Tag: PMTA

  • Juul Sues FDA for Failure to Disclose Documents

    Juul Sues FDA for Failure to Disclose Documents

    Credit: Insurance Journal

    The battle between Juul Labs and the U.S. Food and Drug Administration continues to gain steam. The vapor manufacturer has now filed a lawsuit against the FDA over the agency’s refusal to disclose documents supporting its marekting denial order (MDO) that bans a company from selling e-cigarettes on the U.S. market.

    In a complaint filed on Tuesday with a federal court in Washington, D.C., Juul Labs accused the FDA of invoking the “widely abused” deliberative process privilege to improperly withhold scientific materials that are “central” to understanding the basis for the June 23 issuance of the MDO, according to Reuters.

    The company claims the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims Juul e-cigarettes help smokers quit combustible cigarettes, and whether the agency’s reasoning was scientifically sound.

    “The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years,” Juul Labs stated.

    An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.

    Juul Labs accused the FDA of violating the federal Freedom of Information Act by withholding a majority of the “scientific disciplinary reviews” underlying the sales ban.

    The company said it filed an administrative appeal of its MDO through the agency, but the FDA missed a Sept. 13 deadline to resolve it.

    A federal appeals court temporarily stayed Juul’s MDO on June 24.

    Earlier this month, Juul Labs settled youth marketing lawsuits with 33 states and Puerto Rico.

  • Norcia: FDA Amps up Attacks on Unauthorized Vapes

    Norcia: FDA Amps up Attacks on Unauthorized Vapes

    Credit: Puwasit Inyavileart

    During an interview with Politico on Sept. 6, Brian King, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), would not say whether the agency was willing to take unauthorized vaping products off the market.

    In his first interview since taking the reins of CTP, King said that he was “committing to explore all viable pathways that are legally and scientifically defensible,” adding that “nothing is off the table.”

    He did not acknowledge anything about the commission of external experts looking into CTP procedures, however, writes Alex Norcia of Filter, the agency is already in the process of seeking court orders, threatening lawsuits and demanding the destruction of unauthorized next generation nicotine products.

    “Filter has confirmed that the FDA, by September 1, advised the Department of Justice (DOJ) that at least two open-system vape companies were in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) because the manufacturers did not file premarket tobacco product applications (PMTAs) and were continuing to sell their products,” Norcia writes. “According to a letter to one of the vape companies, viewed by Filter, the feds are seeking court orders, threatening lawsuits and demanding the destruction of unauthorized products.”

    CTP has denied an estimated 99 percent of marketing applications and dozens of companies have sued over their denials, which they have largely argued were “arbitrary” and “capricious.”

    “We plan to seek a court order to permanently enjoin you … from, among other things, directly or indirectly manufacturing, distributing, selling, and/or offering for sale any new tobacco product at or from any of your facilities, unless and until, among other things, the product receives, and has in effect, marketing authorization from FDA,” reads the letter, signed by DOJ Senior Litigation Counsel Christina Parascandola and dated September 1. “The enclosed proposed consent decree,” it continues, “states the terms upon which the government would be willing to settle the suit that we plan to file.”

    Filter agreed not to disclose the names of the individuals and companies that received the letters (one of the companies has now ceased business operations) because of the possibility that litigation could unfold. The FDA did not respond to Filter’s request for comment by publication time.

    “Defendants shall bear the costs of destruction and the costs of FDA’s supervision.”

    One industry insider, who requested anonymity so as not to affect his company’s PMTA process, said that the letter was “a clear escalation”—the first time, to his knowledge, that the FDA had gone beyond warnings and explicitly threatened to sue over sales of unauthorized nicotine vapes.

    “Their exercise of enforcement discretion to date has reached almost legendary proportions, so this would be at least a small deviation from that,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network and the American Cancer Society’s former vice president for tobacco control, told Filter. “My sense is that there are many, many instances of such behavior across the country, which Mitch Zeller and others have referred to as requiring FDA to play whack-a-mole, so a big question would appear to be whether this signals a new direction or is a random example of enforcement action.”

    The two companies known to have received letters, at least, have been ordered to physically destroy their own products, under FDA supervision, according to Norcia.

    “Within thirty (30) days after entry of this Decree, Defendants shall, under FDA’s supervision and pursuant to a written destruction plan approved in writing by FDA prior to implementation, destroy all Defendants’ ENDS products in their custody, control, or possession as of the date this Decree is signed by the parties,” the letter reads. “Defendants shall bear the costs of destruction and the costs of FDA’s supervision incurred under this paragraph.”

  • Second Chance: MDO Legal Win Presents Opportunity

    Second Chance: MDO Legal Win Presents Opportunity

    Photo: andranik123

    How companies can make the most of a recent court ruling requiring the FDA to reassess thousands of PMTA rejection notices.

    By Neil McKeganey

    It would be hard to overstate the threat that youth vaping in the United States poses to the use of e-cigarettes as a means of tobacco harm reduction. Respected national surveys have shown a rising trend in youth vaping, with the threat to the vaping industry as predictable as night following day.

    Former Food and Drug Administration Commissioner Scott Gottlieb could not have been clearer in signaling that threat when he said that the offramp to adult smoking could not be justifiably achieved at the cost of the on-ramp of teen vaping. If anybody was in any doubt about the risks that youth vaping poses to the entire e-cigarette industry, those doubts would have surely been extinguished in the recent ruling against Juul Labs, which required the company to pay in excess of $438 million to compensate states for the harms caused by past marketing practices increasing the likelihood of youth using their eponymously named vaping device.

    For vaping companies, the threat of youth vaping may have lifted slightly in a recent U.S. court ruling requiring the FDA to pay attention to what vapor companies are doing in trying to restrict youth access to their products. Odd as it may sound, after having encouraged vapor companies to pay attention to their marketing and sales practices in light of the rising trend in youth vaping, the FDA’s position appears to have been that those efforts were almost certainly doomed to fail, with youth accessing what are often easy-to-conceal vaping products with relatively little difficulty through their social networks.

    With vapor companies having invested heavily in age verification software, point-of-sale restrictions and in the removal of flavored e-liquids, it would have been a bitter pill to swallow to be told that the regulators had largely ignored those efforts to reduce youth access to their products.

    The logic behind the FDA’s decision seems to have been that it would be easier to expedite the large number of premarket tobacco product applications (PMTAs) by adopting a “Fatal Flaw” approach—rejecting those applications that did not present data from either longitudinal customer studies or randomized trial evaluations and simply ignoring what the companies were doing to lessen the likelihood that their products would be found in the hands of youth.

    By ruling against the FDA in legal action initiated by six vapor companies that had received marketing denial orders without the FDA even paying attention to their youth sales restriction efforts, the judges have effectively provided vapor companies with a second chance to have their PMTA applications reassessed.

    So, what should vapor companies do given the legal victory that has been dropped in their lap? Clearly, it is going to be important for companies to do all they can to restrict youth access to their vapor products. But actions taken by these companies is not the same thing as being able to present evidence to the FDA that their products are not being used by youth.

    To this end, research undertaken by the Centre for Substance Use Research (CSUR) in Scotland may help many of the companies concerned. For the last two years, the CSUR has been measuring the prevalence with which over 200 e-cigarette devices are being used by youth and adults within the United States. This ongoing research provides vapor companies with product-specific data showing the extent to which their products are being used, or more crucially, are not being used by youth.

    Valuable as the data from this study undoubtedly are, vapor companies also have to be able to show the benefit of their products to adult smokers. The fastest route to obtaining this data is through an actual use study in which adult smokers using a company’s vapor products are monitored over a number of weeks to determine how many smokers are able to quit or reduce their cigarette smoking through using the company’s vapor products.

    To obtain a marketing authorization, vapor companies have to be able to show two things—that their products are not being used by youth and that they can help adult smokers in quitting or reducing cigarette consumption. Succeed in these two things and vapor companies can have a bright future. Fail in either one and the future looks a lot bleaker.

    Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.
  • Wheeler: FDA Understates PMTA Acceptance Numbers

    Wheeler: FDA Understates PMTA Acceptance Numbers

    Amanda Wheeler (Credit: AVM)

    The U.S. Food and Drug Administration is understating the number of non-tobacco nicotine (NTN)-related premarket tobacco product applications (PMTAs) it has accepted for review in order to avoid criticism from tobacco control groups that seek prohibition of all vaping products, reports Vaping360, citing American Vapor Manufacturers Association (AVM) President Amanda Wheeler.

    On Sept. 8, the FDA announced it has accepted over 350 PMTAs (out of nearly 1 million applications) for NTN products. Wheeler insists that AVM member companies alone have received acceptance letters for 4,700 PMTA submissions.

    “Once again the FDA and its Center for Tobacco Products are misleading the public and press on crucial data and methods in its approval process for vaping products,” Wheeler said in a statement. “The figures stated in its press release today on synthetic nicotine applications are demonstrably inconsistent with FDA letters to our own members indicating many thousands more applications successfully filed than FDA now claims.”

    An acceptance letter indicates that the application has met the basic requirements to move forward in the review process. It does not authorize the applicant to market the product.

    The AVM also says the FDA altered required PMTA forms close to the submission deadline to disqualify already-submitted applications. According to Wheeler, the application forms were “abruptly altered” without public notice, “apparently as a means to disqualify wide swaths of already-filed applications.”

    In March, U.S. President Joe Biden signed legislation authorizing the FDA to regulate synthetic nicotine products. Manufacturers had until May 14 to submit PMTAs, and were given two additional months to continue selling products with pending PMTAs. When the grace period ended July 13, all synthetic nicotine-based products became subject to FDA enforcement.

  • FDA Reports Progress With NTN Applications

    FDA Reports Progress With NTN Applications

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration has sent more than 44 warning letters to manufacturers and over 300 warning letters to retailers for violations relating to nontobacco nicotine (NTN) products since President Joe Biden signed legislation authorizing the agency to regulate tobacco products containing nicotine from any source. Additionally, the FDA has issued new warning letters to 102 retailers for illegally selling NTN products to underage purchasers.

    In an update, the agency detailed what it described as “significant progress” in processing and reviewing premarket tobacco product applications for synthetic nicotine products.

    On March 15, 2022, a new federal law gave the FDA the authority to regulate tobacco products containing nicotine from any source. This law took effect April 14, 2022, and after July 13, 2022, any new NTN product that has not received premarket authorization from the FDA cannot be legally marketed.

    The FDA says it received nearly 1 million NTN applications from more than 200 companies. To date, all applications submitted by May 14 have been processed, and more than 85 percent have been reviewed to determine if they meet the minimum requirements to be accepted for further review, according to the agency. In total, the FDA has issued refuse to accept (RTA) letters for more than 800,000 NTN products in applications that do not meet the criteria for acceptance.

    In total, the FDA has accepted over 350 applications for NTN products, with the vast majority being for e-cigarette or e-liquid products. The agency stresses that acceptance is not a determination about the products’ authorization status. “Accepted applications will enter further review, which ensures certain criteria are met for applications to proceed with further review,” the FDA wrote in its update.

    More information about the FDA’s premarket review progress and compliance and enforcement actions is available at the agency’s NTN product webpage.

  • Court Confirms FDA’s Authority Over Vaping Products

    Court Confirms FDA’s Authority Over Vaping Products

    Photo: Mikhail Reshetnikov

    A U.S. appeals court endorsed the Food and Drug Administration’s  authority over vaping products in a case challenging a marketing denial order (MDO), reports ECigIntelligence.  

    New York-based Prohibition Juice had disputed an MDO, asserting that the agency lacked the statutory authority to consider a product’s “relative effectiveness at promoting cessation of combustible cigarette use versus another product with an otherwise similar health risk profile and labeling.”

    However, the U.S. Court of Appeals for the District of Columbia Circuit ruled that the FDA is entitled under the Tobacco Control Act to determine whether a product is appropriate for the protection of public health, and that meant an applicant must supply all information concerning investigations that have been made on the health risks of a product as well as whether a product presents less risk than others.

  • Gripum Denied MDO Petition for Review by Appeals Court

    Gripum Denied MDO Petition for Review by Appeals Court

    Seventh Circuit Court of Appeals

    A U.S. appeals court denied a petition to review the Food and Drug Administration’s marketing denial order (MDO) to Illinois-based e-liquid manufacturer Gripum, reports Vaping360.

    Gripum submitted premarket tobacco product applications (PMTAs) in September 2020 for about 200 bottled e-liquid products in nontobacco flavors. The company received an MDO on Sept. 8, 2021. Gripum filed a petition for review on Oct. 8 and was granted a stay of FDA enforcement in November 2021. The company participated in oral arguments before the court on April 20.

    Gripum argued that the MDO was unfairly issued because Congress and the FDA did not establish any “ascertainable standards” to determine if the company’s products are “appropriate for the protection of public health.” The company also said that the agency changed the evidentiary standard for a successful PMTA after the application deadline had passed and that the agency failed to conduct individualized PMTA reviews as required by the Tobacco Control Act.

    The 7th Circuit Court of Appeals rejected all of Gripum’s arguments, finding that the FDA’s approach to resolving the application was both reasoned and consistent with the Tobacco Control Act.

    Gripum’s defeat follows a successful MDO challenge by six vapor companies. On Aug. 23, the U.S. Court of Appeals for the 11th Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications.

  • Vapor Makers Prevail Over FDA in PMTA Denial Suit

    Vapor Makers Prevail Over FDA in PMTA Denial Suit

    Credit: Tanasin

    A split 11th Circuit on Tuesday told the U.S. Food and Drug Administration it shouldn’t have denied six e-cigarette companies’ premarket tobacco product applications (PTMAs) to sell flavored vaping products without first taking a look at their marketing and sales plans designed to minimize youth exposure and access.

    The U.S. Court of Appeals for the Eleventh Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications in a 2-1 decision. According to Chief Judge William Pryor, the agency didn’t assess “the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.”

    The court explicitly labeled the FDA’s decision-making as “arbitrary and capricious.” Prior legal decisions have determined that FDA action must consider all relevant factors in order to be legally justifiable. In the case of these vape manufacturers, the court ruled that the FDA had not performed such consideration.

    “These tobacco companies submitted survey information from their customers about smoking cessation, literature reviews, scientific studies about switching to e-cigarettes, smoking cessation, and the role of flavors, and details about its marketing and youth-access-prevention plans,” notes the court in its opinion. “For example, Diamond uses technology for its online sales that relies on public records to verify a purchaser’s age.”

    Vapor industry advocates welcomed the decision. Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association said that while court ruling does not order the FDA to grant PMTAs—and that the agency is likely to deny the applications in the future—the companies involved could end up in the queue for review in 2025, which keeps them in business.

    “Additionally, this leaves the door open for further litigation on these and other PMTAs,” Conley wrote on Twitter. “The FDA’s vague and undefined ‘appropriate for the protection of public health’ standard has long been open for attack. This is just the start.”

    The 11th Circuit decision follows revelations that forced the FDA to admit to not considering all evidence when issuing marketing denial orders (MDOs) to vape products made by Juul and Turning Point Brands. In the interests of public health, future FDA decision-making must engage with all available evidence, not just evidence that leads to their preferred outcomes.

    The court also recognized relevant distinctions between closed/cartridge systems and the e-liquids used in open systems. The court also found that the FDA’s refusal to review marketing plans was “error and not harmless” (disagreeing with Fifth and DC Circuits).

    All petitioners’ appeals were granted, denial orders vacated and remanded.

    In her dissent, Judge Robin Stacie Rosenbaum wrote that anyone who knows all the relevant facts of this lawsuit probably already knows how this case will eventually end.

    “The Majority faults the FDA for not considering the companies’ proposed restrictions on kids’ use. And to be sure, the FDA said that factor would be relevant,” stated Rosenbaum. “But even assuming that the FDA erred when it didn’t consider the Companies’ proposed marketing and access-restriction plans, the FDA’s framework for evaluating pre-market tobacco product applications leaves no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”

     

  • ‘FDA Took Unfair Shortcuts in Reviewing PMTAs’

    ‘FDA Took Unfair Shortcuts in Reviewing PMTAs’

    Image: smolaw11

    In establishing whether a nicotine product is appropriate for the protection of public health, the U.S. Food and Drug Administration held its Center for Tobacco Products (CTP) reviewers to a lower standard than the companies submitting premarket tobacco product applications, according to Alex Norcia writing in Filter.

    Citing documents obtained through the Freedom of Information Act, Filter describes procedures such as batching and bracketing, which allowed the CTP to apply conclusions to categories of products rather than evaluating them separately. “Despite imposing extremely onerous bureaucratic requirements on applicants, the agency was happy to find ways to cut through its own paperwork,” writes Norcia.

    “It’s clear that FDA allows itself efficient shortcuts that it has denied to applicants,” Clive Bates, director of The Counterfactual, told Filter.

    “The problem has always been that FDA’s extraordinarily burdensome process was obviously tremendously wasteful for applicants, but of course it was always going to be unmanageable for the assessors in FDA. Without this sort of shortcut, the PMTA process would have become a human resources nightmare. So FDA has allowed itself the kind of efficiencies it should have offered to the applicants—batching and bracketing thousands of near-identical products.”

  • FDA Received Nearly 1 Million Synthetic PMTAs, No Approvals

    FDA Received Nearly 1 Million Synthetic PMTAs, No Approvals

    Credit: JHVEPhoto

    One month into his new job, Brian King is already praising his agency’s hard work. The director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) released a statement that he wanted to make it “unequivocally clear” that the agency was “working diligently” to process synthetic nicotine premarket tobacco product applications (PMTAs).

    “A substantial number of applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long,” King stated. “Preparing these applications for review takes several steps and submissions varied widely in their organization, size, and completeness of data, which impacts the time it takes to process the information.”

    Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM), Tweeted, “Read between the lines: Millions of applications submitted, ZERO approved, yet King assures us the system is working. We do know the only thing preventing vape products from saving lives is the FDA itself, rigging the system in favor of prohibition over harm reduction,” in response to King’s statement.
     
    Despite the challenges of reviewing PMTAs, King stated that the agency was “making significant progress” in processing and reviewing the applications. The FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products for applications that “do not meet the criteria” for acceptance. Applications are required to provide important information needed for processing and reviewing.

    “Without the required information, applications cannot proceed past the acceptance phase of the review process,” King stated. “The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.

    Of the nearly a million applications submitted by May 14, the FDA only accepted an estimated 350, with the vast majority being for e-cigarette or e-liquid products, according to the statement. Accepted applications are then evaluated in the filing stage before going under scientific review.

    “The substantive review phase includes evaluation of the scientific information and data in an application, which often results in follow-up questions and conversations with companies, including in situations where elements of an application raise questions needing clarification,” stated King. “It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order.”

    All bark, no bite

    After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received a marketing order from the FDA. This means that it is illegal for a retailer or distributor to sell or distribute a synthetic nicotine products is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement. 

    King stated that the agency’s compliance and enforcement work is a multi-step process that cannot “happen overnight.” it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards. Typically, the FDA will first issue warning letters to promote compliance and then follow up to ensure the violations addressed in the warning letter are corrected. If firms continue to violate the law, the FDA can pursue further actions, such as civil money penalties, seizures, and injunctions.

    Many retailers simply ignore the FDA warnings. One owner told Vapor Voice that they “know” the agency is overworked and understaffed and is unlikely to follow up or pursue further steps. The agency has also made some very public mistakes over the past month, including its reversal of Juul’s marketing denial order (MDO), that has damaged  the agency’s public perception.

    While there isn’t much data surrounding what tobacco products remain on the market that have received warning letters, however, numerous companies on the agency’s MDO list still market products in the U.S.

    It isn’t only for tobacco products that the agency doesn’t enforce its warnings. A considerable proportion of  drug supplement products remain available for purchase after issuance of FDA warning letters, according to a research letter published in the July 26 issue of the Journal of the American Medical Association. Researchers found that the FDA issued warning letters regarding 31 supplement products. Only one of these 31 products was recalled by the manufacturer.

    At a mean of six years following the issue of warning letters, nine of the products (29 percent) remained available for purchase online, according to the authors. Four of these nine products (44 percent) listed the presence of at least one prohibited ingredient on the label: One label declared the prohibited ingredient included in the FDA warning letter and three listed other FDA-prohibited ingredients. Five of the nine products were found to contain at least one FDA-prohibited ingredient after chemical analysis: Four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued the warning letter.

    Despite its challenges, the FDA issued 17 new warning letters on Aug. 1 to manufacturers for marketing products without FDA approval. On July 28, the agency issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage purchasers.

    “Our goal is clear communication and transparency, and toward that end, we intend to include information about non-tobacco nicotine products in our regular metrics reporting in the future,” stated King. “To keep stakeholders and the general public informed, we also launched a non-tobacco nicotine product webpage that includes information about how synthetic nicotine is made and our regulation of non-tobacco nicotine products.”