Avail Vapor has received its first premarket tobacco product application (PMTA) acceptance from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products, reports Vapor Voice.
Blackbriar Regulatory Services led the highly strategic regulatory process for Avail’s submission. The application now moves to the substantive scientific review where the FDA will determine if Avail has scientifically proven that its nicotine vapor products are appropriate for the protection of public health.
James Xu
This is one of numerous applications that Avail plans to file prior to the Sept. 9, 2020 deadline. The products will provide a wide-ranging flavor portfolio to meet the needs of adults seeking alternative choices to combustible tobacco products.
“We started mapping out our regulatory framework and PMTAs in 2015, before nicotine vaping products became subject to the FDA’s tobacco authority,” said James Xu, chairman of Avail.
“We couldn’t be more pleased that the years of hard work, investment and dedication have gotten us to this point. Our end goal is to seek an FDA marketing order, which would allow us to continue to keep our products on the market for those adult smokers looking for alternatives to traditional tobacco products.”
New Zealand will enact flavor restrictions and ban vapor product advertising in November, reports the New Zealand Herald.
The country’s House of Representatives passed the Smokefree Environments and Regulated Products Vaping Amendment Bill on Aug. 5—just before the final sitting day in this term of government.
Associate Health Minister Jenny Salesa promised to regulate the industry in November 2018 but didn’t introduced the bill until this year. She described the legislation as the most significant change to the Smokefree Act.
The new law will:
Ban the sale of vaping products to those under the age of 18.
Prohibit advertising the products and encouraging people to buy them in-store.
Limit the sale of all flavors to specialist stores, including online retailers, with shops Like dairies, supermarkets and petrol stations restricted to mint, menthol and tobacco.
Allow specialty stores to continue offering loyalty points and discounts.
Ban vaping in cars with children.
Enable all retailers to display products in-store.
Provide a framework for regulations to be set where people can vape in or outside premises.
Introduce a safety system which would allow the Ministry of Health to recall products, suspend them and issue warnings.
Critics said the new rules are too restrictive and could prompt people using vaping as a smoking-cessation tool to turn back to cigarettes.
“The vaping regulations rushed through under urgency are an absolute boon for the tobacco industry,” said Jordan Williams, spokesman of the New Zealand Taxpayers’ Union. “Decreasing the availability of appealing alternatives to cigarettes will keep disproportionately poor New Zealanders on the durries, paying a massive price in excise tax and devastating health outcomes.
“The range of appealing flavors is one of the key attractors for smokers transitioning off cigarettes,” he said. “When someone walks into a convenience store and is denied access to flavored vape liquid but can still buy their favorite cigarette brand, they’re at risk of falling off the wagon. And a complete ban on advertising for vaping products will prevent these brands from appealing to smokers to make the switch,” said Williams.
The decision by Bhutan’s government to allow the opening of tobacco sale outlets in the country is consistent with the nation’s Tobacco Control Act and constitution, according to the Office of the Attorney General (OAG).
While the Tobacco Control Act of 2010 restricts the domestic sale and purchase of tobacco products, it allows individuals to import tobacco for personal consumption.
Because of the coronavirus crisis, however, Bhutan has closed official border crossings, boosting illegal imports. By allowing limited domestic sales, the government hopes to crack down on smuggling.
Responding to critics who questioned the legality of the measure, the OAG said the extraordinary situation brought about by the coronavirus crisis justified the measure. However, the office insisted that the domestic sales outlets could be tolerated only for the duration of the pandemic.
Massachusetts’ ban on the sale of flavored tobacco products has shifted rather than reduced tobacco consumption, according to Ulrik Boesen, senior policy analyst with the Center for State Tax Policy at the Tax Foundation.
On June 1, Massachusetts’ ban on the sale of flavored tobacco products, including menthol cigarettes, took effect. At first sight, early data suggests a public health success: sales of cigarette tax stamps in the Bay State have declined 9.2 percent in the first half of 2020 compared to the same months last year.
However, sales of tax stamps in the Northeast region (Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island and Vermont) have remained stable in the first half of 2020, suggesting Massachusetts consumers are now buying their tobacco products in neighboring states.
From Jan. 1, 2020, to June 30, 2020, 311,848,000 stamps were sold in the region. For the same period in 2019, that number was 311,974,000. For June alone, sales actually increased from 53,877,000 in 2019 to 63,449,000 in 2020.
Tobacco tax collections, too, have shifted elsewhere, according to Boesen. In December last year, the Massachusetts Department of Revenue estimated the ban would decrease collections by $93 million in 2021. That revenue is now being collected by Massachusetts neighbors.
“It is not in the interest of Massachusetts to pursue a public health measure that merely sends tax revenue to their neighboring states without improving public health,” writes Boesen. “In addition, the ban on flavored tobacco highlights the complications of contradictory tax and regulatory policy, the instability of excise taxes that go beyond pricing in the cost of externalities, and the public risks of driving consumers into the black market through excessive taxation or regulation.”
The health ministry of India has deferred implementation of its new pictorial health warnings for tobacco products. The new warnings will be enforced from Dec. 1 instead of Sept. 1.
Public health advocates criticized the postponement.
“By delaying the next round of pictorial warnings on tobacco products, the health ministry is not only contradicting its own advisory to hold back tobacco use during the Covid-19 pandemic, it is adversely impacting the motivation of tobacco users to quit while being in conducive environment socially,” said Rakesh Gupta, a consultant working for Tobacco Cessation.
Some 270 million adults in India consume tobacco, which is blamed for more than 1.3 million premature deaths every year.
The Global Adult Tobacco Survey 2016–17 showed that 62 percent of cigarette smokers and 54 percent of bidi smokers said they had thought of quitting because of the mandatory 85 percent pictorial warnings on packs. Forty-six percent of smokeless tobacco users thought of quitting because of warnings on smokeless tobacco products.
The nicotine industry prepares for a shakeout in the wake of the premarket tobacco product application deadline.
By Kenneth Robeson
Chris Allen
The phrase “time is money” has seldom been more apt for the tobacco industry.
The United States District Court recently granted the Food and Drug Administration’s (FDA) request for an extension of the premarket tobacco product application (PMTA) submission deadline for certain tobacco products, which the FDA requested due to the Covid-19 pandemic. Applications are now required to be filed by Sept. 9, 2020, for many e-cigarettes, cigars and other deemed tobacco products.
What does this mean for the tobacco industry? Several things—from a significant reduction in the products that retailers can place on store shelves to changes in management, manufacturing, R&D and marketing.
“Those working towards a PMTA have benefited most as this has either provided the time to complete existing studies or generate more data,” said Chris Allen, vice president of scientific and regulatory affairs for Broughton Nicotine Services, a privately owned laboratory delivering analytical, scientific and regulatory services for the electronic nicotine-delivery systems (ENDS) industry based in Lancashire, England. “Also, those that are intending to exit the market have a slight reprieve in that they can continue selling their products for an extra 120 days.”
In addition to a significant reduction in the product portfolio, said Allen, manufacturers are coming to the realization that they are going to need to invest “far more” in their quality-management systems as manufacturing guidance evolves. “Although it is not expected the manufacturing regulations will be as stringent as pharmaceutical GMP, it may be significantly higher than the standards that many companies currently work to.”
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‘The reality’
Barnaby Page
“The deadline change was triggered by the Covid situation and requested by the FDA, which stated, among other things, that it had refocused some of FDA CTP staff on other emergency matters related to Covid,” noted Patricia I. Kovacevic, a global legal and regulatory strategist and attorney and the founder of consulting firm Regulation Strategy, which has offices in Tampa, Florida, USA, and London. “While the extra time appears beneficial to the entire industry, the reality is that most clinical studies, testing labs and so on would not have carried on, at least during the three critical lockdown months, April to June.”
Thus, Kovacevic added, there is “a slight benefit” for the industry to have additional time to refine PMTA submissions. “But those who were not ready with the substantive work needed for PMTAs—including various clinical and nonclinical controlled trials—would not see their situation improve much due to the extension.”
“For vapor, it doesn’t substantively change the picture,” suggested Barnaby Page, editorial director of ECigIntelligence, a provider of detailed global market and regulatory analysis, legal tracking and quantitative data for the e-cig, heated-tobacco and combustible-alternatives sector worldwide, and TobaccoIntelligence. “Any company which was not already reasonably well prepared to submit by 20th May is unlikely to be able to make it by 9th September.”
However, Page added, “for those who were close, it will be welcome given that the run-up to the 20th May deadline came at possibly the most disruptive point of the Covid pandemic.”
According to George Parman, director of communications for Altria Client Services in Richmond, Virginia, USA, his company submitted PMTAs for 35 On! Nicotine Pouch products on May 15, and the FDA accepted them for scientific review in the second week of June. They are manufactured by Helix Innovations, an Altria joint venture responsible for the global On! nicotine pouch product portfolio. To support the applications, Altria submitted more than 66,000 pages of documentation, including six primary studies.
The On! nicotine pouches are tobacco leaf-free and available in seven flavors and five nicotine levels. The product line was distributed in over 28,000 stores at the end of the first quarter, including the top five convenience store chains by volume. According to IRI, total oral tobacco-derived nicotine category sales in 2019 grew approximately 275 percent compared to 2018.
“We believe the scientific evidence in these applications demonstrates that the marketing of On! is appropriate for the protection of public health,” said Paige Magness, senior vice president of regulatory affairs for Altria Client Services, in a release. “On! nicotine pouches are a key part of our vision to responsibly lead the transition of adult smokers to a noncombustible future.” The FDA will now undertake a substantive scientific review of the applications.
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‘Subjective term’
Maggie Gowen
And for those companies that will not be ready in time?
“Ready,” Kovacevic believes, “is a subjective term in this context.” Small manufacturers would not have had the resources needed to comply no matter what the deadline might have been “but would have enjoyed the additional time to participate in the market. The top five bestselling products manufacturers were preparing for this moment, some as early as 2013.”
If a company has not amassed the necessary science and assembled the right scientific and regulatory team beginning at least two years ago “or at least early last year, at this point it is too late to consider anything else but a last-moment attempt at litigation if even that were possible,” Kovacevic added.
Maggie Gowen, marketing director for Avail Vapor in Richmond, Virginia, USA, said that ENDS manufacturers who don’t submit a PMTA by the new date will be considered noncompliant. “It will be up to the FDA how they choose to enforce the industry after the deadline. Reasonable regulation is needed based on sound science.”
What comes next cannot help but be influenced by the Covid-19 pandemic, said Broughton’s Allen, who emphasized that ENDS products are designed to deliver chemicals deep into the lungs. “We may not like or agree with regulation, but it is inevitable for any major industry and there to protect us. There is undoubtedly a loss in consumer confidence in the safety of ENDS and no data on the risk of long-term use.”
The regulations, he added, must see to it that everything possible is done to ensure that “the safest of products are on the market [to] protect the public but also the long-term future of the industry.”
At the manufacturer level, ECigIntelligence’s Page predicted, there will be fewer companies, “probably many fewer, clear winners and losers from the PMTA process.” For retailers and consumers, the long-term changes “will not be so dramatic once the short-term shock of many brands disappearing has been adjusted to.” What he termed the “wildcard” is whether the FDA turns out to prefer certain kinds of devices to others. “For example, if it seems to favor open or closed systems. That could have a substantial effect on retailing if some channels end up with lots of legal products and others with many fewer.”
“The immediate—as in 10th September—impact on retailers and consumers is likely to be negligible,” Page said. “We don’t expect the FDA to start enforcement immediately on brands that have not submitted a PMTA application.” Over the longer term, of course, the number of available products will diminish. Just how long that “longer term” is remains an open question. “It could be a few months; it could even be a couple of years.”
Page and his colleagues think it likely that there will be “some tolerance” shown to applicants who miss the deadline “as long as they can demonstrate they are well advanced in preparing their application and are serious about doing it.” Retailers and consumers, however, “can’t really prepare with any confidence. The ball is in the manufacturers’ court right now and then the FDA’s.”
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‘Appetite for enforcement’
Patricia Kovacevic
Most c-stores and major chains primarily sell products manufactured by companies that will have met the PMTA submission deadline, noted Kovacevik, and may legally continue to sell their products “for at least one year thereafter and longer if FDA issues a marketing order following the review of the respective products’ PMTAs.”
At the same time, she noted, the FDA’s “appetite for enforcement is relatively low in general, and the product universe is so vast, with so many SKUs—potentially millions of SKUs—that it will take FDA months, if not years, to figure out what products need to be taken off the market because a PMTA or other type of premarket application was not filed by the respective deadline, and to issue warning letters, then to follow up with more stern enforcement action.”
Another factor to consider is that a new administration in Washington, D.C., might bring “interesting developments not necessarily favorable to the ENDS industry,” Kovacevik added, “and change is always challenging.”
Consumer choice will shrink, Avail Vapor’s Gowen concurred, because not every manufacturer will be able to afford the “enormous” expense of the PMTA process. “There is a big fear that we will see a shift back to deadly combustibles, unfortunately.” There is, she conceded, “a lot of politics in play at the executive, federal, state and local levels.” There is also what she called “an enormous amount” of misinformation about the vapor industry, which “as a whole has been unfairly blamed due to a few bad actors, and that includes the CDC [Centers for Disease Control and Prevention]. If a company wants to remain a player in the marketplace, the hope is they will submit a PMTA by the Sept. 9 deadline.”
And for the remainder of 2020?
“It’s difficult to tell at this point,” Gowen concluded. “It will certainly be an interesting year, as if it hasn’t been interesting enough.”
A comprehensive set of tobacco control measures has been adopted after the president of Kazakhstan, Kassym-Jomart Tokayev, approved the legislation on July 8, 2020.
Under the new legislation, the definition of tobacco products has been expanded to include all nicotine products, such as e-cigarettes and heated-tobacco products. The law also bans the import, production, sale and distribution of smokeless tobacco products.
The list of smoke-free places has been expanded, now including bus stops, outdoor playgrounds, underground walkways, transit areas and cars with children inside. Using new products in these places is also banned, and waterpipes are not allowed to be used in public; they are only allowed in homes.
Fines have been increased.
Manufacturers must now disclose information on the content of all nicotine-containing products, and the size of pictorial health warnings has increased. Tobacco products cannot be displayed at point-of-sale, and the purchase age has been raised to 21 years.
Juul Labs has submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for the company’s Juul system, an electronic nicotine delivery system (ENDS) product. The company’s submission includes comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.
With its PMTA submission, Juul Labs has provided a scientific foundation for the FDA to evaluate whether these products are “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole. The application includes detailed scientific data from over 110 studies totaling more than 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.
As part of the PMTA process, Juul Labs has built a comprehensive research program focused on examining the public health impact of the Juul system. This includes research addressing the harm reduction potential of the product, including its ability to convert adult smokers from combustible cigarettes. This research is supplemented with information on the controlled design and repeatable manufacturing processes associated with the Juul system, as well as data-driven measures to limit unintended consequences to the overall population, including initiation among nonusers.
“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.
“Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use,” said Joe Murillo, chief regulatory officer at Juul Labs. “We respect the PMTA process and believe it is the right forum to determine the role ENDS products can play in transitioning and completely switching adult smokers from combustible cigarettes to potentially less harmful alternative products while combating underage use.”
Late last year, the company, under Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.
Juul Labs has built up its science and evidence-based capabilities and will use its research and data to explore additional pathways in other countries. The company will continue to share its research with regulators and the public health community globally through peer-reviewed journals, conferences, and one-on-one meetings.
India’s Ministry of Health on July 23 issued new sets of specified health warnings with enhanced pictorial images to be printed on all tobacco products. The amended rules will be applicable from Dec. 1, 2020, and will be in force till 12 months thereafter.
In a statement, the Health Ministry said, “All tobacco products manufactured or imported or packaged on or after Dec. 1, 2020, shall display the first set of images while the second set of images will be displayed by the tobacco products manufactured or imported or packaged on or after Dec. 1, 2021. Any person engaged directly or indirectly in the manufacture, production, supply, import or distribution of cigarettes or any tobacco products shall ensure that all tobacco product packages shall have the specified health warnings exactly as prescribed.”
Violators risk imprisonment or fines as prescribed in Section 20 of the Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act of 2003.
The State Duma MPs in Russia have adopted a bill restricting the use of electronic cigarettes and hookahs.
According to a statement from the lawmaking authority, the measure sets restrictions on the use of electronic nicotine delivery systems (ENDS) and hookahs inside certain territories, premises and objects; issues requirements for demonstration of electronic smoking articles in audiovisual works for minors and adults.
Moreover, the document restricts the sale of vapor products and bans their sale to minors and involvement of children in the use of them, according to a Russian state information agency.
There is also a proposal to introduce administrative fines for violations of the imposed restrictions.
