Tag: Marketing Denial Order

  • FDA Denies Market Access to Myblu

    FDA Denies Market Access to Myblu

    Photo: Alex Kalmbach

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem US for several Myblu electronic nicotine delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health.

    According to a notice published on the FDA’s website, the currently marketed products receiving MDOs include Myblu Device Kit, Myblu Intense Tobacco Chill 2.5% and Myblu Intense Tobacco Chill 4.0%.

    In reviewing premarket applications for tobacco products, the FDA evaluates the risks and benefits of those products to the population as a whole, including users and nonusers of the tobacco product, and considers, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.

    Based on the information submitted by Fontem US for these Myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the FDA. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, the agency said.

    Tobacco products subject to an MDO may not be offered for sale, distributed or marketed in the U.S.

  • Court Stays Bidi Vapor Marketing Denial Order

    Court Stays Bidi Vapor Marketing Denial Order

    The U.S. Court of Appeals for the Eleventh Circuit has stayed the marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021.

    The Feb. 1, 2022, ruling allows Bidi Vapor and Kaival Brands to market and sell all of its Bidi Stick electronic nicotine-delivery systems (ENDS), including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor’s premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.

    With the judicial stay decision going in favor of Bidi Vapor, the company expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.

    “We expect this judicial stay will result in a rebounding of Bidi Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor, in a statement. “Many wholesale and retail partners had discontinued or slowed purchases of the Bidi Stick until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”

    “We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA. We are extremely pleased with the court’s decision on this judicial stay order and continue to expect to be successful on the merits case as well.”

    “The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs,” Patel said.

  • Down to the Wire

    Down to the Wire

    Photo: kurgu128

    Uncertainty lingers about the future for vaping as the FDA decides the fate of the remaining marketing applications.

    By Stefanie Rossel

    Two months after the Sept. 9, 2021, deadline for the U.S. Food and Drug Administration to determine the fate of millions of premarket tobacco product applications (PMTAs), uncertainty continues to prevail, and the fate of e-liquids with flavors other than tobacco remains unclear. The agency’s approach to e-cigarette regulation to date, alternatingly labeled a “fiasco” or “bureaucratic chaos” by critics, suggests that the U.S. may be heading toward a de facto ban of all nontobacco flavors.

    The 2009 Tobacco Control Act (TCA) gave the FDA authority to regulate cigarettes, smokeless tobacco, cigarette tobacco and roll-your-own tobacco. The “deeming rule” of Aug. 8, 2016, extended the agency’s authority to electronic nicotine-delivery systems (ENDS), cigars, pipe tobacco, nicotine gels and hookah tobacco. As a result, deemed products are now subject to all TCA rules, including the requirement that any new tobacco product must receive premarket authorization from the FDA to be legally marketed.

    Following litigation by anti-tobacco groups, a court set the deadline for manufacturers to submit their applications by Sept. 9, 2020, and gave the agency one year to decide on them. The time frame presented a daunting challenge to the chronically understaffed agency. The FDA received more than 6.5 million marketing applications for newly deemed tobacco products alone. At press time, the agency had acted on more than 98 percent of these applications. Its actions included refuse-to-accept letters to more than 200,000 applications, a refuse to file order for approximately 4.5 million products submitted by a single company and marketing denial orders (MDOs) for more than 1 million nontobacco-flavored ENDS. Only three new tobacco products received marketing granted orders. The FDA still needs to rule on applications covering about 80,000 products, including those submitted by market leaders such as Juul and NJOY.

    David Sweanor

    Retroactive Change of Requirements

    Most of the MDOs were directed at vape products with flavors other than tobacco, including menthol. The manufacturers, the agency claimed in its MDO letters, had failed to provide sufficient evidence that their nontobacco-flavored products deliver a net public health benefit for adult smokers compared with the “threat posed by the well-documented, alarming levels of youth use” of flavored vapes through either a randomized controlled trial in which a specific group of people is examined through intervals of time, or a longitudinal cohort study, which tracks large groups of people over an extended period of time.

    “It appears that the FDA is planning to significantly hobble the vaping category and thus protect lethal cigarettes from what is perhaps the greatest threat that business has ever faced,” says David Sweanor, adjunct professor of law at the University of Ottawa. “But how far this succeeds depends on many factors, not least what the courts will say about the process.”

    The requirement is now part of the PMTA rules, which the agency finalized in October 2021, and which took effect in November. However, it had not been in the original guidance for PMTA applications, according to critics.

    For most smaller vape manufacturers, the FDA’s ruling has meant the end of their business activities. “Like most vape companies, we cannot remain financially viable with only two [tobacco-flavored] products, and we will most certainly be forced to close our business after eleven years,” California-based Kai’s Virgin Vapor states on its website.

    Paul Blair

    Temporary Stays Granted

    Others have taken legal action. Arguing that the FDA moved the goalpost by retroactively changing the PMTA requirements, MDO recipients filed more than 40 petitions for review and stay on the grounds that the FDA had acted in an “arbitrary and capricious manner.” At the time of writing, at least five companies had been granted a temporary stay either by the FDA or the courts, and their products were back under review.

    Among them was Turning Point Brands, which may now continue to market its vapor products while its PMTAs are being reassessed. “We’re encouraged that the agency has acknowledged the robust nature of our PMTAs for a wide range of tobacco, menthol and other flavored vapor products,” Paul Blair, vice president of government affairs at Turning Point Brands, told Tobacco Reporter. “These open system e-liquids, sold predominantly in vape shops across the U.S., play an important role in providing reduced-risk options to more than 30 million adult smokers who may be looking for alternatives to combustible cigarettes. It is our hope that at the end of the PMTA review process, the agency will preserve the important off-ramp from cigarettes to a wide range of vapor products used by adults. Preserving these options will ensure that the diverse vapor marketplace can help ultimately achieve a more significant reduction in smoking rates across the U.S.”

    “The cases look strong,” Sweanor states. “Administrative bodies, like referees in sporting competitions, are challenged when they seek to change the rules mid-game. This is supposed to be an example of transparent rule-making in a democratic society. There is also a history, in the U.S. and globally, of vaping companies using the courts to overturn laws and administrative rulings that have overly restricted their products and marketing.”

    However, a second review does not guarantee that the products will receive authorization. Critics fear that manufacturers who have received an MDO will continue to appeal the decisions to maximize the time to sell their products. THR advocates hope that legal challenges will force the FDA to make more careful decisions.

    Uncertain Future for Flavors

    There are many indications that the era of nontobacco vapor flavors is coming to an end in the U.S. After bombarding the vapor business with MDOs, the FDA on Oct. 12 approved R.J. Reynolds Vapor Co.’s Vuse Solo and accompanying tobacco-flavored e-liquid pods—the first-ever marketing granted order for an e-cigarette.

    Tobacco harm reduction advocates received the news with mixed feelings. While welcoming the agency’s acknowledgement that vape products can help adult smokers to quit cigarettes, they were disappointed that the order pertained to an outdated device with few users. Furthermore, while authorizing two Vuse tobacco-flavored e-liquid pods, the agency issued 10 MDOs for Vuse Solo nontobacco-flavored pods, claiming that Reynolds failed to demonstrate they were appropriate for the protection of public health.

    The agency is still evaluating Reynolds’ application for menthol-flavored products under the Vuse Solo brand. Menthol is another bone of contention: In late April, the FDA announced that it would initiate a notice and comment rule-making process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos within the next year. Vape manufacturers are hence unsure of whether their mentholated products will remain on the market.

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    Sloppy Assessment

    In its denial of providing marketing authorization to nontobacco-flavored e-liquids, the FDA referred to the most recent National Youth Tobacco Survey (NYTS), arguing the study had shown that among the estimated 2 million middle school and high school students that were using e-cigarettes in 2021, more than eight in 10 were using nontobacco-flavored vape products. It did not mention that, according to the same study, the use of e-cigarette among youths has more than halved over the past two years, from 27.5 percent in 2019 to 11.3 percent currently.

    Critics have accused the FDA of being “obsessed with youth vaping rates and flavors.” The online publication Filter revealed that, in order to cope with the unprecedented flood of PMTA submissions before the court-ordered deadline, the FDA relied on a database query to identify the top-12 manufacturers with the largest number of pending PMTAs for nontobacco-flavored e-liquid products not in the third of three FDA review phases.

    This approach allowed the agency to filter out 85 percent of all pending PMTA applications. It then introduced, apparently for the first time, a “fatal flaw” standard. The fatal flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. “The fatal flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” according to an FDA Center for Tobacco Products Office of Science memorandum cited by Filter.

    With its attempt at speeding up matters, the agency has done itself no favors, say critics. The road to regulatory certainty in the U.S. vape market will likely become even longer. “At this point,” Sweanor suggests, “the solution could be to announce reasonable product standards aimed squarely at reducing harms—as is done with foods—rather than treat each subcategory of each product as if totally independent of other products.”

  • FDA Rescinds Marketing Denial for Humble Juice

    FDA Rescinds Marketing Denial for Humble Juice

    Photo: AliFuat

    The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) issued Sept. 15, 2021, for Humble Juice Co.’s flavored e-liquid products, the company announced on Nov. 5.

     Humble had filed a petition in October with the U.S. Court of Appeals for the Ninth Circuit, challenging the FDA’s decision and seeking to have the MDO vacated. Following the receipt of the rescission letter, Humble withdrew its petition as FDA’s rescission of Humble’s MDO places the brand’s flavored e-liquids back into the PMTA review process and provides Humble with a pathway to market its products while its PMTAs are pending.

    FDA’s rescission letter states that upon further review it identified information contained in Humble’s PMTA that requires additional evaluation such as “randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating intentions to use or likelihood of use in current smokers, current ENDS users, former tobacco users, and never users.”

    The agency also stated that due to the unusual circumstances, it “has no intention of initiating an enforcement action” against any of Humble’s flavored e-liquid products with pending PMTAs. Humble will continue to market its products while its application remains in the review process.

    “FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Humble CEO Daniel Clark. “We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble’s adult consumers with flavor-filled and affordable e-juice long into the future.”

  • Filter: Some PMTAs Not Evaluated on Merits

    Filter: Some PMTAs Not Evaluated on Merits

    Photo: Ronstix

    Confronted with an unexpected large volume of premarket tobacco applications, the U.S. Food and Drug Administration subjected some premarket tobacco product applications (PMTAs) to only a superficial review, according to documents obtained by Filter.

    The report follows the FDA’s denial of more than 1,167,000 marketing applications since Sept. 9, 2021.

    The PMTA review process comprises three phases: Phase I (Acceptance), which essentially means an application has been received; Phase II (Notification or Filing), which entails acknowledging a company had enough information for its applications to be formally filed; and Phase III (Review), which involves a substantive scientific evaluation, followed by a marketing granted order or marketing denial order (MDOs).

    Overwhelmed by the large number of PMTAs and facing a court-ordered deadline of Sept. 9, 2021, the FDA in effect opted for a shortcut, according to Filter.

    The publication cites a memorandum signed on July 9 by Matthew Holman, the director of FDA Center for Tobacco Products Office of Science (OS). “Considering the large number of applications that remain to be reviewed by the September 9, 2021, deadline, OS will conduct a Fatal Flaw review of PMTAs not in Phase III for non-tobacco-flavored ENDS products,” it reads.

    The Fatal Flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. “The Fatal Flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” the memorandum states.

    Filter suggests that CTP reviewers created what’s probably a new method to get through a backlog of millions of PMTAs, searched those applications for longitudinal cohort studies and randomized clinical trials without evaluating any other evidence, and for applications lacking them, did not advance them beyond Phase II and just sent out templated MDOs.

  • Clouded in Confusion

    Clouded in Confusion

    Photo: Prostock Studio

    Confusion persists even as the U.S. Food and Drug Administration approves an ENDS product for marketing.

    By Timothy S. Donahue

    The U.S. Food and Drug Administration has created quite the mess. The regulatory agency’s handling of premarket tobacco product applications (PMTAs) has left many in the nicotine industry bewildered. It started with numerous refuse to accept and refuse to file letters. Then the agency began sending out marketing denial orders (MDOs). After publicly rescinding one of the MDOs—and with rumors circulating about additional rescissions—the agency is now being sued by at least 28 companies for making “arbitrary” decisions in reviewing PMTAs. The MDOs of least four companies have been granted a temporary stay through the courts or by the FDA itself.

    As of this writing, the FDA has granted the Vuse Solo device and two tobacco-flavored pods produced by the R.J. Reynolds Vapor Co. (RJRVC) the first-ever marketing orders for a vapor product. The decision shocked many because the Vuse Solo is an unpopular and outdated device, according to some observers. RJRVC’s main e-cigarette product, Vuse Alto, which accounts for the vast majority of the company’s market share, has yet to receive a marketing order. The Alto PMTA was submitted an estimated two years after the Solo PMTA, according to media reports.

    Sam Salaymah, president of AMV Holdings, parent to Kure CBD and Vape, called the FDA action a historic win for adult smokers that confirms e-cigarettes have been scientifically proven “appropriate for the protection of public health.” “[This] verifies that adult users are exposed to significantly fewer toxic aerosols and less harmful or potentially harmful constitutes than found in combustible cigarettes,” he says. “The science has spoken, and this is a great public health win for countless adult smokers looking to transition from deadly cigarettes.”

    Vuse Solo received the first-ever marketing orders for an ENDS product.
    (Photo: RJRVC)

    But while approving Vuse Solo tobacco-flavored pods, the FDA rejected five of RJRVC’s flavored products. The agency is expected to only approve tobacco flavored pod systems; however, the outlook for open systems (alongside bottles of flavored e-liquids) is anyone’s guess. James Xu, president and founder of Avail Vapor, says that eventually he expects the FDA to approve an open system and some bottled tobacco-flavored e-liquids. He says that studies have shown that very few youths use an open system to vape, and the FDA is likely considering that factor. “I think it is just a matter of time,” he says. “In light of the many lawsuits and confusion in the vaping industry, the FDA is now likely taking more time to review the PMTAs before making any more decisions either for or against a product. I think we will have an open system with a marketing order at some point.”

    Chris Howard

    As of Oct. 19, the agency had announced 323 MDOs, accounting for more than 1,167,000 flavored vaping products (there may be more unannounced). Many vaping industry representatives and public health researchers believe the removal of all flavored products would negatively impact harm reduction efforts in the United States. “Some vapers will undoubtedly return to smoking combustible cigarettes,” says Chris Howard, vice president, general counsel and chief compliance officer of E-Alternative Solutions. “And smokers who might have transitioned to ENDS [electronic nicotine-delivery system] products may now elect not to do so.” The current state of the ENDS industry is what many industry observers predicted as far back as 2016, according to Howard. Given the entry of ENDS products into an already highly regulated space, manufacturers would need to be “significantly capitalized and possess material expertise to navigate the requirements” to survive FDA regulation, he says.

    “Unfortunately, despite a near universal view that flavored ENDS products present a tremendous harm reduction opportunity to smokers seeking to quit or reduce their combustible cigarette intake, cost-saving shortcuts during the premarket approval process are very unlikely to meet FDA’s threshold regarding the quality, quantity and type of data required to obtain market orders,” says Howard. “In the short term, this will have a significant impact on consumers as they will now have significantly fewer choices of both devices and flavors available. That said, I remain confident that given time, the industry will obtain more clarity, and a path for the return of flavored vapor options will materialize. FDA is the biggest proponent of harm reduction when it comes to tobacco and recognizes that providing adult smokers with options is important.”

    Jamex Xu

    In the meantime, MDO recipients are fighting back. Pursuant to Section 912 of the Tobacco Control Act, companies who receive PMTA denials have 30 days to petition for a judicial review of the decision. Days after it received its MDO, Turning Point Brands (TPB) filed a petition for review with the United States Court of Appeals for the 6th Circuit, followed shortly thereafter with a motion to stay the MDO. Just days later, the FDA rescinded Turning Point’s MDO. The FDA admitted that after “further review of the administrative record,” it made an error in TPB’s PMTA review, and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, TPB’s president and CEO, in a statement following the rescission. “It is important that the PMTA process is transparent, purposeful and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance.”

    Azim Chowdhury

    The FDA has set an extremely high bar when it comes to authorizing e-liquid flavors, explains Azim Chowdhury, a partner at the law firm Keller and Heckman who specializes in vapor, nicotine and tobacco product regulation. According to Chowdhury, the MDOs essentially created a new standard for flavors: Applicants must demonstrate an “added benefit” of a nontobacco flavor that outweighs the known risk to youth use through the use of either a randomized controlled trial (RCT) or a longitudinal cohort study (LCS).

    “[The] FDA clearly jumped the gun with at least some of these companies in the way that they issued the MDO without giving the PMTAs a full scientific review as required by the statute. That being said, even if some of these lawsuits are ultimately successful, the outlook for flavored ENDS, to me, looks pretty grim,” says Chowdhury. “Even if we’re successful in these lawsuits and the MDOs get vacated and the PMTAs go back into review—which is good—the FDA is ultimately going to have the final say in what science is required and what is going to be enough for them to believe a flavored product is appropriate for the protection of public health.”

    Whatever data Vuse submitted for its flavored PMTAs hasn’t been disclosed publicly. Chowdhury says that it was likely robust and exceeding anything that most small manufacturers submitted for their flavors. “Right now, no one can tell you what it takes scientifically to get a flavor through,” he says. “Even in the best-case scenario, if we get the courts to say that FDA did this wrong, they should have done a hard look at the PMTAs, that they should have given companies fair notice about this requirement for RCTs and LCSs, they should have perhaps even gone through a notice and comment rulemaking period … even if one of those arguments win in court, it’s still only going to result in the PMTAs going back into scientific review.”

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    TPB’s stay motion (which the company dropped after the FDA rescinded its MDO) stated that the agency had moved the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far.” Nearly every MDO/PMTA lawsuit filed has followed TPB’s blueprint and is asking the courts to review the FDA order “on the grounds that it is arbitrary and capricious.” The FDA has already had MDOs for Triton Distribution, My Vape Order and Gripum LLC placed on hold by the courts, and the agency has told at least two other companies that received MDOs that it would rescind the orders or “not enforce” them, according to sources.

    Chowdhury said that technical project lead reports concerning PMTA reviews obtained through Freedom of Information Act requests revealed that the FDA performed a “box checking” exercise to see if an application contained an RCT or LCS instead of an actual scientific review of the application. “The first thing they have in these decision memos is, literally, a table where it says, ‘Do you have an RCT?’ No. ‘Do you have an LCS?’ No … then that’s it. If you said ‘no’ to both of those responses, they didn’t look at the rest of the application. This is mind-boggling because the statute, guidance and final PMTA rule, etc., all make clear that the APPH standard is a complex, multifactor standard. It requires all sorts of evidence and data, and it doesn’t require any one particular type of study. FDA avoided considering any of the other information contained in the PMTAs, including marketing restrictions and youth access prevention measures.”

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    Chris Allen

    The FDA’s rationale for banning flavored products is its desire to address what the agency has long described as an “epidemic” of youth vaping. However, recent evidence seems to show that the overall youth use of e-cigarettes in the U.S. is declining. According to the 2021 National Youth Tobacco Survey (NYTS), the FDA and the Centers for Disease Control and Prevention (CDC) found that youth use of e-cigarettes fell sharply in 2021. It’s the second consecutive year of major declines.

    Many in the industry say the FDA’s negligence in the PMTA review process and its single-minded focus in preventing youth uptake is going to create additional issues, further clouding the vapor industry’s outlook. Chris Allen, chief scientific officer at Broughton, a contract research organization (CRO) delivering analytical, scientific and regulatory services for the ENDS industry, says that the FDA might well be using the NYTS to justify the “flurry of MDOs” issued for flavored e-liquids. He also said the majority of the companies that have fallen foul of the recent MDOs are responsible manufacturers supporting tobacco harm reduction.

    “I completely accept that youth use is unacceptable; however, the issue doesn’t appear to lie primarily in open systems but a product that is currently outside the jurisdiction of FDA: a disposable containing synthetic nicotine,” says Allen. “Regardless of the product, or the source of nicotine, there’s no place for irresponsible marketing and distribution practices that keep adding fuel to this fire. I fear that the latest action is simply going to lead to a seismic shift into the black market and unregulated (synthetic nicotine) products, which will be near on impossible for the U.S. government to control. From my personal perspective, this doesn’t seem an appropriate way to support THR [tobacco harm reduction].”

  • FDA Stays Bidi Vapor MDO Pending Review

    FDA Stays Bidi Vapor MDO Pending Review

    The U.S. Food and Drug Administration has issued an administrative stay of its marketing denial order (MDO) for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).

    Bidi Vapor’s flavored Bidi Sticks may remain on the market without the threat of enforcement while the FDA reviews the company’s request.

    Bidi Vapor, which is part of Kaival Brands, submitted PMTAs for all 11 flavor varieties of its Bidi Stick. The applications ran over 285,000 pages and contained information supporting the products as appropriate for the protection of the public health.

    On Sept. 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the 11th Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act as well as the U.S. Constitution.

    “We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Bidi Vapor Niraj Patel in a statement. “As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored Bidi Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing.”

    “That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit,” Patel noted.

    The company has now filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals citing the “irreparable harm” it continues to suffer from the MDO.

    Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.

    According to Filter, Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

  • Court: Triton Can Sell Flavored E-Cigs Despite MDO

    Court: Triton Can Sell Flavored E-Cigs Despite MDO

    Photo: kwanchaift

    The 5th U.S. Circuit Court of Appeals has ruled that Triton Distribution can continue selling its flavored e-cigarettes despite a decision to the contrary by the Food and Drug Administration, reports Reuters.  

    In a unanimous opinion on Oct. 26, the 5th U.S. Circuit Court of Appeals said that when the FDA last month denied the Texas company’s application to sell its products, the agency did not adequately consider Triton’s marketing plan to reduce the products’ appeal to youth.

    The court found the FDA pulled a “surprise switcheroo” from earlier guidance stating that manufacturers would not need long-term studies to support e-cigarette applications.

    The FDA initially said in guidance accompanying the deeming rule that it did not expect companies would need long-term studies to support their application. However, in an August announcement that it would deny a first batch of applications, the agency said that manufacturers would likely need studies that followed a cohort of people over time to show that their products’ use in helping adult smokers quit cigarettes outweighed the risk to youth.

    Triton challenged the agency’s decision, saying it had relied on the earlier guidance in its application.

    Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.

    More recently, the FDA issued an administrative stay of its MDO for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its PMTAs.

    According to Filter, Bidi and Gripum too recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

     

  • FDA Rescinds Another Marketing Denial Order

    FDA Rescinds Another Marketing Denial Order

    The U.S. Food and Drug Administration has rescinded another marketing denial order (MDO), placing Fumizer’s flavored vapor products back under review, reports Filter. Fumizer received its MDO in September.

    This recission comes just weeks after the agency withdrew an MDO issued to Turning Point Brands (TPB).

    In a letter to Fumizer’s, the FDA stated that “upon further review of the administrative record, FDA found relevant information that was not adequately assessed previously.”

    “Specifically,” the letter states, Fumizer’s “application did contain randomized controlled trials comparing tobacco flavored ENDS [electronic nicotine-delivery systems] to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review.”

    The FDA has indicated that it “does not intend to initiate an enforcement action” on Fumizer’s flavored vapor products returning to the market during the new review.

    Many MDO recipients have complained that the FDA has been “shifting its goal posts,” during the review process, demanding certain studies that it did not appear to require before the PMTAs were filed.

    According to industry insiders, the most recent MDO recission demonstrates that TPB’s successful petition for review and motion for a stay wasn’t a one-off, resulting from the legal jurisdiction it was filed in.

    “A rescission in California for Fumizer is evidence of the systemic failure of the agency to ‘adequately assess’ the science and data of a wide range of small- and mid-sized applicants while giving all of their time and attention to the large companies like Juul and Reynolds,” a source told Filter

    Multiple companies have challenges their MDOs. Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

  • ‘MDO Rescission Not Necessarily a Precedent’

    ‘MDO Rescission Not Necessarily a Precedent’

    Photo: tashatuvango

    Even as consumer activists, vapor manufacturers and tobacco harm reduction advocates have taken heart from the U.S. Food and Drug Administration’s decision to rescind the marketing denial order (MDO) it had issued to Turning Point Brands (TPB), it is unclear whether that move sets a precedent, writes Alex Norcia in Filter.

    The problem, according to Norcia, is that TPB’s premarket tobacco product application is not publicly available, so that other manufacturers are left to guess how the company managed to get the agency to backtrack.

    At least 27 manufacturers and distributors, including Avail Vapor, Triton Distribution and My Vape Order (MVO), have filed petitions asking federal circuit courts to review their MDOs, according to Vaping360.

    In his article, Norcia details the travails of MVO, which on Oct. 20 petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on the company’s vapor products that have been removed from the market.

    Lawyers for MVO revealed that their client had shared studies and data with TPB and other companies, essentially arguing that the company did not receive the same treatment as TPB, even though the applications contain some of the same information.