Category: News This Week

Study: Vapor Flavor Ban Would Boost Smoking

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If vapor product sales were restricted to tobacco flavors, one-third of U.S. vapers between the ages of 18 and 34 would switch to smoking combustible cigarettes, according to a new study in Nicotine & Tobacco Research.
The study analyzed data from February to May 2020 and looked at 2,159 young adults in Atlanta, Boston, Minneapolis, Oklahoma City, San Diego and Seattle, examining support for e-cigarette sales restrictions and the perceived impact of flavor and vaping bans.
This study precedes the FDA’s impending Sept. 9 deadline for premarket tobacco product application (PMTA) decisions, which could potentially take most vapor products off the market.
The FDA’s deadline will be “like watching an unstoppable object hit an immovable wall,” said Charles Gardner, executive director of INNCO, a global nonprofit supporting the rights of adults using safer nicotine products. “The FDA must know flavor bans will increase teen, young adult and older adult smoking.”
“In general, the FDA does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health,” an FDA spokesperson said.
Two other recent studies showed similar results. A study in JAMA Pediatrics showed that following San Francisco’s flavor ban, teens were more likely to smoke than those in other school districts. A different study in Nicotine & Tobacco Research shows that teens who vape would be smoking cigarettes if vapes hadn’t become available.
“All hell will break loose if [the FDA] authorize[s] flavors as ‘appropriate for the protection of public health,’” said Gardner. “The Truth Initiative and the Bloomberg-funded Campaign for Tobacco-Free Kids have staked their reputations on the public health benefits of flavor bans. And many key leaders in the U.S. Congress believe them.”
August 11, 2021
No Auction After Carlyle Declares Bid Final

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The takeover battle between Philip Morris International and private equity firm Carlyle Group for the British inhaled treatments maker Vectura will avoid an auction sale after Carlyle declared its £958 million ($1.33 billion) bid final, reports Reuters.
On July 9, PMI offered £852 million for Vectura as part of the company’s ambition to leverage its expertise in inhalation and aerosolization into adjacent areas.
The Carlyle Group then raised an earlier offer to £958 million. Carlyle had struck an agreement to buy Vectura in May until PMI emerged with its offer in July.
In response, PMI raised its offer to £1.02 billion while stressing that Vectura would operate as an autonomous business unit under its umbrella.
The bidding war prompted Britain’s takeover regulator to intervene, saying that it would enter a rare head-to-head auction here if the bidders did not make final bids by Aug. 10.
PMI’s bid unleashed a storm of criticism from public health advocates who dislike the idea of a tobacco company investing in the lung health business.
The Vectura directors on Friday acknowledged reports of uncertainties relating to the possible impact on Vectura stakeholders if the company were owned by PMI.
Founded in 1997, Vectura makes inhalers and nebulizers, which enable patients to breathe in medication as a mist, either through a mouthpiece or a mask. Its customers have included Novartis and GlaxoSmithKline.
PMI is counting on Vectura to help achieve its goal of at least $1 billion in sales outside nicotine by 2025. Its $820 million acquisition of Fertin Pharma, a maker of nicotine chewing gum and oral drugs for pain, gives the company expertise in oral deliveries, but it would take Philip Morris longer to develop inhaled therapies without Vectura.
A deal with either one of the U.S. companies would require shareholder approval.
August 11, 2021
TPB Increases Stake in ReCreation Marketing

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Turning Point Brands has increased its equity stake in ReCreation Marketing, a Canadian distribution company, from 50 percent to 65 percent.
ReCreation Marketing is a specialty marketing and distribution firm focused on building brands in the Canadian smoking accessories, vaping and alternative products categories. As part of this transaction, ReCreation will transition its company name to Turning Point Brands Canada Corp. over the next 90 days.
ReCreation has significantly expanded the reach of Zig-Zag papers, which now has presence in 75 percent of the volume-weighted distribution within the private dispensary channel. As a result of the ReCreation partnership, TPB expects to continue to expand its presence in Canada, creating an avenue for its broader portfolio of products to enter the Canadian market.
“Increasing our stake in ReCreation Marketing was a logical move as Turning Point Brands continues to invest in the cannabis and tobacco-related sectors,” said Larry Wexler, CEO of Turning Point Brands, in a statement.
“Our partners at ReCreation Marketing are significantly expanding the distribution of our brands while also gaining market share in Canada, most notably capitalizing on Zig-Zag’s strong market position in the country. The increased stake and renaming into Turning Point Brands Canada signify the commitment to our strategy in Canada. We look forward to continuing to work closely with this accomplished team to strengthen our prominence in the market.”
“Turning Point Brands’ robust portfolio of leading brands, coupled with ReCreation Marketing’s proven ability to support distribution in traditional and alternative channels, is a natural expansion of our work together,” said Chris Riddoch, president of ReCreation Marketing. “This transaction will provide both companies the opportunity to penetrate the market and to increase our visibility and accessibility to Canadian retailers and consumers alike.”
August 11, 2021
FDA Refuses to File JD Nova PMTAs

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The U.S. Food and Drug Administration has issued a “refuse to file” (RTF) letter to JD Nova Group. The letter notifies the company that the premarket tobacco product applications (PMTAs) it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.
As a result of this RTF action, JD Nova Group must remove approximately 4.5 million products from the market or risk enforcement action by the FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.
The FDA’s action affects a significant share of PMTAs under review. The agency has received applications for more than 6.5 million products from over 500 companies.
According to the FDA, JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate environmental assessment. Under the FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.
This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020, deadline are still moving through the review process, according to the FDA.
The list of affected products is available here.
August 10, 2021
U.K. Retailers “Missed” in Menthol Buyback

Photo: Miriam Doerr | Dreamstime.com
U.K. retailers say tobacco companies have “missed” significant volumes of now-illicit menthol cigarettes during the initial returns phase following the country’s ban on such cigarettes.
The U.K. prohibited sales of menthol cigarettes on May 20, 2020. Prior to the ban, tobacco companies pledged to take back and credit retailers for any noncompliant stock remaining once the legislation came into force.
However, six retailers across England told Better Retailing that they still have menthol brands from Philip Morris Limited (PML) and British American Tobacco U.K., with some holding stock with a combined value worth several hundreds of pounds.
BAT U.K. said it carried out a significant menthol pack return exercise from September to December 2020. “Despite our best efforts, some of our retail partners appear to have been missed in this initial returns phase; we are sorry for any inconvenience caused,” a BAT spokesperson said, adding that a second returns phase would be introduced at the end of this year.
PML said it introduced a nationwide “buy-back” scheme from May to July 2020, which covered all plain packaging products with duty paid.
August 10, 2021
Poda Commences Clinical Trials

Photo: Poda Lifestyle and Wellness
Poda Lifestyle and Wellness has started setting up the first clinical trials for its smoking cessation products.
“I have already initiated the process of setting up the first clinical trials related to the efficacy of Poda’s products as smoking cessation tools,” said Poda Chief Medical Officer Jagdeep Gupta, who joined the company in July, in a statement. “I am currently in the process of setting up a pilot study, which will give us a solid platform for developing strong and effective clinical trials.
“These clinical trials will be designed to result in the publication of level 1 evidence in respected medical journals globally if the data provides evidence. The pilot studies will also be designed to establish a scientific basis for the efficacy of Poda’s products as smoking cessation tools and additionally may provide Poda with access to research grants and other funds that can be used for additional studies, clinical trials and validation research.”
The company has also entered into an agreement with Command Marketing predominantly to develop Poda’s e-commerce platform and brand identity. As part of this branding campaign, Command Marketing will also provide investor relations services.
August 10, 2021
Study: Graphic Health Warnings May Work

Image: Tobacco Reporter archive
Graphic health warnings on cigarette packs do indeed scare smokers, but they should be combined with other anti-smoking measures, reports HealthDay, citing new research published by Jama Network Open.
For the study, David Strong, professor in the School of Public Health and Human Longevity Science at the University of California, San Diego, assessed how 357 smokers in San Diego responded to graphic warning labels used on cigarettes sold in Australia.
Participants in the study received one of three types of cigarette packs: a pack with a graphic warning label; a blank pack; or a standard commercially available U.S. pack.
Those who received cigarettes in the standard pack or a blank pack had no change in their positive views of cigarettes, but there was a decline among those who received a pack with a graphic warning label, the investigators found.
Health concerns increased in all three groups, likely because they were forced to think about the health consequences of smoking more often, the study authors noted.
“While these labels make smokers more likely to think about quitting, it did not make them more likely to make a serious quit attempt nor was it sufficient to help them quit their nicotine addiction,” said study senior author Karen Messer.
“Thus, graphic warning labels are an integral component of tobacco control strategies, but they are only one tool for governments to reduce the societal costs from the death and disease caused by tobacco smoking,” Messer said in a university news release.
According to Strong, graphic warning labels are used in more than 120 countries to counter marketing that promotes cigarette smoking. U.S. lawmakers approved graphic health warnings in 2009, but implementation has been stalled until legal challenges to the law by the tobacco industry are resolved.
August 10, 2021
PMI to Buy Respiratory Drug Developer OtiTopic

Photo: ASDF
Philip Morris International announced the acquisition of OtiTopic, a U.S. respiratory drug development company with a late-stage inhalable acetylsalicylic acid (ASA) treatment for acute myocardial infarction.
“The acquisition of OtiTopic is an exciting step in PMI’s ‘Beyond Nicotine’ ambitions,” said Jacek Olczak, CEO of PMI, in a statement. “We have world-class expertise in the research, development and commercialization of aerosolization and inhalable devices to help speed the delivery of this exciting product to market.”
This acquisition is part of PMI’s plan to leverage its expertise, scientific know-how and capabilities in inhalation to grow a pipeline of inhaled therapeutics and respiratory drug delivery beyond nicotine products. Following the completion of clinical trials and pending approvals by the U.S. Food and Drug Administration, PMI can leverage its expertise and the capabilities of other companies in the “Beyond Nicotine” portfolio to bring Asprihale to market.
Asprihale is a patented, dry powder inhalation of ASA delivered through a unique self-administered aerosol—it is expected to move from clinical trials to filing with the FDA for approval in 2022. Early clinical trials have shown that the product system catalyzed peak plasma concentration and the desired pharmacodynamic effect, i.e., inhibition of platelet aggregation in two minutes compared with 20 minutes for coated chewable aspirin, according to PMI. This speed is unprecedented and has significant potential implications for improving the survival of patients at risk of heart attacks.

With its acquisition of OtiTopic, PMI looks forward to completing the planned Asprihale registration program and bringing this important treatment to market to address a significant unmet medical need in a clinical condition where every second counts.
Jorge Insuasty, chief life sciences officer, PMI
OtiTopic will complete its assessment program and filing with the FDA using the FDA’s 505 (b)(2) pathway, a pathway designed for drugs already available on the market but requesting approval either for a new indication, dosage form or regimen, strength, combination with other products, or other unique traits. This pathway will allow PMI to build on existing data available for ASA reference products and focus on delivering the evidence that the inhalable form, Asprihale, outperforms the current standard of care—oral delivery—of ASA.
“In the United States alone, someone has a heart attack every 40 seconds. With its inhalable version of acetylsalicylic acid, OtiTopic has developed an asset that promises to have a much faster onset of effect compared to oral ASA,” said Jorge Insuasty, chief life sciences officer for PMI. “With its acquisition of OtiTopic, PMI looks forward to completing the planned Asprihale registration program and bringing this important treatment to market to address a significant unmet medical need in a clinical condition where every second counts.”
“This transaction aligns well with OtiTopic’s goals of unlocking what we believe to be a significant opportunity in inhaled therapeutics science,” said Kambiz Yadidi, CEO of OtiTopic. “We are entering this transaction to accelerate Asprihale’s FDA filing with the goal of delivering innovative therapies for people with intermediate to high risk for myocardial infarction.”
OtiTopic was founded in 2012 as an innovative pharmaceutical startup company and holds several key patents, differentiated intellectual property, and has confirmed a 505(b)2 pathway through constructive interactions with the FDA.
The acquisition follows other nontobacco acquisitions by PMI. Earlier, the company purchased British drug maker Vectura and Fertin Pharma, a manufacturer of nicotine chewing gum.
August 9, 2021
Philip Morris Raises Vectura Bid

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Philip Morris International has raised its bid to buy Vectura to more than £1 billion ($1.4 billion) reports the BBC.
PMI increased its offer to £1.65 per share after U.S. private equity firm Carlyle offered £958 million Friday.
Vectura previously stated that it was backing Carlyle’s offer and withdrawing its recommendation for PMI’s earlier bid. Vectura argued it could be better positioned under Carlyle’s ownership due to “reported uncertainties relating to the impact on Vectura’s wider stakeholders arising as a result of the possibility of the company being owned by PMI.”
“The PMI increased offer values the entire issued and to be issued ordinary share capital of Vectura at approximately £1.02 billion,” PMI said in a statement. “PMI intends to operate Vectura as an autonomous business unit that will form the backbone of its inhaled therapeutics business.”
PMI’s bid unleashed a storm of criticism from public health advocates who dislike the idea of a tobacco company investing in the lung health business.
In July, U.K. Business Minister Kwasi Kwarteng asked officials to monitor PMI’s proposed takeover of drugmaker Vectura Group.
August 9, 2021
U.K. Mulls Higher Tobacco Buying Age

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Individuals under the age of 21 may be banned from buying cigarettes and flavored vapor products as part of a plan to curb smoking in the U.K., reports the Daily Mail.
Health Secretary Sajid Javid is reportedly considering the change to help reach the government’s goal of becoming smoke-free by 2030.
“Smoking cuts lives short and costs the NHS billions—we will publish a plan later this year to set out how we will help the country become smoke-free by 2030,” said a Department of Health spokesperson.
Further advertising bans are also reportedly being considered. E-cigarettes are already banned from promotion on TV, radio, online and in print.
Raising the purchase age would be “very, very welcome news,” according to Mary Foy, chair of the Westminster All-Party Parliamentary Group on Smoking. “We know that generally adults don’t take up smoking. It’s children and young people who start and unfortunately get hooked, often for life. Studies show most adults regret ever starting in the first place.”

If you can have sex at 16, join the army and drive a car at 17, you should be allowed to buy tobacco at 18.
Simon Clark, director, Forest
Simon Clark, director of smokers’ group Forest, rejected the idea of raising the tobacco purchase age. “If you can have sex at 16, join the army and drive a car at 17, you should be allowed to buy tobacco at 18,” he said. “In the eyes of the law, you are an adult at 18. Treating young adults like children insults their intelligence. You certainly don’t have to be 21 to know that smoking is potentially harmful. It’s drummed into every child from an early age.”
“Outlawing the sale of tobacco to anyone under 21 won’t stop young people smoking,” he said. “It will simply drive tobacco underground, bypassing legitimate retailers and enriching criminals who won’t stop to ask for proof of age. Far from protecting younger consumers, it will expose many more to illicit and counterfeit tobacco, origin unknown. For some, it may even make smoking cool again.”
August 9, 2021