Tag: e-cigarettes

Jury Awards PMI $10 Million in Vuse Patent Violation Suit

Credit: Aleksandar Radovanov
Philip Morris International was awarded $10.7 million by a jury in Alexandria, Virginia on Wednesday after finding rival R.J. Reynolds Vapor Co’s Vuse e-cigarettes violate its patent rights.
The federal court jury said RJR’s Vuse Solo and Alto devices infringe two Philip Morris patents covering parts of a vaping device for heating substances and preventing leaks. The case is part of multi-front patent dispute between Philip Morris and RJR parent company BAT.
A spokesperson for Winston-Salem, N.C.-based RJR said the company was disappointed by the infringement findings and said it may appeal, but was pleased that the jury cleared its Vuse Alto of infringing one of the patents, according to Reuters.
A Philip Morris spokesperson said the company was “grateful” for the verdict, which “rejects an attempt by BAT to free-ride on our hard work and investment.”
RJR’s Vuse line is one of the two top-selling e-cigarette brands in the United States, along with Juul. The Tuesday verdict concerned counterclaims in RJR’s ongoing patent lawsuit over Philip Morris’ IQOS heated-tobacco device, which is on hold.
June 16, 2022
NIH, FDA Fund Study to Understand Effect of Flavors

Credit: Feng Yu
The National Institutes of Health and the U.S. Food and Drug Administration have given the University of Louisville a $3.6 million grant to study the effects of flavorings like mango and bubblegum used in vaping products.
Researchers at UofL’s Christina Lee Brown Envirome Institute hope to better understand the short-and long-term impacts of flavorings -specifically on the heart- and catalog which are potentially harmful, according to Kentucky Today.
“E-cigarettes are still relatively new, and we don’t yet fully understand what their health effects are,” said Alex Carll, an assistant professor in the Department of Physiology and co-lead on the project. “Understanding this could help us make better purchasing and regulatory decisions.”
The FDA banned flavors used in disposable e-cigarette and has not approved any flvors except tobacco through its premarket tobacco product application (PMTA) process. The agency contends that some flavors could appeal to kids and help fuel rising rates of youth vaping.
Matthew Nystoriak, an associate professor of medicine and co-lead on the project, said some flavors may seem harmless because they taste like or use the same ingredients as in food. But while those ingredients are safe to eat, they may not be safe to inhale.
“Our goal is to understand how individual flavoring chemicals impact the heart,” Nystoriak said. “There are many flavor chemicals used in e-cigarettes and if we know which are potentially more harmful than others, it’s possible for people to make more informed decisions about which products they use.”
Identifying their biological effects also is likely to help the FDA in regulating flavoring additives in e-cigarettes in the future.
June 16, 2022
UAE Drivers Urged Not to Leave E-Cigarettes in Cars

Fire chiefs in the United Arab Emirates have warned drivers that leaving e-cigarettes and vaping devices in a vehicle could lead to a fire as temperatures rise during the summer. It was over 103 degrees Fahrenheit in Dubai on June 15.
Electronic nicotine-delivery systems (ENDS) devices and other battery-powered gadgets can be extremely susceptible to heat, causing them to melt and catch fire, the chiefs stated.
In the first three months of this year, Dubai’s emergency services responded to 94 reports of blazes involving cars, buses and trucks for several factors including electronic devices overheating. Everyday household items such as lighters, batteries, power banks, e-scooters, electric cigarettes, perfume bottles and gas cans can start fires if left in cars during extreme heat.
Lithium-ion batteries can catch fire as they are extremely sensitive to high temperatures and are found in many common devices such as e-cigarettes, mobile phones, e-scooters and power banks.
“Authorities warn against keeping all objects that have the ability to ignite such as the items mentioned,” Thomas Edelman, managing director of Road Safety UAE, told The National.
“This is the reason why airlines are very cautious about these items. Imagine how much warmer batteries can get when left inside cars during the hotter weather. They can react and potentially explode which poses great danger,” said Edelman. “When temperatures rise, gases can form more easily and a spark can basically ignite those gases and lead to a fire.”
June 15, 2022
Report: China’s ENDS Exports to Reach $27 Million in 2022

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The Blue Book of Electronic Cigarette Exports released on Tuesday estimates that the China’s electronic nicotine-delivery product (ENDS) exports will reach 186.7 billion yuan ($27.82 billion) this year, with exports for the first quarter already totaling 45.3 billion yuan.
According to the Blue Book, produced by the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce, the exports of ENDS in China was 138.3 billion yuan in 2021, an increase of 180 percent year-over-year. Among the over 1,500 e-cigarette businesses in China, more than 70 percent are export-oriented.
The Blue Book counts the scale of China’s ENDS exports in different markets in the first quarter of 2021. Among them, the U.S. market is the largest destination with 58 percent ($73.3 billion), followed by the European Union and Britain, which account for 24 percent ($34 billion), then Russia with 8 percent ($9.7 billion). Southeast Asia and the Middle East account for 5 percent and 4 percent, respectively.
“Although there has been some controversy in the development of e-cigarettes, many still want to consider the industrial value and explore the harm reduction technology that comes along with the new business model,” according to Pan Daily. “In 2021, there were more than 1,500 domestic e-cigarette manufacturing and brand enterprises, more than 190,000 e-cigarette retail outlets, and nearly 100,000 e-cigarette supply chains and merchandise service enterprises. The domestic e-cigarette industry directly employs about 1.5 million people and indirectly employs 4 million people, totaling about 5.5 million people.”
In March this year, China began to enforce its Measures for Electronic Cigarettes Management and the National Standards for Electronic Cigarettes. The regulations put forward clear standards and requirements for compliance operations in production, wholesale and retail, as well as strengthening the protection of minors.
June 15, 2022
L.A. Mayor Signs Flavor Ban into Law, Begins Jan. 1

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A flavor ban for vaping and tobacco products passed by the Los Angeles city council in early June by a 12-0 vote, is scheduled to go into effect on Jan. 1, 2023, after it was signed by Mayor Eric Garcetti on Monday.
While the law could face legal challenges before its effective date arrives, it could also come after a statewide ban on the sale of flavored tobacco might be in place, as voters will decide the matter as part of the November election.
If voters approve a statewide ban, it could be in effect as early as Dec. 8. Flavored shisha tobacco sold in existing hookah lounges that have their own ventilation system are expemt.
Premium cigars did not receive any exemption in the city’s ban, nor did any products that use menthol. The ordinance does not prohibit the possession or use of flavored tobacco products.
The ban that California’s voters will decide includes an exemption for both shisha tobacco as well as large flavored cigars, though in order to be exempt these cigars would need to have a wholesale price of at least $12, meaning they would retail for around $37 given California’s high tax rate on cigars, according to Halfwheel.
June 15, 2022
Kaivel and PMI Reach Global Distribution Agreement

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Kaival Brands Innovations Group, the U.S. distributor of all products manufactured by Bidi Vapor, has reached an agreement with Philip Morris Products (PMP), a wholly owned affiliate of Philip Morris International, for the development and distribution of electronic nicotine-delivery system (ENDS) products in markets outside of the U.S., subject to market (or regulatory) assessment.
The company’s recently formed wholly owned subsidiary, Kaival Brands International (KBI), entered into a licensing agreement with (PMP) on June 13, 2022. The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium ENDS device, known as the Bidi Stick in the U.S., as well as potentially newly developed devices, to permit PMP to manufacture, promote, sell and distribute such ENDS device and newly developed devices in international markets outside of the U.S.
The parties believe this agreement promotes their joint vision of a smoke-free future.
“We believe that in addition to the Bidi Stick having wide acceptance among legal-age nicotine users in the United States, Bidi Vapor’s numerous decisions around design; responsible adult-oriented marketing and stringent youth-access prevention measures; and sustainability bolstered its appeal to PMI,” said Niraj Patel, CEO of Kaival Brands, in a statement.
“We, along with PMI and Bidi Vapor, share the vision of a smoke-free future. The Bidi Stick offers legal-age nicotine users a high-quality alternative to cigarettes that satisfies their taste preferences. Further, we, along with Bidi Vapor, are committed to prioritizing the appropriate regulation and responsible commercialization, inclusive of taking the necessary measures to make sure these products do not appeal to unintended audiences, including youth. By example, Bidi Vapor does not engage in direct online sales to consumers and requires age verification contracts with our distributors and retailers.
“While Bidi Vapor continues to pursue the U.S. Food and Drug Administration premarket tobacco product authorization, cooperation with a major multinational company like PMI, a leader in scientifically substantiated smoke-free products, opens doors on a global scale. Kaival Brands looks forward to a long, productive relationship with PMI to accelerate the end of smoking.”
“We have previously mentioned our intention to broaden our current smoke-free product portfolio for adults who would otherwise continue to smoke cigarettes or use other nicotine products. This agreement supports that vision and is another step toward accelerating the delivery of a smoke-free future. We are excited to start our agreement with Kaival Brands—led by CEO Niraj Patel—who shares the same vision as we do, to accelerate the end of combustible cigarette smoking,” says PMI President of E-Vapor Ashok Rammohan.
June 14, 2022
31 Attorneys General Ask for FDA to Ban Synthetics

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A bipartisan coalition of 31 attorneys general are calling on the U.S. Food and Drug Administration to reject marketing authorization for all non-tobacco nicotine products, which are currently being sold without regulation of their contents, manufacturing, health effects, required warning labels or marketing claims.
In a letter to the agency, the coalition argues that these products currently don’t meet the FDA’s public health standard, and the regulatory agency should not gamble on the unknown effects of the products. The letter specifically calls for the FDA to reject a request by product manufacturers to grant marketing authorization for non-tobacco nicotine products.
The letter also insists that if the agency does grant marketing authorizations for these products, it imposes the same restrictions required of tobacco-derived nicotine products including a ban on all products with a flavor other than tobacco and strict regulatory requirements regarding their contents, manufacturing, and effect on users’ health.
Products should carry warnings concerning their addictiveness, and manufacturers should be required to validate health claims made about their products, including claims that a product is safer than tobacco.
“E-cigarettes containing synthetic nicotine and other synthetic nicotine products are putting our kids’ health at risk,” said North Carolina Attorney General Josh Stein. “The FDA has the power to do more to protect them, and I hope it takes action to prohibit manufacturers and retailers from marketing and selling to young people, using youth-friendly flavors, and putting exorbitant amounts of nicotine in these products, especially because we don’t yet know how dangerous these products are. I appreciate that the FDA has started taking some steps, but it must do more to rein in this industry and keep our kids safe.”
June 13, 2022
Study: Smokers Boost Vascular Health by Switch to Vape

A new study has found that long-term smokers who switched to vaping were halfway towards achieving the vascular health of a non-smoker within a month.
The research shows that while the use of non-tobacco nicotine products may still involve potential risks, the harm reduction they present have immense potential to prevent death and disability from tobacco use, and may indeed even boost government efforts towards a tobacco-free society, according to Journal Online.
The study saw a “clear early benefit” in switching from smoking to vaping, in the largest clinical trial to date.
Those who ditched cigarettes and vaped instead saw their blood vessel function increase by around 1.5 percentage points within four weeks compared with those who continued smoking.
The study didn’t claim that this benefit would be sustained, noting that more research is needed to delve into the long-term implications of vaping. It also warned that vaping isn’t safe, merely “less harmful” than smoking.
But it declared that if this improvement were sustained into the long-term, those who switched would have at least a 13 per cent reduced risk of cardiovascular events, such as heart attacks.
June 13, 2022
FLOW to End Sales of Flavored Products in China

The Beijing-based e-cigarette brand FLOW announced that in compliance with the national policy on e-cigarettes, the company has decided to discontinue the production of its fruit and all non-tobacco flavored cartridges in the Chinese market beginning July 1, 2022, or after the stock of raw materials is consumed this month.
Beginning March of this year, the Measures for the Administration of Electronic Cigarettes and the mandatory national standards for Electronic Cigarettes have been issued in succession. It puts forward clear standards and requirements for operations to be compliant in their production, wholesale and retail of e-cigarettes, while also strengthening the protection of minors.
According to the Measures for the Administration of Electronic Cigarettes and other regulations and the instructions in the regulatory transition period, after October 1, all of the sales of e-cigarettes in China will be included in a unified trading management platform, according to Pan Daily. Store owners will only be able to buy through the unified platform while consumers will only be allowed to purchase electronic cigarettes from dealers who have the appropriate retail license.
According to the Blue Book of the E-Cigarette Industry in 2021 issued the by Electronic Cigarette Industry Committee, China Electronics, there are nearly 190,000 e-cigarette retail stores in China, including 138,000 authorized stores, 47,000 specialty stores, and 5,000-7,000 collection stores. Under the compliance requirements, the retail market will inevitably face some restructuring and several e-cigarette stores could close or transform their business operations.
Currently, fruit-flavored e-cigarettes account for more than 70% of sales in many retail outlets. The Electronic Cigarette Management Measures prohibits the sale of flavored e-cigarettes and the type that can be swapped for customized and atomized substances.
June 13, 2022
NJoy Daily Disposable Gets FDA Marketing Approval
Credit: NJOY
NJOY now has two devices that have received marketing approval from the U.S. Food and Drug Administration. The regulatory agency today issued marketing granted orders (MGOs) under the premarket tobacco product application (PMTA) process for NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the MGO states. “The issuance of these marketing granted orders confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco products.”
The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the company to legally market them in the United States.
“Our finding that permitting the marketing of the new products is APPH does not mean FDA has ‘approved’ the new tobacco products specified in Appendix A,” the MGO states. “Therefore, you may not make any express or implied statement or representation in a label, labeling, or through the media or advertising, that the new tobacco products specified in Appendix A are approved by FDA.”
The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. These are presumed to be for flavored products other than tobacco. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.
Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
June 10, 2022