Tag: e-cigarettes

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

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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

Image: Tobacco Reporter archive
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
TMA to Host TPMP Workshop Open to All Industry

Image: Tobacco Reporter archive
TMA is collaborating with EAS Consulting Group to host a one-day workshop on tobacco product manufacturing practices (TPMPs) on Tuesday, June 13, 2023, from 9 a.m. to 3:30 p.m. at the Hyatt Regency Crystal City at Reagan National Airport.
The workshop will include expert speakers from manufacturers, suppliers and law firms to give a balanced and comprehensive analysis of the proposed regulation, its impact on business and the ability to hear shared experiences.
The event is open to all industry stakeholders interested in attending, though space is limited.
Registration is currently open.
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
Former Hong Kong Official Wants Export Ban Back

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A former health secretary in Hong Kong on Sunday said it is not ideal for the government to allow e-cigarettes to be re-exported via the Special Administrative Region of the People’s Republic of China.
A ban on alternative smoking products came into force in the SAR in April last year.
But there was an exemption for re-export via air cargo and the authorities want to extend this to sea-to-air and land-to-air shipments, to support the logistics sector.
Former Secretary Sophia Chan said such a move would be risky, especially with Hong Kong aiming to further reduce its smoking population from the current 9.5 percent to 7.8 percent.
The Council on Smoking and Health said earlier that a relaxation regarding re-exports would inevitably increase the diversion of such products into the community and significantly weaken the effectiveness of the city’s ban on alternative smoking products, according to RTHK.
“The process to fully ban e-cigarettes and heated tobacco products was difficult, but we did it. The main reason we did it was to reduce the risk,” said Chan.
“On the one hand, we understand the government needs to boost the economy after the pandemic. But on the other hand, we should push ahead with tobacco control efforts for people’s health and to reach the 7.8 percent goal in 2025.”
May 28, 2023
UK Lawmakers Under Fire to Ban Disposable Vapes

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Pressure is mounting against UK lawmakers to impose an outright ban on single-use vapes, amid concern about their rising popularity among youth and doubts over regulators’ ability to control the fast-moving sector.
A government call for evidence on vaping and young people in England is due to end on 6 June, with action expected on measures to clamp down on illegal vape sales, as well as the marketing and placement of relatively cheap single-use vapes.
One government official said the latter was a particular worry. They said: “Some of the marketing and branding is pretty appalling – it can look like a sweet shop.”
Some health groups have wider concerns about the approach of the government, set out by the junior health minister Neil O’Brien in a speech last month, to encourage vape use as a substitute for traditional tobacco products, with a planned “swap to stop” scheme offering a million smokers in England a free vaping starter kit.
They argue that the relatively short history of e-cigarettes means there is minimal knowledge about long-term health effects, and that evidence about their efficacy as methods to stop smoking is similarly limited, pointing to countries such as Australia, which permit them only on prescription, according to The Guardian.
The most immediate battle is likely to be fought over single-use vapes, now the chosen product for more than half of young people who use e-cigarettes.
May 28, 2023
Cook County, Illinois Bans Flavored Vape Products

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The Cook County Board has approved a ban on selling flavored tobacco products in suburban Cook County. Cook County is the largest county in Illinois and contains 134 municipalities in its region, the City of Chicago being the most well-known.
Passed by a unanimous voice vote, the ban on the sale of flavored tobacco products applies to all vaping cartridges and includes menthol flavors, according to Audacy.
Under the ordinance, any of the reported 42 licensed tobacco retailers in unincorporated Cook could face a $250 fine the first time they are caught selling flavored vapes.
“Our statutory authority only applies to unincorporated Cook. Those businesses that are located in unincorporated Cook will be impacted,” Cook County Board President Toni Preckwinkle said. “When we make legislation of this sort, that’s where it applies. Local municipalities can enact their own legislation should they wish.”
May 26, 2023
Altria Set to Complete Purchase of NJOY Holdings

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Altria Group today announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 has expired in connection with the company’s previously announced pending acquisition of NJOY Holdings.
This confirms that no further regulatory review by the federal antitrust authorities is required in connection with the transaction. Subject to the satisfaction of other customary closing conditions.
Altria states that it expects to complete the acquisition in the second quarter of 2023.
In 2022, the U.S. vapor category comprised nearly 14 million U.S. adult tobacco consumers, including 9.5 million exclusive adult vapers, according to Altria. The segment generated approximately $7 billion in U.S. retail sales and represented approximately 15 percent of total estimated equivalized U.S. tobacco volumes and more than 50 percent of total estimated equivalized smoke-free tobacco volumes.
To date, the U.S. Food and Drug Administration has approved the marketing of 23 vapor products and devices. In 2022, NJOY received marketing granted orders for the NJOY Ace device, along with several tobacco-flavored pods. The regulatory agency is still reviewing NJOY’s premarket tobacco product applications for several NJOY menthol-flavored e-vapor products.
Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for the IQOS Tobacco Heating System.
The NJOY deal followed an announcement by Altria that it would exchange its entire minority investment in embattled Juul Labs for a nonexclusive global license for certain of Juul’s heated tobacco intellectual property.
In total, Njoy Holdings has received six of the 23 marketing orders granted by the FDA as of this writing for the entire vaping product category, including pods, disposables and open systems.
A major factor in Altria purchasing Njoy is the Ace device didn’t come with the stigma tied to youth vaping, according to Altria CEO Billy Gifford.
“We believe Njoy has taken a responsible approach to marketing its products. According to the 2022 National Youth Tobacco Survey, Njoy-branded products are not included among the top usual brands among middle school and high school e-cigarette users. Additionally, Njoy is developing access restriction technology for its devices to further address underage use,” explains Gifford. “Our consumer research indicates that once consumers try Njoy Ace, it is a competitive product for both smokers and vapers. After trying the authorized nonmenthol Ace variant, 19 percent of surveyed smokers and 27 percent of surveyed vapers indicated that they would definitely buy the product.”
May 26, 2023