Category: News This Week

FDA Proposes New Rules for Manufacturing
Photo: Tobacco Reporter archive
The U.S. Food and Drug Administration is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of all tobacco products.
The proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency, according to an FDA statement.
“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,”
Brian King / Credit: FDA
said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”
The proposed new requirements would help manufacturers comply with the Federal Food, Drug, and Cosmetic Act by helping minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances—such as metal, glass, and plastics—which have been found in tobacco products. T
The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids, “Such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins,” the agency states.
The proposed rule would also establish several requirements related to the identification, tracing and corrective actions for tobacco products that don’t meet specifications or are contaminated, including for tobacco products that have already been distributed.
In the event of an issue, these requirements would require manufacturers to take corrective actions, which may include conducting a recall.
The proposed requirements apply to manufacturers of finished and bulk vaping and other tobacco products. As laid out in the proposed rule, a finished tobacco product is a tobacco product, including any component or part, sealed in final packaging; for example, an e-cigarette, a pack of cigarettes or a can of moist snuff.
A bulk tobacco product is a tobacco product that isn’t sealed in final packaging, but is otherwise suitable for consumer use.
The proposed rule establishes a framework for manufacturers to adhere to, including:

establishing tobacco product design and development controls;

ensuring that finished and bulk tobacco products are manufactured according to established specifications;

minimizing the manufacture and distribution of tobacco products that don’t meet specifications;

requiring manufacturers to take appropriate measures to prevent contamination of tobacco products;

requiring investigation and identification of products that don’t meet specifications to institute appropriate corrective actions, such as a recall; and

establishing the ability to trace all components or parts, ingredients, additives and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of those that don’t meet specifications.
The FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups, and the public.
The proposed rule also will be available for public comment for 180 days. The agency will review all comments as part of the rulemaking process for this foundational rule.
“We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law,” said King. “We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits a comment based on sound grounds, that can make an important difference in the agency’s decision-making.”
The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations. The FDA intends to make TPSAC meeting materials available on its website no later than 48 hours before the meeting.
March 8, 2023
Zimbabwe: Prices up as Auctions Open

Photo: Taco Tuinstra
Tobacco prices in Zimbabwe fetched $4.35 per kg at the start of the new marketing season today, up from $4.20 last year, reports Reuters.
“It looks like we are going to have a good crop,” said Tobacco Industry and Marketing Board (TIMB) Chairman Patrick Devenish, who credited favorable rainfalls.
The TIMB expects the country to produce 230 million kg of tobacco this year, 8.5 percent more than in 2022.
Tobacco land use grew to 117,000 hectares this year from 110,000 hectares in 2022, according to the TIMB. The industry also saw an increase in the number of tobacco farmers to 148,527 this year from 123,000 in 2022.
The tobacco industry contributes nearly $1 billion to export earnings every year, Zimbabwean Vice President Constantino Chiwenga said on March 8. Government statistics showed it accounted for more than 12 percent of exports in January.
Zimbabwe is currently implementing a “Tobacco Value Chain Transformation Plan,” which seeks to extract more profit from the sector by processing raw leaf into higher-value products.
“We seek to localize the financing of tobacco. We wish to transform the tobacco sector so we don’t export value,” Agriculture Minister Anxious Masuka said on March 8.
“This industry is on the cusp of growth.”
March 8, 2023
Kaival Signs New Distribution Agreements

Photo: Bidi Vapor
Kaival Brands Innovations Group, the exclusive U.S. distributor of Bidi Vapor products, has entered into agreements representing potential new distribution to approximately 13,500 locations.
Under the terms of the agreements, Bidi Vapor’s Bidi Stick will initially be activated in 700 locations, with another 1,500 locations expected within the next 90 days. All of the new locations meet Kaival Brand’s and Bidi Vapor’s requirements for customer identification verification and youth-access prevention.
“We are excited to announce these significant new distribution agreements, totaling up to 13,500 new locations, as we look to continue the ramp up of marketing and sales activity for Bidi Stick. Since Bidi Vapor succeeded in its merits case against the FDA vacating FDA’s marketing denial order for ENDS products in August 2022, we have seen a resurgence of interested retailers and potential distributors,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.
“While the FDA continues to move slowly in enforcing against bad actors, major retailers are showing their commitment to e-cigarettes as a category and using corporate discretion to select brands that are committed to youth-access prevention and responsible marketing of adult products. We believe our products fit squarely in this category, and we are hopeful that this positioning will lead to greater revenues for Kaival Brands during 2023.”
“We are excited to increase the reach of the Bidi Stick by up to 13,500 new stores,” stated Russell Quick, president of QuikfillRx, which operates under the name Kaival Marketing Services. “These new agreements represent an immediate impact of 700 new locations to start and we believe represents a vote of confidence that retailers have in us and our products.”
March 8, 2023
Appointments at RAI

Priscilla Samuel (Photos: RAI)
Reynolds American Inc. (RAI) has appointed two senior leaders within its operating companies.
Priscilla Samuel, currently senior vice president of scientific regulatory affairs within the Reynolds organization, has been appointed to the role of executive vice president of scientific research and development, succeeding James Murphy. In her new role, Samuel will serve on the RAI management team and report to Reynolds’ president and CEO, Guy Meldrum. Murphy will join the BAT management board as director of research and science, reporting to BAT CEO Jack Bowles.
In her role, Samuel will oversee the Reynolds organization’s scientific research and product development efforts on tobacco harm reduction and “beyond nicotine” as well as regulatory strategies and advocacy efforts, accelerating the delivery of the global BAT Group’s “A Better Tomorrow” corporate purpose in the U.S.
She is an experienced research and development executive, a seasoned business leader and a scientist, with strategic global expertise in scientific and regulatory affairs, product and ingredient innovation, clinical and pre-clinical research and key opinion leader engagement. Before joining Reynolds, Samuel was chief science officer for Blue California, an ingredient company, and before that, she held progressive research and development executive roles with companies across the food, supplement, ingredient and nutrition sectors, including PepsiCo, Mead Johnson/Bristol Myers Squibb, Tate and Lyle, PureCircle Ltd. and Standard Process Inc.

Jonathan Reed
Jonathan Reed, currently group head of combustibles at BAT, will succeed Jorge Araya as executive vice president of marketing and chief commercial officer within the Reynolds organization and join the Reynolds American management team. Araya will transition into the role of area director of South Eastern Europe at BAT.
In his role, Reed will oversee U.S. marketing functions, including consumer, trade and digital marketing, and support the global strategy through a sharp focus on driving U.S. volume share growth as well as increasing U.S. revenue from the group’s U.S. strategic portfolio. Reed’s career with the BAT Group spans over two decades. He has held a variety of senior marketing and general management roles in Europe, Indonesia, the South Pacific, the Middle East and Malaysia.
March 8, 2023
Altria Asks FTC to Drop its Juul Challenge

Photo: Paul Brady
Altria Group has asked the U.S. Federal Trade Commission (FTC) to drop its 2020 challenge of the company’s 2018 acquisition of a 35 percent share in Juul Labs, reports Reuters. On March 3, the tobacco giant announced it had exchanged its stake for a license to Juul’s heated tobacco intellectual property rights.
In its legal challenge, the FTC contends that the tobacco giant’s $12.8 billion investment in Juul violates antitrust law because the company acquired the position rather than continuing to compete against Juul in the market for closed-system e-cigarettes.
In February 2022, an administrative law judge dismissed the FTC’s claims, finding that the evidence failed to sustain the alleged violations.
The next step would have been for the full commission to decide whether to accept that decision and dismiss the FTC case.
However, Altria recently exited its investment and previously terminated a non-compete agreement with Juul that the FTC opposed.
“There is nothing left of the transaction to be challenged. Altria and JLI respectfully ask the commission to dismiss this matter as moot,” Altria Group and Juul Labs wrote in a filing to the FTC.

March 8, 2023
Forest Urges Freeze on U.K. Tobacco Duty

Photo: John Gomez
Smokers’ rights group Forest is urging the U.K. government to freeze excise duty on tobacco in its March 15 budget after a poll found that almost two thirds of respondents (65 percent) believe the tax on tobacco in the United Kingdom is already “about right” (38 percent) or “too high” (27 percent).
Only one in five (20 percent) of those asked think the tax on tobacco is “too low,” while 15 percent said they “don’t know.”
Conducted on behalf of Forest by Yonder, the poll follows a recent report that the cost of a pack of cigarettes could go up by £1.15 ($1.36) after the Budget, while a 30-gram pouch of hand-rolled tobacco could rise by £2, if Chancellor Jeremy Hunt decides to stick with the annual tobacco escalator of inflation plus 2 percent.
The poll also found that 62 percent of adults think that purchasing tobacco from the black market is an “understandable” response given the high cost of tobacco sold legally in the United Kingdom whereas only 22 percent of respondents believe this is not an “understandable” response. Sixteen percent said they “don’t know.”

The Chancellor should freeze duty on tobacco and give smokers a break.
Simon Clark, director, Forest
According to the survey, Brits also believe that the government has more pressing concerns than tackling smoking.
Asked to consider a list of 10 issues for the government to address in 2023, respondents said tackling the rising cost of household utilities such as electricity and gas is the most important priority (54 percent), followed by improving the health service by providing more beds, frontline staff and cutting waiting lists (48 percent), tackling inflation (40 percent), and addressing care for the elderly (32 percent).
Other top priorities included tackling climate change (28 percent), the housing shortage (26 percent), and helping businesses recover from the impact of the pandemic (17 percent).
Tackling smoking was bottom of the list (10 percent), alongside tackling obesity (10 percent), and tackling misuse of alcohol (9 percent).
“The chancellor should freeze duty on tobacco and give smokers a break,” said Forest Director Simon Clark.
“Raising the tax on tobacco not only discriminates against poorer smokers, it will drive more consumers to the unregulated black market.
“This is bad news for legitimate retailers and bad news for the Treasury which could lose billions of pounds in revenue if more consumers buy their tobacco from illicit traders.”
“Significantly, there is very little stigma attached to buying tobacco on the black market. In a cost of living crisis the public understands that many consumers will opt for the cheaper option, even if it’s illegal.”
March 8, 2023
U.K. Chancellor Rejects Single-Use Vape Levy

Photo: marcin jucha
U.K. Chancellor Jeremy Hunt has rejected calls from health officials to introduce a new levy on single use vapes in the government budget due to be presented on March 15, reports the news outlet I.
The Department of Health and Social Care has been pushing for the new tax to crack down on underage vaping. The proposals are expected to be included in the government’s response to the Khan Review on smoking, but treasury sources told I that the new levy will not be included in the March 15 budget.
“Department of Health officials are keen, but it’s not going to happen,” a source told I.
Anti-smoking activists too have been urging the government to start taxing disposable vapes. “Increasing the tax on single use disposable vapes in the March budget would be easy to do and by making them less affordable could reduce both child vaping and the vast quantities of single use vapes being thrown into landfill,” Action of Smoking and Health CEO Deborah Arnott was quoted as saying.
“Adult smokers find vaping useful in helping them quit, and that’s something we support. However, in the light of the recent increase in child vaping, government action is urgently needed to tighten regulation and increase enforcement,” Arnott added.
U.K. ministers are reportedly contemplating a range of measures to discourage underage vaping. Among the plans under consideration are a ban on candy-flavored vaping liquids and a crackdown on colorful marketing that could appeal to youth.
Britain bans sales of vapes to anyone below the age of 18, but national surveys have shown an increasing trend of 11-17 year olds using the devices, with health leaders blaming the rise on the marketing and flavors associated with them.
March 8, 2023
Zimbabwe: Optimism Ahead of Sales Season

Photo: Taco Tuinstra
Zimbabwe’s tobacco auctions will open tomorrow, March 8, with an official ceremony at the Tobacco Sales Floor (TSF), reports Chronicle. Although the auctions sell only around 5 percent of Zimbabwe’s crop, they are the major price setter and must thus occur first. Deliveries for the contract crop are scheduled to start March 9.
This year’s marketing season kicks off earlier than last year because favorable rainfall has resulted in sufficient volumes of cured and graded tobacco to start selling. In addition to the TSF, the Tobacco Industry and Marketing Board has licensed the Premier Tobacco Auction Floor and the Boka Tobacco Floors to auction tobacco this season.
Farmers interviewed by The Herald said they were optimistic about the upcoming sales season, citing favorable growing conditions and good quality leaf.
“This year’s yield will be better than the previous season due to the implementation of best agronomic practices,” Victor Mariranyika, president of the Tobacco Farmers’ Union Trust, was quoted as saying. “In terms of agronomic practices, the farmers have been looking after the crop very well, from seedbed to the auction, and we don’t expect any damage to the tobacco as a result of the rains.”
Tobacco growers will receive 85 percent of their earnings in U.S. dollars this year, up from 75 percent last. The remainder will be distributed in local currency. About 160,000 farmers grow tobacco in Zimbabwe, which is then exported to 60 countries.
March 7, 2023
Malaysia Urged to Reassess ‘Endgame’ Bill

Image: studioDG | Adobe Stock
The Malaysian Society for Harm Reduction (MSHR) has called on the Malaysian government to reassess the generational endgame (GEG) measure regarding vaping, reports the New Straits Times.
Sharifa Ezat Wan Puteh, MSHR chairman, stated that many smokers are using vaping to quit smoking cigarettes and that the GEG could be counterproductive as it positions vaping as equally harmful as smoking.
“While vaping has health risks, we cannot ignore scientific evidence that vaping is at least 95 percent less harmful than smoking,” said Puteh. “Several reputable public health organizations have made that estimate and endorsed by multiple developed countries. In addition, vape is also recognized as an effective tool to reduce smoking hazards and rates.”
The MSHR has suggested that vaping be regulated and training be provided to vendors on proper ways to switch to nicotine-replacement therapies and vapor products. It also suggests forming an independent committee driven by science and evidence to conduct in-depth research on vapor products.
“If we look at the decline in the smoking rates in countries with higher vaping rates, it speeds up as the vaping rate increase[s],” said Puteh.
“Legislative process for the new bill will take a lengthy time,” she said. “In addition, a bill should only be tabled with detailed discussion and studies on the proposed GEG measure that the previous minister proposed.
“Given this, we believe the government should take immediate steps to regulate vape products using existing laws to speed up regulations on the products to protect consumers from prohibited ingredients by introducing standards on the product as well as prohibiting access by minors.”
March 7, 2023
UL Solutions Obtains Consent Decree

Image: lexiconimages | Adobe Stock
UL Solutions obtained a consent decree against two companies selling vaporizer devices with unauthorized UL Marks, reports PR Newswire. Arizer, a manufacturer of vaping devices, and Greenlane Holdings, a distributor of vaping devices, both stipulated to a consent decree, permanent injunction and judgment of $2.2 million as part of a settlement of UL Solutions’ claims against them for trademark counterfeiting and false advertising in the Northern District of Illinois.
These consent decrees are part of a years-long effort by UL Solutions to deter vaping devices with counterfeit UL Marks from entering the marketplace. In 2019, UL Solutions brought its first suit against several manufacturers and distributors of these devices, including Kandy Pens and AFG Distribution. This case also ended with a consent decree, permanent injunction and judgment.
UL 8139, Standard for Electrical Systems of Electronic Cigarettes and Vaping Devices, was published in 2018. The UL 8139 safety standard is used to evaluate these products’ electrical, heating, battery and charging systems.
While compliance with UL 8139 is voluntary, over 35 manufacturers now have their vaporizer devices certified to this standard. Manufacturers that achieve UL certification have made the choice to put their products through the certification testing process, demonstrating their commitment to preventing serious injuries from lithium-ion battery fires and explosions.
With the increasing adoption of UL 8139 across the industry, some manufacturers applied counterfeits of the UL Mark to their products or packaging.
“Our investment in deterring counterfeiting delivers tangible value to our customers,” said Tammi Burke, director of customer marketing at UL Solutions. “Our customers invest heavily in designing and manufacturing their products to meet the requirements for UL certification. Only those companies that have earned our certification have the right to benefit from using the UL Mark. Counterfeiters of the UL Mark unfairly compete in the marketplace and claim an achievement they have not legitimately earned.”
“UL Marks appear on billions of products globally to demonstrate that these products meet scientific safety, performance or sustainability standards,” said Jackie McLaughlin, executive vice president and chief legal officer at UL Solutions. “To help safeguard the integrity of the UL Mark, we are committed to protecting our brand and taking on counterfeiters where necessary to protect the public and help fulfill our mission of working for a safer world. We applaud this decision by the Northern District of Illinois as it will help ensure the UL Mark remains a symbol of trust to the public.”
March 7, 2023