Category: Regulation

FDA Denies Marketing Order for Flavored Vuse Alto Pods

Image: Rangizz
The U.S. Food and Drug Administration on Oct. 12 issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.
After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth, according to the agency.
“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”
Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.
These actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. The FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. Applications for six tobacco-flavored Vuse Alto products remain under FDA review.
October 12, 2023
U.S. Supreme Court Declines to Hear Avail Vapor Case

Credit: Avail Vapor
The U.S. Supreme Court declined Tuesday to hear arguments against the Food and Drug Administration’s regulatory authorization process.
The denial order comes in one of several cases questioning the FDA’s oversight of the vaping industry.
The US Court of Appeals for the Fourth Circuit sided with the FDA, finding that Avail hadn’t shown that its products had benefits for adults that offset the risk to youth.
The case is connected to the FDA’s 2021 determination to deny all of Avail Vapor’s requests to approve fruit and dessert-flavored e-cigarettes. The company claimed that the agency made the application process intentionally difficult, which led to mass denials of new product submissions.
In a Supreme Court brief filed Aug. 3, the company claimed the FDA failed to inform companies of a change in policy that would only allow for approval if the applications included data from studies conducted over time comparing the effectiveness of the multi-flavored products to that of tobacco flavored ones as an aid in adult smoking cessation.
Avail Vapor had asked the U.S. Supreme Court to examine a lower court’s refusal to review a marketing denial order issued by the FDA to Avail products.
In its petition, known as a Writ of Certiorari, Avail asked the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues in its petition that the FDA’s decision making was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
October 10, 2023
Texas: Group Wants Dallas to Enact Public Vape Ban

Credit: Lucitanija
A citizen advisory group has recommended that the City of Dallas follow other major Texas cities with a ban on vaping in public spaces in the name of public health.
The city’s Environmental Commission has recommended adopting a policy restricting the use of e-cigarettes, citing a “correlation between vaping aerosol exposure and negative health effects for vulnerable populations,” said Candace Thompson, chair of the commission’s environmental health committee.
In August, the commission unanimously approved a recommendation to expand the city’s 2016 smoking ban to include the prohibition of vaping of nicotine and non-nicotine products in most public spaces, with a few exceptions, including bars, restaurants and parks controlled by private partners, according to the Dallas News.
Dallas City Councilwoman Kathy Stewart, who chairs the parks, trails and environment committee, said she saw the recommendation in a memo. But her committee has not discussed nor voted on the proposed ban, which would be required before City Council action.
Vaping was banned in Austin in 2017 and in Houston in 2022.
October 9, 2023
Portugal Considers Ban on Public Use, Online Sales

Credit: Paulo MF Pires
The government in Portugal is discussing a new draft law regulating vaping and other tobacco product use. The new EU delegated act of the Tobacco Products Directive would be brought into the national legislation on heated tobacco products, including several provisions on vaping that have not been a part of the original delegated act.
Draft Law No. 88/XV aims to extend smoke-free areas’ restrictions to the use of vaping products – effectively banning vaping in outdoor spaces such as the terraces of bars and restaurants – and to restrict the sale of vaping products by banning online sales, according to an emailed press release.
Alberto Gómez Hernández, community manager of the World Vapers’ Alliance, said the measures represent a step backward in the adoption of an “open and evidence-based approach” to alternative nicotine products.
“Instead of making it more difficult for smokers to access safer nicotine products, Portugal should follow the steps of countries that are successfully reducing smoking rates by encouraging smokers to switch, such as the United Kingdom and Sweden,” he said. “Banning the online sale of vaping products leaves smoking as the only option for those who do not have alternative nicotine product outlets nearby.”
October 3, 2023
FDA Issues Civil Money Penalties to 22 Retailers

Credit: VetKit
The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.
The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions.
“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.
The retailers can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint or file an answer and request a hearing. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
Courtesy: US FDA
In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.
Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.
“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”
September 28, 2023
October 1 Begins New Strict Oklahoma Vaping Laws

Credit: Nasibli
Vaping product sales in Oklahoma are set to get more complicated. On Oct. 1, the state will publish a list of vaping products allowed for sale within its borders.
Oklahoma’s new rules prohibit sales of products that have not received a marketing granted order (MGO) by the U.S. Food and Drug Administartion or are still under review in the regulatory agency’s premarket tobacco product application (PMTA) process.
Vaping product manufacturers were required to submit documentation by July 1 to the Oklahoma Alcoholic Beverage Laws Enforcement (ABLE) Commission that attested under penalty of perjury that the products listed were available for sale before Aug. 1, 2016 (the effective date of the FDA’s Deeming Rule), and that a PMTA had been submitted for each product on or before the agency’s Sept. 9, 2020 PMTA submission deadline.
The bill creating the Oklahoma law passed the state legislature in 2021, but vaping advocates were able last year to get implementation postponed until 2023. Attempts this year to repeal the law or delay it again until 2024 were unsuccessful.
The law will make vape shop owners criminals if they are found to be selling bottled e-liquid or disposable vaping products not named on Oklahoma’s list. Giving false information about the authorization status of any product submitted to the list is also a crime.
Manufacturers are required to notify the state of Oklahoma within 30 days of a change to the product’s authorization status with the FDA.
September 28, 2023
U.S. FDA Seeks New Industry TPSAC Nominations

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is requesting nominations by Oct. 11, 2023, for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.
In addition, the CTP is seeking any industry organizations interested in participating in the selection of this TPSAC nonvoting representative.
Nomination materials for prospective TPSAC candidates and letters from industry organizations interested in participating in the selection process should be sent to the CTP by Oct. 11, 2023. Please see the Federal Register notice for further details on the nomination and selection procedures.
TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.
September 18, 2023
New Global Vape Alliance to Boost Unity in Industry
Photo IEVA
A new Global Vape Alliance has been announced at the InterTabac Trade Fair in Dortmund, Germany, alongside a declaration to foster collaboration, promote responsible practices and champion the cause of harm reduction in the vaping industry.
The Global Vape Alliance brings together major international vaping bodies including the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce (ECCC), the U.S. Vapor Technology Association (VTA), the U.K. Vaping Industry Association (UKVIA) and the Independent European Vape Alliance (IEVA).
The declaration aims to underscore the power of unity within the vaping industry. By coming together under its umbrella, industry leaders will commit to effecting responsible and positive change on a global scale, thereby signifying a new era in the industry’s dedication to public health, environmental sustainability and the well-being of smokers seeking alternatives to traditional tobacco products.
Key highlights of the Global Vape Alliance declaration include:
Regulatory Compliance: The alliance will facilitate the sharing of best practices to ensure member companies adhere to existing laws, regulations and industry standards, with a strong focus on responsible marketing and protecting youth.
Industry Promotion: The alliance aims to elevate the vaping industry’s professionalism, importance and sustainability by fostering communication among industry stakeholders and encouraging technological innovation.
Public Health: Emphasizing harm reduction, the alliance will actively promote the adoption of vaping products among conventional smokers to reduce harm, while openly providing information about their impact on physical health.
Environment Protection: In pursuit of a greener future, the alliance will advocate for eco-friendly strategies, promote recycling, low-carbon design and urge compliance with environmental laws.
Our goal is clear—to make a significant impact on public health, support those looking to quit smoking and contribute to a sustainable, environmentally friendly future.
Dustin Dahlmann, president, IEVA
The Global Vape Alliance firmly believes that unity and cooperation within the vaping industry can lead to a world without smoking.
“Our goal is clear—to make a significant impact on public health, support those looking to quit smoking and contribute to a sustainable, environmentally friendly future. With this declaration, we are combining the international forces of the industry to achieve important goals for the benefit of consumers,” said Dustin Dahlmann, president of the IEVA.
“The signing of the declaration, as I believe, will guide the global vaping industry to the future of healthy development and prosperity. In this regard, ECCC will continue to deepen the cooperation with other partners,” said ECCC Secretary-General Will Ao.
“The vaping sector is entering a critical chapter in its history with increased scrutiny from policy makers, regulators, public health officials, academics and campaigners,” said John Dunne, director general of the UKVIA. “It has to stand up and be counted, show strong leadership and the greatest levels of responsibility. The launch of the Global Vape Alliance and the declaration sets out to show the world that we are committed to best standards, practices and above all making smoking history.”
“Despite the enormous body of science that has declared vaping nicotine dramatically safer than smoking, the vapor industry’s detractors around the globe push a dramatically misinformed narrative,” said Tony Abboud, executive director of the VTA. “Declaring a shared commitment to furthering sound science, truthful information, and a commitment to meaningful regulations, industry leaders around the world can better serve companies and, more importantly, millions of consumers using vaping products to reduce and/or quit smoking cigarettes.”
For more information about the Global Vape Alliance declaration, please visit the Global Vaping Alliance website.
September 14, 2023
Health Expert Condemns Kazakhstan’s Vape Ban

Delon Human (Photo: Taco Tuinstra)
Leading international public health experts have expressed serious concern about Kazakhstan’s imminent ban on vapes as a “backward step” that contradicts the unprecedented success of more progressive countries that are dramatically reducing tobacco’s toll through the use of alternative nicotine products.
The Kazakh government’s intention to enact the prohibition by Jan. 1, 2024, endangers the lives of the country’s 3.2 million smokers who will be deprived of their best chance to quit their deadly habit, according to the Smoke Free Sweden, a movement highlighting Sweden’s progress in becoming smoke-free.
“We note with great concern this retrogressive move by the Kazakhstan Ministry of Health, which defies the extraordinary achievements of some countries that have adopted a progressive approach to modern products such as vapes and oral pouches,” said Delon Human, a global health advocate and founder of Smoke Free Sweden, in a statement.
“Around the world, alternative nicotine products are helping to save millions of lives by giving smokers an escape from combustible cigarettes. They are proven to be at least 95 percent less harmful than cigarettes and the most effective way for smokers to quit.
“To ban these reduced-risk products will simply condemn many smokers to stick with cigarettes and sentence them to an unnecessarily premature death.”
Human urged Kazakh authorities to emulate the approach of Sweden, which is on course to drop below a 5 percent tobacco smoking prevalence in the next few months. This is the level at which a country is considered officially smoke-free.
Sweden is the first EU country to achieve this milestone—17 years ahead of schedule—through its policy of making vapes and pouches available, acceptable and affordable to adult smokers.
“Quitting smoking like Sweden saves lives,” says Human. “Compared to the rest of Europe, Sweden has 44 percent fewer tobacco-related deaths, a cancer rate that is 41 percent lower, and 38 percent fewer deaths attributable to any cancer.
“Sweden is leading the way for other nations, such as the United Kingdom where the health service is giving free vape kits to smokers to help them quit. The government is funding the ‘swap to stop’ scheme with the aim of turning the country smoke-free by 2030.
“Meanwhile, only last month, the largest study of its kind in the United States confirmed the immense value of vapes as cessation aids. Researchers at Hollings Cancer Center in South Carolina found that vapes nudged people towards quitting smoking – even those who had entered their trial saying they had no intention of quitting.
“Such evidence is compelling and should be ignored no longer. If Kazakh authorities are serious about saving lives, they should be following the science and offering affordable access to vapes, instead of blocking this proven ‘fire escape’ for smokers,” concluded Human.
September 14, 2023
White House Set to Step Up Fight Against Smoking
Photo: Alexander Ryabkov | The White House
The White House on Sept. 13 announced a $240 million investment to fight cancer, along with a slew of new health resources to further the administration’s “Cancer Moonshot” initiative.
The announcements from the Biden Cancer Moonshot include:
New investments to reduce the impact of menthol and other flavored commercial tobacco products in communities that experience health disparities
A new plan to decrease the impact of smoking on Americans’ health by expanding efforts to prevent smoking and to support everyone who wants to quit. To ensure Americans who want to quit have the support they need, the Department of Health and Human Services will finalize its Framework to Support and Accelerate Smoking Cessation this year.
New smoking cessation resources for underserved communities, including American Indian, Alaska Native and Black communities, to reduce cancer health disparities.
A new pilot program to increase veteran engagement in tobacco use treatment. The Department of Veterans Affairs, in collaboration with the National Cancer Institute, will conduct a clinical demonstration project to assess how to more effectively engage veterans in tobacco-use treatment programs.
New resources and actions to reduce exposures to environmental carcinogens. The Environmental Protection Agency (EPA) is launching gov/cancer, with new information and prominently featured resources from EPA and other federal agencies about secondhand smoke, smoking cessation and other cancer-related topics.
Tobacco harm reduction activist have been urging Biden administration to embrace less harmful alternatives in its Cancer Moonshot initiative. “If President Biden is serious about beating cancer, then embracing tobacco harm reduction is not just an option, it’s a necessity,” said Michael Landl, director of the World Vapers Alliance (WVA), in a statement.
Landl pointed to the examples of Sweden and the United Kingdom, which he said have proven the effectiveness of vaping and other less harmful products in reducing smoking rates. “Instead of fighting less harmful alternatives, the Biden Administration needs to embrace vaping as a smoking cessation aid,” he said.
The investments in programs aiming to reduce smoking among marginalized groups would be more impactful if they included harm-reducing alternatives, according to Landl.
“To achieve the desired outcomes in cutting cancer-related deaths, it’s imperative that the United States foster a comprehensive harm reduction strategy that acknowledges vaping’s potential to save lives. Many smokers fail to quit, so to beat cancer we need to get real about that and encourage the use of less harmful alternatives such as vaping,” he said.
The WVA urged the Biden administration to develop an inclusive strategy that incorporates a range of less harmful alternatives to smoking. “Flavor bans, high taxation on safer nicotine products and the overly bureaucratic FDA approval process must end immediately,” said Landl.
September 13, 2023