Author: Taco Tuinstra

  • First Warning Letters for Synthetic Nicotine

    First Warning Letters for Synthetic Nicotine

    Photo: 103tnn

    The U.S. Food and Drug Administration on July 13 sent its first warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization.

    In March, President Joe Biden signed into law a spending bill that gives the FDA authority over synthetic nicotine. The provision took effect in April and gave manufacturers until May 14, 2022, to submit marketing applications to the FDA.

    Products did not receive marketing authorization by July 13, 2022, are considered illegal and must be removed from the market.

    The recipients of the FDA’s first warnings letters, AZ Swagg Sauce and Electric Smoke Vapor House, have listed a combined total of approximately 10,000 products with FDA. Neither company submitted a premarket application for its non-tobacco nicotine products by the deadline, according to the FDA.

    In addition, the FDA issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers.

    “FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement.  “In the coming weeks, we will continue to investigate companies that may be marketing, selling, or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate.”

    The FDA says it is currently processing applications for approximately 1 million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline.

    “FDA is working diligently to process the substantial number of applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted,” said King. “We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products.”

     

  • Association Calls For Investigation Of MDO’s

    Association Calls For Investigation Of MDO’s

    Photo: Andrey Popov

    The American Vapor Manufacturers Association (AVMA) has asked the U.S. Department of Health and Human Services’ (HHS) Inspector General to investigate whether the Food and Drug Administration’s marketing denial orders for vaping products are driven by political pressure.

    The AVMA says it wants the inspector general to help the public learn about FDA Commissioner Robert Califf’s coordination with elected officials, allied activists and reporters as his agency continues its review of premarket tobacco product applications (PMTA).

    Amanda Wheeler

    In a letter sent to HHS Inspector General Christi A. Grimm, AVMA President Amanda Wheeler contends that interference has corrupted FDA’s statutory obligation to properly implement its PMTA review process based solely on scientific, empirically based judgment.

    “Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” Wheeler wrote. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The Office of Inspector General should open the door and hold the FDA accountable to its standards.”

  • Brazilian Institute Hosts Debate on Child Labor

    Brazilian Institute Hosts Debate on Child Labor

    Photo: Sinditabaco

    Brazil’s Growing Up Right Institute organized a seminar on child labor prevention at the Santa Cruz Country Club in Santa Cruz do Sul on July 7.

    Under the theme, “Child labor: care, welcome and protection,” participants discussed the progress made in combatting child labor, along with the work that still needs to be done.

    “The Institute was founded with the mission to fight child labor and generate opportunities for adolescents from the rural setting, especially in tobacco growing regions,” said Iro Schunke, president of the Growing Up Right Institute, in a statement. “It is a complex task, but with good partnerships we have achieved great results. We have already become known nationally and internationally for the innovative method of offering opportunities to adolescents from the countryside through the learning law.”

    Since 2016, the rural professional learning program has benefited 596 young people in Rio Grande do Sul. As part of the program, tobacco companies associated with the Growing up Right Institute hire young apprentices and pay them a salary proportional to 20 hours a week.

    Instead of working, however, the apprentices attend a rural management and entrepreneurship course in the shift opposite to their regular school hours. The classes typically take place in the apprentices’ normal schools or in venues provided by the municipal administrations, which also provide for food and transport logistics thus making it viable for the adolescents to attend the course.

    According to a report by the International Labor Organization and by the United Nations Children’s Fund, 160 million children and adolescents, aged 5 to 17, were subjected to child labor in early 2020. The Covid-19 pandemic has exacerbated the problem of child labor around the world, with a sharp increase in poverty, closure of schools and consequent school evasion.

    In Brazil, the National Household Sample Survey, demonstrated that 1.77 million children and adolescents works, 53.7 percent of whom are in the 16-17 year age group.

  • Underage Vaping Nearly Doubles in U.K.

    Underage Vaping Nearly Doubles in U.K.

    Photo: Oleg

    Current vaping among U.K. children aged 11-17 was up from 4 percent in 2020 to 7 percent in 2022, according to the annual YouGov youth survey for Action on Smoking and Health (ASH) carried out in March and published on July 7. The proportion of children who admit ever having tried vaping has also risen from 14 percent in 2020 to 16 percent in 2022.

    Disposable e-cigarettes are now the most used product among current vapers, up more than seven-fold from 7 percent in 2020 and 8 percent in 2021, to 52 percent in 2022. Elf Bar and Geek Bar are overwhelmingly the most popular, with only 30 percent of current users having tried any other brands.

    Over the past year there has been growing concern about the increasing popularity of disposable vapes with young people, but this is the first time national figures have been available to show the scale of the change. ASH said the increase in vaping shown by the survey is a cause for concern, and needs close monitoring. However, 92 percent of under 18s who’ve never smoked, have also never vaped, the organization pointed out—and only 2 percent have vaped more frequently than once or twice.

    “Just to give it a try” is still the most common reason given by never smokers for using an e-cigarette (65 percent). For young smokers the most common reason for using an e-cigarette was “because I like the flavors” (21 percent) followed by “I enjoy the experience” (18 percent) then “just to give it a try” (15 percent),  but they also said, “because I’m trying to quit smoking” (11 percent) or “I use them instead of smoking” (9 percent). Fruit flavors remain the most popular (57 percent).

    Vaping behavior is strongly age related, with 10 percent of 11-15 year olds ever having tried vaping, compared to 29 percent of 16 and 17 year olds (the figures for those currently vaping are 4 percent and 14 percent respectively).  And while underage vaping has risen, underage smoking is lower than it was in 2020 (14 percent in 2022 compared to 16 percent in 2020).

    For the first time this year the survey asked about awareness of promotion of e-cigarettes. Over half (56 percent) of 11-17 year olds reported being aware of e-cigarette promotion, most frequently in shops, or online, with awareness highest amongst those who’d ever vaped (72 percent). Tik Tok was the most frequently cited source of online promotion (45 percent) followed by Instagram (31 percent).

    In response to the survey results, the U.K. Vaping Industry Association (UKVIA) called for a range of get-tough measures to crack down on unscrupulous retailers who sell vapes to young people.

    “The UKVIA understands the need for the right balance between supporting adult smokers to quit without encouraging take up amongst under-18s and ‘never-smokers,’” said UKVIA’s Director General John Dunne in a statement.

    In a letter to the Department for Health and Social Care, the UKVIA proposed a set of recommendations to come down hard on those who sell vapes to minors while maintaining vaping’s critical role for helping smokers to quit, including  fines of £10,000 ($11,897) and a national retail licensing scheme.

  • TIMB Vows Crackdown on Side Marketing

    TIMB Vows Crackdown on Side Marketing

    Photo: Taco Tuinstra

    Zimbabwe’s Tobacco Industry and Marketing Board (TIMB) vowed to crack down on side marketing, noting that five exporters lost $57 million due to the practice in 2021, according to News Day.

    Side marketing is a form of contract breach in which contracted tobacco growers sell their produce to third parties in violation of an agreement to sell all their leaf to the party who provided the agricultural inputs.

    “This year, 2022, the Tobacco Industry and Marketing Board is on an accelerated drive to end tobacco side-marketing. This criminal practice is responsible for the loss of millions of dollars annually and has the potential to kill the tobacco industry,” the TIMB wrote in an article published on its website.

    “TIMB cannot accurately ascertain how much is lost annually since side-marketing is an illegal activity whose statistics cannot be accurately ascertained. However, in 2021 alone five exporters lost US$57 million as a result of several factors and chief among them being side marketing,” it said.

    Prior to Zimbabwe’s radical land reform program in the early 2000s, most of the country’s tobacco was produced by commercials farmers who funded their own operations and sold their leaf at auction. Today’s Zimbabwean tobacco production is dominated by smallholder production and contract buying, as most of the new farmers are unable to pre-finance their crops.

    In 2021, the TIMB created a special unit, the inspectorate department, to prevent, detect and investigate side marketing and other illegal activities in the tobacco industry.

  • U.K. Counterfeit Cigarettes Sales up by One-Third

    U.K. Counterfeit Cigarettes Sales up by One-Third

    Photo: BAT

    Consumption of counterfeit cigarettes jumped by more than a third in the U.K. in 2021, reports Talking Retail, citing a recent KPMG study commissioned by Philip Morris International.

    As a result, the number of counterfeit cigarettes smoked in the U.K. topped 3 billion for the first time since the study began 16 years ago.

    “The KPMG report highlights how both illicit tobacco and vapes are becoming increasingly prevalent in the U.K., with the situation getting steadily worse over the past five years,” said Cem Uzundal, head of Philip Morris’ U.K. field force.

    “There’s a real job to be done to tackle this issue by authorities, tobacco manufacturers and even convenience retailers, who can help by reporting stores selling illicit tobacco in their area.”

    “The KPMG report underlines what my team see on British streets month in, month out: illicit products—particularly counterfeits—widely available for sale,” said Will O’Reilly, a former Scotland Yard detective chief inspector who carries out regular test purchases of illicit products on behalf of Philip Morris.

    “Organized criminal groups appear to consider the risk of being caught well worth the prospect of making around £1.5 million profit [$1.79 million] for every container load they bring into the U.K.”

  • Pouch Segment Growing Rapidly in Spots

    Pouch Segment Growing Rapidly in Spots

    Photo: Swedish Match

    While not yet widely available, sales of nicotine pouches are developing rapidly in select geographies, according to a blog post by the Foundation for a Smoke-Free World (FSFW) of reduced-risk products. The largest markets are currently in high-income and middle-income countries, with Sweden and the United States topping the list, partly as a result of their strong oral tobacco cultures.

    Of the 15 companies ranked by the FSFW’s Tobacco Transformation Index, which measures the extent to which nicotine companies are making progress toward reducing the consumption of high-risk products, seven currently offer nicotine pouches. In 2021, nicotine pouches represented 0.3 percent of the world tobacco market in value terms.

    Twenty-four of the 36 countries covered by the Tobacco Transformation Index allow nicotine pouches. Of those 24 markets in 2021, the market size exceeded 10 million units in seven: the United States, Sweden, the United Kingdom, Germany, Ukraine, Switzerland and Poland.

    Legislation differs among the studied geographies, with some countries treating nicotine pouches as consumer products and others viewing them as tobacco products. Germany’s Federal Office of Consumer Protection and Food Safety determined that nicotine pouches are a foodstuff containing an unauthorized novel food ingredient—nicotine—and thus illegal for sale.

  • Canada Working on Medicago’s ‘Tobacco Problem’

    Canada Working on Medicago’s ‘Tobacco Problem’

    Photo: Auramar, artwork: Dan Kurtz

    The government of Canada is “working on a solution” to help Medicago donate its Covid-19 vaccine to low-income countries, reports CTV News.

    In February, Health Canada approved the pharmaceutical firm’s Covifenz vaccine for people aged 18–64. The federal government has signed a contract to buy up to 76 million doses with plans to donate vaccines to low-income countries.

    However, the World Health Organization has rejected the vaccine because Philip Morris is a minority shareholder in Medicago, and the U.N. agency has a strict policy about engagement with the tobacco industry. Donations are not allowed without WHO approval.

    Medicago’s majority shareholder, Mitsubishi Tanabe Pharma, has approached the Quebec government for support so Medicago’s vaccines “can receive a favorable reception from the WHO and be marketed on a large scale,” according to an entry in the Quebec Registry of Lobbyists.

    During a meeting with Mitsubishi executives in Japan, Innovation, Science and Industry Minister Francois-Philippe Champagne indicated that there were discussions about the future of Medicago as a global vaccines manufacturer.

    While ruling out buying shares in Medicago for the time being, Champagne indicated that the government was looking at other ways to help make Medicago a “global champion.”

    Quebec Economy Minister Pierre Fitzgibbon said in June that he has been in discussions with Mitsubishi Tanabe Pharma executives to resolve the impasse, but the Japanese company must first negotiate the purchase of Philip Morris’ stake itself.

  • 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.

  • Boka Tobacco Sales Suspended

    Boka Tobacco Sales Suspended

    Photo: Taco Tuinstra

    Zimbabwe’s Tobacco Industry Marketing Board (TIMB) has suspended the Boka Tobacco Sales Floor (BSF) from purchasing tobacco from farmers with immediate effect, reports Africa Press.

    The regulator acted on July 14 following several reports by growers that they have spent more than a month without receiving payment for their produce.

    TIMB Public Affairs Officer Chelesani Moyo said the suspension will be reviewed after the BSF clears all its outstanding dues and provides proof of adequate financial resources.

    “We have received several complaints from growers who have not been paid by Boka Tobacco Sales Floor after sales,” she said.

    “As a regulator, we have engaged with Boka management to resolve the issue in an amicable manner.

    With immediate effect, TIMB has suspended all tobacco purchases by Boka until they have cleared all outstanding payments and provided proof of adequate financial resources.”