Tag: news

Health Groups Urge FDA Action on Top Vape Brands

Photo: Dmytro
Health groups are urging the U.S Food and Drug Administration to make haste in addressing the remaining premarket tobacco applications (PMTA) for leading e-cigarette brands such as Juul, Blu, Vuse (Alto) and NJOY, which make up 75 percent of the U.S. market and are among the most popular with youth.
“We are grateful to see movement again by the FDA on the e-cigarette pre-market approval process under Dr. Califf’s leadership and the recognition of the risks these products pose to America’s youth while assessing the public health benefit for adult smokers,” wrote Robin Koval, president and CEO of the Truth Initiative, in a statement following the FDA’s authorization of Logic Technology Development’s tobacco-flavored e-cigarettes. Logic, however, makes up a small percentage of the U.S. e-cigarette market, with just over 1 percent according to retailer scanner data.
The Truth Initiative also expressed concern about the FDA’s failure to deny marketing applications for Logic’s menthol e-cigarettes, which remain under review. “According to the latest NYTS data, nearly 30 percent of young people who use e-cigarettes reported using a menthol flavor,” wrote Koval. “As the FDA prepares to issue a proposed rule removing menthol cigarettes from the market, we continue to urge the FDA to remove all flavored tobacco products, including menthol to protect our nation’s youth.”
Meanwhile, tobacco harm reduction advocates, took the approval of Logic, which is ultimately owned by Japan Tobacco International, as further evidence that the PMTA process favors deep-pocketed tobacco multinationals.
“It’s mildly gratifying to hear FDA say out loud the obvious and simple truth that vaping is helping Americans quit smoking,” Amanda Wheeler, president of the American Vapor Manufacturers Association told Filter. “But meanwhile in the bureaucratic shadows, they are strangling the life out of our entire innovative, entrepreneurial industry.”
“The FDA should be thoroughly embarrassed that the only vaping products with PMTAs are ones that have been rejected by adult consumers,” Greg Conley, the president of the American Vaping Association, told Filter. “If JTI did not have cigarette sales to subsidize their minimal effort offerings in next-gen products, market forces would have caused them to stop selling these products years ago.”
March 28, 2022
South Africa: Concern Over New Vaping Rules
Photo: Adrian | Adobe Stock
The Free Market Foundation is concerned that the South African government’s plans for regulating vaping products will push more people back toward smoking combustible cigarettes and buying from the black market, reports BusinessTech.
“The South African government argues that e-cigarette and vaping products are harmful and warrant regulation,” the Free Market Foundation said. “However, e-cigarettes and vaping innovations are tobacco harm reduction products aimed at mitigating the adverse health impacts associated with combustible tobacco products.”
“The total excise duty to be levied on nicotine and a non-nicotine solution, e-cigarettes and vaping, will range from ZAR33.30 [$2.28] to ZAR346. Therefore, poorer communities suffering disproportionately from tobacco-related diseases would be more incentivized to continue smoking cigarettes than pick healthier alternatives.”
“In reality, smokers may simply opt for illicit products, which are cheaper and constitute 42 percent of the informal market for cigarettes. Additionally, illicit goods are more harmful since production standards are not adhered to.”
The illicit cigarette market in South Africa grew substantially during a temporary ban on tobacco and it has yet to shrink to pre-lockdown volumes.
“National Treasury’s proposals to tax e-cigarette solutions that contain no tobacco or nicotine may, in particular, be questioned by some stakeholders as it does not necessarily support the government’s stated policy intention of reducing the consumption of tobacco products,” said Webber Wentzel, a legal firm. “It also could stimulate the illicit trade in e-cigarettes as has happened in the tobacco sector.”
The proposed tax would go into effect Jan. 1, 2023, if passed.
March 28, 2022
Malaysia: July Intro for Post-2005-Birth Nicotine Ban Bill
A new law in Malaysia that would ban the use of all vaping and other tobacco products for those who were born after 2005, will be presented to Parliament in July, said the country’s health minister, Khairy Jamaluddin.
This means that Malaysians who are 17 years old today will not be able to legally buy tobacco, vape, or e-cigarettes next year when they turn 18, the current legal age for smoking in Malaysia, or ever, in their lifetime. Neither will subsequent generations be ever permitted to purchase cigarettes and other smoking products.
Jamaluddin said that the bill was currently being finalized by the Attorney-General’s Chambers.
Credit: Krzysztof Wiktor
“I think in one to two weeks it will be completed, and then I can present it to the Parliamentary Select Committee on Health and Technology,” he told the media after the launch of the national-level community health agent, MyCHAMPION, according to Malay Mail.
Earlier, in his speech, Khairy said that the introduction of the new law related to cigarettes was one of the efforts of the Ministry of Health (MOH) in intensifying the smoking cessation campaign among Malaysians.
“We will introduce a new law so that it is a legal offence to sell cigarettes to anyone born after 2005. But I think this is the first step towards us ending smoking for a generation. It is a generational end game,” he said. “Indeed enforcement will be a challenge. Nothing to stop these young people from asking adults to buy cigarettes for them.”
The government previously announced during the tabling of Budget 2022 plans to tax vape and e-cigarette liquids containing nicotine, essentially illegalizing vape products that are presently under a grey area of regulation.
It should be noted that tabling a bill means to introduce the bill to legislature in every country but the United States, where tabling means to place an already introduced bill on hold.
March 27, 2022
U.K. Review of TRPR Finds Vaping Helps to Stop Smoking
The UK’s Department for Health and Social Care’s (DHSC) review into the Tobacco and Related Products Regulations (TRPR) laws which govern sales of nicotine products found that existing TRPR regulations “met their original objectives” and that they “could not be better achieved through alternative regulatory measures.”
The UK government has set itself a target of reducing the amount of UK smokers to just 5 percent of the population in the next eight years with the TRPR and other developments, such as the yet to be published Tobacco Control Plan (TCP), set to play a major role in helping to realize that ambition.
The DHSC’s view, published March 25, states the government believes in proportionate regulation of e-cigarettes, recognizing that they are not risk free. However, e-cigarettes and vaping products have been an effective tool to stop combustible cigarette smoking. Youth use is very limited, the report found.
“The current regulatory framework in TRPR aims to reduce the risk of harm to children, protect against renormalization of tobacco use, provide assurance on relative safety for users, and provide legal certainty for businesses,” the review states. “We know that a small proportion of children are experimenting with e-cigarettes, but regular child use remains consistently low in England.”
In response to the review, John Dunne, director general of the UK Vaping Industry Association (UKVIA), said that at first glance the response appears to be “status quo” and a win for the UK’s vaping sector as the review clearly states the positive impact that vaping can have in helping people to quit smoking.
“We have to remember this is only a review of all points made and some initial positions the government is taking; our hope now is that those proposals and recommendations are carried forward and manifested in the Tobacco Control Plan.” – John Dunne
“As part of the TRPR consultation we submitted a whole raft of proposals aimed at creating a better commercial and regulatory environment to make it easier for the industry to help people trying to give up smoking and it is good to see those acknowledged,” Dunne stated in a release.
The UKVIA, which promotes vaping as a less harmful alternative to smoking and its significant impact in helping smokers quit, as well as dispelling the misinformation on vaping that exists, submitted a landmark package of recommendations to the TRPR consultation, including:

The use of Government-approved expert health claims on products to address misinformation leading to misperceptions on vaping, and therefore encourage smokers to switch

Greater opportunities to engage with smokers, as current regulations restrict vaping’s ability to provide smokers with evidence-based knowledge to make informed decisions when looking to quit

The extension of certain regulations to cover additional vaping products, such as non-nicotine e-liquids, thereby ensuring a highly responsible and safe industry.
“What this tells me is that the industry is doing its job in bringing to the fore some of the things that have been holding back vaping’s ability to support the Government’s smokefree targets to full effect,” continued Dunne. “We have to remember this is only a review of all points made and some initial positions the government is taking; our hope now is that those proposals and recommendations are carried forward and manifested in the Tobacco Control Plan.”
March 26, 2022
Vaping Industry Advocates ‘Not Surprised’ by Logic Approval

When U.S Food and Drug Administration authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S. the vapor industry wasn’t surprised. Vaping advocacy groups have long expected the FDA to approve many of the brands that had premarket tobacco product applications (PMTAs) submitted and are owned by major tobacco companies.
“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”
Logic, based in Teaneck, New Jersey, is a part of the JT Group of companies. JTI is a international tobacco and vaping company headquartered in Geneva, Switzerland, with operations in more than 130 countries. JTI employs over 50,000 people. In a release, Logic stated that it submitted PMTAs for its Logic Pro, Logic Power, and Vapeleaf products on August 19, 2019, well before the Sept. 9, 2020, PMTA deadline.
“We take the quality of our products extremely seriously, along with the way they are marketed and sold, and we are proud that we have received marketing orders from FDA for our Logic products to remain on retailers’ shelves,” said Corrado Mautone, president of Logic. “By receiving FDA marketing orders now, Logic can remain a reliable partner for retailers going forward.”
Amanda Wheeler, owner of Jvapes and the president of American Vapor Manufacturers, said that it is good to see that the FDA is acknowledging that vaping is safer than combustible cigarettes, but the fight for small business owners continues.
“People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”
The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products, mostly non-tobacco flavors.
“While Logic received marketing orders for its tobacco-flavored products, it is still awaiting a determination from the FDA on its menthol products. At the FDAs discretion, products like Logic’s menthol capsules can continue to be marketed while under review,” Logic stated in the release. “Additionally, Logic received marketing denial orders (MDOs) for flavored products that are not currently on retailers’ shelves. Logic is reviewing the FDAs determination and rationale before taking further action.”
The FDA also indicated that it was moving closer to issuing decisions on other applications that account for “a large part” of the marketplace, which based on Nielsen ratings, are mostly owned by large tobacco companies.
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
March 25, 2022
GeekVape Wants More Action on Counterfeit Vape Products
Vape manufacturer GeekVape, the parent of Geek Bar, has written to trading standards departments in major UK cities asking them to take more action to combat the growing market for illicit vaping products.
GeekVape previously established a primary authority partnership with Oldham Council to focus on the growing issue surrounding illicit disposable products, according to Talking Retail. It has now followed this up by approaching other trading standards departments requesting their commitment to do all they can do to cut off the supply of non-compliant and counterfeit disposables.
Allen Yang, CEO of GeekVape, said it was easy to blame the manufacturer, but the truth is that illicit products are finding their way into the UK through customs and being sold in retail outlets across the country.
“It’s a huge issue for our own reputation and the vape sector as a whole,” Yang said. “Enough is enough, and there needs to be more collaboration and enforcement involving all parties including trading standards, the vaping industry, trade associations representing retailers and the medicines and healthcare products regulatory agency.”
The company has been working closely with the authorities in China to identify factories producing fake products. This has resulted in the closure of 12 counterfeit production facilities and the seizure of more than 100,000 fake products destined for the UK.
March 25, 2022
VPR Settles 3 More Patent Suits for Auto-Draw Technology

Illustration: VPR Brands
XL Vape, VGOD and Saltnic have agreed to pay VPR brands $155,000 to settle patent-infringement litigation related to VPR’s auto-draw technology, according to a press release. As part of the deal, VPR brands has granted each of the companies a non-exclusive license to practice the invention set forth in the disputed intellectual property.
Dating from 2009, U.S. patent 8,205,622 covers electronic cigarette products containing an electric airflow sensor, including a sensor comprised of a diaphragm microphone. The sensor turns the battery on and off, and covers most auto-draw, button less e-cigarettes, cig-a-likes, pod devices and vaporizers using an airflow sensor rather than a button. The technology is covered under electronic cigarette utility patent
VPR Brands has started to identify and notify over 50 of the leading companies using its auto-draw technology. XL Vape, VGOD and Saltnic were prioritized based on their sales volumes and popularity.
According to VPR Brands, most nicotine vaping devices sold in the U.S. today utilize an auto-draw/button-less technology. The company is investigating all button-less vape devices within the nicotine, CBD, and cannabis space that initiate vaporization from the user’s airflow inhalation as they would be suspect of infringement.
The company says it may also seek a buyer for its patent in the future, citing the example of Ruyan, which in August 2013 sold its e-cigarette patent to Imperial Tobacco group for $75 million.
VPR’s settlement with XL Vape, VGOD and Saltnic follows earlier settlements with Nepa 2 Wholesale and HQDTech, and PHD Marketing.
March 25, 2022
FDA Issues Marketing Orders to 8 Logic Vaping Products

The U.S Food and Drug Administration today authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S.. The brands include Logic Vapeleaf, Logic Power and Logic Pro, including hardware devices. The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
These products were authorized after the agency said its review of the product applications concluded, among other things, that the “likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.
While today’s action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they “FDA approved.”
“Retailers should contact Logic with any questions about products in their inventory. Applications for Logic’s additional products, including menthol, remain under FDA review,” an FDA release states. “The FDA has taken action on approximately 99 percent of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than 1 million ENDS products.”
The agency is close to making additional decisions on applications for popular ENDS products that account for a large part of the market. The continued marketing of these products has the potential to have a substantial public health impact—either positively or negatively—as they hold an overall large market share and are used by a lot of people.
“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” said FDA Commissioner Robert M. Califf. “We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine. The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”
Under the premarket tobacco product application (PMTA) pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products.
This is especially important for youth. Before a product is authorized under the PMTA pathway, the agency reviews a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.
“Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating. We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn’t provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth. We are committed to continuing to take the appropriate actions to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.”
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
March 24, 2022
Connecticut Legislative Panel Moves Forward With Flavor Ban
Credit: Quatrox Production
A Connecticut legislative panel on public health pushed forward Wednesday with a plan to ban the sale of flavored vaping products in an effort to reduce nicotine use by minors.
According to CT News Junkie, lawmakers have debated for the last two years without passing a proposal that would prohibit the sale of any vaping flavor other than tobacco and increase penalties for businesses caught selling nicotine products to youths.
Wednesday’s 19 to 12 vote found members of the committee split on the issue. Several lawmakers voiced concern that banning flavored vaping products could have the unintended consequence of leading nicotine consumers to more harmful combustible products like cigarettes.
Rep. Jamie Foster pointed to testimony from Yale professor Dr. Abigail Friedman suggesting the policy could increase tobacco use by minors and reduce smoking cessation by adults.
“It would be easier and significantly more comfortable to me to align with the advocates who want children to not have access to tobacco,” Foster said. “It would be easier if we could just say ‘E-cigarettes are evil’ and ban them. I wish we could. I wish the science supported that but it doesn’t.”
March 24, 2022
Canada Opens Consultation on Tobacco And Vaping Act

Photo: JHVEPhoto
The government of Canada has opened public consultation on the Tobacco and Vaping Products Act (TVPA) ahead of its mandatory parliamentary review. Stakeholders can provide input until April 27, 2022.
In 2018, the TVPA was amended to protect youth and nonsmokers. The amended act recognized that vaping was significantly less harmful than smoking, and smokers that switched to vaping could reduce their exposure to thousands of chemicals. The Act introduced measures to protect youth through various labeling and promotion regulations.
Darryl Tempest
Tobacco harm reduction advocates welcomed the consultation. “Vaping has helped millions of smokers quit and has the potential to help millions more if it weren’t for the misrepresentations of the industry by media and misperceptions surrounding the product itself. It is imperative that Parliamentarians have the opportunity to hear from a wide range of experts as part of the TVPA review process,” said Darryl Tempest, government relations advisor to the Canadian Vaping Association (CVA)
Health Canada’s discussion paper states, “For adults who smoke, there appears to be a lack of awareness that vaping products are a less harmful source of nicotine for those who currently smoke and switch completely to vaping. A 2020 survey found that only 22 percent of current smokers recognized that vaping is less harmful than smoking cigarettes.”
In its consultation submission, the CVA will urge Health Canada to rectify this through the issue of relative risk statements for approved use by licensed specialty vape shops. In 2018, Health Canada proposed a “List of Statements for Use in the Promotion of Vaping Products.” According to the CVA, this proposal has been put on the back-burner and has languished in Health Canada’s bureaucracy to the detriment of potential public health gains from smokers switching to vaping.
“Instead of issuing reasonable statements for use by specialty vape shops, the TVPA has effectively gagged the vape industry through Section 30.43,” the CVA wrote in a press release. Section 30.43 prohibits “the promotion of a vaping product in a manner that could cause a person to believe that health benefits may be derived from the use of the product or from its emission or by comparing the health effects arising from the use of the product or from its emissions with those arising from the use of a tobacco product or from its emissions. The purpose of this prohibition is to prevent the public from being deceived or misled with respect to the health hazards of using vaping products.”
“The CVA looks forward to actively participating in the review process and will advocate for enhanced measures to protect youth, as well as increased smoker targeted messaging on the benefits of switching to vaping. We encourage all stakeholders to submit feedback,” said Tempest.
March 24, 2022