Tag: PMTA

  • 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order (MDO) for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).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 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 challenges 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 In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.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 Pending MDO Review

    Court: Triton Can Sell Flavored E-Cigs Pending MDO Review

    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

    Credit: AliFuat

    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 rescission 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.

  • Judges Grant Triton Stay on FDA’s Market Denial Order

    Judges Grant Triton Stay on FDA’s Market Denial Order

    Wages and White Lion Investments, parent to Triton Distribution, has been granted a stay of the marketing denial order (MDO) it received from the U.S. Food and Drug Administration. The panel of judges for the U.S. Court of Appeals for the Fifth Circuit issued the order on Oct. 15 that also granted motions to expedite the appeal case and a ruling for emergency relief.

    Credit: Pixelbliss

    The motion granted means the company can continue to market its electronic nicotine-delivery system (ENDS) products until the court decides on the company’s appeal of the FDA’s decision to deny its premarket tobacco product applications (PMTAs).

    Triton Distribution filed a motion to stay after the FDA denied the company’s PMTA, in which Triton stated that it had been irreparably harmed as a result of the FDA’s actions and faced an imminent shutdown of its business if the motion to stay had not been granted.

    “Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence it required to support a premarket tobacco product application (“PMTA”) for a marketing order for flavored electronic nicotine delivery system (“ENDS”) products almost a year after such applications were due,” the motion states. “FDA also acted arbitrarily and capriciously by ignoring relevant evidence found in Petitioner Wages and White Lion Investments, LLC d/b/a Triton Distributions (“Triton”) PMTA and applying a double standard to its consideration of that evidence when it issued Triton a marketing denial order (“MDO”). Further, by imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law.”

    At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands (TPB) and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).

    The FDA admitted 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. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS 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.”

     

  • Yach: Vuse Approval a Positive for Tobacco Harm Reduction

    Yach: Vuse Approval a Positive for Tobacco Harm Reduction

    Derek Yach

    More governments need to follow the science.

    By Derek Yach

    The evidence is in. For the first time, the U.S. Food and Drug Administration has authorized the marketing of an e-cigarette in the country because it determined the help it offers adult smokers outweighs the attraction such products may hold for youth.

    The decision to allow the sale of British American Tobacco’s Vuse Solo closed electronic nicotine-delivery system, along with three tobacco-flavored cartridges, marks the third time in less than two years that the agency, despite vociferous, emotion-driven opposition from politicians and interest groups, has used peer-reviewed scientific evidence to approve tobacco harm reduction (THR) products.

    With this latest move, the FDA has signaled a distinct turn in the oft-contentious debate surrounding e-cigarettes, in which opponents claim little is known about what toxic chemicals they contain and that the tobacco industry has a terrible track record when it comes to being forthcoming about its products.

    That was not the case here, indicated Mitch Zeller, the director of the agency’s Center for Tobacco Products. “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust scientific premarket evaluation,” he said in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.”

    We have said it before, and we’ll continue to say it again (and again and again) in the face of all this misinformed vitriol and distrust: THR products are effective tools to help smokers lessen their risk of developing diseases such as lung cancer and COPD. So says one study after the next, including a recent measured, sober look at the risks and benefits of e-cigarettes that is signed by no less than 15 former presidents of the Society for Research into Nicotine and Tobacco, a leading international proponent of evidence-based science.

    The key word here is “evidence.” Although e-cigarettes are not risk-free, they have been found to be up to 95 percent less harmful than combustible cigarettes because they contain no tar and significantly fewer chemicals that make up the toxic stew of smoke in combustible cigarettes.

    Evidence, carefully compiled, weighed and debated, is how the FDA reached its earlier decisions to provisionally authorize the sale of Swedish Match’s snus and Philip Morris International’s IQOS heat-not-burn sticks as modified-risk tobacco products (MRTPs), subject to regular review. And “evidence” is how it made its first decision to approve the marketing of Vuse.

    It reached its decision through dispassionate, rigorous diligence—a risk-proportionate, microscopic gauging of the potential harm e-cigarettes pose for young people versus their potential therapeutic uses for adults who smoke combustible cigarettes and would like a less damaging alternative. Indeed, the FDA’s approval process is so thorough, it is accepted as the international gold standard for vaccines, pharmaceuticals and medical devices. As Adam I. Muchmore, a Pennsylvania State University law professor, explained last month [August] in an interview with Newsweek about the wait for Covid-19 vaccine approval, “There are a lot of ‘i’s’ to be dotted and ‘t’s’ to be crossed, and these are not simple bureaucratic requirements. Both producing this data, and reviewing it, requires the work of multiple experts in a wide range of scientific fields.”

    We hope the FDA will continue to use scientific evidence to approve the sale of menthol-flavored e-cigarettes so that combustible menthol cigarette users, among them the majority of African-American smokers, also have the opportunity to reduce their health risk. And we hope it will consider that nicotine-replacement therapy gums and sprays are already marketed in menthol and other flavors, all to help smokers quit.

    One does not need to look far to see the effects of FDA decisions: Following its full approval last August of Pfizer-BioNTech’s Covid-19 vaccine, a “tidal wave” of people were expected to line up for their jabs, spurred by employers and businesses that have been waiting for the green light and at least some doubters who needed more reassurance it is safe.

    And the National Institutes of Health’s Anthony Fauci aptly summed up the FDA’s influence in a comment earlier this year about its approval for Aimmune Therapeutics’ Palforzia, the first drug to treat peanut allergy for children. “Science is showing us the path to a future in which new therapeutic options may provide both solutions as well as peace of mind that individuals with food allergies and their families deserve,” he said.

    Those words could well apply to the field of THR too, although the FDA’s policy of placing the onus solely on individual companies to prove they contribute to public health (to wit, the 2.3 million pages of evidence PMI submitted on behalf of its IQOS application) has already left some smaller, streamlined companies out in the cold.

    That said,  governments in lower and middle income countries (LMICs), where the vast majority of the world’s 1.14 billion smokers live, would do well to study all three of the FDA decisions regarding THR products as they work to strengthen their own national research and regulatory capabilities and to take note of the careful steps the agency continues to take as it examines the applications of other companies that manufacture e-cigarettes, including Juul.

    These governments and their public health authorities need to review the statistics from places such as the United Kingdom, which has supported e-cigarette use as an effective way to lessen health risks and even quit combustible smoking altogether. Or, conversely, they could take two minutes and 42 seconds to watch a graphic Public Health England demonstration of the viscous, oozing, sticky dark brown residue left in the lungs from the smoke from 16 packages of cigarettes over the period of one month compared to the barely discernible trace of vapor left by the equivalent number of e-cigarettes over the same period.

    Right now, a huge gap exists between research output in tobacco control by a few developed countries and LMICs, and when it comes to reduced-risk products, the gap is even greater, a reflection of both the lack of support for homegrown scientific research and a concomitant reliance on advanced industrialized countries for regulatory scientific advice and support. The Foundation is committed to playing its role in closing this gap to allow LMICs to have the scientists able to fully inform their policymakers about the potential benefits of THR.

    There appears to be no interest in tobacco harm reduction as a principle or a tendency to unquestioningly accept the warnings by bodies such as the World Health Organization, which itself is mired in a past overtaken by technological advancements and sounds like the proverbial Greek chorus as it points to the lack of long-term testing and the perils such products pose to youth.

    The most extreme example of this governmental attitude is in India, where, despite 1.3 million people dying each year from tobacco-related diseases, e-cigarettes were banned in haste by the government, which was urged to do so by The Union, a Bloomberg-funded NGO based in Paris that recommends such extreme measures for LMICs on the supposed grounds that youth in these countries are particularly vulnerable. In turn, this has led to a burgeoning black market that prices these products out of reach of many of the disadvantaged communities who could use them most.

    The fact is, the most favored tobacco control measure in India is tax increases, which only serves to exacerbate the difference between the rich and the poor, for the latter group must turn to cheaper, even more dangerous products such as bidis, thin cigarettes composed of unprocessed tobacco that are hand-rolled in leaves and contain higher concentrations of nicotine, tar and carbon monoxide than conventional cigarettes sold in the United States.

    In Indonesia, where more than a quarter of the population smokes, including 19.4 percent of young people between the ages of 13 to 15, the local—and significantly cheaper—cigarette of choice is the unfiltered kretek, made from a blend of tobacco, cloves and other additives. Yet, there is little government oversight, with children even exposed to lengthy tobacco advertisements before blockbuster Hollywood films.

    Still, the WHO refuses to apply the consequences of harm reduction always being part of the definition of tobacco control in the Framework Convention on Tobacco Control. A good start would be for the WHO to consider recent peer-reviewed research by leading scientists that underpins the FDA submission and not reject it simply because it has been funded by the tobacco industry. In its Report on the Global Tobacco Epidemic—2021, it does not waver from its position, stating that new and emerging products simply chart a “new threat to tobacco control.”

    “As they emerge and rapidly evolve, these products can be difficult to characterize and therefore bring with them many regulatory challenges,” it states. “At the same time, the tobacco and related industries behind these newer products pedal misinformation campaigns, marketing them as ‘clean,’ ‘smoke-free’ or ‘safer,’ and claim they are effective cessation aids. By doing so, these industries attempt to appear part of the solution to the tobacco epidemic as opposed to instigators and perpetrators of the epidemic.”

    How disheartening! Yes, the tobacco industry has acted unconscionably in the past, lying about the toxicity of cigarettes and shamelessly professing its primordial dedication to the health and welfare of smokers. But, to paraphrase the old saying, change—real change—starts from within. We are seeing signs of that in the tobacco industry, with the results recognized by the FDA, leading health experts and authorities in countries such as the U.K.  

    It is time for all of us to move on—together.

    To stop treating all nicotine products as the same.

    To acknowledge that we all have a stake in people’s health and well-being and in a healthy future for our children, their children and for generations to come.

    And to start saving up to 4 million lives a year in the interim as the battle—our battle—continues to eradicate combustible tobacco for good.

    Derek Yach is the president of the Foundation for a Smoke-Free World.
  • Howard: Will Harm Reduction Prevail?

    Howard: Will Harm Reduction Prevail?

    Credit: Fotolia Premium

    It could be some time before the U.S. Food and Drug Administration issues marketing orders for flavored vapor products.

    By Chris Howard

    For the past 10 years, we have ridden a rollercoaster together. We have experienced the same highs and lows and shared the hope that harm reduction will prevail in the end. Then, over the course of the past several weeks, the journey ended abruptly with marketing denial orders (MDOs) for so many. Not surprisingly, several question whether the vapor industry can ever recover.

    The FDA’s Recent Actions

    For what it’s worth, the recent actions of the U.S. Food and Drug Administration should not have been a surprise to anyone in the vapor industry. We have known for several years that being part of a highly regulated segment would not be easy. In fact, the FDA made its expectations clear in its 2016 Draft Guidance entitled Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (ENDS). In sum, this document revealed that obtaining a marketing order for vapor products would require scientific expertise, extensive data development and very deep pockets.

    That said, the FDA’s rationale for such broad-based denials has raised questions among many. More specifically, the FDA provided the following rationale in its Aug. 26, 2021, news release:

    In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.

    Chris Howard
    Chris Howard

    The primary question we are left to ponder is whether this balancing of interests exceeds the FDA’s standard for assessing whether a product is appropriate for the protection of public health. Based on Section 910 of the Tobacco Control Act, which describes the appropriate standard of review, it appears that this balancing is one of many facets of an application that the FDA is required to consider.

    Appropriate for the Protection of Public Health

    Section 910 of the Tobacco Control Act provides the FDA’s standard of review for new tobacco products:

    …whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—

    (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

    (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

    So clearly, the risk of initiation of flavored ENDS products by youth is relevant as is the likelihood of ceasing use by smokers generally. Without a doubt, the FDA has determined that evidence related to part (A)—cessation—must outweigh part (B), initiation. This risk balancing, in the FDA’s own words, is reflected in data from clinical studies or longitudinal studies demonstrating that adult use of flavored ENDS leads to cessation (or switching) outcomes that exceed the risk of youth initiation of tobacco product use. And yet, despite this seeming clarity, many questions surround this analysis. For example, by how much must adult cessation exceed youth initiation? What if both tobacco varieties and flavored varieties show the same or similar cessation rates? Has the FDA considered the reduction in use by youth resulting from the recent change in the age to purchase tobacco products to 21 when examining the balancing of risks versus benefits?

    These questions are likely to remain unanswered for quite some time. Many committed companies are already beginning efforts to satisfy the FDA’s outstanding requests for clinical studies and/or longitudinal data, but the development of data will take several months. Obviously, this is likely to do significant damage to an already fractured market—and even more potential damage to smokers seeking an alternative to combustible cigarettes.

    Flavors Are Critical for Harm Reduction

    Despite these tumultuous past few weeks, the FDA is arguably the biggest advocate for harm reduction. Given the agency’s desire to provide options to adult smokers to move away from traditional combustible cigarettes, it seems clear that a pathway for flavors to return does indeed exist.

    Along with the rest of the industry and many public health researchers, I believe that 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. And smokers who might have transitioned to ENDS products may now elect not to do so. In the studies conducted at my company, E-Alternative Solutions, we demonstrated that adults prefer flavors and that flavors assist adults in transitioning from combustible cigarettes to potentially less harmful alternatives. Existing literature documenting the research conducted by others also supports this proposition. Moreover, anecdotal reports are easy to find on Twitter and multiple other social media forums.

    While it may not be apparent from the FDA’s recent actions, I do not believe that flavored ENDS are finished in the United States. While the bar appears high, I hope and expect, for the sake of adult smokers in this country, that we will see flavored ENDS on the U.S. market again. That said, it could take time until the agency issues market orders for flavored vapor products.

    What’s Next?

    The FDA’s recent decisions will likely prompt many to appeal and some to resort to litigation [at least two suits are known to have been filed already]. The FDA appears prepared to address these initiatives and is prioritizing enforcement of those failing to comply with MDOs and/or who are selling vapor products that have not undergone premarket review. While these activities are ongoing, many will begin longitudinal studies and the hard work to identify alternative methods to show the FDA that flavors are determinative in adult smokers’ efforts to switch from combustible cigarettes.

    Ultimately, we will have to wait while the remainder of the story unfolds. Hopefully, the FDA will be prepared to work directly with sophisticated manufacturers to ensure that flavored ENDS can continue to play a role for adult smokers seeking alternatives.

    Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.

  • FDA Grants First Vapor Marketing Orders to RJR’s Vuse

    FDA Grants First Vapor Marketing Orders to RJR’s Vuse

    The U.S. Food and Drug Administration announced today it has authorized the marketing approval of three new vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse device and two tobacco-flavored pods It marks the first set of electronic nicotine-delivery system (ENDS) products ever to be authorized by the FDA through the premarket tobacco product application (PMTA) pathway. It also denied Vuse PMTAs for flavored products other than tobacco.

    The FDA issued marketing granted orders for RJR’s Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.

    The agency suggests the data submitted to the FDA by RJR demonstrated that marketing of these products is appropriate for the protection of public health. The authorization allows these products to be legally sold in the U.S.

    “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”

    Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health. These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes, according to a release.

    “The toxicological assessment also found the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies. 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,” the release states. “This included review of available data on the likelihood of use of the product by young people. For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.

    The FDA also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products.

    These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand.

    “Additionally, today’s authorization imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products,” the release states. “RJR Vapor Company is also required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.

    The FDA may suspend or withdraw a marketing 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 significant increase in youth initiation. While today’s action permits the products to be sold in the U.S., it does not mean these products are safe or “FDA approved.”

    The agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public

  • Triton Distro FDA Lawsuit Decision Expected This Week

    Triton Distro FDA Lawsuit Decision Expected This Week

    Triton Distribution filed a motion to stay the U.S. Food and Drug Administration’s decision to issue the company marketing denial orders (MDOs) for its premarket tobacco product applications (PMTAs). The company requested a decision from the judge by Oct. 15.

    “Black-letter rules of administrative law prevent an agency from retroactively changing legal requirements and from doing so without accounting for reliance interests. FDA failed to satisfy these requirements when it executed an about-face on the evidence it required to support a premarket tobacco product application (“PMTA”) for a marketing order for flavored electronic nicotine delivery system (“ENDS”) products almost a year after such applications were due,” the motion states. “FDA also acted arbitrarily and capriciously by ignoring relevant evidence found in Petitioner Wages and White Lion Investments, LLC d/b/a Triton Distributions (“Triton”) PMTA and applying a double standard to its consideration of that evidence when it issued Triton a marketing denial order (“MDO”). Further, by imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law.”

    Triton states that it has been irreparably harmed as a result of the FDA’s actions and faces an imminent shutdown of its business in approximately two weeks. This is why Triton entered an emergency stay of the “FDA’s MDO for Triton’s products by October 15, 2021, and order expedited merits briefing. Respondent FDA consents to the proposed expedited merits briefing schedule but opposes a stay.”

    At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands (TPB) and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).

    The FDA admitted 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. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS 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.”

  • FDA Admits Error, Rescinds Turning Point Brands MDOs

    FDA Admits Error, Rescinds Turning Point Brands MDOs

    Turning Point Brands (TPB) has had its marketing denial orders (MDOs) rescinded by the U.S. Food and Drug Administration. The company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s premarket tobacco product application (PMTA).

    “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, president and CEO, Turning Point Brands. “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. We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”

    Credit: Momius

    The FDA admitted 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. “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads the FDA letter to TPB. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS 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 letter comes after TPB filed a petition with the court that forced the FDA to provide an administrative record for its decisions on PMTAs. TPB sells various flavored e-liquids marketed under the Solace, VaporFi and Vapor Shark brands. TPB then filed a stay motion asking the the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”

    Avail Vapor and several other companies that received MDOs have also now filed petitions for information related to their PMTA reviews. After the FDA rescinded TPB’s MDOs, the company dropped its lawsuit against the regulatory agency.

    “In light of the unusual circumstances,” the FDA’s Center for Tobacco Products (CTP) Director Matt Holman stated in the letter. “FDA has no intention of initiating an enforcement action” against TPB’s products that had previously received an MDO.

  • FDA Issues First Warning Letters for MDO Violations

    FDA Issues First Warning Letters for MDO Violations

    The U.S Food and Drug Administration today issued warning letters to 20 companies for unlawfully continuing to market electronic nicotine-delivery system (ENDS) products that are the subject of marketing denial orders (MDOs).

    These are the first warning letters issued for the marketing of products subject to MDO determinations on their premarket tobacco product applications (PMTAs), according to an FDA statement. The FDA has also issued warning letters for the unlawful marketing of tobacco products to one company that received Refuse to File (RTF) determinations on their PMTA, one company that received both RTF and MDO determinations on their PMTA, and six companies that did not submit any premarket applications.

    “Collectively, these 28 companies have listed a combined total of more than 600,000 products with the FDA. All new tobacco products sold, distributed, or imported in the United States without FDA authorization are marketed unlawfully and risk FDA enforcement,” the statement reads. “On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.”

    Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.

    Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.