Top News - Tobacco Reporter

22nd Century to Launch VLN Cigarettes in U.S.

22nd Century Group plans to launch its VLN reduced-nicotine cigarettes in a major U.S. metropolitan market by March 2022. The debut will be followed by a nationwide launch.

On Dec. 23, 2021, the U.S. Food and Drug Administration authorized 22nd Century Group’s VLN King and VLN Menthol King as the first reduced-nicotine content cigarettes under the agency’s modified-risk tobacco product designation. Scientific studies show the company’s VLN reduced-nicotine content cigarettes “help you smoke less.”

“The FDA’s MRTP authorization of VLN ushered in a new reality—a combustible cigarette carrying an authorized harm reduction claim supported by extensive scientific and clinical studies, most of which were funded by federal health agencies,” said James A. Mish, CEO of 22nd Century, in a statement.

“VLN is the only reduced harm product of its kind, and we are confident based on the research that it can absolutely be successful on its own or in combination with other harm reduction products. With an estimated 1,300 deaths per day associated with U.S. smoking, our products that can help people smoke less offer a truly game-changing prospect for millions of American adults who currently smoke.”

During the pilot phase, 22nd Century Group will test and optimize its marketing mix. The pilot will help the company better understand how adult smokers will use this product prior to advancing to national distribution, providing an unmatched tool for helping adult smokers find an off-ramp from nicotine addiction.

“22nd Century has secured a well-known national retail partner for VLN’s pilot market launch phase,” said Mish. “We intend to deploy and test a wide array of marketing materials aimed at adult smokers looking for ways to help them smoke less. These will include marketing at the point of sale, direct materials sent to self-identified adult smokers interested in VLN and online resources, such as our new product site at tryvln.com.”

While 22nd Century owns or controls the intellectual property that makes VLN tobacco possible, the company has reiterated its willingness and expectation to license the technology to strategic partners.

January 18, 2022

RAI Heating Technology Declared ‘Unpatentable’

The U.S. Patent Trial and Appeal Board (PTAB) has determined as unpatentable several claims by RAI Strategic Holdings relating to tobacco-heating technology, reports The Winston-Salem Journal.

According to federal law, a claim is unpatentable if “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”

The board’s rulings are the latest developments involving several patent infringement lawsuits between RAI and Philip Morris International.

In November, the U.S. Trade Representative affirmed a legal victory by RAI’s parent company, British American Tobacco, against rival Philip Morris International and its U.S. partner, Philip Morris USA.

On Sept. 29, the U.S. International Trade Commission issued a final determination of a violation of the Tariff Act of 1930 by Philip Morris USA and Altria Client Services as it related to two BAT product patents.

Altria Group, parent of PM USA, asked trade representative Katherine Tai to overturn the ban. The U.S. Trade Representative’s office confirmed no action was taken by Tai.

As a result of the ITC ruling, PM USA is barred from importing PMI’s IQOS 2.4, IQOS 3 and IQOS 3 Duo heat-not-burn cigarette products into the United States.

PMI welcomed the PTAB ruling. “We are extremely pleased with the well-reasoned PTAB decisions, which further demonstrate the futility of RJR/BAT’s efforts to litigate this patent family,” a PMI spokesperson said.

Reynolds said in a statement that “we disagree with the decision finding (the ‘915’ ruling) invalid partially contradicting the International Trade Commission’s ruling, which was based on a highly developed evidentiary record, including a six-day trial with live witnesses.”

Reynolds said an ITC panel and the full commission “agreed with Reynolds’ position regarding the patent.”

PTAB decisions can be appealed for review to the U.S. Court of Appeals for the Federal Circuit, which Reynolds has indicated it will pursue.

Another option for Reynolds, according to the patent board’s ruling, is for Reynolds to amend its patents in dispute or request a reexamination of the challenged patent.

January 18, 2022

Institute Warns Against Overregulation of Vapor

A new study by the American Consumer Institute highlights the dangers of overregulating e-cigarettes and vaping products. Co-authored by Steve Pociask and Liam Sigaud, the report investigates the empirical evidence surrounding the consumer risks and benefits of using e-cigarettes and vaping products compared to using combustible tobacco products.

The reports assets that vapor products are significantly safer than smoking and more effective than other nicotine-based smoking cessation treatments in getting smokers to quit cigarettes.

The authors contend that excessive regulation of e-cigarettes not only ignores the prevailing scientific consensus on health risks, but also deters smokers from switching to safer alternatives while pushing vapers back to smoking.

Therefore, the authors argue, overregulating vapor products will have serious health consequences for consumers who smoke.

“This report provides much-needed clarity on an issue of profound importance for public health,” the publishers wrote in a press release accompanying the report. “As the authors note, ‘informed by rigorous research, the U.S. can better chart a responsible course that encourages smokers to seek safer substitutes and quit, while protecting our youth from the dangers of tobacco products.’”

January 18, 2022

Broughton: China Vapor Laws is Opportunity

Recent amendments to China’s Tobacco Monopoly Law present an opportunity for responsible companies to demonstrate how alternative high-quality products are an important and appropriate element of tobacco harm reduction, according to Broughton.

Writing on the website of the contract research organization, Broughton’s head of regulatory affairs, Lloyd Smart, and regulatory consultant Xiangyin Wei summarize China’s tobacco monopoly law changes and explain what they means for electronic nicotine delivery systems (ENDS).

On Nov. 26, 2021, China’s State Council amended the country’s tobacco law, giving the State Tobacco Monopoly Administration jurisdiction over e-cigarettes. Next-generation products will now be managed in the same way as combustible cigarettes.

Among other things, this means that ENDS companies, including exporters, will need to apply for a license. A single transaction platform will be implemented for product distribution and all products must comply with a new national standard. Regulation of products likely to be introduced following an initial transition period of between three and five months, during which no new products may be brought to market. Products with synthetic nicotine will be banned in China.

According to Broughton, the recently announced changes to e-cigarette regulation in China offer an excellent business opportunity for companies that want to build consumer trust by showcasing their product’s high quality and safety standards.

“As with all regulatory requirements, the most important initial step is to understand fully what’s needed—to provide reassurance or identify gaps that need to be addressed. And to act quickly; seizing the opportunity while making sure you don’t get left behind as the market changes,” write Smart and Xiangyin.

January 18, 2022

Surge Pioneers Ultrasonic Technology

Surge Vapor has introduced new ultrasonic technology to improve the vaping experience.

Typical vaping devices use a coil made of resistance wire. The wire is heated with an electrical current, turning e-liquid into vapor. Due to the heating process, traditional coils need to be replaced frequently and can produce unpleasant “dry hits” or burnt flavors.

To address this problem, the Surge engineering team developed an ultrasonic vaping chip. Vibrates 3 million times per second, the chip splits e-liquid into a cloud of vapor without using a traditional heating wire.

Ultrasonic heating creates smaller vapor particles, delivering nicotine content more efficiently for increased satisfaction, according to Surge vapor. Since no wires are heated to produce vapor, “dry hits” and burnt flavors are eliminated from the vaping experience. Additionally, the lower working temperature of the ultrasonic process reduces potential toxin emission and maintains the chemical stability of the e-liquid.

Surge Vapor’s first device was created for new vapers, with a lightweight design, automatic draw activation and pre-filled ultrasonic pods. The device features six flavors, which have been specifically developed to pair with ultrasonic technology.

“Our mission was to create new vaping technology, which advances tobacco harm reduction and maximizes satisfaction,” the company wrote in a statement. “After years of research and development, this is now a reality. We are excited for vapers around the world to experience the next generation of vaping with Surge.”

January 18, 2022

Thai Minister Commits to Legalize Vaping

Thailand’s digital economy and society minister, Chaiwut Thanakamanusorn on Jan. 14 he would continue efforts to legalize e-cigarettes, according to the Bangkok Post.

Thanakamanusorn believes vapor products are safer than combustible cigarettes. He said legalization of e-cigarettes would enable the country to tax sales and would provide people who found themselves unable to quit smoking with a safer option.

The minister intends to create a working group to study legalization and invite people to sign in support of a request next month that the Constitutional Court rule if the ban on imports of e-cigarettes violates people’s rights, especially the right to have access to less dangerous products.

The minister insisted he had no vested interest in legalizing vaping. Tobacco harm reduction advocates have been pushing for legalization in Thailand.

January 14, 2022

Campaigners Attack Cost-of-Smoking Claim

Smokers’ rights campaigners have rejected a claim that smokers cost society £17 billion ($23.3 billion) a year in the U.K.—£5 billion more than previously estimated.

On Jan. 14, Action on Smoking and Health (ASH) published an economic analysis of U.K. data suggesting that the cost of smoking is significantly higher than previous estimates have shown.

The higher estimate is a result of a new assessment of the impact of smoking on productivity. According to ASH, smokers are more likely than nonsmokers to become ill while of working age, increasing the likelihood being out of work and reducing the average wages of smokers. Smokers are also more likely to die while they are still of working age, creating a further loss to the economy.

The report also cites smoking-related fires as a major cost to society, in the form of fire-related deaths, injuries and property damage.

“The suggestion that smokers are a significant economic burden on society is absurd,” countered Simon Clark, director of the smokers’ lobby group Forest.

“More than 80 percent of the cost of tobacco in the UK is tax and the revenue from the sale of legal tobacco is almost £10 billion a year. That’s a fact.

“In contrast, the contrived claim that smoking costs society £17 billion is based on nothing more than estimates and calculations.

“As well as making a huge contribution to the public purse, smokers make a significant contribution to the local economy because without the money they spend on tobacco many village shops and convenience stores would lose a regular source of income.

“The health risks of smoking are well known. If adults choose to smoke that’s a matter for them not government. Ministers must remember that and not be swayed by exaggerated claims about the cost of smoking to society.”

January 14, 2022

Taiwan: Bill Approved to Raise Smoking Age

The Taiwan Cabinet approved a draft amendment to the Tobacco Hazards Prevention Act, which would raise the legal smoking age to 20 from 18 as well as impose a ban on electronic cigarettes and flavored tobacco products, according to Focus Taiwan.

The draft amendment will now go to the legislature for deliberation.

If signed into law, those found in violation of the new age restrictions would face a fine ranging from TWD2,000 ($72) to TWD10,000.

Those found violating the ban on manufacture, import, sale, supply, display, advertising and use of all tobacco-like products, including e-cigarettes, could face a fine ranging from TWD10 million to TWD50 million.

The proposed bill would provide a legal basis for regulation of new tobacco products, such as heated-tobacco products, stating that suppliers of new tobacco products with unknown health risks should file an application for assessment of said products within a specific time period before suppliers are allowed to manufacture or import the products. Those caught violating this regulation could face a fine up to TWD50 million.

The bill goes further, expanding the smoking ban to colleges and universities, kindergartens, baby care centers and in-home childcare locations. Smoking in bars and nightclubs would only be allowed in designated areas. Graphic warnings and text would also be increased to 85 percent from 35 percent of the total package surface.

January 13, 2022

Poda Receives Patent for Closed Bottom Pod

Poda Holdings has received a U.S. patent for its closed bottom vaporizer pod. The patent was granted on Dec. 28, 2021.

“Receiving this Notice of Issuance is the culmination of a substantial amount of work by Poda and our intellectual property team,” said Ryan Selby, CEO of Poda, in a statement. “The application for this invention was initially filed on March 17, 2017. After almost five years of dedicated work and substantial financial investments, I am extremely proud to have this valuable patent granted by the U.S. Patent and Trademark Office.

“With the granting of this U.S. patent, Poda will effectively be the only company that can market a closed-ended heat-not-burn cigarette in the United States. We have already received a granted Canadian patent for this invention, and we now look forward to receiving granted patents for this application in the over 60 additional countries where this application has been filed. We believe this patent has incredible applicability in the global heat-not-burn market, and we look forward to marketing our patented products on a global scale.”

January 13, 2022

Poda and Landewyck Explore Partnership

Poda Holdings and Landewyck Tobacco are exploring the potential of a partnership.

The companies intend to enter into a cooperation agreement based on both parties’ intellectual property, branding, manufacturing facilities and distribution channels to develop one or more products for commercialization.

Before further developing the cooperation project, the parties intend to assess the relevance of their cooperation by implementing a trial period for blend development, which could be used for the potential cooperation products.

By bringing together Landewyck’s tobacco manufacturing and distribution expertise and Poda’s patented heat-not-burn technology, the aim is to develop a consumer-centric product offering both convenience and optimal flavor in the reduced-risk sphere.

“We’re very excited to further strengthen our collaboration with Ryan and the Poda team,” said Georges Krombach, general manager of export and new-generation products for Landewyck, in a statement. “The technology and intellectual property behind Poda are disruptive and deliver a strong customer experience. By adding our tobacco and our European regulatory and distribution expertise, we expect to have great success in the European marketplace.

“We manufacture tobacco and cigarettes at our own facilities exclusively in Western Europe and attach great importance to maintaining the highest manufacturing, working and product standards that are socially acceptable to our consumers, partners and importers worldwide. Our master tobacco blenders travel to the farthest reaches of the globe to hand select the best leaves, hence ensuring the unique flavor of our tobacco products—and all so our customers can enjoy the ultimate in tobacco pleasure.

“From product and manufacturing standards to employees and retailers, we always ensure that our business decisions and the products we supply are in keeping with our family spirit and upholding our tradition of delivering 100 percent quality, flavor and customer satisfaction.”

“This marks another milestone in Poda’s commercialization efforts in Europe and abroad,” said Ryan Selby, Poda’s CEO. “Landewyck has been working in the tobacco space for over 170 years and brings a tremendous amount of manufacturing and distribution experience and expertise. We intend to get moving immediately on the blend development trial and hope to move quickly into large-scale commercialization of the cooperation products.”

January 12, 2022

Category: Top News