches and the others were given placebos. The data is being analyzed, and the first results should be out in June.
While the findings are interesting, Pitie-Salpetriere doctor Zahir Amoura warns people against taking up smoking to protect themselves from Covid. “Smoking is a scourge. It’s important to repeat that,” he told RFI.
May 25, 2021