Mitch Zeller, the former head of the U.S. Food and Drug Administration’s Center for Tobacco Product, has joined the advisory board of a company developing a first-of-its-kind smoking cessation inhalation product.
Zeller said Qnovia’s nicotine inhalation product, RespiRX, has the potential to be a “game changer” in lowering the use of combustible cigarettes.
The former director of the Center for Tobacco Products (CTP) from March 2013 until his retirement in April 2022, Zeller is now providing policy and regulatory strategy consulting to Qnovia, Inc.
The company is currently preparing an application to the FDA’s Center for Drug Evaluation and Research (CDER) for a cessation therapy which, if approved, will be the first inhaled prescription therapy to help tobacco smokers quit.
Zeller’s addition to the company’s advisory board comes as the FDA aims to finalize proposed bans on menthol cigarettes and flavored cigars by August. The FDA also plans to propose a rule limiting nicotine levels in cigarettes and some other tobacco products.
Zeller said access to Qnovia’s product can be one essential tool along with an administration-wide effort to provide support to those with nicotine addictions once those product standards take effect.
“Some people will be able to quit cold turkey, but a whole bunch won’t, and they will be seeking nicotine elsewhere,” Zeller said in an interview, told Bloomberg Law.
“The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product,” he added.
Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.
RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.
RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.
“The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”
Late last year, Qnovia raised $17 million to continue the development of its RespiRx nicotine replacement product.
In June of 2020, the company appointed Quigley, a 16-year veteran of Altria Group, as its Chief Operating Officer. At Altria, Quigley served as CEO of its smokeless tobacco business from 2012 to 2018, a $2.3 billion business with over 800 employees,
When the U.S. Court of Appeals for the 5th Circuit granted a stay to R.J. Reynolds Vapor Co. (RJRV) of the U.S. Food and Drug Administration’s denial of its 150,000-page premarket tobacco product application (PMTA) for its menthol Vuse products, the judges indicated that the court believes RJRV is likely to prevail on the merits when the full review is heard.
Tobacco harm reduction expert Clive Bates of Counterfactual said the substantive decision rests on three main arguments, as outlined by the judges granting the stay. The order states: “Specifically, RJRV demonstrates that the FDA failed to reasonably consider the company’s legitimate reliance interests concerning the need for longitudinal studies and marketing plans; failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes; and has created a de facto rule banning all nontobacco-flavored e-cigarettes without following APA notice and comment requirements.”
The three main points argued by the court are outlined below:
FDA changed the decision-making criteria after the application.
1. Legitimate reliance interests
“The FDA did not reasonably consider RJRV’s legitimate reliance interests before changing its position on the types of comparative studies and marketing plans critical to a compliant and complete PMTA.”
Failure to consider Reynolds’ arguments adequately
2. Failure to consider relevant factors
The FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse while popularity among youth would remain low overall. For example, RJRV’s application contained studies that “switching from smoking to use of menthol Vuse Vibe substantially reduces toxicant exposure in a manner similar to smoking abstinence.” RJRV also submitted evidence of low popularity among youth relative to other flavored electronic nicotine-delivery systems (ENDS).
Bates stated that at least one portion of the court’s argument looks troubling for Brian King, the newly appointed director of the FDA’s Center for Tobacco Products (CTP).
“Then in July 2022, a new CTP director appeared on the scene and told OS that ‘the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found [appropriate for the protection of the public health] only if the evidence showed that the benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.’ OS then changed its position.”
FDA has been implementing a de facto tobacco product standard (a flavor ban) without using the rule-making process, public comment, etc.
3. “Tobacco product standard”
RJRV has adduced evidence that the FDA has effectively banned all nontobacco-flavored e-cigarettes pursuant to its new and secret heightened evidentiary standard without affording affected persons any notice or the opportunity for public comment. There is no dispute that the TCA requires the FDA to abide by notice-and-comment rulemaking procedures before establishing a “tobacco product standard.” 8 21 U.S.C. § 387g(c)–(d). Similarly, it is clear that a ban on all but tobacco-flavored e-cigarettes would constitute a “tobacco product standard.”
Bates explains that the court justifies its assertion that the FDA is imposing a de facto standard with reference to the so-called “fatal flaw memo.” This was an expedited decision-making regime that stipulated that applications for nontobacco-flavored products must be supported with controlled trials or longitudinal studies showing a quitting or switching advantage over a tobacco flavor. Otherwise, they would be automatically denied.
“We conclude that the Fatal Flaw memo’s heightened evidentiary standard ‘bears all the hallmarks’ of a substantive rule. City of Arlington, 668 F.3d at 242. First, the memo is binding on its face by mandating that applications contain ‘the necessary type of studies.’ Second, it has been applied in a way that indicates it is binding; indeed, the subsequent, myriad Denial Orders refer to the same deficiencies identified as ‘fatal’ in the memo. Third, it took away the FDA reviewers’ former discretion to consider individual PMTAs solely on their merits and instead requires a cursory, box-checking review.
“Finally, it affected the rights of literally hundreds of thousands of applicants whose PMTAs were denied. This is not a close call.”
Bates stated that the third point the court makes is potentially “very” serious for the FDA and “not a close call,” as the court suggests. “A tobacco product standard under the TCA s.907 means that the burden is on the FDA to show that its de facto standard is appropriate for the protection of public health—e.g., considering the impact of closing down all vape shops, the likely impact on adults or youth who smoke, unintended consequences, illicit trade, etc.,” explains Bates. “It shifts the analysis from the individual applicant (PMTA) to the system-wide impact (Product Standard)—and FDA will find this difficult or impossible to meet, in my view.”
Taking everything into account, the court weighs up its decision to grant the stay against four criteria, as Bates outlined:
“Our judgment is ‘guided by sound legal principles’ that ‘have been distilled into consideration of four factors: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.’”
Bates stated that the first of these four criteria reflects the courts’ view on the merits discussed in the three above-stated substantive arguments. In the fourth: where the public interest lies, the court gives significant weight to the “highest public importance that federal agencies follow the law” and states: “In sum, ‘there is generally no public interest in the perpetuation of unlawful agency action,’ Texas v. Biden, 10 F.4th at 560. And there is no evidence that ‘Congress’s policy choice’ included an exemption from mandatory federal administrative procedures.”
No date has been set for the court to complete its full review.
A new webpage was published by the U.S. Food and Drug Administration of all the tobacco products-related citizen petitions received by the agency’s Center for Tobacco Products (CTP).
A citizen petition is a way for the FDA to give individuals, regulated industry representatives, or consumer groups to petition the agency to issue, amend, revoke a regulation, or take other administrative action. The requirements for a citizen petition are set out in the Code of Federal Regulations.
As part of CTP’s stated commitment to increase transparency, the webpage was developed to provide the public with more easily accessible and user-friendly information about tobacco product-related citizen petitions submitted to FDA and the center’s responses.
This webpage was one of the immediate actions toward transparency outlined by CTP Director Brian King in CTP’s Response to the Reagan-Udall Foundation’s report.
The National Police Agency confirmed to Taiwan News that police can now issue on-the-spot fines of up to TWD10,000 ($330) to those caught vaping after Taiwan’s legislature passed amendments to Taiwan’s Tobacco Hazards Prevention Act.
E-cigarette users can either be fined on the spot, or photo and video evidence can be used by the government to send the fines to violators’ registered addresses, similar to fines currently issued for smoking in nonsmoking areas, jaywalking and other minor offenses.
The fine for vaping is now the same as for smoking in areas designated as nonsmoking, between TWD2,000 and TWD10,000.
The amendments also increase the legal age for purchasing cigarettes from 18 to 20 and prohibit the sale of e-cigarettes and heated-tobacco products. Importers, manufacturers and sellers can now be fined up to TWD50 million.
The government of Hong Kong has decided to reverse its ban on the transshipment of vapor products, reports Loadstar.
Media reports claim the banned cargo amounts to about 330,000 tons a year—the equivalent of some 10 percent of Hong Kong’s annual export volumes by air, according to the Hong Kong Association of Freight Forwarding and Logistics.
The value of the re-export cargo affected by the ban was estimated to exceed CNY120 billion ($17.33 billion).
While some transshipment by air had continued to be permitted, beginning in April of last year, vapes entering Hong Kong by land or sea for onward transport by air were banned. However, with the bulk of these products made in neighboring Dongguan, exporters were keen to ship them via land to Hong Kong International Airport.
Once the proposal is passed, the goods will be able to enter Hong Kong through a secure channel on dedicated barges and be delivered straight to the airport.
“The scheme is only to facilitate direct transshipment through Hong Kong, and the goods will not be available for domestic consumption. The proposal is in response to the demand of the Hong Kong air freight industry,” said Willy Lin, chairman of the Hong Kong Shippers Council.
“We hope we could get back some flights lost to competitor airports due to [the] stoppage of shipments of e-cigarettes and related substances through Hong Kong.”
The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.
Reynolds is expected to challenge the order.
The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.
After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.
In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA issued MDOs for menthol products after receiving a scientific review.
A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the 3rd Circuit that temporarily stayed the order.
The U.S. Food and Drug Administration is proposing new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of all tobacco products.
The proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency, according to an FDA statement.
“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,”
Brian King / Credit: FDA
said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”
The proposed new requirements would help manufacturers comply with the Federal Food, Drug, and Cosmetic Act by helping minimize or prevent the manufacture and distribution of tobacco products contaminated with foreign substances—such as metal, glass, and plastics—which have been found in tobacco products. T
The proposed rule would also help address issues related to inconsistencies between e-liquid product labeling and the actual concentrations in e-liquids, “Such variability can be misleading to consumers, potentially intensifying addiction and exposure to toxins,” the agency states.
The proposed rule would also establish several requirements related to the identification, tracing and corrective actions for tobacco products that don’t meet specifications or are contaminated, including for tobacco products that have already been distributed.
In the event of an issue, these requirements would require manufacturers to take corrective actions, which may include conducting a recall.
The proposed requirements apply to manufacturers of finished and bulk vaping and other tobacco products. As laid out in the proposed rule, a finished tobacco product is a tobacco product, including any component or part, sealed in final packaging; for example, an e-cigarette, a pack of cigarettes or a can of moist snuff.
A bulk tobacco product is a tobacco product that isn’t sealed in final packaging, but is otherwise suitable for consumer use.
The proposed rule establishes a framework for manufacturers to adhere to, including:
establishing tobacco product design and development controls;
ensuring that finished and bulk tobacco products are manufactured according to established specifications;
minimizing the manufacture and distribution of tobacco products that don’t meet specifications;
requiring manufacturers to take appropriate measures to prevent contamination of tobacco products;
requiring investigation and identification of products that don’t meet specifications to institute appropriate corrective actions, such as a recall; and
establishing the ability to trace all components or parts, ingredients, additives and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of those that don’t meet specifications.
The FDA will hold a public oral hearing on April 12 to gather additional comments from stakeholders, including industry, the scientific community, advocacy groups, and the public.
The proposed rule also will be available for public comment for 180 days. The agency will review all comments as part of the rulemaking process for this foundational rule.
“We remain committed to transparency and stakeholder engagement, including providing clarity to industry so that they are equipped to comply with the law,” said King. “We encourage all interested individuals and organizations to participate in the rulemaking process. When the public submits a comment based on sound grounds, that can make an important difference in the agency’s decision-making.”
The FDA will also hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on May 18 to seek recommendations from the agency’s outside panel of experts on the requirements laid out in the proposed rule. As part of the TPSAC meeting, the public will have an opportunity to make oral presentations. The FDA intends to make TPSAC meeting materials available on its website no later than 48 hours before the meeting.
E-Liquid manufacturer Zinwi Bio-Tech is set to unveil its new logo at the Total Products Expo (TPE) in Las Vegas from Feb. 22 – 24. The company will also be highlighting 15 of its most popular e-liquid flavors for TPE attendees to experience.
Zinwi, a global integrated e-liquid solutions provider, upgraded its branding in December to better reflect the company’s dedication to providing high-quality products and the brand’s entry into a new development phase.
“In this new phase, Zinwi will place more emphasis on product research and development, and provide diversified products to meet the needs of global markets,” a Zinwi spokesperson told Tobacco Reporter. “Zinwi is committed to continuing to explore e-liquid technology, pursue innovation and provide cutting-edge integrated e-liquid solutions.”
Zinwi’s new logo resembles a drop of e-liquid oil, which alludes to the company’s unwavering commitment to product research and development. The Zinwi “Z” and oil design are integrated to symbolize the company’s dedication to continuous product research and development, according to a press release. The light blue color of the logo features Zinwi’s laboratories that conduct its scientific product research and development in the background.
Currently, new nicotine salt and glycerol alternatives are two major topics of research for Zinwi. The company’s product research and development team has produced a new nicotine salt that has distinct advantages compared with the traditional benzoic acid nicotine salt.
“This new innovation brings with it a significant reduction in the number of impurities released. Zinwi is also in the process of researching and developing glycerol alternatives,” the spokesperson said. “The research and development of glycerol alternatives is an effort to reduce the toxins released during atomization and to allow the products to be more environmentally friendly.”
The 15 e-liquid products Zinwi is set to showcase at TPE include five tobacco flavors and 10 non-tobacco flavors. They are Zinwi’s best-selling flavors and have been widely recognized by the company’s global client base. One of the flavors, Caramel Tobacco, has a distinctive caramel flavor along with a mild tobacco accent.
In order to allow the show attendees to experience the different flavors, Zinwi will provide disposable vaping devices pre-filled with the Zinwi e-liquids in the 15 flavor profiles. “Trade show attendees will be able to try out the different flavors in different devices with a variety of settings, enabling them to reach the optimal puff experience,” the spokesperson said.
With Republicans in control of the U.S. House, some experts expect the vape industry to thrive.
By Timothy S. Donahue
The next two years should be better than the past two years. That was the overall outlook from vapor industry experts speaking during the Vapor Technology Association’s (VTA) 2022 Post-Election Round-Up webinar in late November. Tony Abboud, executive director of the VTA, told attendees that his organization has been working diligently with two Washington, D.C.-based firms, West Front Strategies, a lobbying group, and FORA Partners, a public affairs agency, to promote the interests of the vaping industry as Republicans take over the U.S. House of Representatives in 2023. “We have a very specific agenda, some of which we’ve discussed (as an overview of what) we are pursuing,” he said. “We’ve done an enormous amount of groundwork.”
Shimmy Stein
Shimmy Stein, a partner with West Front Strategies, said the change in leadership at the House could have a positive impact on the vaping industry until at least the next election cycle. “Anytime you can take over the gavels, take over the control of the messaging, take over control of the chairmanships and the legislation, that is an important piece of governing,” he explained. “And so, while it was not to the extent or to the size which Republicans were hoping for in terms of the majority in the House of Representatives, it’s still pretty significant and will change the manner in which Washington will function.”
Over the next two years, the vaping industry should feel “a little more comfortable, a little more secure” going into a divided Congress (the U.S. Senate leadership did not change), according to Craig Kalkut, a partner with West Front Strategies. However, the vaping industry has always faced threats from both Democrats and Republicans due to their concerns over teen vaping. “We still need to work with both parties. We still could face issues and threats of overregulation and poorly conceived legislation. But the bottom line is that we will have a more comfortable environment with Republicans controlling one house of Congress,” said Kalkut.
Craig Kalkut
Reconciliation, a way for Congress to enact legislation on taxes, spending and the debt limit with only a majority vote, is no longer a threat to the vapor industry, according to Kalkut. He said that’s just not something that can happen in a divided Congress. “What that means, ultimately, is that anything that passes will need to have bipartisan support,” said Kalkut. “And because of that, [legislation] will likely be more limited, more moderate, and hopefully, if there’s any legislation passed in our area, that will be something that allows us to thrive, which addresses the concerns that linger over teen vaping but does not overregulate and drive people away from vaping.”
Kalkut also confirmed that gridlock is a concern in a divided Congress; however, gridlock could also provide incentives for both parties to compromise. “They’re both seen as in charge, so they both sometimes want to get something done. And that will bring people to the table and often over issues that are not central to either party’s ideology,” he said. “It’s hard to come to a compromise on taxes, or it’s hard to come to a compromise on healthcare … but something like vaping, perhaps there will be opportunity for common sense provisions to prevail in an area where Democrats and Republicans can come together.”
Max Hamel
Max Hamel, founding partner of FORA, said when Congress is split, the White House typically relies heavily on its executive privilege. There is no known administration agenda on vaping, so a vaping-related rule is unlikely. With Republicans in control of the House, they also head committees. The House oversight committee and its subcommittees could present opportunity for the vaping industry, according to Hamel.
“We do have new personalities on both the majority and the minority side, so they’ll probably have some growing pains,” he said. “The big question is, how does this new authority, especially in the House, get wielded[?] … whether it’s one seat or 40 seats, the authority with the majority is the same, and it is substantial from [an] investigation and oversight standpoint; [that’s] probably not necessarily true from a legislative standpoint … the oversight subcommittee, we do have the opportunity to surface some things, but it’s really an opportunity for us now to not be on defense and [to] put forth an agenda and some messaging that really focuses on the things that are advantageous to us.”
Additionally, with Juul losing its stranglehold on the vaping market, Hamel said the vaping landscape is changing. Juul became the focus to save youth from vaping, and today, Juul isn’t the focus. The market is made up of a more diverse group of companies with different technologies dedicated to harm reduction. Hamel said this is the message that should be projected. “I think our priority will be focusing on the messages that really emphasize the harm reduction aspects,” he said.
Kalkut then added that the vaping industry has an opportunity now to change the conversation, particularly with Democrats but also Republican critics and skeptics of vaping through the ever-expanding body of science that shows the relative safety and incredible potential for harm reduction that next-generation tobacco products have. “That has become more and more clear as time has gone on over the last couple of years,” he said. “I think once we show that, once we demonstrate our commitment as an association in the industry to addressing teen vaping, we have a real chance of changing the narrative.”
Ashley Davis
Ashley Davis, a founding partner at West Front Strategies, told attendees that, looking back on industry challenges, there has been success. However, her concerns going into the last Congress (2020–2022) were that she didn’t really know in what direction or how forcefully Biden would lean on the vapor industry. She says the industry “dodged a bullet.” The industry could have suffered more than it did those first two years in a Biden administration. She also said the issue of youth use will remain at the forefront of any discussion concerning electronic nicotine-delivery system products.
“We do have to still deal with the youth issue. And I think we all realize that any negative press that comes up is around the youth issue … Everyone loves a microphone. It’s a member of Congress. If there’s an issue to discuss, that’s what they’re going to discuss,” explained Davis. “[We are] trying to make sure that any bad legislation is not passed—it’s much more unlikely in this Congress than it was before.”
Taking a question from the audience, Abboud closed the session speculating on the impact of the Reagan-Udall Foundation’s external review of the U.S. Food and Drug Administration’s Center for Tobacco Products, the results of which are expected in mid-December.
Abboud said that numerous comments from staffers of the FDA for the Reagan-Udall assessment suggest the regulatory agency is in a state of disarray and is being influenced by outside forces not scientific research. He said he hopes the foundation will advise the FDA that premarket tobacco product application (PMTA) decisions should be free from any external pressures, especially political pressure.
“[The review should recommend to the FDA that PMTA] decisions must be made based upon the science that is submitted as well as making sure that the agency does, in fact, review all of the science that has been submitted as part of any applications as well as [reviewing] all of the applications that have [been] submitted,” said Abboud. “Because that was another big failing of the current process where applications have been rejected [without a full review].”
A lawmaker in Scotland wants to ban the public display of e-cigarettes in retail shops. Scottish Greens MSP Gillian Mackay wants retailers to treat them in the same way as cigarettes and hide them from view.
“This is beyond the days of smoking behind the bike sheds—this is a multi-million industry leading the nation’s health down a path to disaster,” Mackay said. “It is a ticking time bomb, and, until we know more, that’s not a risk I or anyone else should be asked to accept.”
She has written to shops and vape manufacturers ahead of taking her campaign to the Scottish Parliament, according to the Daily Record.
Mackay, the Green Party’s health spokesman, said there is growing concern that the number of underage people being attracted by “deliberately sweet-toothed tactics” to market products is spiraling.
She is calling on retailers to lead by example by writing to them urging that they hide the products from view.
The U.S. Food and Drug Administration issued 
