Tag: e-cigarettes

Cigarette, Vape Sales Slow While Pouches Boom

Credit: Jet City Image
Sales of cigarettes and e-cigarettes have declined in the last two weeks, while sales of oral nicotine pouches have seen significant growth, according to analysts at TD Cowen.
They say in a research note that cigarette volumes across multiple channels were down 10 percent in the two weeks ending Jan. 13, a steeper decline than the trailing four weeks and 12 weeks.
Bonnie Herzog, managing director at Goldman Sachs, remain cautious on the U.S. tobacco/nicotine industry in the near term as the tobacco consumer remains under substantial financial pressure.
She stated in an email that many consumers are being more selective in their purchases and turning to more affordable alternatives, such as 4th tier/deep discount cigarettes, modern oral tobacco and, increasingly, illicit or gray market disposable vapor products.
“Shifts in category and consumer spending dynamics have been further exacerbated by flavor ban momentum at the state & federal level (Final Rule expected in March) and uncertainty with regard to the future of the e-cig category and category innovation (with FDA PMTA reviews still pending on big market brands such as JUUL and VUSE Alto, as well as menthol variants more broadly),” Herzog wrote.
E-cigarette sales fell 11.3 percent in the two-week period and 10.7 percent in the four-week period, according to Barron’s.
Sales of smokeless tobacco, including nicotine pouches, meanwhile grew 12.1 percent in the two-week period and 13 percent in the four-week period.
The smokeless category continues to show strong dollar sales growth driven by the Zyn brand, the analysts say.
January 24, 2024
Juul Labs Supports Tighter Rules on Youth Access

Credit: Piter2121
Juul Labs wants tighter e-cigarette regulations to help stave off youth demand while also making the industry safer overall.
In a recent open letter addressed to the Florida House of Representatives and Senate, the maker of JUUL vaping products urged lawmakers to endorse SB 1006 and HB 1007, legislative proposals to regulate the marketplace for legal nicotine vaping products in Florida.
The Senate and House versions of the bill both require state regulators to develop a directory listing of certified nicotine products manufacturers and certified nicotine products. They also subject retail and wholesale nicotine products dealers to inspections or audits; prohibits sale, shipment, or distribution of certain nicotine products into this state; provides criminal penalties; requires entities that seek to sell nicotine products or dispensing devices to obtain wholesale nicotine products dealer permit; provides permit holders must consent to inspections and searches without warrant; provides for seizure and destruction of unlawful nicotine products, according to Florida’s Senate.
In the letter, Juul Labs said it “is on a mission to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products,” according to media reports.
The letter highlighted what the company described as extensive efforts to ensure product quality and compliance with regulatory standards. The letter also emphasized significant investments in product development, regulatory science, and manufacturing quality controls.
Penned by Juul Labs’ regional director for State Government Affairs, Jennifer Cunningham, the letter states that the company wants a better-regulated market. Cunningham cited measures implemented by Juul Labs, including supporting “Tobacco 21” laws to raise the legal age for tobacco product sales to 21, restricting vaping flavors to tobacco and menthol, limiting product purchases per transaction, and promoting retail partner compliance through ID checking and technology advancements.
However, despite these efforts, the letter points out the challenges posed by a burgeoning illegal vape market in Florida, with the state being the primary destination for sales of illicit vapor products in the U.S. The vape maker also expressed readiness to assist Florida legislators in formulating policies that foster a well-regulated market for legal vapor products.
January 23, 2024
FDA Issues MDO for Tobacco-Flavored Bidi Stick
The U.S. Food and Drug Administration has issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick classic e-cigarette. The Bidi Stick is a closed-system, disposable, tobacco-flavored vaping device.
“FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products (CTP). “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”
The company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.
After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product 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, an FDA press release states. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.
“The Center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists,” said Brian King, director of the CTP. “The Center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”
Kavial Brands, the manufacturer of Bidi Stick, is expected to appeal the decision.
China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed an appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit after it received an MDO and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.
on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
January 23, 2024
New PMTA Finish Date is June 30: FDA Status Report

Credit: Postmodern Studio
The U.S. Food and Drug Administration now states that it will complete all covered marketing applications by June 30. In its latest court-ordered status report, the agency stated that continued review is
necessary in light of recent judicial decisions, including the D.C. Circuit’s decision in Fontem US.
“Further, several of these remaining applications present complex scientific issues that require careful review and consideration.
In the Fontem case, the court’s unanimous decision in Fontem US v. FDA upheld the regulatory agency’s denial of Fontem’s application to market flavored vaping products, in line with prior D.C. Circuit precedent but rejected the FDA’s denial of Fontem’s applications for unflavored products.
The agency stated that it was also facing challenges from manufacturers that filed premarket tobacco product applications (PMTAs) that made amendments to their applications after several legal decisions were handed down by courts.
“Many of these amendments contain substantial data and scientific explanation,” the agency wrote. “The amendments range from a few pages to hundreds of pages and were received on a rolling basis, with the most recent 2023 amendment being filed in December 2023.”
Also, on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
The regulatory agency is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.
For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.
The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.
The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA could not meet due to the extremely large number of PMTAs filed by manufacturers.
The most recent and FDA’s seventh status report was filed on Oct. 23, 2023. Specifically, in these reports, the FDA provides an update on the progress to finalize the agency’s review of pending PMTA “covered applications.”
A “covered application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar, and reach 2 percent or more of the total retail sales volume in NielsenIQ’s various retail e-cigarette sales reports.
The agency also stated that it now expects to take action on 94 percent of covered applications by March 31. The FDA stated that it would file another status report on or before April 22.
January 22, 2024
COP Must Respect Science, Consumers: Tax Group

Martin Cullip
The Taxpayers Protection Alliance’s (TPA) Consumer Center accused the World Health Organization Framework Convention on Tobacco Control of ignoring science and the rights of consumers in its pursuit of restrictive tobacco control measures, as the global body prepares for its 10^th Conference of the Parties (COP10) this year.
Martin Cullip, an international fellow at TPA issued the statement criticizing the WHO FCTC’s focus on policies known as MPOWER, which rely solely on restrictions on the supply and demand of tobacco products while ignoring other proven measures to help smokers quit.
“While the WHO has had some success in the past, it is far from effective,” Cullip said. “Twenty years ago, when the FCTC treaty was first implemented, there were around 1 billion smokers worldwide and this number is not changing meaningfully.”
Cullip said that despite decades of WHO’s restrictive tobacco control policies, most countries are not reducing smoking fast enough and will miss the WHO’s target to reduce smoking rates by 30 percent.
He said the current approach focusing on control and restrictions, hasn’t delivered on its intended outcomes. “International treaties should have three main aims: grow global membership, encourage parties to implement measures consistent with the aims of the treaty, and measure outcomes as a result of its actions,” he said. “The WHO FCTC does the first two effectively, but not the third one at all.”
“It is the lack of regard for outcomes which has led to many, including former WHO health directors, to declare that its approach is ‘not fit for purpose,’” he added.
Cullip said the WHO’s focus had shifted from tackling the harms of tobacco smoke to fighting nicotine itself. “It seems that reducing death and disease is not an objective for them,” he said. “Their approach has changed to an attack on nicotine, which on its own, causes very little harm, instead of combustible tobacco, which kills.”
He blamed the WHO’s “anti-scientific position” for the rise in global smoking rates, which leave smokers confused and more likely to carry on smoking rather than considering safer products that don’t burn tobacco.
Cullip also criticized the WHO’s alleged disregard for harm reduction strategies, which seek to reduce harm for those who won’t abstain from tobacco use.
He said the WHO has consistently failed to respect article 1(d) of the FCTC which includes “harm reduction strategies” as one of the main pillars of tobacco control.
“Instead, the WHO promotes prohibition. Despite the abject failure of the war on drugs and any other prohibition in modern history, the WHO chooses to wage the war on nicotine. These recommendations distract countries from implementing measures that can improve the lives of their populations,” he said.
Cullip said the WHO’s process excludes public participation and disregards consumer rights, violating the spirit of the Ottawa Charter which emphasizes individual control over health choices.
“It is well past time the WHO FCTC process listened to the public it is supposed to serve,” he said. “The evidence in favor of harm reduction is increasing, and the WHO cannot ignore stakeholders who are central to the debate forever.”
Cullip called on the WHO FCTC to embrace all approaches in its policy discussions, honestly assess evidence and allow for greater public participation to achieve effective tobacco control strategies.
He also suggested that countries explore alternative methods beyond those dictated by the WHO to address their individual smoking challenges.
“Keeping doing more of the same and hoping for a different outcome is insanity. The number of smokers won’t go meaningfully down unless the WHO recognizes that a change is needed. Safer nicotine products are not the enemy, it is smoked tobacco,” he said.
January 22, 2024
UK Delegation to Push Vapes for Cessation at COP10

Photo: IRStone
The U.K. government believes that vapes comprise an important tool for helping adults quit tobacco smoking, a position its delegation will put forward during COP10, according to Dame Andrea Leadsom, the parliamentary under-secretary of state for health and social care.
Leadsom was speaking on Jan. 18 at Westminster during a backbench debate organised by MP Andrew Lewer and aimed at uncovering what stance the government would take at COP10, the 10th Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control, which is due to be held in Panama on Feb. 5-10.
Lewer, and others who spoke during the debate, were concerned that COP10 might resolve to establish equivalence in the regulation of combustible cigarettes and reduced-risk products, thus undermining the U.K.’s successful strategy of using vapes to help smokers quit their habit. Their concerns had been inflamed because previously they had been unable to wring from the government information about who would go to Panama as part of the U.K.’s delegation and what positions they would take.
Leadsom said the U.K. delegation would be led by the U.K.’s deputy chief medical officer, Jeanelle de Gruchy, but gave only a rough overview of the U.K.’s position. Referring to the discussions that would take place about progress on tobacco control worldwide, she said the U.K. was an outlier on the topic of vapes, and would be putting forward its position that vapes were a very important tool for helping adults to quit. The U.K. government would welcome other parties going further on tobacco control, but it would be monitoring the negotiations to ensure that “nothing becomes mandatory.”
On novel and emerging tobacco products, said Leadsom, different parties took different approaches. Currently, the U.K. was still looking at issues around heated tobacco, so the U.K. delegation would be in listening mode in this respect.
She said the U.K. had no plans to implement further restrictions on advertising and sponsorship, and she said that it would be pressing for no increase to be made in assessed FCTC contributions.
This last point was likely to have been in response to concerns expressed by some during the debate that while the U.K. was a major contributor to the FCTC, it seemed diffident in its approach to tobacco COPs. It was suggested that U.K. taxpayers might end up paying for policies that ran counter to their interests.
This was perhaps something of a concern because the debate never got to grips with the issues of how COP proposals could be blocked by individual parties, and, if they were not blocked, whether they were binding on all parties. The latter issue would not be so worrisome currently because the U.K. government has shown itself to be relaxed in its approach to complying with international agreements and laws, but it might become more of an issue if the current government is replaced in this election year.–George Gay
January 22, 2024
VTA: CTP Continues ‘De-Facto’ Flavor Ban With MDOs
Tony Abboud, director of the Vapor Technology Association.
When the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) issued marketing denial orders (MDOs) for Suorin and Blu PLUS+ e-cigarette products, Tony Abboud, executive director of the Vapor Technology Association (VTA), said the decision was just the latest installment of the FDA and CTP’s efforts to implement its de-facto ban on e-cigarettes in the U.S.
“The constant refrain from CTP is that e-cigarette manufacturers are not providing ‘sufficient scientific evidence’ in their PMTAs, yet CTP refused to answer the Reagan-Udall Foundation’s most fundamental criticism of CTP’s entire regulatory process: that CTP has not clearly articulated what is required to prove what is appropriate for the protection of the public health (APPH) or how it is interpreting what is APPH,” Abboud stated in a release.
He stated that the FDA has failed to objectively define the APPH standard while simultaneously using it to deny marketing authorization to critical smoking cessation and harm-reduction products, which is a “gross overreach” for any governmental institution whose mandate is to follow the science.
“Courts have found that the process has become ‘arbitrary and capricious’ in practice, with CTP leadership choosing on a case-by-case basis how the standard ought to be defined,” he stated. “Meanwhile, companies are simply trying to do the right thing by complying with and adhering to the PMTA process set forth by the FDA.”
Abboud stated that the actions of the FDA and CTP do nothing to protect public health or help Americans who smoke. “VTA once again calls on CTP to reverse course on its misguided actions and restore scientific integrity to its regulatory and decision-making process. Enough is enough,” he wrote.
January 21, 2024
SMOK Files Appeal of FDA’s Marketing Denial Orders
SMOK’s factory
One of the oldest MOD makers in the vaping industry has filed an appeal of the U.S. Food and Drug Administration’s marketing denial orders for six of the company’s open-system vaping devices.
China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed the appeal after with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit, and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.
The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the SMOK products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.” The agency also stated that SMOK failed to provide a specific e-liquid and consumers could use any e-liquid in the devices.
Shenzhen IVPS strongly challenges those assertions, as the company “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.
Welfer Ouyang, Shenzhen IVPS CEO, said he was “very concerned” that the agency issued marketing denial orders on open-system devices that are sold without any nicotine-containing e-liquid.
“FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices, and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Ouyang.
On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting PMTAs of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.
The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.
The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.
January 20, 2024
Natasha Lyonne Quit Smoking Using Vape Products
The actress Natasha Lyonne told the media that she quit smoking combustible cigarettes last year using vaping products.
She also said she attempted to quit vaping, but she stopped because she enjoyed it. She stated that she “quit quitting vaping” in a post on X, formerly Twitter, after a fan asked, “How’s the vape quitting going?”
The fan also attached a screenshot featuring a conversation from her television series Poker Face where Lyonne’s character Charlie Cale is told cigarettes are “really bad for you.”
“Quitting cigarettes was a big enough swing for a while,” she wrote in the post.
The raspy-voiced actress told People magazine that quitting cigarettes had been “a nightmare.”
“I’ll be honest. It’s the worst decision I ever made,” she said jokingly. “Of course, my true and deep hope is that the technology will get there such that I’m able to smoke again consequence-free since it’s one of the great loves of my life.”
Recently, the European Parliament, in full assembly, adopted a report recognizing the role of vaping in aiding smoking cessation. This comprehensive adoption by the Parliament marks a pivotal moment in the fight against smoking-related illnesses, according to an emailed World Vaper’s Alliance release.
The report, a part of the Parliament’s broader initiative on non-communicable diseases, acknowledges vaping as an effective method for smoking cessation and may also set a new direction for health policies within the EU.
The move follows the EU’s Subcommittee on Public Health (SANT) endorsement on Nov. 7. However, the initial recommendation by the SANT to limit vaping in certain public areas remains a point of contention.
January 20, 2024
Khyber Pakhtunkhwa Bans Vapes Provisionally

Photo: SakhanPhotography
The government of Pakistan’s Khyber Pakhtunkhwa province has banned the storage, sale and use of e-cigarettes for 60 days, according to the Associated Press of Pakistan.
All deputy commissioners have been directed to impose a complete ban on the sale of e-cigarettes and vapes to those under age 21 and its sale and storage within a 50-meter radius of all educational institutions in the province.
Those caught violating these orders will face legal consequences under Section 188 of the Pakistan Penal Code.
The interim ban follows a series of meetings with the Provincial Alliance for Sustainable Tobacco Control, Blue Veins and KPTCC focused on the dangers of e-cigarettes and vapes and that examined global legislative and policy practices regarding the products’ sale and storage.
“The decision has been taken in wake of alarming increase in use of electronic cigarettes (e-cigarettes) and vaping devices particularly among children and youth in the province,” said an official notification by the Home and Tribal Affairs Department of Khyber Pakhtukhwa, according to the Pakistan Observer.
“This interim ban is a commendable step by the KP government, reflecting its proactive approach to public health,” said Qamar Naseem, civil society activist. “However, we must solidify this progress through comprehensive provincial legislation to ensure a permanent solution to this growing health concern.”
“This ban is a significant victory for the health and well-being of our children and youth,” said Sana Ahmad, coordinator of the Child Rights Movement KP. “It prevents easy access to addictive substances and protects our future generations from the allure of harmful vaping products.”
“We, the healthcare providers, appreciate the governor and chief secretary of Khyber Pakhtunkhwa for this decisive ban,” said Qazi Shahbaz, president of the Provincial Doctors Association. “It’s a step forward in the right direction, and we now urge the government to enact comprehensive legislation for a complete ban. This is not just a win for public health but a strong message that the health and safety of our citizens, especially our youth, are of paramount importance.”
January 19, 2024