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.
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.
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.
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.
The U.S. Food and Drug Administration (FDA) has issued warning letters to 10 companies, including Puff Bar parent Cool Clouds Distribution, asking for the removal of flavored disposable e-cigarettes from the market. The FDA cites youth-appeal and a lack of a required premarket authorization.
“These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America,” said FDA Commissioner Stephen Hahn. “The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data.”
Three firms are receiving warning letters for illegally marketing disposable e-cigarettes—Puff Bar, HQD Tech USA LLC and Myle Vape Inc. The FDA’s review of the companies’ websites revealed that each firm is selling or distributing unauthorized tobacco products that were first introduced or modified after Aug. 8, 2016—the effective date of the deeming rule that extended the FDA’s authority to all tobacco products.
“Despite suspending in-person inspection activities—such as retail compliance checks and vape shop inspections—due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarette products has endured,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations.”
Any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic Act (FD&C Act) is adulterated and misbranded and may not be marketed without FDA authorization, according to the FDA. Puff Bar and HQD Tech USA LLC were also cited for an additional violation for marketing their products as modified risk tobacco products without an FDA order in effect that permits such marketing.
Additionally, the FDA issued seven other warning letters to the following firms: Eleaf USA, Vape Deal LLC, Majestic Vapor LLC, E Cigarette Empire LLC, Ohm City Vapes Inc., Breazy Inc. and Hina Singh Enterprises (doing business as Just Eliquids Distro Inc.), who “sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke and popcorn, or feature cartoon characters.”
The FDA has requested responses from each firm within 15 working days detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance. Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission, according to the FDA.
The FDA’s actions during the COVID-19 pandemic also include a recent warning letter to e-liquid manufacturer StemStix Inc. for violations of the FD&C Act, including marketing new tobacco products without authorization, marketing tobacco products with false and misleading advertising and marketing unauthorized modified risk tobacco products.
Additionally, last month the agency issued letters to seven tobacco product manufacturers requesting information to help the FDA examine whether certain tobacco products were first marketed after the deeming rule’s effective date and therefore not subject to FDA’s policy on deferred enforcement of the premarket requirements for certain deemed products. Over the past four months, the agency has also refused admission into the U.S. of at least 74 entries of disposable ENDS products for violations of the FD&C Act.
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.”
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.
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.
Lawmakers in the U.S. House asked the U.S. Food and Drug Administration (FDA) to ban Puff Bar. The disposable device is the fastest-growing vapor product on the market and has quickly replaced Juul as the vape of choice among young people, according to a story in The New York Times.
The disposable devices come in more than 20 flavors, among them piña colada, pink lemonade, watermelon and O.M.G. Puff Bar, which launched last year, has been the key beneficiary of an FDA loophole allowing flavors in disposable devices. Based on data used only for tracked channels, which include convenience stores and some other retailers but not online sales or vape shops, Puff Bar sales have consistently been over $3 million a week since April, with volumes now over 300,000 sticks per week.
“Puff Bar is quickly becoming the new Juul,” Rep. Raja Krishnamoorthi, Democrat of Illinois, wrote in a letter to the F.D.A. on Monday. Mr. Krishnamoorthi, the chairman of the House Subcommittee on Economic and Consumer Policy, accused the e-cigarette company of exploiting the coronavirus to sell its products to schoolchildren.
To make his case, the lawmaker included a copy of a Puff Bar advertisement featuring a photograph of a bedroom, with the words: “We know that the inside-vibes have been … quite a challenge. Stay sane with Puff Bar this solo-break. We know you’ll love it. It’s the perfect escape from the back-to-back zoom calls, parental texts and WFH stress.”
Mr. Krishnamoorthi said that “this advertisement is designed to convince children home from school to vape in their rooms without their parents noticing.”
A second advertisement included in the complaint features an attractive young woman wearing a tight T-shirt and spewing big clouds of vapor. The same picture was used in a separate advertisement that suggested vaping a Puff Bar as a way to relax over spring break.
Todd Eric Gallinger, a lawyer who represented a company called Cool Clouds Distribution in a trademark application for the Puff logo, did not return a call seeking comment. The Puff Bar website does not list the names of any of the company’s executives. Indeed, since it began, the provenance of the Los Angeles-based business has been a secret. Its website states: “Who makes Puff Bar? Everyone wants to know the mastermind team behind the latest craze in the world of electronic cigarettes. Where did the Puff Bar team come from and where do they plan to go from here?”
Wherever it is, the company isn’t telling. The only details revealed indicate that the product is made in China and the flavors are developed in Malaysia.
The F.D.A. declined to discuss Puff Bar. Still, in an email, Mitchell Zeller, the director of the agency’s Center for Tobacco Products, wrote that the agency intended to take action against any electronic nicotine product “if it is targeted to youths, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent minors’ access, according to the story.
In recent weeks, the agency has blocked the importing of two e-cigarette products from China: EonSmoke, which sold disposable e-cigarettes in a number of flavors before shutting down, and RELX, available in flavors including Drunk in Mexico, Naked in Iceland and Mango
Recent warning letters demonstrate that the FDA is looking beyond devices when enforcing its rules against youth appeal.
By Bryan Haynes, Agustin E. Rodriguez and Dascher Pasco
On April 27, 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 retailers and manufacturers who “sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.”1 Nine of these warning letters targeted ENDS products such as flavored e-liquids and ENDS designed to look like handheld gaming systems, watches and fidget spinners.
However, one warning letter targeted products “such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette.” In its warning letter to Vaprwear Gear, the FDA asserted authority over Vaprwear’s sweatshirts and backpacks because they were components and parts of tobacco products.
Pursuant to the “Deeming Rule,” published in May of 2016, the FDA has asserted authority over all tobacco products, including ENDS products and their “components and parts.” However, the FDA does not have authority over tobacco products’ “accessories.”2 The practical consequence of the Deeming Rule is that ENDS, and their components and parts, are subject to the tobacco control authorities set forth in the Tobacco Control Act (TCA). This includes premarket authorization requirements, which, when not met, result in deemed new tobacco products being considered adulterated.
Earlier this year, the FDA published guidance clarifying how it intended to prioritize enforcement resources regarding the marketing of certain deemed new tobacco products that do not have premarket authorization. Specifically, the FDA stated it would prioritize enforcement against flavored, cartridge-based ENDS products, as well as ENDS products that were targeted to minors or the marketing of which was likely to promote use of ENDS by minors. The guidance noted that the FDA is particularly concerned with ENDS products with flavors that youth find appealing as well as products with design features that make them more appealing to youth by allowing discreet use, or enabling youth to “use the product in circumstances where the use of tobacco products is prohibited.”3
Given the FDA’s stated priorities, much of what was seen in the April 27 warning letters did not come as a surprise. For example, some of the warning letters targeted e-liquids that the FDA claimed were labeled and/or advertised in a way that resulted in the product resembling “food products that are typically marketed toward and/or appealing to children.”4 Others targeted ENDS products that resembled smartwatches, identified by FDA as a product that is “commonly worn by children” allowing the ENDS product to “be carried and worn without revealing to parents, teachers, or other adults that the product is a tobacco product.”5 As e-liquids and ENDS products, the products targeted in those warning letters are well recognized as regulated products within the FDA’s authority as stated in the Deeming Rule.
Bryan Haynes (Credit: Troutman Sanders)
Less obvious is the basis of the FDA’s authority to regulate products such as sweatshirts and backpacks as “components and parts” of ENDS. For purposes of the Deeming Rule, components and parts are defined as “any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product.” In contrast, accessories do not contain tobacco, are not derived from tobacco and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product.6
The warning letter to Vaprwear states that the Vaprwear Weekend Pullover, Vape-Ready Hoodies and Vaprwear HydroVape, as well as the Vape-Ready Backpacks are all components or parts of tobacco products and, as such, are subject to FDA jurisdiction. While FDA’s regulation of these products initially seems like a startling overreach, upon closer inspection of the products and their marketing it becomes more apparent how FDA claims authority.
Each of these products contains a “hosing system” that can be connected to a pod system and used to deliver vapor to the wearer. For example, the Vape-Ready Hoodies contain a drawstring made from hosing and woven into the hood. One end of the drawstring connects to the device and the other end is used to inhale. The Vaprwear products are largely monochromatic with few or no graphics and contain pockets that allow for storage of the ENDS device while it is being used with the products’ vapor delivery system, allowing for discreet use of ENDS devices in a number of environments.
Agustin E. Rodriguez (Credit: Troutman Sanders)
The hosing system, which is an integral part of Vaprwear’s products, physically connects to the ENDS device and is used to deliver vapor directly to the consumer. This system is identified by Vaprwear as a “vapor delivery system” that “delivers compatibility with the hundreds of vape devices now on the market,”7 and allows the FDA to claim that the products are used for the consumption of a tobacco product and alter or affect the tobacco product’s performance, composition, constituents or characteristics.
There are a couple of takeaways from FDA’s warning letter to Vaprwear. First, the FDA’s decision to target Vaprwear’s sweatshirts and backpacks demonstrates FDA’s view that a product does not have to be a necessary element of an ENDS device, such as an e-liquid or an atomizer, to be considered a component or part within the FDA’s purview. Additionally, the FDA is not only focused on discreet ENDS devices, but on all products that may be appealing to youth because they facilitate discreet use.
Dascher Pasco (Credit: Troutman Sanders)
In conclusion, the April 27 warning letters highlight the FDA’s continued focus on ENDS marketing. The FDA appears to be keeping up with the ENDS market and its consumers, recognizing and regulating the new ways individuals can easily and discreetly vape. Much of this regulatory energy is focused on retailers.
For example, while some of the companies that received an April 27 warning letter were manufacturers, each of the 10 entities operates as a retailer. Further emphasizing this point, both Wizman Limited, a manufacturer and online retailer, and EighCIt, an online retailer, received warning letters regarding a product manufactured by Wizman Limited.
The bottom line is that the FDA expects retailers to undertake appropriate due diligence with regard to all marketed products. Retailers may ultimately be held responsible by the FDA, whether or not any action is taken against the manufacturer, as the agency continues to focus on the ENDS industry and the potential youth appeal of its products.
Bryan Haynes, a partner with Troutman Sanders, specializes in tobacco industry regulatory compliance and enforcement matters.
Augustin Rodriguez, counsel for Troutman Sanders, provides cross-functional, multidisciplinary counsel to advertising, marketing and consumer goods and services companies.
Dascher Pasco, an associate with Troutman Sanders, specializes in government and regulatory white collar and government investigations and enforcement actions and investigations.
1 FDA, news release, “FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market,” April 27, 2020, available at https://bit.ly/2LIenHu.
2 21 CFR § 1100.1.
3 FDA, “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” (Revised), April 2020, available at https://bit.ly/3dYFkTu.
4 FDA, Warning Letter to VapeCentric, MARCS-CMS 607375, April 27, 2020, available at https://bit.ly/36dWGZO (finding the product appeared “very similar to Pocky Strawberry biscuit sticks”) and FDA, Warning Letter to Vape Royalty, MARCS-CMS 606271, April 27, 2020, available at https://bit.ly/3bHKDVX (finding the product appeared “very similar to Sour Patch Kids candy”).
5 FDA, Warning Letter to Vapewear, MARCS-CMS 605196, April 27, 2020, available at https://bit.ly/2XfBs9O and Warning Letter to Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc., April 27, 2020, available at https://bit.ly/2yf7uu8.
6 81 FR 28973 at 28975. The Deeming Rule defines an accessory as “any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or temperature of a stored product or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product.”
