Tag: regulation

VPASA: Bill Will End South African Vapor Industry

Asanda Gcoyi
South Africa’s new tobacco bill will destroy the vapor industry if it becomes law, the Vapour Products Association of South Africa (VPASA) warned.
Among other provisions, the Tobacco Products and Electronic Delivery Systems Control Bill opens an avenue for the government to ban the sale of flavored e-liquids, which tobacco harm advocates insist are key to entice smokers away from cigarettes.
VPASA contends that the government neglected to consult the industry about its proposed legislation, which mistakenly conflates vaping with smoking, according to the industry group.
“While the Cabinet statement announcing the adoption of the bill noted that the Department of Health had conducted extensive consultations, it conveniently failed to state that other than anti-tobacco campaigners, no other stakeholders had seen a copy of the revised bill before it was gazetted on Sept. 29,” VPASA CEO Asanda Gcoyi was quoted as saying by The Saturday Star. “This is despite numerous requests for a copy made by industry stakeholders.”
VPASA also believes the proposals on table are not based on science or empirical evidence, treating vaping and smoking as if they are one and the same thing. “Vaping requires a separate set of guidelines recognizing that it is not the same as smoking and therefore cannot be regulated in the same manner,” said Gcoyi.
October 12, 2022
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
Malaysia Removes NRT, not Vape from Poisons List

Photo: dalaprod
Malaysia’s Health Ministry has categorized nicotine-replacement products as nonpoisons to make them more accessible to consumers, reports The New Straits Times.
Minister Khairy Jamaluddin said the move was done by granting an exemption to nicotine under the Poisons Act 1952 for products in the form of patches or gum registered under the Control of Drugs and Cosmetics Regulations 1984.
“This exception is expected to help smokers, who are motivated to quit smoking, in dealing with the withdrawal symptoms,” said Khairy.
At present, smokers who want to quit smoking have limited access to nicotine-replacement products as they are regulated under the Poisons Act 1952.
Under the law, nicotine is classified as a “Group C poison” and can be dispensed only by licensed pharmacists or registered medical practitioners.
The New Straits Times article made no mention of nicotine vapor products, which tobacco harm reduction advocates consider to be the most effect nicotine-replacement products on the market.
Malaysian lawmakers are currently considering the Control of Tobacco Product and Smoking Bill 2022, which, among other measures, would ban the sale of tobacco products, including e-cigarettes, to anyone born after 2007.
October 7, 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
China Rules Make Shops Close, Black Market Growing

Before China’s national standards were implemented, vape shops were growing rapidly throughout the country. (Photo: Timothy S. Donahue)
China’s National Standard for Electronic Cigarettes have begun, however, a reporter from Beijing Youth Daily claims many businesses still secretly sell the “fruit flavor” that has been banned from sale, a Chinese news outlet claims.
The report also states that after the implementation of the national standard several vape shops have closed. A reporter from Beijing Daily visited some e-cigarette sales stores or brand counters on October 2 and found that a small number of stores had been closed, and the words “transfer” were also posted.
In stores that are still in operation, only an estimated six brands of vaping products are on display, and there only two or three varieties of products. Some stores have seen the increased sale of combustible tobacco products.
China’s ban on flavored vapor products went into effect on Oct. 1 along with other new vaping product standards that were decided on earlier this year.
In November 2021, Chinese law was amended to bring the vapor industry under control of the State Tobacco Monopoly Administration, which regulates China’s tobacco products.
Products meant for export will not have to meet Chinese standards unless the destination country does not have its own specific standards.
October 5, 2022
European Vape Alliance Opposes Dutch Flavor Ban

Photo: Wirestock
The Independent European Vape Alliance (IEVA) has expressed concerns about the Draft Amendment of the Tobacco and Smoking Products Order for regulation of e-cigarette flavors presented by the Dutch Ministry of Public Health, Welfare and Sports.
According to the statement submitted by the Dutch authorities, the draft amendment intends to ban flavors other than tobacco in e-liquids in order to “reduce the temptation for young people and former smokers to purchase e-cigarettes.” The measure, authorities note, is “justified by the need to protect public health.”
The proposal also suggest that the Netherlands will be more likely to achieve its objective of a smoke-free generation by 2040 if e-cigarettes are rendered less attractive.
According to the IEVA, the proposed flavor ban is neither proportional nor necessary, as it is too strong a measure for the objective it seeks to achieve and fails the EU requirement that member states choose the means that least restricts the free movement of goods.
The IEVA insists that the ban will boost black market activity and jeopardize tens of thousands of jobs, while leading to a reduction in government revenues by reducing tax collection.
October 4, 2022
McKeganey on the Mystery of the PMTA Process

Photo: Olivier Le Moal
How effective must a product be in helping adult smokers quit to overcome the theorized level of harm to youth?
By Neil McKeganey
If there is one thing that you can say about the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process, it is that it is exceedingly data heavy. E-cigarette manufacturers’ submissions under the PMTA process can run to the thousands of pages, reporting the results of research costing millions of dollars. To receive a marketing authorization, e-cigarette manufacturers have to be able to show that their product is “appropriate for the protection of the public health” (APPH).
The APPH standard has become something of a modern-day mantra in the world of tobacco regulation, but what exactly does it mean? While nobody would accuse the FDA of excessive clarity in its communications with industry, this much is clear—in the simplest of terms, manufacturers need to be able to show that their product is helping adult smokers to quit, or at least to substantially reduce their smoking, and that their products are not being used by nonsmokers. This, in a nutshell, is what the FDA means when it talks about the importance of assessing the net public health impact of new tobacco products—the capacity to assess the likely overall impact of a new tobacco product on the nation’s health.
The kind of evidence that manufacturers are required to present under the PMTA process ranges from longitudinal customer studies collecting data from consumers of their products over weeks or months to assess how those products are impacting on the individual’s smoking behavior. Alongside such customer studies are the randomized control trials that monitor changes in smokers’ behavior when they are using the new tobacco product under control conditions. The randomized trials are probably the sort of things most manufacturers have heard of before even if they have not carried them out. These studies are often presented as the gold standard in research evaluating the impact of a new drug. The shortcoming with the control trial design, though, is that it tells you about the impact of your product under controlled conditions; it does not tell you how people will use your product in their real life.
The results of these studies can be presented to the FDA along with studies showing which population groups are currently using the new tobacco product and which ones are likely to start using the new tobacco product if it were approved. This is where the PMTA process starts to get more mysterious. One of the key groups that the FDA wants to know about is young people. With recent studies showing that more than one in 10 young people in the U.S. are using e-cigarettes, the FDA has repeatedly stressed that in deciding whether a manufacturer’s product is going to be judged as APPH, it needs to balance the impact of the product on adult smokers and young people. When the former FDA commissioner stated in 2018 that the “offramp” to adult smoking must not be achieved at the cost of the on-ramp to youth vaping, he was making it clear that the FDA would be prepared to deny approval to a new tobacco product that might be helping adult smokers to quit if at the same time it was being used by youth or likely to be used by youth.
In a scenario where youth use of a new tobacco product can become a deal breaker for a company seeking regulatory approval for their new tobacco product, it is clear that the FDA is placing greater weight on youth vaping prevention than on adult smoking cessation. For many people, the greater value placed on youth vaping prevention may seem entirely fair—but the question at the heart of all this is by how much is the FDA valuing youth vaping prevention over adult smoking cessation? The answer to that question, or more accurately, the failure of the FDA to answer that question, is the mystery at the heart of the PMTA process. An e-cigarette manufacturer may be able to present stellar data to the FDA showing the benefit of their product in helping adult smokers to quit and still receive a marketing denial order on the basis that in the view of the FDA, the product poses too great a risk to youth.
In interpreting the results of the empirical studies that manufacturers may have carried out, the FDA is trying to model the likely impact of the product on the total population—adults and youth. Modeling, though, is a mysterious process in which you try to anticipate what you think might happen in the future under various assumed conditions in the present. Some years ago, the National Academies of Science Engineering and Medicine carried out a modeling exercise to try to quantify the impact of e-cigarettes on population health in the U.S. This was a limited exercise carried out under precisely stated assumptions about how effective e-cigarettes might be in helping smokers to quit and how harmful they may be compared to combustible cigarettes. In contrast to such transparency, the FDA has never specified how it is weighing youth harm prevention against adult smoking cessation. As a result, e-cigarette manufacturers will never know how effective their product needs to be in helping adult smokers quit to overcome the theorized level of harm to youth to be judged APPH.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

October 3, 2022
Mendelsohn: Prescription-Only Vaping Policy Has Failed

Photo: makistock
Australia’s prescription-only model for nicotine vaping has failed, according to Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association. Writing in Filter, he urges the country to adopt a more realistic regulatory model for nicotine products.
In October 2021, the Australian government introduced a policy that requires nicotine vapers get a doctor’s prescription and purchase supplies exclusively from pharmacies or international online vendors.
The regulations were intended to prevent youth vaping and to allow access for adults as a smoking-cessation aid. One year on, the policy has achieved neither of those goals, according to a report prepared by Mendelsohn.
Instead, the rules have created a thriving illicit market for unregulated vaping products that do not comply with Australian standards. Meanwhile, vaping by adolescents has reportedly increased in Australia. With no age controls in an unregulated market, vaping products are easily accessible by teens from stores and through social media.

Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries.
Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association
While the prescription model has made it harder for adults legally access nicotine vapes, combustible cigarettes remain widely available.
According to two recent surveys, between 88 to 97 percent of vapers do not have a prescription and only 2 percent of purchases are made from a pharmacy. Exposed to frequent negative messaging by Australia’s medicines regulator, the Therapeutic Goods Administration, general practitioners have been reluctant to prescribe nicotine.
The only way forward, according to Mendelsohn, is to replace the prescription-only model with a legal and regulated retail market. “Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries,” he writes. “There should be strict age verification and penalties up to loss of license for underage sales.”
October 3, 2022
Azerbaijan Sets Excise Tax Rate for Vaping Products
Credit: ArtEvent ET
Azerbaijan has determined its excise rate for vaping and other e-cigarette products, according to media reports.
The Cabinet of Ministers has made relevant changes to the “Excise duties for imported excise goods into the Republic of Azerbaijan,” according to Today.az.
An excise tax rate of 14 manat ($8.20) has been set for 1,000 units of the product.
The corresponding decision will enter into force 30 days after its publication.
October 2, 2022
Altria Ends Non-Compete Agreement With Juul Labs

Altria Group on Friday said it had exercised the option to be released from its non-compete deal with Juul Labs. The move comes nearly four years after the tobacco giant purchased a 35 percent stake in the e-cigarette manufacturer that at the time was dominating the market.
Altria is looking to permanently terminate its non-competition obligations to Juul Labs, give up certain rights including its board designation rights and reduce its voting power, according to a 8-K filing to the Securities and Exchange Commission.
The filing states Altria has exercised its option to permanently terminate its non-competition obligations to Juul Labs, losing the right to the board designation and significantly reducing its voting power, according to Barron’s.
“This decision … increases the financial and strategic options we can pursue to secure our business and address the impact of the (U.S. Food and Drug Administration’s) now stayed [marketing denial] order,” a Juul spokesperson said.
In July, Altria slashed the value of its stake in Juul to $450 million, down from the original value of $12.8 billion, allowing itself the option to be released from the non-compete clause and invest in or engage with any other e-cigarette manufacturers.
However, it did not seek to be released from the obligations at the time, and said it saw value in its investment rights in Juul. “The decision to terminate our non-compete maximizes our flexibility to compete in the e-vapor space while maintaining our economic interest in Juul,” Altria said on Friday.
A change in its stance means Altria could go it alone or pursue other vaping products. Privately owned Njoy, which has already survived the FDA’s controversial premarket tobacco product application (PMTA) process, could be a takeover target for Altria, according to some analysts.
In July of this year, NJOY Holdings Inc hired bankers for a possible sale of the company. The news report stated that privately held NJOY was likely to be valued at up to $5 billion.
“It’s more likely that Altria will seek to buy its way back into the e-cigarette category (which represents 7 percent of U.S. nicotine sales),” Cowen analyst Vivien Azer said.
October 1, 2022