Category: U.S. FDA

  • FDA Grant to Study Effects of Flavors

    FDA Grant to Study Effects of Flavors

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.

    The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.

    Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”

    “The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”

    The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.

    “If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.

  • FDA Denies Marketing of Myblu Menthol

    FDA Denies Marketing of Myblu Menthol

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration on July 10 issued a marketing denial order (MDO) for Myblu Menthol 2.4 percent, an e-cigarette product made by Fontem US. The order prohibits the company from marketing or distributing this product in the United States.

    “Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweighs the known risks.”

    Among other shortcomings, the application presented insufficient scientific evidence to show that the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes, according to the FDA.

    Fontem US may resubmit a new application to address the deficiencies for the product subject to this MDO.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. Last year, the FDA issued MDOs to Fontem US for several other Myblu products, which are the subject of ongoing litigation.

  • Ninth Circuit Denies Lotus MDO Review

    Ninth Circuit Denies Lotus MDO Review

    Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)

    The U.S. Court of Appeals for the 9th Circuit on June 30 declined to review a Food and Drug Administration marketing denial order for Lotus Vaping Technologies’ flavored e-liquid products.

    The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.

    Lotus challenged the ruling in court, but the judges held that the text of the Family Smoking Prevention and Tobacco Control Act authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids.

    The judges also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless.

  • CTP Reports Progress on Reagan-Udall Review

    CTP Reports Progress on Reagan-Udall Review

    Image: Tobacco Reporter archive

    Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.

    At the request of FDA Commissioner Robert Califf, the Reagan-Udall Foundation evaluated the CTP’s operations. In December, the foundation submitted its report, which identified several problems hindering the agency’s ability to regulate the industry and reduce tobacco-related disease. Among other recommendations, the foundation urged the CTP to make process improvements and increase transparency.

    According to King, the CTP has made significant strides in putting its plans for improvement into action. The agency, he said, is on track to issue proposed goals this summer, and to release the final plan by December 2023. The CTP intends to hold a public meeting in summer 2023 to seek stakeholder feedback about the strategic plan.

    Meanwhile, said King, the CTP Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas, including through the establishment of transparency liaisons. Externally, the center is planning for upcoming public meetings to gather stakeholder input. CTP also published a webpage of all the tobacco products-related citizen petitions received by the center to provide the public with information about such citizen petitions that is easy to access and user-friendly.

    According to King, the center has reviewed 99 percent of tobacco product applications submitted over the past three years, authorizing 23 tobacco-flavored e-cigarette products and devices. The CTP is currently planning a public meeting to take place in fall 2023 regarding the application review process.

    Meanwhile, the center is in the process of finalizing rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.

    CTP also recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.

    King also highlighted the CTP Office of Science leadership’s participation in conferences and external meetings. For example, representatives from the Office of Science recently presented at the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the E-Cigarette Summit and the TMA annual meeting (see Todd Cecil’s TMA presentation here).

    “I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future,” said King.

    A comprehensive list of CTP status updates for each Reagan-Udall Foundation recommendation is available here.

  • FDA Issues Warning Letters to 189 Retailers

    FDA Issues Warning Letters to 189 Retailers

    Credit: Monticello

    The U.S. Food and Drug Administration issued warning letters to 189 retailers for selling unauthorized products, specifically Elf Bar and Esco Bars, according to a press release.

    “The FDA is prepared to use all of its authorities to ensure these and other illegal and youth-appealing products stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.”

    The warning letters were the result of a nationwide retailer inspection blitz over the past several weeks, according to the FDA.

    “All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products. “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

    Elf Bar and Esco Bar products do not have the required marketing authorization from the FDA. The FDA has authorized 23 tobacco-flavored e-cigarette products and devices to date. The distribution and sale of unlawfully marketed products is subject to compliance and enforcement action.

    As of June 16, the FDA has issued more than 570 warning letters to firms for manufacturing, selling and/or distributing illegal tobacco products, including e-cigarettes, and filed civil money penalty complaints against 12 e-cigarette manufacturers.

  • Second Circuit Appeals Court Rules for FDA

    Second Circuit Appeals Court Rules for FDA

    Credit: Andrey Popov

    The U.S. Food and Drug Administration acted reasonably in denying vapor maker Magellan Technology’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the 2nd Circuit ruled May 16.

    The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

    The agency found Magellan’s evidence—four nonclinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine-delivery systems in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberg Law.

    The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services, claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process that cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order that the FDA issued to Magellan, according to the lawsuit filed Thursday.

    The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full 2nd Circuit) or could appeal to the Supreme Court of the United States. 

  • Justice Groups Push Back Against Flavor Ban

    Justice Groups Push Back Against Flavor Ban

    Image: Tobacco Reporter archive

    A coalition of more than 50 criminal justice reform groups sent a letter to U.S. President Joe Biden warning that the U.S. Food and Drug Administration’s proposed ban on flavored tobacco products will lead to overpolicing in communities of color, according to The Hill.

    Prohibition-style policies, like the one proposed, “have serious racial justice implications,” wrote the organizations, which include Blacks in Law Enforcement, the National Association of Criminal Defense Lawyers, the National Latino Officers Association and the Sentencing Project.

    “Banning the legal sale of menthol cigarettes through licensed businesses will lead—and, in fact, has already led in some states—to illegal, unlicensed distribution in communities of color while triggering criminal laws in all 50 states, increasing the incidence of negative interactions with police and ultimately increasing incarceration rates,” the letter said. “There are far better solutions for reducing menthol cigarette use than criminalizing these products and turning this issue over to the police.”

    The aim of the flavor ban is not only to make smoking less attractive but also to advance health equity, according to Health and Human Services Secretary Xavier Becerra

    “FDA has the power to provide smokers with less harmful options and information to help accelerate reductions in smoking,” the coalition wrote in its letter. “Rushing forward with a total ban without these alternatives in place contradicts everything we know—and everything the administration has been saying in other spheres—about why harm reduction works and criminalization doesn’t.” The coalition urged the FDA to reconsider the ban and find solutions opposed to criminalization.

  • Debt Ceiling Could Stress FDA Budget

    Debt Ceiling Could Stress FDA Budget

    Image: Tobacco Reporter archive

    The proposed debt ceiling budget could stress the U.S. Food and Drug Administration’s budget, according to Inside Health Policy.

    The legislation’s nondefense federal funding cap makes it harder for programs like the FDA’s budget to get funding increases, and it could threaten some agencies’ existing funds, according to Steven Grossman, director of the Alliance for a Stronger FDA. “This is never a good situation for agencies whose mission and responsibilities keep expanding each year, as is the case with FDA,” he wrote.

    The Fiscal Responsibility Act of 2023 caps nondefense federal spending at $704 billion for the next two years. According to Grossman, after taking out funding for Veterans Affairs medical care and appropriations adjustments, the remaining nondefense funds are about $637 billion, which is roughly unchanged from fiscal 2023.

    There is still room to determine how much funding can be specifically allocated to the FDA, though, according to Grossman, despite the FDA’s funding being limited by the macro-budgetary levels determined by the debt ceiling.

    “FDA’s mission and responsibilities are incredibly consequential and visible,” he wrote. “It needs resources to protect public health and safety and to set standards for products that encompass 20 percent of all consumer spending (about $2.7 trillion).”

    The House GOP’s FDA funding bill cleared the Appropriations FDA-agriculture subcommittee last month; it would provide $6.6 billion in total funding with $3.5 billion in flat discretionary funding.

  • Funding for Tobacco Surveillance Center

    Funding for Tobacco Surveillance Center

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    The U.S. Food and Drug Administration and the National Institutes of Health (NIH) have awarded funding for a new Center for Rapid Surveillance of Tobacco (CRST). Through rapid surveillance and reporting of information, CRST will enhance the Center for Tobacco Products (CTP) and the research community’s ability to understand, document and quantify changes in the tobacco product marketplace and tobacco use patterns.

    Research results from the CRST are expected to generate findings and data that are directly relevant in informing the FDA’s regulation of the manufacture, distribution and marketing of tobacco products to protect public health. In particular, the CRST will support more time-sensitive data collection, analysis and reporting—making potentially actionable information available before more traditional data collection methods. 

    “Given the rapidly evolving tobacco landscape, it’s critical that we have nimble surveillance tools that can keep pace to best protect public health,” said Brian King, director of the FDA’s CTP. “This new center is another important addition to our surveillance toolbox to help identify emerging issues and to inform timely action.”

    The CRST is supported through the Tobacco Regulatory Science Program, an interagency partnership between the NIH and CTP to foster tobacco regulatory research. After undergoing a competitive funding announcement, the CRST is being administered through a cooperative agreement under award number U01CA278695. The work is led by Rutgers Center of Excellence in Rapid Surveillance of Tobacco with substantial involvement from a large collaborative network that triangulates multiple data sources, federal scientific staff at CDC, NIH and CTP as well as external advisors with relevant expertise.

  • FDA Cracks Down on Illegal Disposables

    FDA Cracks Down on Illegal Disposables

    Credit: Waldemarus

    The U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022. The Puff products include Puff Bar.

    “Protecting our nation’s youth from tobacco products—including disposable e-cigarettes—is a top priority for the FDA,” said FDA Commissioner Robert M. Califf. “We’re committed to holding all players in the supply chain—not just manufacturers but also retailers and distributors—accountable to the law.”

    According to the FDA, the warning letters are part of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth—specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes, which are the most commonly used e-cigarette product type among youth. Puff Bar and Hyde were the first and third most popular brands used by youth who reported using e-cigarettes, according to the 2022 National Youth Tobacco Survey. Among youth e-cigarette users, about 20 percent reported usually using Puff Bar or Hyde brand products in 2022.

    “Since becoming director of CTP [Center for Tobacco Products], I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well known to appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action.