Author: Staff Writer

Retailers Want FDA List of Legal Vaping Products

Retail associations have asked the U.S. Food and Drug Administration to provide them with list of e-cigarettes and vape products that are legal to market, reports NACS.
In October 2021, NACS and five other retail associations sent a letter to the FDA asking the agency to publish the names of vapor products for which it has taken action. In their letters to FDA, the associations expressed the critical nature of this list for their retail members who need to know which products are legal to sell and which are not.
The FDA formally responded in January 2022, stating that it understands the retail groups’ request for specific names of products and that the agency is working on updating the list with final actions taken on individual products, including those that received marketing denial orders (MDOs).
“Given the large number of products involved, sharing this information requires additional time and resources so that the Agency does not disclose confidential commercial information (CCI) about products that are not yet marketed,” stated the agency.
In a more recent letter to the FDA, the associations said they “can appreciate the immense task of reviewing millions of applications. However, there remains widespread confusion in the marketplace as to which products can remain on shelves and which need to be removed.”
“While Director Zeller encouraged retailers to contact manufacturers with any questions about products in their inventory, this is not an adequate or fair solution. It places the burden on retailers to verify the marketing status of ENDS and vape products with the manufacturers. Many of our members are small operators who do not have the resources or bandwidth to contact the manufacturers,” wrote the associations.
“Moreover, manufacturers providing a list does not guarantee accuracy or give the assurance that a verified list from the agency would give. These retailers stand to face enforcement if they are out of compliance with the law and the only way to ensure they can comply is if they have a verified list from the agency.”
Renewed support for a list of legal products come after the FDA issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized Puff Bar and Hyde disposable vaping products. The FDA typically sends warning letters to manufacturers, however, now retailers are facing stiffer scrutiny.
FDA Commissioner Robert Califf said cracking down on disposable products most used by youth is a priority for the regulatory agency. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law,” he said.
June 2, 2023
European Elections Could Impact Support of Vaping

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Elections in several European countries could affect support of reduced-risk nicotine products like e-cigarettes, according to Tamarind Intelligence Policy Radar research.
Governments in Europe are the most likely to officially support reduced-risk products.
According to Tamarind Intelligence, forthcoming elections in Finland, Spain, Ireland and the Czech Republic as well as elections for the European Parliament could be significant in determining the future of the products.
“Our analysis of official attitudes toward e-cigarettes and other tobacco harm reduction products shows some clear global trends,” said Tamarind Intelligence Editorial Director Barnaby Page. “For example, European countries tend to have more favorable attitudes while Asian countries tend to be much more polarized.
“However, the laws in this area can change very rapidly—sometimes because government itself changes or at other times because issues such as underage vaping or the environmental impact of disposable vapes come into the spotlight.”
Researchers expect worldwide regulation of reduced-risk products to become stricter, especially in upper-middle-income and high-income countries. Flavored products are expected to receive the most attention with countries proposing bans on the products.
June 2, 2023
FDA, NIH Fund Center for Rapid Surveillance of Tobacco
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The U.S. Food and Drug Administration and the National Institutes of Health (NIH) have awarded funding for a new Center for Rapid Surveillance of Tobacco (CRST). Through rapid surveillance and reporting of information, CRST will enhance the Center for Tobacco Products (CTP) and the research community’s ability to understand, document and quantify changes in the tobacco product marketplace and tobacco use patterns.
“Nothing like this has ever been attempted before now,” said Cristine Delnevo, director of the Rutgers Center for Tobacco Studies and principal investigator of the rapid surveillance center. “No one has collected such comprehensive information, let alone organized and disseminated it rapidly. We think it will provide the FDA with meaningful and timely data to inform their congressionally authorized regulation of the tobacco market.”
Research results from the CRST are expected to generate findings and data that are directly relevant in informing the FDA’s regulation of the manufacture, distribution and marketing of tobacco products to protect public health. In particular, the CRST will support more time-sensitive data collection, analysis and reporting—making potentially actionable information available before more traditional data collection methods.
“Given the rapidly evolving tobacco landscape, it’s critical that we have nimble surveillance tools that can keep pace to best protect public health,” said Brian King, director of the FDA’s CTP. “This new center is another important addition to our surveillance toolbox to help identify emerging issues and to inform timely action.”
The CRST is supported through the Tobacco Regulatory Science Program, an interagency partnership between the NIH and CTP to foster tobacco regulatory research.
The work is led by Rutgers Center of Excellence in Rapid Surveillance of Tobacco with substantial involvement from a large collaborative network that triangulates multiple data sources, federal scientific staff at CDC, NIH and CTP as well as external advisors with relevant expertise.
“The signals about JUUL’s popularity with youth were there as early as 2017, but without identifying early, meaningful signals and subsequently implementing nationally representative large surveys with appropriate measures, it took much longer to evaluate the problem,” Delnevo said. “Successful rapid surveillance will facilitate a comprehensive understanding of the problem in a timely manner.”
The grant money will fund the Rutgers Center of Excellence in Rapid Surveillance in Tobacco, which officially began operations on June 1, pulling information from numerous data sources. Researchers will:

Collect information from marketing company databases, tobacco maker websites, social media and merchant outlets to spot new marketing strategies;
Analyze retail scanner data to track tobacco-product sales and spot trends involving new product characteristics such as innovative flavors or delivery mechanisms;
Triangulate responses from surveys of youth, young adults, and adults who use tobacco and nicotine products to understand preferences and behaviors;
Synthesize the data to identify meaningful trends early and provide the FDA with actionable information to improve its regulation of tobacco products.
Another seven faculty members from the Center for Tobacco Studies will join Delnevo on the rapid surveillance project, as will 13 co-investigators from Roswell Park Cancer Institute, East Carolina University, Stanford University, the University of Kentucky, The Ohio State University, Columbia University, and Westat, Inc.
June 2, 2023
Altria’s Acquisition of Njoy Comes to a Close

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Altria Group has completed its acquisition of Njoy Holdings. The tobacco giant has also updated its guidance for 2023 full-year adjusted diluted earnings per share (EPS) in connection with the transaction.
“The completion of this transaction is a transformative step in our goal of ‘Moving Beyond Smoking,’” said Billy Gifford, Altria’s CEO. “We are pleased to have received antitrust clearance, and we are now fully focused on responsibly accelerating U.S. adult smoker and adult vaper adoption of Njoy Ace, currently the only pod-based e-vapor product to receive marketing authorization from the FDA.
“Our updated 2023 full-year EPS guidance range includes planned investments behind the U.S. commercialization of Njoy Ace and reflects our goal to deliver strong shareholder returns while making progress toward our vision.”
“We are excited to combine our resources with Njoy’s talented team to benefit adult tobacco consumers across the country,” said Shannon Leistra, the new president and CEO of Njoy.
As a result of the transaction, Altria expects to deliver 2023 full-year adjusted diluted EPS in a range of $4.89 to $5.03, representing a growth rate of 1 percent to 4 percent from an adjusted diluted EPS base of $4.84 in 2022.
“Our 2023 full-year adjusted diluted EPS guidance range includes planned investments in support of the company’s vision, such as (i) continued smoke-free product research, development and regulatory preparation expenses, (ii) enhancement of the company’s digital consumer engagement system and (iii) marketplace activities in support of the company’s smoke-free products, including planned investments behind the U.S. commercialization of Ace,” Altria wrote in a press note.
Altria’s updated guidance range also includes estimated amortization charges of approximately $50 million for the remainder of 2023 related to intangible assets acquired in the transaction.
June 1, 2023
Kaival Brands Acquires GoFire Patent Portfolio

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Kaival Brands Innovations Group announced it has acquired an extensive patent portfolio from GoFire, Inc. with the goal of diversifying its product offerings and creating near- and longer-term revenue opportunities.
The GoFire patent portfolio includes 12 existing and 46 pending with novel technologies across extrusion dose control, product preservation, tracking and tracing usage, multiple modalities (i.e., different methods of vaporizing) and child safety.
The patents and patent applications cover territories including the United States, Australia, Canada, China, the European Patent Organisation, Israel, Japan, Mexico, New Zealand and South Korea. The portfolio also includes a proprietary mobile device software application that is used in conjunction with certain patents in the portfolio.
“We are excited to place these valuable assets into Kaival’s hands. After working hard to create this intellectual property with a goal of providing safer and healthier products to the marketplace, we engaged in a comprehensive assessment of how best to further its development into actual products and services with consumer reach,” Peter Calfee, CEO of GoFire, stated. “At the end of that process, we chose to invest our patent portfolio in Kaival in exchange for Kaival equity as the right fit for our technology.”
The acquired assets will be housed in Kaival Labs, Inc., a subsidiary of Kaival Brands that develops new branded and white-label products and services in the vaporizer and inhalation technology sectors, according to a press release.
In the near term, Kaival Brands expects to seek third-party licensing opportunities in the cannabis, hemp/CBD, nicotine and nutraceutical markets as a means of monetizing its new patents.
Longer term, Kaival Brands believes it can utilize the acquired patents to create innovative and market-disruptive products, including patent-protected vaporizer devices and related hardware and software applications.
“This is a transformative asset acquisition for Kaival Brands,” stated Eric Mosser, president and chief operating officer of Kaival Brands. “As we look to the future of our company beyond our core BIDI Stick distribution business, the purchase of this extensive patent portfolio marks the first step in diversifying our product offerings for adult consumers and potential revenue streams.
“We believe this forward-looking acquisition, with the acquisition consideration structured in key respects at premiums to the current market value of our common stock, broadens and strengthens our company and our prospects considerably as we seek to drive value for our stockholders.”
June 1, 2023
McKinney Hires Fearon as Chief Scientific Officer

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McKinney Regulatory Science Advisors stated today that it has appointed Ian Fearon as its new Chief Scientific Officer.
Fearon will play a pivotal role in enhancing the regulatory science consulting firm’s capabilities and expanding its range of services to clients, according to a press release.
“Fearon brings over 15 years of invaluable experience in the field of Tobacco Harm Reduction, with a specific focus on clinical and behavioral studies of these products,” the release states. “His deep understanding of regulatory submissions in the United States and Europe will enable McKinney Regulatory Science Advisors to provide unparalleled support and guidance to clients navigating the complex regulatory landscape.”
Prior to joining McKinney, Fearon held key leadership positions at several industry organizations such as senior director of Clinical and Regulatory Affairs EMEA at Juul Labs, where he helped advance the scientific understanding of tobacco and nicotine products and supported the company’s premarket tobacco product application (PMTA) submission to the U.S. Food and Drug Administration.
Fearon also served as the director of Tobacco Research at Celerion, where he contributed to the development of clinical evidence to support regulatory filings, and as principal scientist and head of Clinical Research at British American Tobacco.
Fearon has published more than 60 papers, including more than 20 on tobacco/nicotine product assessment, which generated more than 3,200 citations, according to the release.
“We are thrilled to welcome Ian as our Chief Scientific Officer,” said company CEO Willie McKinney. “His extensive experience and deep knowledge of tobacco and nicotine science and worldwide regulations make him an invaluable asset to our team. With Ian’s guidance, we will continue to provide exceptional scientific and regulatory consulting services to our clients, facilitating their success in bringing innovative consumer products to market.”
As the Chief Scientific Officer at McKinney Regulatory Science Advisors, Fearon will oversee the company’s scientific operations, lead strategic initiatives, and drive innovation in the regulatory science domain, according to the release.
May 31, 2023
U.S. FDA Sends Warnings to Sellers of Puff Bar, Hyde

Credit: Hyde
Warning letters have been issued to 30 retailers, including one distributor, for illegally selling unauthorized disposable vaping products. The FDA typically sends warning letters to manufacturers, however, now retailers are facing stiffer scrutiny.
The U.S. Food and Drug Administration stated today that the unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022, according to the FDA.
The “action underscores the agency’s unwavering commitment to addressing the role retailers and distributors of unauthorized tobacco products play in this concerning public health issue facing America’s youth.,” according to the release.
FDA Commissioner Robert Califf said cracking down on disposable products most used by youth is a priority for the regulatory agency. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law,” he said.
The warning letters are a result of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth – specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes.
“Since becoming director of CTP, I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”
The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation.
Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition to today’s actions among retailers, the FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing.
In February, FDA filed the agency’s first civil money penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil money penalty complaints against ten e-cigarette manufacturers.
And in October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. From January 2021 through May 2023, FDA issued more than 560 warning letters. All of these actions are part of FDA’s standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis.
“FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth,” the release states.
May 31, 2023
U.S. FDA Commissioner Califf Laments Lawsuits

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U.S. Food and Drug Administration Commissioner Robert Califf has lamented the FDA’s ongoing tobacco industry litigation following the agency’s attempt to regulate e-cigarettes, according to Politico. The FDA is facing over 40 lawsuits from companies whose premarket tobacco product applications have been denied.
“We are in a legal battle every single day, and it’s draining on the agency,” Califf said at the annual public meeting of the Reagan-Udall Foundation. “It has a big impact and a much bigger impact than I thought.”
“None of us expected 27 million applications for vaping,” he said.
Califf also noted that enforcement is difficult when it comes to illegal product. “I find myself in the midst of really an epic struggle … when I think of how to enforce when you have an industry that is amazingly creative.”
Califf hinted that the FDA would meet with the Department of Justice soon to discuss enforcement but declined to say more: “Stay tuned on that one.”
May 31, 2023
Switzerland Set to Ban Vape, Tobacco Advertising

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Switzerland will ban advertising of tobacco products and e-cigarettes aimed at young people, the government said, implementing a decision passed in a referendum last year.
The cabinet said it would strengthen its already planned restrictions to bar advertising in places and media where young people can see it.
The new laws will come into force from mid-2026, and strengthen restrictions on packaging and advertising on tobacco and e-cigarettes due to take effect from next year, reports Reuters.
The move, which will affect print media, online advertising and festivals, is designed to reduce tobacco consumption and related deaths.
Smoking remains relatively widespread in Switzerland with 9,500 people dying prematurely every year as a result of tobacco consumption, the government said, describing it as one of the country’s biggest public health problems.
“Tobacco use causes numerous non-communicable diseases, and the cost of their medical treatment amounts to 3 billion Swiss francs ($3.37 billion) per year,” the government said.
In future, no advertising for tobacco products or e-cigarettes will be allowed in print media, shops or events which can be visited by minors.
In addition, sponsorship of events which people under 18 attend will be banned. Online advertising will be still permitted provided age control systems are in place.
The tighter restrictions follow the success of the referendum “Yes to the protection of children and youths from tobacco advertising,” which was approved by 57% of Swiss voters in February 2022.
May 30, 2023
Vietnam Government Set to Restrict E-Cigarette Use

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The Vietnamese government has approved a new national program to restrict the use of e-cigarettes, shisha and other new tobacco products.
According to media reports, it is part of a comprehensive program proposed by the Ministry of Health to prevent the harmful impacts of cigarettes.
It aims to reduce the percentage of smoking males above 15 years of age to below 39 percent and that of women to below 1.4 percent.
It also hopes to prevent passive smoking at workplaces, restaurants, hotels, coffee shops, and other public places.
Research will be conducted into the negative impacts of tobacco, especially new products, the reports suggest.
The government is also working on increasing taxes on vaping and other tobacco products and determining minimum prices for them.
May 29, 2023