Tag: U.S. Food and Drug Administration

  • Confusion Persists About Magellan MDO

    Confusion Persists About Magellan MDO

    Photo: Damir Khabirov

    The U.S. Food and Drug Administration has confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products.

    In response to the FDA press statement announcing the order, Magellan Technology denied having received an MDO, saying the agency had refused to accept its premarket tobacco product application (PMTA) on a technicality without reviewing the PMTA on its merits.

    Magellan Technology demanded that the FDA not only retract the press announcement but also issue a corrective statement, making clear that the FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.

    In response to an inquiry by Vaping360, the FDA reiterated that it had served Magellan Technology with an MDO.

    “After reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders for these applications submitted by Magellan Technology Inc. on Oct. 6,” the agency told Vaping360. “In addition to the MDOs issued on Oct. 6, as acknowledged by Magellan Technology Inc. in their statement, FDA also issued a Refuse to Accept letter for other Hyde e-cigarette products.”

  • VTA Questions FDA’s Youth Vaping Analysis

    VTA Questions FDA’s Youth Vaping Analysis

    Tony Abboud (Photo: Taco Tuinstra)

    The U.S. Food and Drug Administration misrepresents the latest data on youth vaping, according to Vapor Technology Association (VTA) Executive Director Tony Abboud.

    On Oct. 6, the FDA and the U.S. Centers for Disease Control and Prevention released new data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth.

    “The FDA represents the NYTS data to show that youth vaping ‘remains high,’ yet a deeper dive into the data show[s] only a small uptick in experimental or infrequent use while regular use remains flat or is slightly down,” said Abboud in a statement.

    Abboud notes that since 2019, according to the CDC, the number of high school students who have tried vaping (one time in the last 30 days) has dropped by 50 percent, and the number of middle school students has plummeted by 70 percent. During that same time period, the number of high school students who “frequently” vape dropped by 37 percent, and the number of middle school students dropped by 65 percent.

    “FDA’s near single-minded focus on youth who experiment with vaping versus those who are frequent users ignores what clearly is a consistent trend of youth away from vaping products. Rather than focusing on removing products from the market in an attempt to impact youth vaping, the FDA should instead support common sense regulatory reforms that would better restrict access to products instead,” said Abboud. “Simply removing products from the market is not the answer when those products are also proven to help adult smokers quit.”

    According to Abboud, it is well documented that flavored vapor products help adult smokers switch to less harmful vaping and “study after study after study” has confirmed the data. Since 2010, when e-cigarettes became widely available in the U.S., smoking rates have declined by more than half, he noted.

    “Tobacco use is down. Youth vaping is down. These are both good things and are not in dispute. Unfortunately, there are still 40 million Americans addicted to cigarettes,” Abboud said. “Every year, 500,000 die from smoking-related diseases and yet less than 3 percent of our kids are using vapes on a regular basis. The FDA’s failure to acknowledge this reality ignores the role vaping plays in harm reduction and smoking cessation and puts more lives at risk.”

  • Magellan Denies Receiving MDO

    Magellan Denies Receiving MDO

    Photo: Surendra

    Magellan Technology insists it did not receive a marketing denial order (MDO) for its Hyde Brand, despite a U.S. Food and Drug Administration announcement to the contrary.

    In an email to Tobacco Reporter’s sister publication, Vapor Voice, Magellan CEO Jon Glauser said his company had received a “refuse to accept” (RTA) letter. An RTA is not a judgment on the product’s appropriateness for the protection of public health. It is merely a determination that the premarket tobacco product application doesn’t conform to the FDA’s standards, and it leaves the applicant the option to refile.

    “A refuse to accept letter is a refusal based on nothing more than a technical review of the applications’ contents, which, in this case, was a missing document, i.e., a sworn certification related to the translation of certain components of the application,” wrote Gauser. “In other words, the refusal to accept was based on bureaucratic technicalities.”

    In its letter to Magellan, the FDA wrote that the absence of the forms prevented the agency from accepting and processing the applications. “In other words, FDA could not have conducted any scientific review because it refused to accept the application,” wrote Glauser. “Our counsel has demanded that FDA not only retract the press statement it made but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.”

    Magellan is not the first company to take issue with the FDA’s handling of the PMTA process. The agency is currently facing more than 20 lawsuits and has had to backtrack on MDOs issued to companies such as Juul Labs, Turning Point Brands and Kavial Brands.

  • FDA Seeks TPSAC Nominations

    FDA Seeks TPSAC Nominations

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products is requesting nominations for two individuals to serve as voting members on the Tobacco Products Scientific Advisory Committee (TPSAC). According the FDA website, individuals may self-nominate or be nominated by any interested person or organization.

    Nominations received on or before Nov. 25, 2022, will be given first consideration. Nominations received after Nov. 25, 2022, will be considered as later vacancies occur.

    TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.

    The notice has been published in the Federal Register.

  • Juul Sues FDA for Docs Justifying Product Ban

    Juul Sues FDA for Docs Justifying Product Ban

    Juul Labs is suing the U.S. Food and Drug Administration to force the agency to disclose documents supporting its order banning the company’s products, reports Reuters.

    On June 23, the FDA ordered Juul Labs to pull its e-cigarettes from U.S. store shelves, saying the e-cigarette manufacturer had submitted insufficient evidence that they were “appropriate for the protection of the public health.”

    A federal appeals court then granted Juul Labs an emergency stay of the order to give the judges time to evaluate the merits of Juul’s appeal. The e-cigarette company separately asked the FDA to stay its own order pending the appeal.

    In a complaint filed on Sept. 21 with a federal court in Washington, D.C., Juul accused the FDA of invoking the deliberative process privilege to improperly withhold scientific materials that are key to understanding the basis for the June 23 sales ban.

    Juul said the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims they help smokers quit 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 said.

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

  • Filter: FDA Cracks Down on Unauthorized Vapes

    Filter: FDA Cracks Down on Unauthorized Vapes

    Photo: svetazi

    The U.S. Department of Justice is seeking court orders, threatening lawsuits and demanding the destruction of unauthorized vapor products, according to Alex Norcia, writing for Filter. The actions are remarkable given Center for Tobacco Products Director Brian King’s reluctance to say whether the agency was willing to take unauthorized vaping products off the market during a recent interview with Politico.

    Filter says it has confirmed that the Food and Drug Administration, by Sept. 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 because the manufacturers did not file premarket tobacco product applications and were continuing to sell their products.

    “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 one letter, signed by DOJ Senior Litigation Counsel Christina Parascandola and seen by Filter.

    The two companies known to have received letters have been ordered to physically destroy their own products under FDA supervision.

    One industry insider told Filter 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.

    “It is just beyond outrageous that the FDA is now conscripting the Department of Justice in its misbegotten war on vaping,” Amanda Wheeler, a vape shop owner in Arizona and the president of American Vapor Manufacturers, told Filter. “We are talking about hardworking small businesses that are helping ordinary Americans to quit smoking, and they are now facing jaw-dropping threats from federal law enforcement agents.”

  • A Second Chance

    A Second Chance

    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.
  • ‘FDA Downplays PMTA Acceptance Numbers’

    ‘FDA Downplays PMTA Acceptance Numbers’

    Amanda Wheeler (Photo: AVM)

    The U.S. Food and Drug Administration is understating the number of nontobacco 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.

  • Court Rejects Gripum’s MDO Appeal

    Court Rejects Gripum’s MDO Appeal

    Photo: Mikhail Reshetnikov

    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.

  • ‘FDA Failed to Consider Marketing Plans’

    ‘FDA Failed to Consider Marketing Plans’

    Photo: tanasin

    The U.S. Food and Drug Administration must reevaluate the premarket tobacco product applications (PTMAs) of six e-cigarette manufacturers after an appeals court ruled that the agency failed to adequately consider the companies’ marketing plans, reports Bloomberg Law.

    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. 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.

    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.