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.
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.
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.
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.”
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.
Matt Holman
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.
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.
Eric Mosser
“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.
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.”
On July 14 and Aug. 6 of this year, Tobacco Reporter published two articles (“Pakistan’s Track-and-Trace System Under Fire” and “More Firms Adopt Tracking System”) with incorrect information about Inexto, a Swiss company active in the field of tracking and tracing.
The articles reference Codentify software and a legal challenge to Pakistan’s decision to award its track-and-trace system to the National Radio and Telecommunication Corp.
Unfortunately, the “news” contained in these articles turned out to be based on outdated information presented on a tobacco news aggregation website.
Codentify has long been replaced by a product called Inextor, and the referenced legal challenge was decided in May 2020 when the Islamabad Court canceled the bidding process for procedural motives unrelated to Inexto or its product.
Tobacco Reporter regrets the error and any harm caused to Inexto. The articles were removed from our website on Aug. 29.
The U.S. Food and Drug Administration is understating the number of nontobacco nicotine (NTN)-related premarket tobacco product applications (PMTAs) it has accepted for review in order to avoid criticism from tobacco control groups that seek prohibition of all vaping products, reports Vaping360, citing American Vapor Manufacturers Association (AVM) President Amanda Wheeler.
On Sept. 8, the FDA announced it has accepted over 350 PMTAs (out of nearly 1 million applications) for NTN products. Wheeler insists that AVM member companies alone have received acceptance letters for 4,700 PMTA submissions.
“Once again, the FDA and its Center for Tobacco Products are misleading the public and press on crucial data and methods in its approval process for vaping products,” Wheeler said in a statement. “The figures stated in its press release today on synthetic nicotine applications are demonstrably inconsistent with FDA letters to our own members indicating many thousands more applications successfully filed than FDA now claims.”
An acceptance letter indicates that the application has met the basic requirements to move forward in the review process. It does not authorize the applicant to market the product.
The AVM also says the FDA altered required PMTA forms close to the submission deadline to disqualify already-submitted applications. According to Wheeler, the application forms were “abruptly altered” without public notice, “apparently as a means to disqualify wide swaths of already-filed applications.”
In March, U.S. President Joe Biden signed legislation authorizing the FDA to regulate synthetic nicotine products. Manufacturers had until May 14 to submit PMTAs and were given two additional months to continue selling products with pending PMTAs. When the grace period ended July 13, all synthetic nicotine-based products became subject to FDA enforcement.
An Israeli food technology startup company is using tobacco plants to help it create vegetarian hamburgers, reports The Jerusalem Post.
BioBetter has deployed tobacco plants as natural bioreactors to create the growth factors necessary for the cellular development of cultivated meat.
According to the firm, this development could significantly reduce the cost of cultured meat and help rapidly advance its commercialization. Cultured meat could eventually replace beef cows, which are a major factor in producing greenhouse gases and promoting hazardous global warming.
“World population growth and dwindling natural resources are going to put incredible strain on meat supply and the already fragile environment in the coming decades,” said BioBetter CEO Amit Yaari. “Cultivated meat offers a promising solution to these problems and can ensure a more resilient supply chain with better economic and environmental returns.”
In addition to addressing environmental challenges, the work will also create a new source of income for local tobacco farmers, who have suffered losses as cigarette consumption dwindles.
Boosted by a fresh injection of venture capital, BioBetter plans to scale up production in 2023 and commercialize its tobacco plant-derived, food-grade growth factor portfolio by 2024.
