Tag: Marketing Denial Order

  • Authorization Denied

    Authorization Denied

    Credit: Waldemarus

    The U.S. Food and Drug Administration devastates small businesses with a plethora of marketing denial orders.

    By Timothy S. Donahue

    At press time, the U.S. Food and Drug Administration had yet to approve an electronic nicotine-delivery system (ENDS) product for sale in the U.S. But it had killed much of the U.S. market for such products. As of Sept. 23, the agency had issued 323 marketing denial orders (MDOs) accounting for more than 1,167,000 flavored vaping products. In addition, the FDA previously refused to accept (RTA) or refused to file (RTF) a significant share of the nearly 7 million applications it received from more than 500 companies.

    At least four lawsuits contesting MDOs have been filed in the 2nd, 4th, 6th and 11th Circuit Courts of Appeals against the FDA. Turning Point Brands (TPB) filed a petition for review with the United States Court of Appeals for the 6th Circuit. The petition 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.

    In a surprise move as this magazine was going to press, the FDA rescinded Turning Point Brands’ MDO. 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. The FDA had not yet responded to the remaining cases as of press time.

    “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” the FDA letter to TPB states. “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.”

    TPB was asking 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.” The company requests the court “vacate or modify” the FDA order and asks that TPB be allowed to “continue to market the products subject to the challenged order.” Bidi Vapor filed a similar suit in the U.S. Court of Appeals for the 11th Circuit, BMF (Bad Modder Fogger) filed in the 4th Circuit and Magellan Technology, parent to DemandVape, has filed in the 2nd Circuit (those lawsuits are still active).

    Credit: CASAA

    In addition to its arbitrary claim, Magellan also claims in its court petition that the “FDA’s issuance of an MDO in the absence of a finalized rule” setting forth the required contents of a PMTA is unlawful. “FDA’s adoption of a comparative efficacy standard for the granting of a marketing order for non-tobacco- and non-menthol-flavored ENDS products versus tobacco-flavored ENDS products is, in reality, a disguised tobacco product standard that has been adopted and is being applied by FDA through adjudication rather than adopted through notice-and-comment rulemaking,” states Magellan’s petition.

    According to Mitch Zeller, the director of the FDA’s Center for Tobacco Products (CTP), many of the accepted applications ultimately received an RTF letter because they did not include required information. “For example, companies received RTF letters for not including required content such as ingredient listings, labels for each product to be marketed or adequate environmental assessments,” he wrote.

    In a joint news release with Zeller and acting FDA Commissioner Janet Woodcock, the FDA explained that the applications from many MDO recipients “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the levels of youth use” of ENDS products.

    The PMTAs submitted by TPB and subsequently denied market access and the brought back under review by the FDA included an in-depth toxicological review, a clinical study and studies on patterns and likelihood of use, according to a motion to stay filed by TPB on Sept. 30. “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.

    Many of the current lawsuits against the FDA accuse the FDA of many of the same issues TPB’s withdrawn suit claimed. For example, TPB’s stay said 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,” according to the stay. TPB noted that the “North Star of administrative law” is that agencies cannot induce regulated parties to rely on “agency representations about regulatory requirements” then penalize them using the previously unannounced criteria after the fact.

    “But that is precisely what FDA did here,” the stay motion states. “[The] FDA reasoned that TPB failed to conduct ‘a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do. Yet FDA previously deemed these studies unnecessary.”

    Tony Abboud, executive director of the Vapor Technology Association, suspects the FDA made an internal policy decision to change the PMTA standard to make it impossible after the fact for a company to comply and get a flavored ENDS application approved. “I think that that decision is being implemented application by application, which I don’t believe is fair under the law,” said Abboud. “I think that the refocusing on open system flavored e-liquids is a direct result of the public and political pressure that was placed upon the FDA by Congress, which expressly said they were trying to interfere with the regulatory process.”

    What’s in a name?

    Critics say the FDA has made several “sloppy” mistakes in reviewing PMTAs and issuing MDOs. Numerous companies say the agency was inconsistent in banning flavors based solely on the flavor’s name. Bidi Vapor’s parent, Kaival Brands, said that the agency banned its “Arctic” flavor, misidentifying it as a “not-menthol” flavor. TPB also says in its stay motion that the FDA is forcing TPB to pull nonflavored products from the market; however, the FDA’s order applies to “Authentic Tobacco” and “Bold Tobacco” yet not “Classic Tobacco” (which the FDA is still considering).

    Credit: Cursed Senses

    “Those are the same flavors with the same formulations; they just use different names across product lines. The same goes for ‘Ripe Tobacco’ (forbidden) and ‘Smooth Tobacco’ (reprieve) and for ‘Mint’ (banned) and ‘Mighty Menthol’ (allowed for now),” the stay explains. “It is anyone’s guess why some of these products must exit the market immediately yet others might pass muster if FDA actually reviews TPB’s studies.”

    Since January 2021, the agency has issued at least 170 warning letters to firms that collectively have listed more than 17 million ENDS products with the FDA and that did not submit premarket tobacco product applications (PMTAs) for the products by Sept. 9, 2020. Applications for products manufactured by major companies, such as Vuse, Juul, Logic and blu, are still under review. During this time, the agency also granted substantial equivalence (SE) status (marketing approval) to over 350 combustible products from the cigar, pipe and hookah tobacco product categories.

    Amanda Wheeler, president of the American Vapor Manufacturers Association (VMA) and the owner of Jvapes e-liquids (see “No Surrender,” page ?), assisted more than 230 small-sized to mid-sized e-liquid manufacturers in submitting PMTAs for more than 1.7 million products. Nearly all of those applications received either an RTA, RTF or an MDO.

    Wheeler tweeted on Sept. 9 that it was a “tough day” for the industry because “lots of very good people who I respect deeply and who helped thousands of smokers quit got told by our government that their products were illegal. To all of you, I am so very sorry. To your customers, I am even more sorry. Our government is wrong on this.”

    Before the announcement, many industry experts said that banning most e-cigarettes from the market could harm public health. In a commentary published on the Reason Foundation’s website, Guy Bentley, the organization’s director of consumer freedom research, states that the sooner that U.S. public health officials embrace vaping’s potential to improve public health by reducing smoking and smoking-related deaths, “the better off we’ll all be.” The result of shutting down a vast portion of the vape industry, he warns, will be more smoking.

    Anti-vaping activists, by contrast, argued for a ban on e-cigarettes. In a recent blog post, Laurie Rubiner, executive vice president of domestic programs at the Campaign for Tobacco-Free Kids, and Linda Mendonca, president of the National Association of School Nurses and an assistant professor at the Rhode Island College School of Nursing, wrote that the “evidence is clear” that as long as any flavored e-cigarettes remain on the market, kids will get their hands on them (no reference to evidence was provided).

    “To truly protect kids and end the youth e-cigarette epidemic, the FDA must eliminate the flavored and high-nicotine products—including the popular menthol flavor—that have driven this crisis,” the pair write. “Parents, educators and health advocates are counting on the FDA to take them off the shelves.”

    Tom Miller, attorney general for the state of Iowa, said the FDA actions against flavors endanger public health. He said that the best science available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes.

    “Let’s not forget the overwhelming risk to public health: The CDC [U.S. Centers for Disease Control and Prevention] estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes,” Miller said in a statement. “We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policymakers must strike the right balance between making accessible potentially lifesaving lower risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.”

    Impacts of regulation

    Several studies have suggested that if vape product sales were restricted to tobacco flavors, many would return to combustible tobacco. One study found that approximately one-third of U.S. vapers aged 18 to 34 say flavor bans would push them back to smoking traditional cigarettes. The study published in Nicotine & Tobacco Research analyzed data from February to May 2020 and looked at 2,159 young adults in Atlanta, Boston, Minneapolis, Oklahoma City, San Diego and Seattle, examining support for e-cigarette sales restrictions and the perceived impact of flavor and vaping bans.

    Credit: JHVEPhoto

    Two other recent studies showed similar results. A study in JAMA Pediatrics showed that following San Francisco’s flavor ban, teens were more likely to smoke than those in other school districts. A different study in Nicotine & Tobacco Research shows that teens who vape would be smoking cigarettes if vapes hadn’t become available.

    Recent evidence also 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 CDC found that youth use of e-cigarettes fell sharply in 2021. It’s the second consecutive year of major declines. As is typical in the release of the NYTS data every year, media reports about the NYTS were all over the board. One headline read, “Big Drop in U.S. Teen Vaping with Covid Closures” while another read, “Teen Vaping Craze Shows No Sign of Slowing.”

    The study shows that an estimated 11.3 percent (1.72 million) of high school students and an estimated 2.8 percent (320,000) of middle school students reported current e-cigarette use, lower than the 19.6 percent (high school) reported in 2020 and substantially lower than the 27.5 percent (high school) reported in 2019, according to previous FDA statements. Middle school vaping fell to 2.8 percent this year from 4.7 percent in 2020—a 40.4 percent decline. Middle school past 30-day vaping in 2020 fell 55.2 percent from 2019.

    Chris Allen, chief scientific officer at Broughton, a contract research organization (CRO) delivering analytical, scientific and regulatory services for the ENDS industry, said 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,” Allen said. “Regardless of the product, or the source of nicotine, there’s no place for irresponsible marketing and distribution practices that keeps 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].”

    Industry representatives predict major battles at the state level. “States are just going to ban the sale of any non-FDA approved product,” said a vape shop owner, who asked not to be identified as he had not yet received an MDO. “This is just going to be a never-ending stream of court battles. I hope every company is at least considering appealing the MDO decisions. The whole PMTA process was a giant bait-and-switch.”

    Manufacturers that submitted their applications by the Sept. 9, 2020, deadline but who have not yet received an MDO can effectively continue to sell their products as no ruling has been made on them; however, the FDA has made it clear that any company that does continue to sell these products will be doing so unlawfully, although they are not likely to face any enforcement action due to the agency’s limited resources.

    Numerous companies are appealing their MDOs. Many are appealing MDOs they believe were wrongly issued because the PMTAs were for tobacco and/or menthol flavors. The AVM is helping its member companies file formal appeals with the FDA because the agency “in their sloppy haste, FDA not only threw out flavored products. They also threw out many [companies] [regular] tobacco and menthol flavors. We’re starting with some of those appeals specifically for what we feel were sort of administrative errors with tobacco and menthol and also working on broader appeals.”

    Companies can also contact the CTP’s Office of Small Business Assistance (OSBA) with general questions regarding statutory and regulatory requirements, including the appeals process. Another option is the FDA Office of the Ombudsman, the agency’s “focal point for addressing complaints and assisting in resolving disputes between companies.”

    Deanna Clark with the Clark-Esposito Law Firm stated in a blog post that each company must submit its own submission appealing the FDA decision. Companies should not send in an appeal combined with other companies, she cautioned. “Next, you want to address arguments refuting [the] FDA’s basis for your denial. It can’t just be where you’re complaining about how it’s unfair and the government sucks,” said Clark. “You need to use some rational basis behind what you’re submitting to them. And thirdly, you need to submit it to the right office and make sure it gets to the right people within the right timeframe.”

    The e-cigarette saga with the FDA is far from over. Between lawsuits and appeals, many decisions may eventually be left out of the hands of the FDA entirely. The FDA’s ombudsman and appeals court judges could now decide the fate of flavored e-liquids. Congress could possibly step in and change the statutes, but many have said that is unlikely. The industry is also still waiting for decisions on the PMTAs filed by the major tobacco companies, and if anyone is approved, it may open the door for standard equivalency products. The only thing that hasn’t changed in the vaping industry is its uncertain future.

  • 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.

  • ‘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, Gripum LLC and My Vape Order (MVO), have filed petitions asking federal circuit courts to review their MDOs. MVO and Gripum has had their motions to stay the MDO granted by courts. Avail is rumored to have had its MDO rescinded. 

    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.

  • 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.
  • 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.