Category: PMTA

Juul and Juul Pods PMTA Moves to Substantive Review

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.
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
511 Solutions Receives PMTA Acceptance for Prism Brand

Credit: Priam E-liquids
The owner of the Prism e-liquid brand, 511 Solutions, announced today that it has filed its first premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA). The application was accepted by the FDA and has now moved to the substantive scientific review phase.
All Prism e-liquids are manufactured by Blackbriar Regulatory Services (BRS) in an ISO class 6 cleanroom, tested in an ISO 17025 laboratory, according to a press release. In compliance with FDA guidelines, Prism e-liquids will be allowed to remain on the market during the FDA review process while waiting for a marketing order.
“When 511 Solutions created this e-liquid line, their goal was to create something really special and to do it right the first time,” said Don Hashagen, sales agent for Prism e-liquids. “They invested an enormous amount of resources into creating high-quality nicotine products for adult smokers looking for alternatives. And, partnering with BRS was a natural choice. Having the ability to streamline the manufacturing, distribution and regulatory needs all under one roof has been a huge win for 511.”
The PRISM brand represents three unique, high-quality e-liquid lines with a total of 19 flavors going through the PMTA process, according to the release. The flavor profiles range from tobacco, menthol, fruits and bakery in a variety of nicotine strengths.
August 18, 2020
Avail Earns PMTA Acceptance Letter From FDA for E-liquids

Credit: Avail
Avail Vapor announced today that it has received its first premarket tobacco product application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. While the company would not say what flavors or how many flavors, it was confirmed that the mixed-berry flavored Mardi Gras was a submitted flavor.
Blackbriar Regulatory Services led the 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 vaping products are appropriate for the protection of public health.
This is one of numerous applications that Avail plans to file prior to the September 9, 2020 deadline which will provide a wide-ranging flavor portfolio to meet the needs of adults seeking alternative choices to combustible tobacco products, according to James Xu, chairman of Avail.
James Xu
“We started mapping out our regulatory framework and PMTAs in 2015, before nicotine vaping products became subject to the FDA’s tobacco authority,” said Xu. “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.”
In order for nicotine vaping products to remain on the market after the FDA’s September 9, 2020 PMTA submission deadline, companies must submit a viable PMTA with the intent of seeking an FDA marketing order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.
August 11, 2020
Juul Labs Submits its PMTA to U.S. FDA

Photo: Jordan Whitfield
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.
July 30, 2020
FDA Gives EAS Acceptance and Filing Letters for PMTA

The U.S. Food and Drug Administration (FDA) has issued Acceptance and Filing letters for E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands for its Leap and Leap Go vapor products. This notification moves the EAS products to the Substantive Review phase of the Premarket Tobacco Product Application (PMTA) process.
“This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS. “FDA Acceptance and Filing Letters are a testament to the strength and thoroughness of our applications, which we believe will meet FDA’s requirements. We want to thank FDA for the prompt turnaround on these materials given the challenging circumstances, and we look forward to partnering with the Agency as we move forward in the process.”
Jacopo D’Alessandris
The Acceptance letters follow the administrative review of EAS’s filings to ensure that the submissions met the baseline criteria for review. The Filing Letters are the result of a preliminary scientific review that ensures that the applications include the necessary ingredients and health analyses. FDA will now conduct a Substantive Review to assess whether the Leap and Leap Go products are appropriate for the protection of public health. If successful, this phase will result in Marketing Orders from FDA authorizing the continued marketing and sale of these products.
“The Substantive Review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health,” said Chris Howard, Vice President, General Counsel and Chief Compliance Officer at EAS. “We are looking forward to continued collaboration with FDA in the weeks and months to come and remain optimistic that the PMTA process will result in Marketing Orders.”
July 8, 2020
FDA Will Not Request Extension to Sept. 9 PMTA Deadline

Credit: Succo
The U.S. Food & Drug Administration (FDA) does not intend to delay the current Sept. 9, 2020 deadline for the vapor industry to submit applications for marketing authorization before a hearing is scheduled for the plaintiffs in the case.
In a status report filed Wednesday to the U.S. District Court for the District of Columbia, the regulatory agency told the court that it does “not currently plan to seek an extension of the September 9, 2020 premarket application deadline.”
Any extension requested by the plaintiffs could be complicated because the request would have to be approved by the Maryland-based federal court that forced the agency to move the deadline to May 12, 2020 due to a separate lawsuit.
The FDA has already delayed the PMTA deadline due to the Covid-19 pandemic. The deadline was previously scheduled for May 12, 2020 but was moved to Sept. 9. According to the FDA’s status report, the plaintiffs in the case are expected to file a status report requesting their preferred argument date for a further extension.
June 26, 2020
EAS Submits PMTA for Leap and Leap Go Vapor Products

Credit: Timothy S. Donahue
Finally, some positive news for the vapor industry. The much anticipated premarket tobacco product applications (PMTA) for the Leap pod system and Leap Go disposable were delivered to the U.S. Food and Drug Administration (FDA) on Tuesday. E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands, is seeking authorization for the marketing and sale of its wide-ranging portfolio of Leap and Leap Go vapor products.
“We are pleased to take this important step in demonstrating our commitment to the vapor industry, retailers and adult smokers seeking an alternative to combustible cigarette smoking with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS.
Jacopo D’Alessandris
“At EAS, we have always held ourselves to high standards, from supplying adult consumers with products they can trust to consistently following ethical marketing practices. We are confident in the strong merits of our PMTAs and want to thank our compliance and research teams for developing and delivering thorough submissions.”
The submission of PMTAs by EAS plays an integral role in supporting the proposition that Leap and Leap Go vapor products are appropriate for the protection of public health, according to a press release. The collective 75,000+ page PMTA submissions for Leap and Leap Go are the result of months of hard work and investigation that included an assessment of the stability of the products over time, toxicological formula reviews, toxicology testing, an assessment of abuse liability, label comprehension studies and behavioral studies.
In addition, EAS undertook an extensive review of available literature on vapor products related to health effects, behavioral factors and toxicological end points. Further, an exacting risk assessment was conducted across many areas of potential risk for Leap and Leap Go products, according to the release.
“Our PMTA submissions provide a robust analysis of the Leap and Leap Go products that will enable FDA to conclude these products are appropriate for the protection of public health,” said Chris Howard, vice president, general counsel and Chief Compliance Officer at EAS.
Chris Howard
“From an industry perspective, the PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith. Looking ahead, a robust collaboration with FDA will help build a strong future for both the vapor industry and adult consumers.”
EAS continues to establish a leadership role in the creation of sensible industry standards and regulations as member of the Board of Directors of both the National Association of Tobacco Outlets (NATO) and the Vapor Technology Association (VTA), where EAS led the initiative to formulate the VTA marketing standards for membership, according to the release. The company continues to advance the interests of the industry’s consumers, manufacturers, wholesalers, small business owners, and entrepreneurs.
June 17, 2020
U.S. FDA Shifts Deadline for PMTA to Sept. 9

Tobacco and vapor companies have an extra four months to file their premarket tobacco applications (PMTAs) for newly deemed tobacco products with the Food and Drug Administration (FDA) following a U.S. court ruling.
On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020.
However, the coronavirus pandemic has drastically impaired the FDA’s ability to adhere to this timeline. As a result of the pandemic and these exceptional and unforeseen circumstances, the agency requested on March 30 a 120-day extension of the May 12 deadline. This request has now been granted.
The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.
Following the Covid-19 outbreak, the agency received numerous inquiries from the tobacco industry expressing concern they would be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad.
In a statement, the FDA said it believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading Covid-19 to others by trying to meet the previous May 12 deadline. In the more than a dozen requests for an extension that the FDA received, this public health concern was mentioned repeatedly.
Another consideration, according to the agency, was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on Covid-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications. Many of those deployed are among the staff that had been playing a critical role as CTP prepared for this deadline.
“Ultimately, a Sept. 9 deadline will better serve the public health by allowing manufacturers to prepare for, and the agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period,” the FDA wrote in its statement.
“Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. Although the FDA’s in-person compliance checks and vape shop inspections are currently on hold due to the pandemic, review of previous inspections continues, and we continue to monitor the online marketplace and will take action as appropriate.
“Accordingly, the January 2020 enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted, although we intend to update it for products for which the Sept. 9 date now applies.”
May 8, 2020
U.S. Fourth Circuit Denies PMTA Appeal

Photo: Skypixel | Dreamstime.com
The Fourth Circuit on Monday dismissed an appeal from various vaping groups challenging a compliance deadline for vapor products. The decision states that January directives from the U.S. Food and Drug Administration (FDA) have rendered the appeal moot.
In a per curiam opinion, the appellate judges held that guidance issued by the FDA in January moots the vape groups’ appeal because that guidance supersedes older directives from August 2017 at issue in the appeal and leaves “no possible meaningful relief” that the court could grant, according to law360.com.
“Any ruling by this court as to the procedural or substantive reasonableness of the August 2017 guidance would amount to nothing more than an advisory opinion,” the court said.
The appeal stems from a Maryland district court ruling that ordered the agency to set a May 2020 deadline for premarket tobacco product applications (PMTA) on smokeless tobacco products. The FDA, along with various health and anti-vaping groups, had argued that the January guidance restricting the sale of flavored, cartridge-based vapes rendered moot the vape groups’ appeal.
“Because the enforcement timetable for e-cigarettes set out in the January 2020 guidance is independent of the district court’s order, an order by this court reversing the district court would have no effect on FDA’s enforcement of the statute and regulations against e-cigarette manufacturers,” the agency had previously said.
But the vape groups disagreed, saying the January guidance was enacted without proper notice-and-comment procedures, according to the opinion.
While the court said it can’t offer the vape groups relief in this case, the panel added in a footnote that the groups can challenge the January guidance in a separate action in federal court. The panel also ruled that a Maryland district court did not abuse its discretion in denying cigar industry groups’ motion to intervene, saying those groups did not intervene in a timely manner.
Counsel for the cigar and vape groups and a representative of the FDA did not immediately respond to requests for comment Monday.
Last month, a Maryland federal judge said that in light of the coronavirus pandemic, he would grant a 120-day extension to the May 12 deadline for e-cigarette PMTAs, which have proceeded slowly since the FDA first determined vapes should be regulated like tobacco products. The new deadline is Sept. 9, 2020.
The FDA had previously asked the Fourth Circuit for approval for the lower court to extend the May deadline, saying it would not affect the merits of the appeal brought by the industry groups. The FDA said many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted in-person testing in light of the COVID-19 pandemic.
Public health groups previously sought to accelerate the FDA’s regulation of vaping products under the Tobacco Control Act, citing vaping-related lung injuries that sickened thousands of people and left nearly 70 dead in 2019. In July 2019, a Maryland district judge effectively allowed the FDA to set the May 2020 deadline, prompting the vape groups to claim the decision was an arbitrary overextension of both the FDA and the court’s authority.
The vape groups had also argued that the May deadline left too little time for manufacturers to file complete applications. Cigar industry groups that filed joint briefs on appeal argued that the district court’s order on deadlines unfairly ensnared cigar and pipe tobacco manufacturers as well.
May 5, 2020
Fontem U.S. Submits PMTAs for Myblu

Imperial Brands subsidiary Fontem US has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its Myblu electronic vapor products.
Fontem US’s Blu products play a fundamental role in the company’s goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products. The PMTA submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.
Fontem US believes the evidence provided shows that Blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA.
“We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health,” said Antoine Blonde, president of Fontem US.
“Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”
April 29, 2020