Category: Regulation

Fontem US Receives Marketing Denial Orders for Myblu
The FDA has issued marketing denial orders (MDOs) to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US.
“On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.
Credit: blu
The currently marketed products receiving MDOs include:

myblu Device Kit

myblu Intense Tobacco Chill 2.5%

myblu Intense Tobacco Chill 4.0%

myblu Intense Tobacco 2.4%

myblu Intense Tobacco 3.6%

myblu Gold Leaf 1.2%

myblu Gold Leaf 2.4%
Based on the information provided in the applications submitted by Fontem US, for these myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the agency. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.
Generally, the submission of a premarket application and intent to commercially market a new tobacco product that has never been marketed would be considered confidential commercial information (CCI) that the FDA would not disclose, according to the FDA. However, the agency determined that the named products are currently marketed based on communication with the applicant during the development of the publicly available Deemed New Tobacco Product Application List, and therefore the applicant has acknowledged the submission of these premarket applications.
“FDA is issuing MDOs for additional myblu products that do not appear on the publicly available list,” the agency stated. “FDA has publicly named only products that the FDA or the manufacturer have confirmed to be currently marketed to avoid potential CCI issues.”
April 8, 2022
Canada Proposes First Federal Nicotine-Only Vape Tax

The Canadian government has proposed the country’s first federal vape tax, which would take effect Oct. 1 if passed, according to Vaping360.
The tax applies only to nicotine-containing products, including pod-style and cartridge-style refills, disposable vapes and bottled e-liquids as well as nicotine base for DIY liquids. It does not apply to hardware that is sold without e-liquids. The tax also includes an option for Canadian provinces to add on their own, equally large, taxes.
Vaping products would see a tax of CAD1 ($0.97) per 2 mL for the first 10 mL of e-liquid in any sealed container and $1 per 10 mL for additional liquid in the same container. Sealed pods would be taxed separately at a minimum of $1 per pod.
Retailers would have until Jan. 1, 2023, to sell any untaxed stock they still have on Oct. 1 when the law would go into effect.
The tax is awaiting a vote by Parliament’s House of Commons, which is expected to take place either at the end of April or beginning of May.
April 8, 2022
Thailand Set to Confirm Ban on E-Cigarettes, Vapes

Image: Arcady
Thailand’s government has rejected an initiative to legalize and regulate nicotine vaping products, opting, instead, to reconfirm the country’s ban on sales and imports of e-cigarettes, according to Vaping360.
Thailand’s ban has been in place since 2014.
The National Tobacco Products Control Committee upheld the ban in a meeting last week, and Public Health Ministry Permanent Secretary Kiattiphum Wongrajit supports the decision. The decision will go to the cabinet for formal approval, and the cabinet is not expected to overrule the decision.
Thailand’s tobacco committee has stated that the country should uphold the ban to prevent cigarette addiction by children and adolescents.
Minister of Digital Economy and Society Chaiwut Thanakamanusorn has urged the government to end its ban on vapes, which he believes offer a low-risk alternative for smokers. As recently as January, he had planned to set up a working group to study the issue and consider public opinion.
April 7, 2022
Brazil Mulls Legalizing E-Cigarettes

Photo: Rmcarvalhobsb
E-cigarettes may become legal in Brazil later this year as ANVISA, the federal health sanitary agency, plans to revisit its regulations regarding the products. Proponents of vaping have been pushing the government to legalize the products to help smokers quit combustibles, but critics are concerned about youth usage as well as potential higher rates of vaping that could follow legalization.
Electronic tobacco products have been banned in Brazil since 2009, but there are currently shops that sell the products anyway, often with statements that the products are safe, according to The World.
“Once the product is legally allowed to be commercialized, it gets into the distribution network of the tobacco companies, which have one of the best distribution systems around,” said Stella Bialous, a Brazilian expert on tobacco issues and a professor from the University of California, San Francisco. She fears that more people would likely take up vaping if the products are allowed to be commercialized. In 2019, less than 1 percent of Brazilians used e-cigarettes. However, if the products are commercialized, they would become more easily available, and that percentage could quickly rise.
“Considering that these products are attractive to youth and that we can’t affirm that they really work for tobacco cessation, we believe that we must prioritize the public policies to prevent smoke initiation and also to promote health for the Brazilian population,” said Monica Andreis, the executive director from ACT Promocao da Saude, a nongovernmental organization that focuses on tobacco control policies.
“Brazil has a leadership role in Latin America and also around the world related to tobacco control policies. I believe that the decision from ANVISA has the potential to influence other countries in Latin America,” Andreis said.
ANVISA has not commented on the situation, stating that it is still analyzing data. “Up to this point, there are still uncertainties and controversies related to the risks attributed to these devices,” the agency stated in February.
April 1, 2022
Michele Mital to Serve as Acting Director of CTP
Mitch Zeller, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), will officially retire on April 8, Zeller confirmed during the 103rd annual TMA meeting this week.
Today, the FDA confirmed to Vapor Voice that Michele Mital will serve as acting director of the CTP when Zeller retires. Mital has served as the deputy director of the CTP since 2018, according to the FDA.
In this position, Mital is responsible for assuring that CTP accomplishes its public health goals and for operationalizing the Center’s vision and mission as it implements the Family Smoking Prevention and Tobacco Control Act.
MItal will have some big shoes to fill. Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest.
The news was first reported Wednesday afternoon in a tweet by FDA Tracker and confirmed by Filter reporter Alex Norcia after speaking with FDA sources. No formal announcement has been made.
This story will be updated when more information is available.
March 31, 2022
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
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
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