Tag: FDA

Vapor Firms Request Delay of PMTA Deadline

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Keller and Heckman has asked the U.S. Food and Drug Administration to postpone its Sept. 9 deadline for filing premarket tobacco applications (PMTAs) by six months because of the Covid-19 pandemic.
On behalf of a group of small vapor product manufacturers, retailers and trade associations, the law firm filed a citizen petition asking the FDA to postpone the PMTA due date until March 8, 2021.
Many of Keller and Heckman’s clients have experienced delays in preparing their applications because of the coronavirus. Without an extension, small vapor companies will either have to file incomplete PMTAs or forego submission altogether, according to Keller and Heckman. This would force them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes, the law firm said.
The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017.
The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the Sept. 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use.

September 3, 2020
RAI Submits Applications for Velo Pouches

Photo: RAI
Reynolds American Inc. (RAI) has submitted a group of premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking orders authorizing the marketing of Velo pouches. A grant of these marketing orders would allow these products to remain on the market after FDA review.
Velo is the group’s brand for modern oral products, designed to provide adult tobacco consumers with innovative alternatives to traditional combustible and smokeless tobacco products. A small, white pouch made with nicotine derived from tobacco but containing no tobacco leaf, Velo is placed between an adult tobacco consumer’s gum and lip. Unlike traditional dip, there is no need to spit the product and no lingering smell. The submitted group of applications includes varying nicotine strength levels and two flavors for Velo pouch products.
As with prior PMTA submissions, these commercially-proprietary applications provide the FDA with product analyses, information on human health risks, and assessments showing that these Velo pouches are appropriate for the protection of public health—including assessments on users and nonusers of tobacco products.
James Figlar (Photo: RAI)
“Velo represents an innovative space for us to identify what adult tobacco consumers want next—thus submitting the final group of Velo brand PMTAs was a great next step to help ensure adult tobacco consumers have consumer-acceptable products available that provide them with lifestyle choices and varying nicotine levels that make sense,” said James Figlar, RAI’s executive vice president and head of scientific and regulatory affairs, in a statement. “As the FDA begins evaluation of our industry’s collective PMTAs after the Sept. 9 deadline, it is critical that our chief regulatory agency continues to enforce against illegally marketed tobacco products introduced after Aug. 8, 2016.”
The PMTAs for Velo pouches are part of Reynolds’ ongoing submissions to the FDA seeking marketing orders following applications for Velo lozenges and Vuse Vibe, Ciro and Solo electronic nicotine delivery systems. The PMTA process allows the FDA to evaluate whether these products should remain on the market as part of the FDA’s public health mission. While these applications include relative risk information, the marketing orders sought make no claims of modified risk.
September 2, 2020
FDA to List PMTA Applicants

Mitch Zeller
The U.S. Food and Drug Administration (FDA) plans to publicly list all e-cigarette manufacturers that want permission to sell their products in the U.S., reports Bloomberg, citing a blog post published on Monday by Mitch Zeller, director of the FDA’s Center for Tobacco Products.
The move could help consumers and retailers spot illegal products.
Vapor product manufacturers who want to keep their products on the U.S. market will have to file requests for marketing authorization with the FDA by Sept. 9.
The FDA has received applications for about 2,000 e-cigarettes and other newly regulated tobacco products already. There are more than 400 million eligible items that would need to apply to stay on the market, according to Zeller.
Products whose applications were filed on time will have a one-year grace period to stay on the market while the FDA reviews them, unless the agency rejects the request. Large manufacturers, retailers who could be liable for selling illegal products and public-health groups had pushed the FDA to make the process more transparent.
In a letter to the FDA, several retail associations had asked the agency to release a list of manufacturers that have PMTAs on file so retailers can know what electronic nicotine delivery system (ENDS) brands can remain on store shelves.

September 1, 2020
FDA Accepts Vaporesso’s PMTA

Photo: Bacho | Dreamstime
Vaporesso received an acceptance letter for its first round of premarket tobacco product applications (PMTAs) from the U.S. Food and Drug Administration (FDA) on Aug. 20, 2020.
The acceptance letter came three days after the company submitted its PMTAs. The application received positive comments from the FDA on its preparation, according to the company’s U.S. scientific CRO agent.
“A successful acceptance has boosted the confidence of Smoore to keep investing in bringing more vaping products into PMTA in the future,” the company wrote in its press release. “Our commitment to vapers in the USA remains the same: We will make vaping as easy as possible, and we will consistently provide high-quality vaping experiences for vapers all over the world. So the first round of application accomplished by Smoore is merely the start with more products to come.”
August 25, 2020
Premium Cigar Makers Get Reprieve from FDA

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The District of Columbia on Aug. 19 ruled that the U.S. Food and Drug Administration (FDA) cannot enforce premarket review requirements for premium cigars until it considers a “streamlined” process for cigar makers to equate their products to older ones.
The ruling means that premium cigar companies will not have to file for product approval on the Sept. 9, 2020, deadline. This ruling applies to almost all cigars found in humidors across the country except for flavored and infused cigars, which are not considered premium by the FDA.
Companies will not need to file paperwork with the FDA to prove that their products are premium; rather, any company selling a cigar that does not meet the definition of “premium cigar” will be subject to the Sept. 9 premarket approval deadline and will need to file for substantial equivalence or another approval pathway.
The ruling does not require the FDA to enact a “streamlined” process for premium cigars but says it must study the issue and cannot require premium cigars to go through substantial equivalence or another process until after that study is complete.
The ruling came from a lawsuit against the FDA by three cigar trade groups: Cigar Association of America, Cigar Rights of America and the Premium Cigar Association (PCA). “This is another monumental victory for the premium cigar industry,” said PCA’s Scott Pearce. “This comes on the heels of legal victories striking down warning labels for premium cigars.”
August 21, 2020
FDA Accepts Juul Applications

Photo: Juul Labs
Juul and Juul pods will now move into the substantive review phase of the premarket tobacco product application (PMTA) process. Juul Labs has received acceptance and filing letters from the U.S. Food and Drug Administration (FDA) for its battery and nicotine cartridges, the company announced Tuesday.
Joe Murillo
Juul Labs filed the applications last month and all PMTA applications are due to the FDA by Sept. 9. 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 percent, 3 percent and information on data-driven measures to address underage use of its products.
“We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application,” said Juul Labs Chief Regulatory Officer Joe Murillo in a statement.
August 19, 2020
Lawmakers Urge Ban on E-Cigs During Pandemic

Photo: Tobacco Reporter archive
Lawmakers have called on the U.S. Food and Drug Administration (FDA) to take e-cigarettes temporarily off the market during the pandemic, citing a new study suggesting that vapers are significantly more likely to contract Covid-19.

Raja Krishnamoorthi
“If we reduce the number of vapers in America, we will reduce the unnecessary stress we are putting on our testing system,” Representative Raja Krishnamoorthi wrote in a letter sent to the FDA by the House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy. “People should not have to wait weeks for Covid-19 test results—removing the risk posed by vaping will help.”

Researchers at the Stanford University School of Medicine found that among young people who were tested for the coronavirus, those who vaped were five times to seven times more likely to be infected than those who did not use e-cigarettes.

The study, which was published online Aug. 11 in the Journal of Adolescent Health, is the first to examine connections between youth vaping and Covid-19 using U.S. population-based data collected during the pandemic.

“Young people may believe their age protects them from contracting the virus or that they will not experience symptoms of Covid-19, but the data show this isn’t true among those who vape,” said the study’s lead author, Shivani Mathur Gaiha.

“This study tells us pretty clearly that youth who are using vapes or are dual-using are at elevated risk, and it’s not just a small increase in risk; it’s a big one,” Gaiha said.

Remarkably, the researchers did not find a connection between Covid-19 diagnosis and smoking conventional cigarettes alone, perhaps because the prevalent pattern among youth is to use both vapor devices and traditional cigarettes. Other research has shown that nearly all nicotine-using youth vape, and some also smoke cigarettes, but very few use cigarettes only.

In addition to warning teenagers and young adults about the dangers of vaping, the researchers said they hoped their findings will prompt the FDA to further tighten regulations governing how vapor products are sold to young people.

“Now is the time,” said senior author Halpern-Felsher. “We need the FDA to hurry up and regulate these products. And we need to tell everyone: If you are a vaper, you are putting yourself at risk for Covid-19 and other lung disease.”

John Dunne
Vaping advocates expressed concern about the study.

“While we welcome any research which can assist people in staying safe during the Covid-19 pandemic, the UKVIA [U.K. Vaping Industry Association] is disappointed by the Stanford-led study, which appears to dismiss the vital harm reduction role of vaping for smokers and draws disproportionate conclusions,” said John Dunne, director at the UKVIA.

Insisting there is no scientific evidence linking smoking and vaping with Covid-19, Dunne said the UKVIA was looking forward to seeing the peer review of the Stanford study.

“It is also somewhat reckless in stating that vapers are putting themselves ‘at risk of Covid-19’ by vaping,” he said. “Vaping products are designed only for smokers and ex-smokers to help them quit conventional cigarettes, which is the most positive action someone can take to improve their health.”
August 12, 2020
Regulator Urged to Reject Flavors

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As manufacturers of e-cigarettes and certain other tobacco products face a Sept. 9, 2020, deadline to apply to the U.S. Food and Drug Administration (FDA) to keep their products on the market, six leading public health and medical organizations are urging the FDA not to authorize the sale of any flavored products.

“The FDA should not authorize the sale of any flavored tobacco product, including e-cigarettes or e-liquids, because of the clear evidence that flavored products appeal to youth and have driven the current epidemic of e-cigarette use among youth and young adults and the lack of evidence that flavored products help smokers quit,” the groups wrote in a joint statement.

“Research shows that 97 percent of youth e-cigarette users report using a flavored product in the past month, and 70 percent say they use e-cigarettes ‘because they come in flavors I like.’ In contrast, there is no credible evidence that flavored e-cigarettes help adult smokers quit. In a report issued earlier this year, the U.S. Surgeon General concluded, ‘there is presently inadequate evidence to conclude that e-cigarettes, in general, increase smoking cessation,’” the organizations wrote.

The groups also called on the FDA to take prompt enforcement action to remove from the market products for which applications are required but are not submitted by the Sept. 9 deadline.

The organizations that issued the statement are the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids and the Truth Initiative.
August 11, 2020
FDA Accepts Avail Tobacco Application

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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.”
August 11, 2020
Counting Down

Photo: Tobacco Reporter archive
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.”
August 1, 2020