Category: PMTA

It’s Official: FDA Denies Juul U.S. Market Access

Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.
“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul Labs, said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.
In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.
Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called the FDA decision “the most significant action the FDA has taken to reverse the youth e-cigarette epidemic. Juul, more than any other product or company, has been responsible for creating and fueling the youth e-cigarette epidemic.”
The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.
“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Gregory Conley, president of the American Vaping Association, asserted on Twitter that the Juul decisions were “manufactured” and “complete nonsense.”
Andrew Bagley is the owner of the Illuminati Smoke Shop in Columbia, South Carolina, and says even with the popularity of Juul, he doesn’t have concerns about the ban’s effect on sales, reports News19.
“I’m not concerned,” he said. “We have quite a few other vape products that are PMTA approved, which just means at this point we are legally allowed to sell them and Juuls were a very small percent of our sales, it’s not that big of a deal.”
June 23, 2022
Juul Expected to be Pulled From Market Soon

Let the shock settle in. The U.S. Food and Drug Administration is preparing to order Juul Labs to take its e-cigarettes off the market in the United States, the Wall Street Journal reported on Wednesday, citing people familiar with the matter.
Todd Cecil, deputy director for the FDA’s Center for Tobacco Products’ Office of Science, told Vapor Voice during the Next Generation Nicotine Delivery seminar in Miami that he could not make a comment on the Juul decision until the FDA formerly issues a marketing denial order (MDO).
The news sent Altria’s stock (MO) on a massive drop, falling more than 10 percent once the news broke.
Wells Fargo analyst Bonnie Herzog wrote in an email that while the news comes as a bit of a surprise, she doesn’t believe all is lost for Altria and the company has several options it can pursue, adding that the sell-off today is overdone with the stock having lost an estimated $7 billion of market capital.
“First, assuming the FDA does in fact issue an MDO for Juul, we believe the impact is far from certain given Juul’s likely options to appeal or challenge it (via a court decision similar to Kaival Brands’ approach for Bidi Vapor Sticks and IMB’s use of the appeals process for myblu), revise its [premarket tobacco product application] PMTA application, or sue the FDA altogether,” wrote Herzog. “Also, with no detail yet on the FDA’s rationale, it is tough to know how the agency is thinking about an MDO on Juul in the context of its broader efforts to encourage adult smokers to quit and/or move down the continuum of risk to less harmful alternatives (e.g., e-vapor, heat-not-burn, oral nicotine pouches, etc) especially given Juul’s critical leadership in e-cigs.
“While it is unclear how the FDA is thinking about the remaining PMTAs that are pending (especially the popular VUSE Alto line), we have a hard time imagining the FDA would categorically remove highly popular e-cig brands without ensuring a suitable off-ramp for users (that isn’t back to combustible cigs).”
It is expected that Juul will receive the MDO in a response to its PMTA because of its product’s potential to appeal to youth. The company has also seen a slump in sales recently, and has been taken over by RJ Reynolds Vapor Company’s Vuse brand e-cigarette in Nielsen rankings for the last two quarters.
“We expect the company to appeal, with the products remaining on the market,” Vivien Azer, managing director for cannabis, consumer beverages and tobacco at Cowen Inc., New York, said in a research note.
George Cassels-Smith, CEO of Tobacco Technologies, says Juul receiving an MDO is ridiculous. “For a company that has that has been a standard in this industry and has some of the highest quality products on the market, its shocking,” he said. “The company has tried hard to move past its early issues of appealing to youth. This isn’t appropriate for the protection of public health and it isn’t good for the industry. It hurts adult smokers because Juul is a product that is successful in helping smokers switch.”
The decision is likely celebrated by some anti-nicotine groups who say Juul is the cause of the rise in teen vaping. That rise has also declined dramatically over the last 2-3 years. Recently, Juul Labs also settled several lawsuits related to youth marketing. Juul Labs — until recently the market leader in e-cigarette product sales — admitted to no wrongdoing in any of its settlements.
Tony Abboud, executive director of the Vapor Technology Association (VTA) said that he was surprised by the news because Juul was always expected to get an approval order.
“The reported denial of Juul’s PMTA application is stunning. While the company has certainly been at the epicenter of conflict, the amount of rigorous, peer reviewed science supporting their products’ ability to help smokers quit, raises serious questions about the FDA’s subjective balancing test, and whether public pressure campaigns will steer science policy,” said Abboud.
Americans for Tax Reform (ATR) strongly condemned the decision. Tim Andrews, ATR’s director of consumer issues, said the Juul MDO will devastate public health across the country, and lead to easily preventable deaths.
“Juul’s reduced risk tobacco alternatives are critical tools of smoking cessation that have been proven to help cigarette smokers across the U.S. save their lives through transitioning away from deadly combustible tobacco,” he said. ““This is a decision grounded in ideology, not science. It is a decision that will cause countless deaths that could have otherwise been prevented. For the sake of public health, it is a decision we hope will be overturned in the courts on appeal.”
In 2018, Altria spent nearly $13 billion taking a 35 percent stake in Juul. The company has taken non-cash charges on the investment as regulatory scrutiny of Juul and its marketing practices have impacted sales. As of March 31, Altria said the estimated fair value of its investment in Juul was $1.6 billion.
In 2019, Juul Labs announced it was suspending its print, broadcast and online advertising in the United States. That same year it halted the sale of its fruit and dessert flavors — including mango, creme brulee and cucumber — that were seen as a significant lure for teen users. The FDA also recently instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. The menthol ban will not yet cover next-generation tobacco products, such as e-cigarettes, but the FDA has the authority to include them if it sees fit.
Juul Labs submitted its PMTAs in July 2020. At the time, the company said its submission included 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.
Juul will not join NJOY as the only FDA-approved closed system, pod-style vaping device. The FDA is expected to make decisions on additional vaping brands that submitted timely PMTAs soon.
Now that at the FDA has approved a quality vaping product in Njoy, many tobacco harm reduction groups are hoping the FDA publicly clarifies that vaping is a less risky alternative to smoking combustible. A recent Rutgers University study found that more than 60 percent of all doctors incorrectly believe all tobacco products are equally harmful, making them less likely to recommend e-cigarettes for people trying to quit smoking.
June 22, 2022
NJoy Daily Disposable Gets FDA Marketing Approval
Credit: NJOY
NJOY now has two devices that have received marketing approval from the U.S. Food and Drug Administration. The regulatory agency today issued marketing granted orders (MGOs) under the premarket tobacco product application (PMTA) process for NJOY Daily Rich Tobacco 4.5% and NJOY Daily Extra Rich Tobacco 6%.
“It should be noted that our determination that the marketing of these products is APPH [appropriate for the protection of public health] is based in part on the submitted microbial stability data,” the MGO states. “The issuance of these marketing granted orders confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco products.”
The designation does not mean the products are safe and they are not “FDA approved,” the agency said, but the MGOs allows the company to legally market them in the United States.
“Our finding that permitting the marketing of the new products is APPH does not mean FDA has ‘approved’ the new tobacco products specified in Appendix A,” the MGO states. “Therefore, you may not make any express or implied statement or representation in a label, labeling, or through the media or advertising, that the new tobacco products specified in Appendix A are approved by FDA.”
The FDA also issued marketing denial orders (MDOs) to NJOY for multiple other Daily e-cigarette products. These are presumed to be for flavored products other than tobacco. Any of those products that remain on the market must be removed or risk FDA enforcement, the agency said. Applications for two menthol-flavored Daily products remain under FDA review.
Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
June 10, 2022
FDA Hands Court PMTA Status Report for Market Leaders
The U.S. Food and Drug Administration has submitted a status report for products that currently have a premarket tobacco product application (PMTA) under review. The regulatory agency states that it expects to have resolved 63 percent of the applications set out in its original priority by June 30, 2022, and 72 percent of the applications in its original priority set by the end of this year. However, the agency does not expect to complete its review of timely submitted applications until June, 2023.
“The FDA’s progress largely reflects the review priorities that the agency established in 2020, when review began. Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the report states. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95 percent of the e-cigarette market at that time: Fontem (blu), JUUL, Logic, NJOY, and R.J. Reynolds (Vuse).”
During a House subcommittee meeting after the release of the report, the head of the FDA said the agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry.
“This is an industry that has amazing capabilities on the legal front,” FDA Commissioner Robert Califf said. “If we make one single error in the process, we can be set back for years in these applications.”
In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.
To determine which applications are for products sold under the listed brand names, the FDA used its internal PMTA database, which organizes applications by manufacturer, according to the agency. The FDA searched its database for the brand names to identify the manufacturers related to each relevant brand name and then searched its database to identify applications submitted by the manufacturers.
The FDA stated that it had conferred with the plaintiffs in the case who agreed that only one brand beyond those listed meets the 2 percent threshold. That brand was not identified. Of those applications the FDA deems requiring status reports, the agency stated that it had identified 240 covered applications. The agency estimates that its best forecast, based on current information, the FDA will take action on:

51% of covered applications by June 30, 2022;

52% of covered applications by September 30, 2022;

56% of covered applications by December 31, 2022;

56% of covered applications by March 31, 2023; and

100% of covered applications by June 30, 2023.
The agency also states that not every covered application has an equal potential impact on the public health. For example, more than 25 percent of the covered applications are for products not currently on the market.
The FDA identified two applications for products sold under the relevant brand names where the applicant stated that the products were not on the market as of August 8, 2016. The FDA also identified three other applications for products sold under the relevant brand names where the applicant did not state whether the products were on the market as of August 8, 2016. The FDA has not included information about these five applications in the current status report.
“Also, some e-cigarette devices consist of a small number of components, resulting in a small number of individual product applications for the entire system. A disposable prefilled device, for example, could constitute a single product, with one application. Other e- cigarette devices, by contrast, consist of many components, with separate tanks, coils, tubes, and pods, resulting in dozens of separate product applications for a single system,” the status report states. “Of the covered applications that the FDA anticipates will remain to be resolved beyond the end of 2022, more than half are for components of a limited number of e-cigarette device systems representing under 2.5 percent of the e-cigarette market. The FDA has made and will continue to make significant progress in reviewing and resolving applications for e-cigarette products to achieve the greatest impact on public health.”
The agency stated that it will file another status report by July 29, 2022, that will include any revisions to the estimates disclosed in the first report.
This story will be updated throughout the day.
May 16, 2022
Vuse Vibe, Ciro Issued U.S. Marketing Orders by FDA
The U.S. Food and Drug Administration today issued decisions on several R.J. Reynolds Vapor Company for several Vuse branded e-cigarette products, including the authorization of six new tobacco products through the premarket tobacco product application (PMTA) pathway. It’s the second and third Vuse branded device to garner an marketing approval. The company’s top selling Alto device is still under PMTA review.
The FDA issued marketing granted orders (MGO) to for the Vuse Vibe and Vuse Ciro e-cigarette devices and accompanying tobacco-flavored closed e-liquid pods. For each device, two versions of the power units were authorized to reflect different battery manufacturers described in the company’s applications. In total, the products receiving MGOs include:

2 Vuse Vibe Power Units

Vuse Vibe Tank Original 3.0%

2 Vuse Ciro Power Units

Vuse Ciro Cartridge Original 1.5%
The authorization allows the products to be legally marketed in the U.S. The FDA also issued marketing denial orders to R.J. Reynolds Vapor Company for multiple other Vuse Vibe and Vuse Ciro e-cigarette products, presumably for flavors other than tobacco. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
Neither the Vibe or Ciro device is popular with vapor consumers. Many consider the products old and outdated technically, unlike Njoy’s Ace device that was granted marketing orders in April. This marks the fourth and fifth vaping product brands (Vuse has 3 seperate products under the Vuse name) to receive an MGO from the FDA. In October 2021, the FDA issued its first marketing granted orders to Vuse Solo. In late March, the agency approved several Logic products for sale in the U.S.
Vuse Vibe / Photo: RJR Vapor

“Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health.
“The authorized Vuse products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke,” the FDA explained. “Further, data provided by the applicant demonstrated that participants who had used only the authorized Vuse Vibe and Vuse Ciro products had lower levels of exposure to non-nicotine HPHCs compared to the dual users of the new products and combusted cigarettes.
“Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.”
The FDA said it considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, especially youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth – provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
The authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products, according to the agency. “The FDA will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products,” it wrote.
Credit: RJRVC
The FDA may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a notable increase in youth initiation.
Before making marketing decision documents available to the public, the FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary for marketing authorizations may not be posted to the MGO webpage until after the order issuance date, according to the agency.
In the interim, to provide as much information as possible at the time of order issuance, the FDA is making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.
The agency is also expected to give status reports on the remaining PMTAs that have a more than 2 percent market share according to Nielsen.
May 12, 2022
May 14 PMTA Deadline Nears for Synthetic Products
Credit: Olly
Time is running out for companies that want to keep their synthetic nicotine products on the market. Manufacturers of non-tobacco nicotine (NTN) products on the market as of April 14, 2022 that wish to continue to market their products are required to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration by May 14, 2022.
The May 14 deadline is only for applicants submitting electronically, as required by the FDA. Applicants can, however, request a waiver from the FDA to submit a PMTA in a different format. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13.
The FDA received from the U.S. District Court of Maryland a 14-day extension to file the first premarket tobacco product application (PMTA) status reports required by the Court’s revised remedial order on April 29.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states.
The new law additionally provides that an NTN product with a tobacco-derived “previous version” that received a negative action on a PMTA from the FDA, such as a refuse to file or marketing denied order, may not continue to be marketed after May 14, 2022, without receiving a marketing granted order from FDA.
Such products must be removed from the market, even if a new PMTA is submitted, until the marketing granted order is received, according to the agency. Products on the market after July 13, 2022 without an FDA marketing granted order are in violation of section 910 of the FD&C Act and may be subject to FDA enforcement.
For products not on the market on April 14, 2022, a PMTA must be submitted to FDA and marketing authorization received before the product can be sold in the United States.
May 12, 2022
Judge: U.S. FDA has Until May 16 to File PMTA Reports
Courtesy: US FDA
The U.S. Food and Drug Administration has received from the U.S. District Court of Maryland a 14-day extension to file the first premarket tobacco product application (PMTA) status reports required by the Court’s revised remedial order.
The plaintiffs in the case consent to the requested extension, according to the motion filed today.
“The extension request is supported by good cause. Compiling the information needed for the status report has required considerable time and effort, and Defendants have been working with Plaintiffs to resolve any ambiguities about which applications will be covered in the status report,” the motion states. “Also, a number of FDA employees helping to prepare the status report were out of the office on pre-planned leave last week, and a key FDA employee responsible for the status report will be out of the country on pre-planned leave next week.
“Defendants do not seek to modify any other deadline, and the FDA’s second status report would remain due July 28, 2022. Defendants are prepared to have this letter serve as their consent motion for a 14-day extension.”
Judge Grimm granted the motion. The new deadline for the first PMTA status reports are due May 16.
April 29, 2022
Smoore Plays Key Role in FDA Marketing Orders for ENDS
When the U.S. Food and Drug Administration issued marketing granted orders to the NJoy Ace and its tobacco-flavored e-liquid pods on April 26, the ACE became the first e-cigarette authorized by the FDA equipped with a ceramic coil. That coil is manufactured by FEELM, the flagship atomization tech brand belonging to Smoore International.
The Ace marketing orders mark the first approval by the FDA of a pod vaping product. It is also the first approval of any vaping product manufactured by a company that is independent of the tobacco industry.
Smoore is no stranger to seeing its products get marketing approval from the FDA. The first brand to receive marketing orders through the premarket tobacco product application (PMTA) pathway, Vuse Solo, is a strategic partner of Smoore, a Smoore representative explained to Vapor Voice. The second set of approved electronic nicotine-delivery system (ENDS) products, produced by Logic, are also manufactured by Smoore.
“NJoy has partnered with Smoore since 2009. The NJoy Ace was launched in 2018 and is powered by FEELM inside, the world’s first black ceramic atomization coil with metallic film. As the first ceramic coil e-cigarette and pod vape authorized by the FDA, NJoy Ace’s approval for sale fully showcases the harm reduction potential of FEELM ceramic coil,” the representative said. “According to the FDA, NJoy Ace is authorized for sale because ‘chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.’”
Based on PMTA requirements, Smoore established a comprehensive analytical testing and safety assessment system, including the vaping industry’s first corporate toxicology laboratory, which explores the health impacts of exposure to e-cigarette vapor by means of cytotoxicity test, evaluating the reaction of living cells to different components of e-cigarette vapor, according to Smoore.
The company has also developed the third generation of in-house safety standards – Smoore 3.0 – that covers all of required PMTA tests, including for HPHCs listed by the FDA.
“The principle of PMTA is to scientifically and systematically substantiate harm reduction performance of the vaping product and show it is appropriate for the protection of the public health (APPH)”, said Dr. Long, director of the Smoore Analytical Testing and Safety Assessment Center. “The manufacturer must demonstrate the product’s potential to switch adult smokers while preventing youth and non-smokers from nicotine addiction.”
Long said this could explain why all the FDA-authorized vaping products so far have been for tobacco flavors, and popular flavored products the agency has said promote youth use have been issued marketing denial orders. It is also an indication that vaping manufacturers should focus on “tobacco flavor reproduction and improve harm reduction performance” in order to be approved under the PMTA pathway.
According to Nielsen, for the two weeks ended April 9, 2022, Vuse has now surpassed Juul and become No.1 in U.S. e-cigarette sales with a market share of 35 percent. Its flagship product Vuse Alto is also equipped with FEELM ceramic coils.
As the No. 3 player in the U.S., NJoy accounts for approximately 3.1 percent market share. Moreover, a federal judge has required the FDA to provide progress reports on PMTAs submitted by major vaping brands and the first reports are due on April 29.
The FDA also found that the risk to youth initiation with NJoy’s Ace was outweighed by the benefit to adult smokers, warning that NJoy must comply with strict post-marketing requirements.

April 27, 2022
Several Njoy Vapor Products get FDA Marketing Approval
The U.S. Food and Drug Administration on April 26 authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods—NJOY Ace Pod Classic Tobacco 2.4%, NJOY Ace Pod Classic Tobacco 5% and NJOY Ace Pod Rich Tobacco 5%.
Simultaneously, the FDA also issued marketing denial orders to NJOY for multiple other Ace e-cigarette products, which must now be removed from the market. These are presumed to be for flavors other than tobacco. Applications for two menthol-flavored Ace e-liquid pods remain under FDA review.
Under the PMTA pathway, the applicant must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health, the FDA explained in a statement.
The authorized NJOY products were found to meet this standard because, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.
Further, data provided by the applicant demonstrated that participants who had used only the authorized NJOY Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes. Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.
Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided that the company follows post-marketing requirements to reduce youth access and youth exposure to their marketing.
Additionally, this authorization imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA said it will closely monitor how these products are marketed and will act as necessary if the company fails to comply with any applicable statutory or regulatory requirements, or if there is a notable increase in the number of non-smokers—including youth—using these products.
April 26, 2022
Troutman Lawyers Detail MDO Lawsuits, FDA Action

By Bryan Haynes, Agustin Rodriguez and Matt Fay
Special to Vapor Voice
Since the U.S. Food and Drug Administration issued the first marketing denial order (MDO) in September 2021 as part of the premarket tobacco product application (PMTA) process for electronic nicotine-delivery systems (ENDS), vapor companies filed 49 appeals in 10 federal courts of appeal around the country. This update on the status of the cases is intended to provide a snapshot of the pending litigation.
As of April 2, 2022, 41 cases remain active and six have been withdrawn, one has been dismissed, and the Wages and White Lion Investments LLC d/b/a Triton Distribution v. FDA case has been merged with the Vapetasia LLC v. FDA case. The Wages and White Lion/Triton case is the furthest case along. The Fifth Circuit granted a stay of the enforcement of the MDO on Oct. 26, 2021, and heard oral argument on the merits of the appeal on Jan. 31, 2022. There is no expected date of the announcement on the ruling on the appeal, and the Fifth Circuit may not be feeling pressure to expedite its decision as the court has stayed the FDA’s enforcement of the MDO.
Fifth Circuit Court of Appeals
Breeze Smoke v. FDA, in the Sixth Circuit, was the next case scheduled for oral argument, with the argument docketed to be heard on Feb. 22, 2022. Breeze Smoke’s motion for a stay was denied by the Sixth Circuit in November 2021, however, and the company’s appeal of that denial was rejected by the U.S. Supreme Court in December 2021. Breeze Smoke then voluntarily withdrew its appeal of the MDO on Feb. 10, 2022, less than two weeks before the date of argument on the merits before the Sixth Circuit.
The other cases that have been withdrawn are American Vapor v. FDA in the Fifth Circuit, Turning Point Brands Inc., et al. v. FDA and Simple Vapor Company LLC v. FDA in the Sixth Circuit, and Humble Juice Co. LLC v. FDA and Al Khalifa Group LLC v. FDA in the Ninth Circuit. Of these cases, Turning Point Brands withdrew its appeal on Oct. 8, 2021, after the FDA rescinded its MDO. All the other withdrawn cases involved active MDOs. Fumizer LLC v. FDA in the Ninth Circuit also had the MDO withdrawn by the FDA in October 2021, and the case was dismissed by the court on Feb. 3, 2022, for failure to prosecute.
Three sets of cases in three different circuits are scheduled for oral argument within the next two months. Gripum LLC v. FDA is scheduled for argument in the Seventh Circuit on April 20, 2022 (no decision timeline). Enforcement of the MDO was stayed by the court on Nov. 4, 2021. Prohibition Juice Co. v. FDA in the D.C. Circuit (which has been consolidated with ECig Charleston LLC v. FDA, Cool Breeze Vapor LLC v. FDA, and Jay Shore Liquids LLC v. FDA) is next up, with argument scheduled on April 22, 2022 (court will resume April 28).
Seventh Circuit Court of Appeals
The D.C. Circuit has not stayed the enforcement of any MDO. The following month, the Eleventh Circuit will hear oral argument on two cases and one set of consolidated cases. These are Bidi Vapor LLC v. FDA, Pop Vapor Co. LLC v. FDA and the consolidated cases of Diamond Vapor LLC v. FDA, Johnny Copper LLC v. FDA, Vapor Unlimited LLC v. FDA and Union Street Brands LLC v. FDA. Of these, the Eleventh Circuit granted a stay of enforcement of the MDO to the Diamond Vapor set of consolidated cases on Feb. 1, 2022, and on March 14, 2022, the FDA did not oppose a motion for a stay filed by Pop Vapor, noting that while the FDA believed the MDO should not be stayed, the agency would not object since the court had already granted a stay in the other set of cases based on what were substantially similar facts.
Of the four sets of cases that have either already had oral argument on the merits or will do so before the unofficial start of summer in late May 2021, three involve courts (Fifth, Seventh and Eleventh Circuits) that have granted a stay of enforcement of the MDO. The fourth will be heard by the D.C. Circuit, which has not granted a stay.
The issues that either have, or will be, argued on the merits are substantially the same. For example, the appellant’s briefings in the cases consolidated along with Wages and White Lion/Triton, Prohibition Juice and Diamond Vapor all have the same four main arguments:
1) the FDA pulled a “surprise switcheroo” on each appellant by not stating in its guidance that the FDA’s determination would hinge on proof that flavored products facilitate smoking cessation in adults in a manner that significantly outweighed their alleged appeal to youth;
2) the FDA engaged in a superficial and cursory review of the respective appellant’s PMTA based on the sheer number of PMTAs filed industry-wide and based on the MDO’s limited discussion of merits or deficiencies of the PMTA’s content, which the appellants have described as “check-the-box” responses;
Credit: FDA
3) the FDA’s requirement to show that flavored ENDS will be more effective at promoting smoking cessation versus tobacco-flavored ENDS created a de facto comparative smoking cessation efficacy requirement that is prohibited under Section 910 of the Tobacco Control Act; or, in the alternative, that
4) if the FDA wants to require long-term studies, it should not be permitted to issue MDOs for at least an additional 18 months to give the appellant sufficient time to conduct these studies.
As the majority of the appellants discussed above have made substantially similar arguments but only three of the four circuits mentioned above have currently stayed the FDA’s enforcement of the MDOs, this increases the likelihood that at least one of these four circuits will rule on the merits in a way that differs from one of their fellow circuits. This would create the “circuit split” necessary for the U.S. Supreme Court to make a decisive ruling on the legality of the FDA’s decision-making process.
Of the remaining active cases not discussed above, it is also possible that these cases will move through the appeals process more slowly as the plaintiffs, the government and the courts wait to see how the pending cases are decided and how quickly the U.S. Supreme Court may act on any split outcome in the other courts. For example, in the Fifth Circuit, there are two cases that have been held in abeyance pending the court’s ruling in Wages and White Lion/Triton, and other circuits have also held cases in abeyance pending their action in related cases.
Bryan M. Haynes is a partner with Troutman Pepper who specializes in tobacco industry regulatory compliance and enforcement matters. He efficiently assists clients in complying with regulatory obligations and managing risk, consistent with clients’ business objectives.
Agustin E. Rodriguez is a partner with Troutman Pepper and has almost two decades of experience counseling tobacco companies in-house and in private practice on tobacco product regulation, taxation and multi-jurisdictional state and local enforcement issues.
Matthew J. Fay is an associate attorney with Troutman Pepper who offers representation in complicated matters, with a focus on complex criminal and internal investigations, government contracting, as well as evolving laws, regulations, and international treaties.

April 22, 2022