Brian King will replace Mitch Zeller as head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP). He will take over the position on July 3 after spending more than a decade at the Centers for Disease Control.
King was most recently the Deputy Director for Research Translation in the Office on Smoking and Health (OSH) within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention (CDC).
“After a robust executive search, I have selected Dr. Brian A. King as FDA’s new Center for Tobacco Products Director,” Califf tweeted. “Dr. King brings extensive and impressive expertise in tobacco prevention and control and has broad familiarity with FDA from his more than 10-year tenure at CDC.”
The move comes just days after the FDA 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.
During a House subcommittee meeting after the release of the report, Califf 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,” Califf said. “If we make one single error in the process, we can be set back for years in these applications.”
Many vaping industry leaders say they are discouraged by the announcement and that “there is no longer any hope for flavored products other than tobacco.”
Matt Meyers, the controversial leader of Campaign for Tobacco Free Kids and an anti-nicotine advocate, called King a “legend” and an “icon.”
In his role at the CDC, King was responsible for providing scientific leadership and technical expertise to CDC/OSH, the lead federal agency for comprehensive tobacco prevention and control. King joined the CDC in 2010 as an Epidemic Intelligence Service Officer, before which he worked as a Research Affiliate in the Division of Cancer Prevention and Population Sciences at Roswell Park Comprehensive Cancer Center in Buffalo, New York. During his time at Roswell Park, his primary research focus related to tobacco prevention and control.
King has worked for over 15 years to provide sound scientific evidence to inform tobacco control policy and to effectively communicate this information to key stakeholders, including decision makers, the media, and the general public.
He has authored or co-authored over 200 peer-reviewed scientific articles pertaining to tobacco prevention and control, was a contributing author to the 50th Anniversary Surgeon General’s Report on Smoking and Health, was the lead author of CDC’s 2014 update to the evidence-based state guide, “Best Practices for Comprehensive Tobacco Control Programs,” and was the senior associate editor of the 2016 Surgeon General’s Report, “E-cigarette Use Among Youth and Young Adults” and the 2020 Surgeon General’s Report, “Smoking Cessation.”
He was also the Senior Official for CDC’s emergency response to the 2019 outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI).
King holds a PhD and MPH in Epidemiology from the State University of New York at Buffalo. King will replace Zeller who retired in April. There has not been an official announcement from the FDA.
In a speech on the Senate floor, U.S. Senator Dick Durbin blasted the U.S. Food and Drug Administration for its delays in complete its public health review of e-cigarette premarket tobacco product applications (PMTAs). The deadline for FDA to finish reviewing e-cigarette applications was September 9, 2021, more than eight months ago.
On June 13, the regulatory agency submitted an update on the agency’s review of e-cigarette applications and stated it will not finish reviewing e-cigarettes until July 2023 and products under review may continue being sold.
“These companies have flooded the market with addictive devices. Companies like JUUL, partially owned by the tobacco companies, understand that they’ve promoted their products to children,” Durbin said, according to a release from his office. “For years none of these products were legally authorized. Who was supposed to be the cop on the beat? The Food and Drug Administration, but they were nowhere to be found.”
In March, Durbin led a bipartisan letter with 14 of his colleagues calling on FDA to finish its review of e-cigarettes immediately; reject applications for e-cigarettes, especially kid-friendly flavors, that do not prove they will benefit the public health; and clear the market of all unapproved e-cigarettes.
“I am calling on the FDA to immediately halt its enforcement discretion and remove all unauthorized e-cigarettes from the market,” Durbin stated. “Don’t allow JUUL and other tobacco companies one more day of endangering our children. Stop cowering before Big Tobacco’s highly paid lawyers.”
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.
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.
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.
Mike Ligon, TMA board chair, and Matt Holman, director of the CTP’s Office of Science, discuss regulatory reaction.
By Timothy S. Donahue
The U.S. Food and Drug Administration has been busy. Before it had the chance to finish the first round of premarket tobacco product application (PMTA) reviews, the agency’s Center for Tobacco Products (CTP) was charged with also regulating all synthetic and other nontobacco-derived nicotine products (see “Unnatural Response,” page 28). Manufacturers must submit PMTAs for the newly regulated products by May 14, 2022.
During the 103rd annual meeting of Vapor Voice’s parent company, TMA, Mike Ligon, TMA board chair, and Matt Holman, director of the FDA CTP’s Office of Science (OS), discussed the regulatory agency’s challenges and lessons learned in regulating electronic nicotine-delivery systems (ENDS) and other novel tobacco products. It was the first time Holman had spoken publicly since Congress granted the FDA the authority to regulate synthetic products, and Ligon emphasized that the audience was eager to hear Holman answer questions.
Holman made clear from the beginning that he heard during the conference that the FDA needs to do a better job with consistency, transparency and predictability. “That’s something I’ve strived to make sure we do as office director, but I’m hearing we’re not doing as good a job as we need to,” said Holman. “That’s something I’m certainly taking back to my colleagues to figure out … I think the point I’ve heard the most along those lines was just the timing and not knowing what the timing would be [for] taking action on applications. We need to do a better job of that.”
Credit: Timothy S. Donahue
After a federal judge ordered the FDA to complete a majority of PMTA reviews by Sept. 9, 2021—one year after the deadline for PMTA submissions—Holman said the review process was still new and that it was a challenge to build the programs necessary to complete reviews on time. He said that staffing the agency, for example, was a giant undertaking.
“Something folks outside the agency don’t think about all that much is staffing levels. When I took over this position, we had something around 325 staff members that were in the office,” Holman explained. “And now, five years later, we have about 575-ish. Any of you who have not been in the federal government and tried to hire—it is a huge-level effort to hire that many people in that period of time; a huge-level effort … half my staff have come on board during the pandemic and have not met colleagues in person.”
Holman said that the big-picture goal for the OS and FDA alike is creating an offramp for smokers to transition to less-harmful products while minimizing any potential on-ramps for youth initiation, adding that youth use has been “decreasing the last couple of years, which is a really positive thing.” He also explained that the agency often hears a lot of criticism, some undeserved, surrounding the misinformation disseminated into the public by “stakeholders” (anti-nicotine organizations, health agencies, tobacco control groups, regulators and industry players).
“We take all the feedback seriously … And we certainly actively encourage all stakeholders to engage with one another. I would hope to be able to sit here and say that I’ve been more successful than I have in that. There’s still a lot of resistance. There’s still a lot of really emotional, heated exchanges and feelings toward stakeholders,” said Holman. “I’m even seeing a shift in some of the stakeholder groups that have been aligned [previously] and now aren’t necessarily aligning.
“I’ve just celebrated 20 years at the FDA in December. That entire 20 years, I’ve spent really actively engaging with all stakeholders, and I think it’s critical as regulators that we hear from and we talk with and we communicate—and we’re trying to be as transparent as possible—with all stakeholders. Unfortunately, I don’t control all the stakeholders. And I keep carrying this message forward. It doesn’t always get heard so well. And so, it’s still very much a work in progress.”
Ultimately, Holman said the FDA is trying its best to base its decisions on the “good” science and not a specific source of data. “I don’t even care who the author is. I mean, the science is science,” he said. “Unfortunately, we have a lot of stakeholders that don’t look [at] it that way, and a lot that think they know what the policies shouldn’t be, and they want to come up with the science to demonstrate that. But we’re very aware of that. We’re very much looking out for that type of thing.”
Being approachable
Holman said he understands the frustration of trying to combat misinformation. On the FDA’s side, he wanted to clarify at least some of the misunderstandings and misperceptions he commonly hears when stakeholders discuss the FDA. For example, he had recently heard a stakeholder saying that the FDA only had one economist on staff. “FDA has more than one economist,” he said. “The CTP has more than one economist. I want to be clear about that … You can agree or disagree with where economists land on their analysis. That’s fine. But just to say that we only have one economist—this concern is just a major misrepresentation of the situation.”
There are also the rumors that the regulatory agency doesn’t read all the docket submissions (everything submitted to the agency, whether a comment on rulemaking or a PMTA). Holman said the quality of the submissions vary greatly, but the agency is required by law to look at every single one. “To suggest that the FDA’s regulators don’t carefully consider the data when we’re weighing options … at the end of the day, we have a public health mission where we’re here to serve,” said Holman. “We’re not here to oppose anyone. I look at data from all sources. I don’t care who it comes from … to suggest anything otherwise, at least for the FDA, honestly, it’s a bit insulting … you can criticize all you want about where we come out on decisions and rulemaking, but at the end of the day, we are very much a science-based organization.”
Credit: Timothy S. Donahue
The agency also tries to consider the unintended consequences of regulatory action, according to Holman.
However, he explained that determining these factors, such as the growth of a black market, is complicated because there’s often not a lot of data.
“It’s very much [speculating] what’s going to happen to the black market or the gray market when we take an action. We don’t often have data on that. So it’s really modeling or predicting,” he said. “We absolutely consider that because, at the end of the day … as I like to say to my staff, we’re trying to tackle this with a scalpel not a machete. Because I think that’s how you sort of leave this fine line that we’re all trying to leave here.”
Ligon asked Holman whether the FDA’s approach to regulating next-generation tobacco products was a workable standard. Ligon wanted to know if the FDA still recognizes that tobacco products exist on a continuum of risk, with combustible cigarettes being the most harmful (the “continuum of risk” is the scientific concept that not all tobacco and nicotine-delivering products are equally harmful). Holman said that while the FDA doesn’t know precisely what the relative risks are of the different products on the spectrum, the agency still believes in the continuum of risk.
“The challenge is having strong, rigorous data that we can stand behind and say, ‘Yes, we know this product is lower in risk than that product.’ That’s one of the biggest challenges still, I think, figuring out how to collect that data, what are the right types of studies, what’s the sort of full body of data that we need to be comfortable saying, ‘Yes, this product is down the continuum from that product,’” he said. “I think the other big challenge in this is … communicating with the consumers because if they don’t understand—and we know there’s a lack of understanding—a lot of misperceptions and misunderstandings [begin to grow].”
Workable solution
Communication is key. Holman said that to better understand the process and the challenges that stakeholders are suffering, the agency needs to better communicate its thought processes and goals. Before the Covid-19 pandemic limited stakeholder interaction, the agency would hold workshops to hear directly from stakeholders about their concerns. Holman wants to bring back that level of communication.
“We need to do workshops. It’s been almost a year since we’ve done the last workshop, and a whole heck of a lot of things have happened in that time period. We’re definitely going to take that back with our staff and talk about how to put some workshops together because the feedback we’ve gotten to date on the workshops we have done [previously] have been very positive,” said Holman. “Folks really appreciate the discussion. Not only to hear what we have to say, but just talks among attendees and some shared ideas and thoughts.”
Matt Holman / FDA
When asked if there were any suggestions from TMA attendees for workshop concepts, several stakeholders offered ideas. One stakeholder wanted to discuss with the FDA how PMTA data is managed and submitted to the FDA. The participant said that his company had received a deficiency letter; however, the additional data requested was already included in the company’s PMTA. Holman said that type of seminar would be a “win-win” for both the agency and the stakeholders.
Another attendee suggested that the agency bring in consumers to allow the FDA to hear from them directly and to understand the consumers’ thoughts, behaviors and attitudes as well as the impact of potential regulations on possible future consumer behavior. “I just feel like there’s a gap,” the attendee said. “I really think that would do a lot in being able to bring all of us together to promote the science.”
Other attendees wanted to have a better understanding of how the FDA comes to its decisions and what some of the common errors were in PMTAs that had received marketing denial letters. “I’m suggesting a little bit [of a] deeper dive by product category into the top 10 reasons you’re finding that something succeeds and [the] top 10 reasons you’re finding that something fails,” the attendee said. “I’m talking more about … here are the reasons why these fail … here’s why this doesn’t work.”
Holman said the fundamental goal of the FDA is moving people down the continuum of risk. He said that the consumer is the most important part of the equation and that all stakeholders need to be better at getting less-harmful tobacco products into the hands of adult combustible smokers. He said that he would hope that five years from now the tobacco product marketplace looks very different. Holman suggested that manufacturers with the ENDS products that exist now, alongside the “products we’re not even talking about that I know are in the pipeline” at various companies, should also consider using the agency’s modified-risk tobacco product (MRTP) pipeline moving forward.
“I would hope that our MRTP program sees a lot more action and that we see a lot more modified-risk statements on products … And again, I think the lack of dialogue amongst stakeholders, and the lack of sort of any level of agreement, really thwarts communication because the information the consumers are receiving, it’s all over the place, right?” Holman suggested. “There’s a lot of misinformation out there that certain stakeholders convey that just doesn’t reflect the science. Just flat out doesn’t … if we could just get stakeholders to agree on some basic key communication points that we would all collectively share with consumers, I think we could really drive this forward. But right now, consumers are just confused.”
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.
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.
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.
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.
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%.
