Category: Regulation

VTA Skeptical of FDA’s Latest Youth Vaping Analysis

After the U.S. Food and Drug Administration released its latest National Youth Tobacco Survey, Vapor Technology Association (VTA) Executive Director Tony Abboud said the FDA’s reporting of the data is misleading.
“Yesterday, the FDA, in coordination with the [U.S. Centers for Disease Control and Prevention ], released new data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth,” Abboud stated. “The FDA represents the NYTS data to show that youth vaping ‘remains high,’ yet a deeper dive into the data show only a small uptick in experimental or infrequent use while regular use remains flat or is slightly down.
Abboud notes that since 2019, according to the CDC, the number of high school students who have tried vaping (1 time in the last 30 days) has dropped by 50 percent, and the number of middle school students has plummeted by 70 percent. During that same time period, the number of high-school students who ‘frequently’ vape dropped by 37 percent and the number of middle school students dropped by 65 percent.
” FDA’s near single-minded focus on youth who experiment with vaping versus those who are frequent users ignores what clearly is a consistent trend of youth away from vaping products. Rather than focusing on removing products from the market in an attempt to impact youth vaping, the FDA should instead support common-sense regulatory reforms that would better restrict access to products instead,” Abboud stated. “Simply removing products from the market is not the answer when those products are also proven to help adult smokers quit.”
Abboud explained that it is well documented that flavored vapor products help adult smokers to switch to less harmful vaping and “study after study after study” has confirmed the data. Since 2010, when e-cigarettes became widely available in the U.S., smoking rates have declined by more than half, he stated.
“Tobacco use is down. Youth vaping is down. These are both good things and are not in dispute. Unfortunately, there are still 40 million Americans addicted to cigarettes,” Abboud stated. “Every year, 500,000 die from smoking-related diseases and yet less than three percent of our kids are using vapes on a regular basis. The FDA’s failure to acknowledge this reality ignores the role vaping plays in harm reduction and smoking cessation, and puts more lives at risk.”
October 9, 2022
FDA, Hyde Bar Disagree on MDO; Puff Bar Defiant

Credit: Jean Claude
It shouldn’t be this complicated. Magellan Technology says it didn’t receive a marketing denial order (MDO). The U.S. Food and Drug Administration says it did. It wouldn’t be the first time the regulatory agency made a mistake. The FDA seems to be making a habit of it recently.
Magellan claims that the FDA made a “glaring error” and the company did not receive an MDO for its 32 products under the Hyde brand. In an email, Jon Glauser, CEO of Magellan, stated that the FDA’s announcement is false for two reasons. First, the regulatory agency only issued the company a Refuse to Accept (RTA) letter and, second, the FDA failed to conduct a proper review of Magellan’s scientific evidence in its premarket tobacco product application (PMTA) review for its Hyde products.
“Contrary to the FDA’s statement, FDA only issued a Refuse to Accept letter for the identified Magellan products, not an MDO,” stated Glauser. “A Refuse to Accept letter is a refusal based on nothing more than a technical review of the applications’ contents which, in this case, was a missing document, i.e., a sworn certification related to the translation of certain components of the application. In other words, the Refusal to Accept was based on bureaucratic technicalities.
“This is much more than a misnomer or clerical error by the FDA since the agency elaborated that it had conducted a scientific review and reached a conclusion that the PMTAs ‘lacked sufficient evidence.’ However, no such scientific review was referred to and no scientific justification was provided in FDA’s correspondence today.”
Magellan currently has pending litigation against the regulatory agency with the Second Circuit Court of Appeals concerning an MDO issued by the FDA last year for Magellan’s pod-based Juno vaping products.
New FDA data from the 2022 National Youth Tobacco Survey (NYTS) shows that 2.5 million U.S. youth use e-cigarettes, according to the published findings in the Morbidity & Mortality Weekly Report released by the FDA in conjunction with the Centers for Disease Control and Prevention. This is a slight rise over last year’s data.
Armed with this information, the FDA also issued Puff Bar (no relation to Magellan products) a warning letter for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA also requested a response within 15 working days of receiving the letter, detailing how the company intends to address the FDA’s concerns.
It’s at least the second letter the FDA has sent to Puff Bar without any follow-up action. The FDA issued at least two warning letters for Puff Bar’s non-tobacco nicotine disposable products.
During a Next Generation Nicotine Conference in Miami, Patrick Beltran, CEO of Puff Bar, said his disposable products were the “end of the road” for vaping products. “This is the end of the road for vaping in my opinion. It doesn’t get any more convenient for the consumer than a disposable vape device.”
Beltran then blamed U.S. retailers and Chinese manufacturers for the youth initiation issues. “We’re pioneering the disposable industry and the disposable sector of this industry, and it’s very tough when I go to the store and I see people and I see these brands being pushed and there is no enforcement whatsoever,” he explained. “I have to go … I have to spend millions of dollars on a PMTA. Juul, [expletive] Juul, and I’m sure everyone here has heard the news what happened … It’s all [expletive],” referring to Juul’s MDO that the FDA later retracted.
During GTNF 2022, a nicotine industry conference held in Washington D.C. in September, Brian King, director of the the FDA’s Center for Tobacco Products, the division charged with regulating next-generation tobacco products, discussed the FDA’s ability to force companies to comply with its MDOs (and warning letters). So far, very few companies that have been told to remove their products from the market have complied (including Puff Bar). King said the agency has multiple enforcement options to bring both manufacturers and retailers to heel.
“We have several tools available to us, including advisory actions,” he said. “We also have regulatory enforcement actions, including voluntary recalls as well as various other requested recalls. We can also take administrative action, civil money penalties (in terms of manufacturers, that penalty cannot exceed $15,000 for any single violation or $1 million for any number of violations related to a single action),” explained King. “When it comes to judicial action, we can do seizure, injunction and also criminal prosecution. I will say that when it comes to enforcement and compliance, nothing is off the table.”
The FDA has not taken any serious action against any vaping company for violating it’s orders. Puff Bar products can still be found at retailers across the U.S., even though the company has received multiple warning letters from the FDA.
Puff Bar has not received an MDO from the regulatory agency to date.
After reviewing PMTAs for 32 Hyde e-cigarettes, however, the FDA issued MDOs for the applications submitted by Magellan (the company argues they were actually RTAs). In conducting its scientific review, the FDA determined that the applications lacked “sufficient evidence demonstrating that the products would provide a benefit to adult users that would be adequate to outweigh the risks to youth.”
No Hyde products have received marketing authorization orders from the FDA.
“To be sure, the FDA expressly wrote to Magellan that ‘The absence of these required FDA forms impedes FDA ingestion and processing of applications.’ In other words, FDA could not have conducted any scientific review because it refused to accept the application,” wrote Glauser. “Our counsel has demanded that FDA not only retract the press statement it made but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.”
The FDA has a history of making mistakes in the PMTA process. It’s currently facing more than 20 lawsuits and has had to retract MDOs from numerous companies, including Juul Labs, Turning Point Brands and Kavial Brands, among others.
“Magellan Technology looks forward to addressing whatever administrative technicalities are present so that FDA can, in fact, conduct a full scientific review of its products,” wrote Glauser.
October 7, 2022
Scotland Urged to Rethink Vape Ad Restrictions

Photo: jazrotorman
The U.K. Vaping Industry Association (UKVIA) has called on the Scottish government to reconsider its proposal to tighten advertising restrictions on vaping.
The call follows the publication of the outcomes of the government’s consultation on the plan. According to the UKVIA, the feedback from the consultation, which involved the input of individuals, local authorities, public health organizations and the vaping community, clearly shows that there is no majority of support for the recommendations put forward by the government, instead dividing opinions and leaving more questions than answers on the future of vaping regulations.
At the time the consultation went live, the UKVIA warned that the Scottish government’s proposals could derail the country’s 2034 smoke-free ambitions and that its stance is “in denial of the facts,” creating a significant risk to the health of people of Scotland looking to quit smoking as well as more uncertainty around vaping caused by misinformation.”

The proposals that were put forward only sought to further conflate vaping with combustible tobacco products by aligning advertising and promotion rules to existing restrictions on tobacco products.
John Dunne, director general, UKVIA
The UKVIA’s position was echoed by the Scottish Grocer’s Federation, which stated that the Scottish government’s move was unjustified and failed to appreciate the potential benefits of vaping products.
Many proposals put forward by the government generated 50-50 responses, and a number resulted in more respondents disagreeing than agreeing with them. These included proposals to ban in-store promotional displays, to make free distribution and nominal pricing of vaping products an offense and to make sponsorship agreements in respect to vaping products an offense. A higher proportion of respondents indicated that the proposed policy would have a negative impact on individuals (50.5 percent who felt it would versus 36.9 percent who didn’t) and on those with socioeconomic disadvantages (48.6 percent versus 25.5 percent).
“The proposals that were put forward only sought to further conflate vaping with combustible tobacco products by aligning advertising and promotion rules to existing restrictions on tobacco products,” said John Dunne, director general of the UKVIA, in a statment.
“Only by working with others, following the evidence and listening to people’s testimonies can we succeed in the goal of tobacco harm reduction.
October 5, 2022
South Africa: Stricter Tobacco, Vape Rules Ahead

Photo: michaeljung
The South African Parliament accepted submission of the Tobacco Products and Electronic Delivery Systems Control Bill, which will replace the Tobacco Products Control Act of 1993, reports Business Insider.
The bill, which was tabled in 2018, aims “to deter people, especially children and youth, from using tobacco products, encourage existing users to quit and protect nonsmokers from tobacco smoke exposure.” Regulation will cover sale, advertising, packaging and labeling of tobacco products as well as where smoking and vaping are allowed.
Under the bill, smoking and vaping in enclosed public spaces will be prohibited. Smoking too close to “an operable window or ventilation inlet of an entrance or exit” of “an enclosed public place, enclosed workplace or in or on a public conveyance” is also prohibited.
The health minister can also prohibit smoking in certain outdoor areas to “reduce or prevent the public’s exposure to smoking.” Smoking in vehicles or enclosed private spaces while in the presence of a child or nonsmoker will be prohibited. Smoking in an enclosed common area of a multi-unit residence will be banned as well.
The bill will also mandate generic packaging for tobacco products; the packaging “must have a uniform plain color and texture” and be of the same “size, type and shape.” The health minister will be responsible for setting standardized packaging and labeling requirements.
The only branding allowed on packaging will be brand name and product name in a standard color and typeface. Packages will be dominated by graphic health warnings.
Additionally, stores will only be allowed to display “a single prescribed notice informing consumers that a list of relevant or related products for sale, along with their prices and quantities, may be requested at the sales counter.” Retailers and wholesalers will no longer be allowed to display tobacco products. They “may make the product available to consumers upon request, provided that the requestor is not a child.”
This bill could also affect flavored vapor products. The health minister can prohibit “any substance or ingredient that creates a specified color, characterized flavor, smell or effect on the consumer.”
“The industry wants to be regulated,” said Asanda Gcoyi, CEO of the Vapour Products Association of South Africa. “We have to be regulated.”
“But we propose that government use [vapes and e-cigarettes] as a tobacco harm reduction product [and] this bill does not actually go that far.”
October 4, 2022
CTP’s King to AP: Nicotine Salts Show Potential
During an exclusive interview with the Associated Press, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), Brian King, said the FDA is well on its way in setting a foundation for substantial reductions in combustible tobacco smoking with the product standards such as a menthol ban and flavor bans for e-cigarettes and cigars.
Brian King / Credit: FDA
When asked about several surveys that have shown many adults think e-cigarettes are as dangerous as traditional cigarettes, King said he was fully aware of the misperceptions surrounding vaping products those misperceptions aren’t consistent with the known science.
“We do know that e-cigarettes — as a general class — have markedly less risk than a combustible cigarette product,” King said. “That said, I think it’s very critical that we inform any communication campaigns using science and evidence. It has to be very carefully thought out to ensure that we’re maximizing impact and avoiding unintended consequences.”
King also said he believes “there’s a lot of really important science and innovations” that have occurred in the vaping industry in recent years, adding that the most notable is nicotine salts in e-liquids.
“We know that when you smoke a tobacco product, it’s a very efficient way to deliver nicotine across the blood-brain barrier. So it’s been very difficult to rival that efficiency in another product,” said King. “But in the case of nicotine salts you have the potential to more efficiently deliver nicotine which could hold some public health promise in terms of giving smokers enough nicotine that they would transition completely.
“But you also have to consider the opposite side of the coin, which is the inherent risks of initiation among youth. So I do worry about that … there’s a lot happening and I think that it could be promise or peril. But I think it’s important that the science drives that.”
September 27, 2022
Nicaragua Bans Imports of E-Cigarette Products

Credit: Adaptice
In Nicaragua, the General Directorate of Customs Services issued the technical circular identified as CT/116/2022, informing the officials of the General Directorate of Customs Services and the public of the prohibition on the importation of electronic cigarettes and the obligation of importers and exporters of tobacco to register before the National Sanitary Regulation Authority.
The ban on electronic cigarettes entering the country is absolute, prohibiting the import, export, storage, distribution, marketing, and use of electronic nicotine delivery systems, electronic cigarettes, vaporizers, or other similar devices with or without nicotine, according to JD Supra.
The regulation prohibits the entry into the country of these products, even for personal use, by empowering customs officials to seize such products from travelers for subsequent delivery to the National Sanitary Regulation Authority (ANRS).
The rule also establishes that companies engaged in the manufacture, import, and export of tobacco products, including vaping products, and their derivatives in Nicaragua must register with the Health Regulation Directorate of the ANRS to carry out customs clearance of this type of merchandise under any customs regime.
Before this provision entered into force, the e-cigarette and vaporizer industry was unregulated.
September 21, 2022
Norcia: FDA Amps up Attacks on Unauthorized Vapes

Credit: Puwasit Inyavileart
During an interview with Politico on Sept. 6, Brian King, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), would not say whether the agency was willing to take unauthorized vaping products off the market.
In his first interview since taking the reins of CTP, King said that he was “committing to explore all viable pathways that are legally and scientifically defensible,” adding that “nothing is off the table.”
He did not acknowledge anything about the commission of external experts looking into CTP procedures, however, writes Alex Norcia of Filter, the agency is already in the process of seeking court orders, threatening lawsuits and demanding the destruction of unauthorized next generation nicotine products.
“Filter has confirmed that the FDA, by September 1, advised the Department of Justice (DOJ) that at least two open-system vape companies were in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) because the manufacturers did not file premarket tobacco product applications (PMTAs) and were continuing to sell their products,” Norcia writes. “According to a letter to one of the vape companies, viewed by Filter, the feds are seeking court orders, threatening lawsuits and demanding the destruction of unauthorized products.”
CTP has denied an estimated 99 percent of marketing applications and dozens of companies have sued over their denials, which they have largely argued were “arbitrary” and “capricious.”
“We plan to seek a court order to permanently enjoin you … from, among other things, directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product at or from any of your facilities, unless and until, among other things, the product receives, and has in effect, marketing authorization from FDA,” reads the letter, signed by DOJ Senior Litigation Counsel Christina Parascandola and dated September 1. “The enclosed proposed consent decree,” it continues, “states the terms upon which the government would be willing to settle the suit that we plan to file.”
Filter agreed not to disclose the names of the individuals and companies that received the letters (one of the companies has now ceased business operations) because of the possibility that litigation could unfold. The FDA did not respond to Filter’s request for comment by publication time.
“Defendants shall bear the costs of destruction and the costs of FDA’s supervision.”
One industry insider, who requested anonymity so as not to affect his company’s PMTA process, said that the letter was “a clear escalation”—the first time, to his knowledge, that the FDA had gone beyond warnings and explicitly threatened to sue over sales of unauthorized nicotine vapes.
“Their exercise of enforcement discretion to date has reached almost legendary proportions, so this would be at least a small deviation from that,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network and the American Cancer Society’s former vice president for tobacco control, told Filter. “My sense is that there are many, many instances of such behavior across the country, which Mitch Zeller and others have referred to as requiring FDA to play whack-a-mole, so a big question would appear to be whether this signals a new direction or is a random example of enforcement action.”
The two companies known to have received letters, at least, have been ordered to physically destroy their own products, under FDA supervision, according to Norcia.
“Within thirty (30) days after entry of this Decree, Defendants shall, under FDA’s supervision and pursuant to a written destruction plan approved in writing by FDA prior to implementation, destroy all Defendants’ ENDS products in their custody, control, or possession as of the date this Decree is signed by the parties,” the letter reads. “Defendants shall bear the costs of destruction and the costs of FDA’s supervision incurred under this paragraph.”
September 15, 2022
Second Chance: MDO Legal Win Presents Opportunity

Photo: andranik123
How companies can make the most of a recent court ruling requiring the FDA to reassess thousands of PMTA rejection notices.
By Neil McKeganey
It would be hard to overstate the threat that youth vaping in the United States poses to the use of e-cigarettes as a means of tobacco harm reduction. Respected national surveys have shown a rising trend in youth vaping, with the threat to the vaping industry as predictable as night following day.
Former Food and Drug Administration Commissioner Scott Gottlieb could not have been clearer in signaling that threat when he said that the offramp to adult smoking could not be justifiably achieved at the cost of the on-ramp of teen vaping. If anybody was in any doubt about the risks that youth vaping poses to the entire e-cigarette industry, those doubts would have surely been extinguished in the recent ruling against Juul Labs, which required the company to pay in excess of $438 million to compensate states for the harms caused by past marketing practices increasing the likelihood of youth using their eponymously named vaping device.
For vaping companies, the threat of youth vaping may have lifted slightly in a recent U.S. court ruling requiring the FDA to pay attention to what vapor companies are doing in trying to restrict youth access to their products. Odd as it may sound, after having encouraged vapor companies to pay attention to their marketing and sales practices in light of the rising trend in youth vaping, the FDA’s position appears to have been that those efforts were almost certainly doomed to fail, with youth accessing what are often easy-to-conceal vaping products with relatively little difficulty through their social networks.
With vapor companies having invested heavily in age verification software, point-of-sale restrictions and in the removal of flavored e-liquids, it would have been a bitter pill to swallow to be told that the regulators had largely ignored those efforts to reduce youth access to their products.
The logic behind the FDA’s decision seems to have been that it would be easier to expedite the large number of premarket tobacco product applications (PMTAs) by adopting a “Fatal Flaw” approach—rejecting those applications that did not present data from either longitudinal customer studies or randomized trial evaluations and simply ignoring what the companies were doing to lessen the likelihood that their products would be found in the hands of youth.
By ruling against the FDA in legal action initiated by six vapor companies that had received marketing denial orders without the FDA even paying attention to their youth sales restriction efforts, the judges have effectively provided vapor companies with a second chance to have their PMTA applications reassessed.
So, what should vapor companies do given the legal victory that has been dropped in their lap? Clearly, it is going to be important for companies to do all they can to restrict youth access to their vapor products. But actions taken by these companies is not the same thing as being able to present evidence to the FDA that their products are not being used by youth.
To this end, research undertaken by the Centre for Substance Use Research (CSUR) in Scotland may help many of the companies concerned. For the last two years, the CSUR has been measuring the prevalence with which over 200 e-cigarette devices are being used by youth and adults within the United States. This ongoing research provides vapor companies with product-specific data showing the extent to which their products are being used, or more crucially, are not being used by youth.
Valuable as the data from this study undoubtedly are, vapor companies also have to be able to show the benefit of their products to adult smokers. The fastest route to obtaining this data is through an actual use study in which adult smokers using a company’s vapor products are monitored over a number of weeks to determine how many smokers are able to quit or reduce their cigarette smoking through using the company’s vapor products.
To obtain a marketing authorization, vapor companies have to be able to show two things—that their products are not being used by youth and that they can help adult smokers in quitting or reducing cigarette consumption. Succeed in these two things and vapor companies can have a bright future. Fail in either one and the future looks a lot bleaker.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

September 12, 2022
Paper Calls for More Balanced Rules for Vaping

Photo: defri
Four tobacco control specialists have called for a more balanced approach toward vaping regulation.
In a paper titled “A Proposed Policy Agenda for Electronic Cigarettes in the U.S.: Product, Price, Place and Promotion,” the authors observe that many Americans are confused about the relative harms of nicotine use and that public messaging around the substance tends to be more focused on stopping youth use than educating adults, according to Filter.
“Policy regarding e-cigarettes in the U.S. has focused on measures intended to reduce youth vaping, including imposing taxes on e-cigarettes and restricting flavors,” said Kenneth Warner, who wrote the paper with his University of Michigan colleagues Cliff Douglas and Karalyn Kiessling, along with Alex Liber of Georgetown University.
“Unfortunately, some of the measures may be backfiring. For example, if not matched by at least comparable increases in cigarette taxes, e-cigarette taxes that reduce youth vaping may also increase kids’ smoking. As well, some of these youth-oriented taxes appear to be reducing adult smokers’ use of e-cigarettes, increasing their smoking and reducing smoking cessation. We need to find policies that simultaneously address the widely shared dual goals of preventing youth vaping and increasing adult smoking cessation.”
The authors advocate for the U.S. Food and Drug Administration to reduce nicotine levels in combustibles, adding that it would have the best outcome if “accompanied by regulations ensuring the availability of alternative products, such as e-cigarettes.”
They also advocate for “states and the federal government [levying] large excise taxes on cigarettes and other combustible tobacco products and a more modest excise tax on e-cigarettes.”
The authors insist that only vape and tobacco shops should be allowed to sell nicotine products, that flavors should be banned in combustible tobacco products and that “all e-cigarette flavors other than tobacco and menthol and possibly a relatively small selection of other flavors with clearly adult-oriented marketing” should be banned.
September 8, 2022
Macau Approves Law Against E-Cigarettes, Full Ban Possible

The Macau parliament approved an amendment to the law on smoking prevention and control that prohibits the manufacture, distribution, import, export and transport of vaping products in and out of the region.
The law provides for penalties of MOP4,000 ($500) for individuals, with a fine of between MOP20,000 and MOP200,000 for companies.
Although the proposal was unanimously approved, during the debate in the Legislative Assembly, several members said that the government should go further, and impose a total ban on e-cigarettes, reports Macau Business.
Leong Sun Lok expressed concern that the new legislation might increase the smuggling or sale of e-cigarettes through the Internet or lead to an increase in the number of conventional cigarette users.
The Macau Special Administrative Region of the People’s Republic of China’s secretary for social affairs and culture confirmed that they are considering a later ban on e-cigarettes after giving “some time” to smokers who may “still have some in stock.”
Elsie Ao Ieong U also promised to review, within three years, the tax on all tobacco products, which in Macau is around 60 percent of the final price.
Ron Lam U Tou advocated increasing the tax, noting that the World Health Organisation (WHO) recommends a value of 75 percent.
The only Portuguese member in the parliament, José Pereira Coutinho, warned that the legislative revision could harm tourists who are only “passing through,” namely to mainland China, where e-cigarettes are allowed.
The legislative amendment will come into force three months after it is published in the Official Bulletin of the Chinese special administrative region.
The sale, advertising and promotion of e-cigarettes have been prohibited in Macau since 2018.
The government justified the changes to the law with “the strong evidence that this type of tobacco product is harmful to health, and can endanger the safety of people,” recalling that the consumption of e-cigarettes has increased, especially among young people.
The government stressed that e-cigarettes are banned in the neighboring region of Hong Kong and Singapore, and the Taiwanese parliament is also discussing a proposed ban.
August 31, 2022