Category: Regulation

  • 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.

  • Putin Signs Tobacco Law

    Putin Signs Tobacco Law

    Photo: sezerozger

    Russian President Vladimir Putin has signed a new tobacco law, reports Interfax.

    The legislation requires the licensing of production, tobacco imports, nicotine-containing products and raw materials. It also compels manufacturers to register their machinery and mothball any unused equipment.

    While the law does not require retailers to obtain licenses, it bans the retail sale of tobacco products and nicotine-containing products not in consumer packaging and imposes restrictions on the movement of products.

    Titled “On the State Regulation of Production and Turnover of Tobacco Products, Nicotine-Containing Products and Raw Materials for Their Production,” the law is modeled on Russia’s regulatory framework for the tobacco industry. Observers expect Russia to extend the Federal Service for Alcohol Market Regulation’s remit to include tobacco and nicotine-containing products.

    Prepared by the Ministry of Finance, the legislation passed the State Duma on June 1 and the Federation Council on June 7. The law will come into force on Sept. 1, 2023, and the articles introducing licensing will take effect March 1, 2024.

  • FDA Urged to Wrap Up E-Cigarette Reviews

    FDA Urged to Wrap Up E-Cigarette Reviews

    Photo: BillionPhotos.com

    U.S. lawmakers are urging the Food and Drug Administration to wrap up its review of pending e-cigarette premarket tobacco product applications, reports Law360.

    In a letter to FDA Commissioner Robert Califf, 50 members of Congress requested the agency finalize its review of pending applications for e-cigarette products; deny applications for all nontobacco-flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.

    The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In its most recent filings with the court, the FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.

    “FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said Colorado Representative Diana DeGette in a statement. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”

    While the FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications—including those for popular products manufactured by Juul Labs, Reynolds Vapor Co. and Smok.

    The lawmakers urged the agency to complete its review of all its pending applications no later than Dec. 31, 2023.

  • 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.

  • CTP to Host Regulatory Science Forum

    CTP to Host Regulatory Science Forum

    Photo: Lek

    The U.S Food and Drug Administration Center for Tobacco Products (CTP) will a hold a forum titled “Advancing Regulatory Science Through Innovation” on June 13-14.

    This free, virtual forum is open to the public, industry, academia, patient advocates, sister agencies and current or potential FDA collaborators. Forum attendees will explore how FDA’s researchers use novel science and technologies to inform regulatory decisionmaking. 

    This year’s keynote address will be given by Murray Lumpkin, deputy director of integrated development at the Bill & Melinda Gates Foundation.

    FDA scientific experts and nationally renowned scientists will present and answer questions on improving clinical and post-market evaluation, empowering patients and consumers and advancing products based on novel technologies, among other topics.

    To register, click here.  

  • Australia: Tougher Tobacco Laws Coming

    Australia: Tougher Tobacco Laws Coming

    Image: Tobacco Reporter archive

    Australia will face tougher tobacco regulations in the next two years if legislation proposed by Health Minister Mark Butler is adopted, according to ABC News.

    The proposed legislation calls for a standardized size for tobacco packets and products, a standardized design for filters, health warnings on individual cigarettes, public health information in loose-leaf and cigarette packets, a ban on flavors and additives like menthol, and a restrictions on certain names used on packaging.

    “[There are] names that are designed to mislead users, [that suggest] the cigarettes they are using are somehow going to be good for them, names like smooth or fresh burst,” Butler said. “These things are a cynical deliberate marketing strategy to bring new smokers into this public health menace and will be prohibited in this legislation.”

    “The legislation that was put in place by former minister Nicola Roxon had a sunset date of April 1, 2024,” Butler said. “So if we do not pass replacement legislation, the current suite of regulations around plain packaging, graphic warnings and the like will lapse on April 1, so we intended to get this legislation passed by the Parliament before April 2024.”

  • Funding for Tobacco Surveillance Center

    Funding for Tobacco Surveillance Center

    Credit: JHVEPhoto

    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.

  • FDA Commissioner Laments Lawsuits

    FDA Commissioner Laments Lawsuits

    Image: Tobacco Reporter archive

    U.S. Food and Drug Administration Commissioner Robert Califf has lamented the FDA’s ongoing tobacco industry litigation following the agency’s attempt to regulate e-cigarettes, according to Politico. The FDA is facing over 40 lawsuits from companies whose premarket tobacco product applications have been denied.

    “We are in a legal battle every single day, and it’s draining on the agency,” Califf said at the annual public meeting of the Reagan-Udall Foundation. “It has a big impact and a much bigger impact than I thought.”

    “None of us expected 27 million applications for vaping,” he said.

    Califf also noted that enforcement is difficult when it comes to illegal product. “I find myself in the midst of really an epic struggle … when I think of how to enforce when you have an industry that is amazingly creative.”

    Califf hinted that the FDA would meet with the Department of Justice soon to discuss enforcement but declined to say more: “Stay tuned on that one.”