Tag: U.S. Food and Drug Administration

  • 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 The decision shocked many because the Vuse Solo is an unpopular and outdated device, according to some observers.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].”

    Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
  • 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.

  • FDA Authorizes Product Not on the Market Since 2019

    FDA Authorizes Product Not on the Market Since 2019

    Photo: Altria Group

    The U.S. Food and Drug Administration has authorized the marketing of four oral tobacco products that are no longer on the market—Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint, manufactured by Altria subsidiary U.S. Smokeless Tobacco Co.

    “We are pleased that FDA has determined that Verve oral nicotine products are appropriate for the protection of public health,” said an Altria spokesman. “While we discontinued selling Verve on Feb. 2, 2019, we applied learnings from this successful application to our on! submissions, which remain under review by FDA. Oral nicotine products play an important role in our vision of moving beyond smoking and remain an important part of our portfolio of products to transition adult smokers away from cigarettes.”

    In a press release dated Dec. 17, 2018, Altria said it would stop the production and distribution of Verve oral nicotine products based upon the expected financial performance of these products and the regulatory restrictions that burdened the company’s ability to quickly improve these products. “We do not see a path to leadership with these particular products and believe that now is the time to refocus our resources,” wrote Chairman and CEO Howard Willard at the time.

    It its Oct. 19, 2021, marketing order, the FDA said it had determined the marketing of Verve products would be consistent with the statutory standard, “appropriate for the protection of the public health.” This includes a review of data showing that youth, nonsmokers and former smokers are unlikely to initiate or reinitiate tobacco use with these products.

    “Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public—especially kids,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.

    “While these are mint flavored products, data submitted to the FDA show the risk for youth uptake of these particular products is low, and stringent marketing restrictions will help prevent youth exposure. Importantly, evidence shows these products could help addicted smokers who use the most harmful combusted products completely switch to a product with potentially fewer harmful chemicals.”

  • Howard: Will Harm Reduction Prevail?

    Howard: Will Harm Reduction Prevail?

    Photo: Photolia 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.

    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.
  • Biden Eyes Robert Califf as FDA Head

    Biden Eyes Robert Califf as FDA Head

    Robert Califf

    U.S. President Joe Biden is likely to nominate Food and Drug Administration veteran Robert Califf to lead the agency, reports The Washington Post. A cardiologist who teaches at the Duke University School of Medicine, Califf was the FDA’s deputy commissioner for medical products and tobacco before leading it from February 2016 to January 2017.

    The FDA has been without a permanent chief since President Biden took office. Its acting commissioner, Janet Woodcock, is nearing the end of the term that acting officials are allowed to serve.

    While some praised Califf as a strong and experienced candidate, others criticized his ties to the pharmaceutical industry.

    “Rob Califf would be a strong, experienced and effective commissioner,” former FDA Commissioner Mark McClellan was quoted as saying by Politico.

    “The country desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical device industries has grown dangerously cozier—resulting in regulatory capture of the agency by industry,” countered Michael Carome, director of Public Citizen’s Health Research Group. “Califf would not be that leader.”

  • ‘Vuse Authorization a Positive for Harm Reduction’

    ‘Vuse Authorization a Positive for Harm Reduction’

    Photo: R.J. Reynolds Vapor Co.

    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 OKs Tobacco-Flavored Vuse Solo

    FDA OKs Tobacco-Flavored Vuse Solo

    Photo: R.J. Reynolds Vapor Co.

    The U.S. Food and Drug Administration has issued marketing orders to R.J. Reynolds (RJR) Vapor Co. for its Vuse Solo closed electronic nicotine-delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods.

    The orders allow RJR to legally sell its Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8 percent G1 and Vuse Replacement Cartridge Original 4.8 percent G2 in the United States. This marks the first set of ENDS products ever to be authorized by the FDA through the premarket tobacco product application (PMTA) pathway.

    “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement. “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.”

    Zeller said the FDA would 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,” said Zeller.

    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.

    Mitch Zeller, director, FDA CTP

    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. The FDA found RJR’s products 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 from aerosols compared to users of combusted cigarettes.

    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 nonusers of tobacco products, and, importantly, youth. 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.

    While authorizing the marketing of tobacco-flavored Vuse Solo e-liquid pods, the FDA 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.

    The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand. 

    BAT welcomed the marketing orders. “We are pleased that, today, Vuse Solo received the first of its kind U.S. Food and Drug Administration marketing authorization for vapor products, authorizing the sale of our U.S. subsidiary Reynold’s Vuse Solo product in Original flavor,” the company wrote in a statement following the FDA announcement. “FDA’s orders confirm that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers aged 21-plus have access to innovative and potentially less harmful alternatives to traditional tobacco products.”

    The company said it was studying the MDOs for five flavors currently not on the market.

    FDA has turned its back on the public health by approving a high-nicotine e-cigarette.

    Raja Krishnamoorthi, chairman of the House Oversight Committee’s Subcommittee on Economic and Consumer Policy

    Anti-tobacco activists expressed disappointment with the FDA’s decision. “While it is a positive step that FDA denied applications for 10 flavored Vuse e-cigarettes, it is concerning that a product that has three times the nicotine concentration as legally permitted in Canada, the U.K. and Europe was authorized,” wrote Matthew Myers, president of the Campaign for Tobacco-Free Kids, on the organization’s website. “Vuse products with this level of nicotine leave our nation’s youth at an undue risk of addiction.”

    “FDA has turned its back on the public health by approving a high-nicotine e-cigarette,” said Raja Krishnamoorthi, chairman of the House Oversight Committee’s Subcommittee on Economic and Consumer Policy. “Many countries around the world have capped the amount of nicotine allowed in e-cigarettes, which allowed them to avoid a youth vaping epidemic.”