Blog - Tobacco Reporter

Studies Refute Vaping-Smoking Link

There is no evidence that the use of e-cigarettes and heated-tobacco products is leading nonsmokers and youth toward smoking, according to several studies.

Action on Smoking and Health (ASH) U.K. cited the results of five large surveys of 11-year-olds to 16-year-olds in the U.K. between 2015 and 2017 showing that “most young people who experiment with e-cigarettes did not become regular users,” according to media reports.

“Overall, there is no evidence that e-cigarettes have driven up smoking prevalence in this age group. In fact, smoking prevalence among young people has declined since e-cigarettes came onto the market,” ASH U.K. stated.

A time-series analysis led by Emma Beard between 2007 and 2018 in the U.K. showed that the increase in the prevalence of e-cigarette use in England among the entire sample does not appear to have been associated with an increase in the uptake of smoking among young adults aged 16 to 24.

A 2022 study by University of Bristol researchers found that, based on the “current balance of evidence, using triangulated data from recent population-level cross-contextual comparisons, individual-level genetic analyses and modeling, we do believe, however, that causal claims about a strong gateway effect from e-cigarettes to smoking are unlikely to hold while it remains too early to preclude other smaller or opposing effects.”

A 2020 study by Colin Mendelsohn and Wayne Hall concluded that claims of vaping serving as a gateway to smoking are unconvincing. “Smoking more often precedes vaping than vice versa, regular vaping by never-smokers is rare, and the association is more plausibly explained by a common liability model,” they stated.

Another comprehensive analysis of whether vaping causes smoking uptake was published by the University of Queensland in Australia. That study also concluded that there was little evidence of a gateway effect. If a gateway effect does exist, it is likely to be small, the study said.

A 2021 study by Wayne Hall and Gary Chan on the “gateway” effect of e-cigarettes found that “e-cigarette use has not been accompanied by increased cigarette smoking among young people in the United States as would be the case if e-cigarette use were a major gateway to cigarette smoking.”

September 19, 2022

New Vaping Quality and Safety Specs in Britain

The British Standards Institution has developed a fast-track informal standard, PAS 8855, to address quality, performance and safety issues related to vaping products, reports ECigIntelligence.

The new PAS (publicly available specification), sponsored by Juul Labs, recognizes the progress made in the construction and use of e-cigarettes since PAS 54115 was issued in 2015.

September 19, 2022

Kathmandu to Ban Public Tobacco Use

Kathmandu will ban the consumption of tobacco products in public places starting Sept. 17, reports Onlinekhabar.

According to Nepal’s Tobacco Products (Control and Regulatory) Act 2011, no person shall be allowed to smoke or consume tobacco in public places.

The ban will cover cigarettes, bidis and cigars as well as smokeless products such as chewing tobacco and gutka.

Violators of the rules risk fines of up to NPR100 ($0.78) and will be removed from the premises.

The city defines public places as government offices, educational institutions, libraries, health posts, airports, old age homes, orphanages, public toilets, cinema halls, theaters, restaurants and factories.

September 16, 2022

Sub-Saharan Africa Urged to Embrace THR

With more than 200,000 smoking-related deaths each year in sub-Saharan Africa, there is an urgent need for the region to embrace tobacco harm reduction, according to a new briefing paper published by Knowledge Action Change (KAC).

KAC argues that tobacco harm reduction could generate significant public health gains for the countries in sub-Saharan Africa and is particularly crucial at a time when the number of tobacco users across the continent as a whole is set to increase to 62 million by 2025.

“Many people either cannot or do not want to quit nicotine use, but smoking is deadly,” KAC wrote in a press note. “Tobacco harm reduction offers smokers the choice to switch from combustible cigarettes to safer nicotine products that pose fewer health risks, including nicotine vapes (e-cigarettes), tobacco-free nicotine pouches, Swedish-style snus (an oral tobacco) and heated-tobacco products.”

Authored by THR Malawi founder Chimwemwe Ngoma, Tobacco Harm Reduction in Sub-Saharan Africa investigates the current status of tobacco harm reduction in the 48 countries of sub-Saharan Africa.

As well as considering the economic role of tobacco in the region, the paper provides a country-by-country guide on the availability and legal status of safer nicotine products. It notes progress is being made with tobacco harm reduction across sub-Saharan Africa, highlighting the work of consumer advocacy groups offering tobacco users accurate information about combustible cigarettes and safer nicotine products.

However, the availability and accessibility of products such as nicotine vapes remains poor in many countries while appropriate regulation is needed for product safety. Many smokers cannot access smoking cessation support. Some governments are unable to meet basic requirements for a robust healthcare system, and there is a lack of funding to prevent the noncommunicable diseases linked to smoking.

There is also widespread and deliberate misinformation circulating about safer nicotine products, and many consumers, healthcare institutions and governments in sub-Saharan Africa remain unaware of tobacco harm reduction’s potential.

“To become smoke-free, sub-Saharan Africa needs safer nicotine products that are locally feasible, affordable, appropriate, accessible and culturally acceptable, supported by sensible product regulation,” says Chimwemwe. “For this to happen, governments in Africa should strive to remain independent, conduct their own social economic impact assessments and make science-based policies that embrace tobacco harm reduction.”

The new briefing paper is part of KAC’s Global State of Tobacco Harm Reduction project, funded by a grant from the Foundation for a Smoke-Free World.

September 16, 2022

Outrage About Inserts

Anti-tobacco activists are outraged about a recent government decree in Uruguay that allows cigarette manufacturers to print information on cigarette sticks and include inserts in tobacco packs.

In 2019, Uruguay became the first country in Latin America to require plain packaging of tobacco products. Pioneered in Australia, plain packaging requires that tobacco packs have a uniform color and texture and prohibits any branding, logos or other promotional elements inside or attached to tobacco products.

The measure is meant to reduce the attractiveness and appeal of tobacco products and increase the noticeability of health warnings.

According to the Campaign for Tobacco-Free Kids (CTFK), the recent government decision allows tobacco companies to market their products in ways the plain packaging legislation was designed to prevent.

“The government has put the interests of the tobacco industry ahead of the health of all Uruguayans,” wrote CTFK President Matthew Myers in a statement, adding that it is not the first time that President Lacalle Pou’s administration “capitulated” to the tobacco industry.

Prior to the administration’s decision on plain packaging, the government reversed a decree that had banned the sale of tobacco-heating products like IQOS and Glo.

September 15, 2022

Dortmund Speakers Call for ‘Nuanced’ Regulation

Speaking during the opening day of the InterTabac trade exhibition in Dortmund, Germany, tobacco industry representatives called for a nuanced regulatory framework in a global economy strained by Covid, supply chain interruptions, inflation and the energy crisis.

Anticipating adjustments to the EU Tobacco Tax and EU Tobacco Products directives, speakers noted that not all tobacco products are created equally. For example, fine-cut tobacco has a different fiscal resilience than cigarettes, protection of minors is not an issue with classic pipe tobacco, and the market for conventional snuff is ever shrinking.

“Especially in the current ongoing crisis management situation, it is of utmost importance not to take a broad-brush approach to regulation,” said Michael von Foerster, CEO of the German Smoking Tobacco Industry Association.

“What we need is not new bans but active promotion of potentially less harmful innovative products, such as e-cigarettes and heated tobacco,” said Jan Muecke, CEO of the German Association of the Tobacco Industry and New Products (BVTE), who also urged Germany to regulate nicotine pouches like e-cigarettes, according to a BVTE press release.

The call for product-appropriate regulation was echoed by the German Cigar Industry Association, whose products are consumed strictly for pleasure, purely occasionally and mainly by older men—which means there are no issues related to the protection of minors, according to the group.

The German Federal Association of Tobacco Retailers drew attention to the uncertainty facing its members due to soaring costs of labor, energy and other expenses.

The InterTabac trade fair takes place Sept. 15–17.

September 15, 2022

Filter: FDA Cracks Down on Unauthorized Vapes

The U.S. Department of Justice is seeking court orders, threatening lawsuits and demanding the destruction of unauthorized vapor products, according to Alex Norcia, writing for Filter. The actions are remarkable given Center for Tobacco Products Director Brian King’s reluctance to say whether the agency was willing to take unauthorized vaping products off the market during a recent interview with Politico.

Filter says it has confirmed that the Food and Drug Administration, by Sept. 1, advised the Department of Justice (DOJ) that at least two open system vape companies were in violation of the Federal Food, Drug and Cosmetic Act because the manufacturers did not file premarket tobacco product applications and were continuing to sell their products.

“We plan to seek a court order to permanently enjoin you … from, among other things, directly or indirectly manufacturing, distributing, selling and/or offering for sale any new tobacco product at or from any of your facilities, unless and until, among other things, the product receives, and has in effect, marketing authorization from FDA,” reads one letter, signed by DOJ Senior Litigation Counsel Christina Parascandola and seen by Filter.

The two companies known to have received letters have been ordered to physically destroy their own products under FDA supervision.

One industry insider told Filter that the letter was “a clear escalation”—the first time, to his knowledge, that the FDA had gone beyond warnings and explicitly threatened to sue over sales of unauthorized nicotine vapes.

“It is just beyond outrageous that the FDA is now conscripting the Department of Justice in its misbegotten war on vaping,” Amanda Wheeler, a vape shop owner in Arizona and the president of American Vapor Manufacturers, told Filter. “We are talking about hardworking small businesses that are helping ordinary Americans to quit smoking, and they are now facing jaw-dropping threats from federal law enforcement agents.”

September 15, 2022

PMI Appoints Former FDA Officials

Philip Morris International has appointed two former U.S. Food and Drug Administration officials to key positions.

Badrul Chowdhury was appointed PMI’s chief life sciences officer for smoke-free products, succeeding Jorge Insuasty, who will complete his move into the recently created position of president of Vectura Fertin Pharma. After a short transition period, Chowdhury will join PMI’s senior management team in January 2023, reporting to CEO Jacek Olczak.

“I am delighted to welcome Badrul to PMI and look forward to working closely with him as he leads our talented team of scientific experts,” said Olczak in a statement. “He is an accomplished scientist and regulatory strategist, with decades of leadership experience, both in industry and as a regulator within the U.S. FDA’s pulmonary division. His wealth of knowledge and experience will be critical to help achieve our ambition of a smoke-free future. I also extend my sincere thanks to Jorge Insuasty for his contributions to the function as he moves to oversee Vectura Fertin Pharma full time.”

Chowdhury joins PMI from a U.S.-based biotech company developing inhalation products for rare respiratory diseases, where he was chief medical officer. Prior to that, he was AstraZeneca’s senior vice president and chief physician-scientist for respiratory inflammation and autoimmunity late-stage development in biopharmaceuticals R&D. From 1997 to 2018, Chowdhury served as director of the division of pulmonary, allergy and rheumatology products at the Center for Drug Evaluation and Research at the FDA.

Matthew Holman was appointed as PMI’s vice president of U.S. scientific engagement and regulatory strategy, reporting to Deepak Mishra, president of PMI Americas.

“We are delighted that Matt will be joining PMI to further accelerate our journey toward a smoke-free future, particularly here in the United States,” said Mishra. “As we transform, we recognize the importance of bringing together diverse perspectives, including those of regulatory bodies and the scientific community. Matt’s solid scientific and stakeholder knowledge, combined with his passion for tobacco harm reduction, will be invaluable.”

Holman joins PMI from the FDA, where he served for more than 20 years, most recently as director of the Office of Science at the Center for Tobacco Products (CTP). At the CTP, Holman was instrumental in building the FDA’s marketing application review programs. He served as the CTP’s chief scientist, playing a significant role in guiding policy decisions, developing rulemaking and guidance documents, and overseeing a robust regulatory science research program for tobacco products.

The appointment of these experts complements the recent hiring of Keagan Lenihan, who joined PMI in May 2022 as vice president of government affairs and public policy and head of its Washington, D.C., office. Lenihan spent two decades working in government, corporate and public policy, including as associate commissioner for external affairs and strategic initiatives and then chief of staff at the U.S. FDA.

September 14, 2022

MDO Stay Boosts Kaival’s Results

Kaival Brands Innovations Group reported revenues of $3.8 million for the third quarter of fiscal year 2022, up from $3.2 million for the same period of 2021. Gross profit was $442,100 compared to a loss of $84,300 for comparable 2021 period.

Kaival attributed its improved revenues in part to an August court ruling that set aside a marketing denial order issued by the U.S. Food and Drug Administration to the company’s nontobacco flavored Bidi Stick e-cigarettes. Arguing that the agency had insufficiently considered Kaival Brands’ marketing and sales access restriction plans, the U.S. Court of Appeals for the Eleventh Circuit ordered the FDA to further review Kaival’s premarket tobacco product applications, allowing the company to continue to market its products.

“The recent 11th Circuit ruling in favor of Bidi Vapor alleviated a significant barrier to our adult-focused B2B sales efforts, which we believe will once again allow us to materially scale our business, grow revenue, move toward net profitability in the future and increase shareholder value,” said Kaival Brands President and Chief Operating Officer Eric Mosser in a statement.

Mosser added that the company is working with Philip Morris to expand international distribution into new global markets. In June, Kaival Brands Innovations Group’s subsidiary, Kaival Brands International (KBI), entered into a licensing agreement with Philip Morris Products (PMP) for the development and distribution of electronic nicotine-delivery system products outside the U.S.

“We expect to begin recognizing revenues from this international licensing agreement in our fiscal fourth quarter,” said Mosser.

In July, Kaival announced the launch of PMP’s Veeba vapor product in Canada, with royalties due to KBI pursuant to the international licensing agreement.

September 13, 2022

Firms Settle New York Tax Evasion Case

New York’s attorney general office announced a $50 million agreement with Grand River Enterprises Six Nations of Canada (GRE) and Native Wholesale Supply Co. (NWS) of New York to settle allegations of tax evasion in the state.

According to the complaint, the two companies brought millions of cartons of unstamped cigarettes into New York from Canada.

The attorney general’s office contends that NWS purchased cigarettes and tobacco products from GRE, imported them into New York, and distributed the cigarettes to retailers in the state—despite having no license to do so. GRE allegedly knew that the cigarettes it sold to NWS would be sold into New York without going through a New York state licensed stamping agent for prepayment of state taxes and would be neither stamped nor taxed as required by New York law.

“Hardworking New Yorkers pay taxes and so should multi-million-dollar companies,” said New York Attorney General Letitia James in a statement. “Regulating and taxing cigarettes is a critical tool to protect public health from the deadly dangers of tobacco. Today’s agreement enforces New York’s laws and will stop the overflow of unstamped cigarettes into New York.”

In addition to paying the $50 million, the companies agreed to modify their business practices to prevent future sales of unstamped cigarettes in New York.

In a statement, NWS clarified that while the settlement ends the litigation, it is not an admission of wrongdoing.

“In this almost decade-long dispute, the NY Attorney General claimed that sales of cigarettes by NWS to certain Native American Nations situated within the geographic borders of New York state were subject to New York state regulation and taxation. NWS, as well as the manufacturer of those products, GRE, vigorously objected to and adamantly denied such claims. As part of NWS’ Chapter 11 plan of reorganization, NWS allowed those claims to proceed in federal court in New York State.

“The settlement announced today brings an end to that litigation, without any admission of wrongdoing or liability by NWS or GRE. The settlement payments are to be paid solely by NWS and are not denominated as payment of back taxes. They are payments that the parties agreed are payments of disputed claims payable under the trust set up in accordance with the Chapter 11 plan of reorganization.

“NWS and GRE have at all times maintained and continue to maintain that the transactions at issue do not and did not violate any federal or New York State laws, particularly in view of well-established sovereign and treaty rights established with the federal government.”

September 13, 2022