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Category: Global Regulation

  • 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.”

  • Vaping to be Banned for Those Under 18

    Vaping to be Banned for Those Under 18

    Image: Tobacco Reporter archive

    Ireland will ban vaping for those under the age of 18, effective July, reports the Irish Times.

    Minister for Health Stephen Donnelly will bring a memo to the Cabinet this week outlining the full legislation. The new law is expected to be enacted before the lower house of Parliament’s summer recess in mid-July.

    The legislation includes restrictions on the types of retailers allowed to sell vapes or nicotine-inhaling products as well as measures to curb advertising of nicotine-inhaling products near schools and other locations frequented by kids and young adults.

    Donnelly is expected to tell the Cabinet that there is “clear evidence” that nicotine exposure in young people has long-term effects on brain development, referencing recently published surveys of Irish school-aged kids. The surveys, including the Health Behaviour in School-Aged Children survey from 2018 and the European Schools Project on Alcohol and Other Drugs survey from 2019, showed that 9 percent of 12-year-olds to 17-year-olds and 15.5 percent of 15-year-olds and 16-year-olds used electronic cigarettes in the past 30 days. Donnelly is also expected to reference a Health Research Board review that found that kids who vaped were five times more likely to begin smoking.

    The government is expected to prioritize passage of the bill through the Oireachtas to allow for full debate and discussion before sending the legislation to President Michael D. Higgins for his signature.

  • Innokin and Breeze Warned

    Innokin and Breeze Warned

    The U.S. Food and Drug Administration has warned the manufacturers of two popular disposable e-cigarette brands that their products are unauthorized for sale in the United States.

    The product involved are Esco Bars, which is manufactured by Shenzhen Innokin Technology Co., and Breeze, which is imported into the U.S. by Breeze Smoke. Esco Bars and Breeze are presently among the most commonly sold brands of disposable products in the country, according to the FDA.

    “The science clearly shows that a majority of youth who use e-cigarettes report that the products they are using are disposable and flavored” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “Given their appeal to youth, these products are a priority for FDA compliance and enforcement action.”

    The recent FDA actions could signal that the agency will no longer consider pending premarket tobacco product applications (PMTAs) when deciding which companies to enforce against. Esco Bar is believed to have a pending PMTA, according to Vaping360. Breeze Smoke reportedly received marketing denials orders for several products in 2021.

    Thousands of other products remain on the market awaiting PMTAs without facing enforcement actions.

    Innokin and Breeze Smoke have 15 days to dispute the allegations in the FDA’s warning letters.

  • Switzerland to Ban Youth Advertising

    Switzerland to Ban Youth Advertising

    Photo: Taco Tuinstra

    Switzerland will ban advertising of tobacco and vapor products to young people, the government announced on May 24, report Reuters and Swiss Info.

    In February 2022, Swiss voters backed a proposal to limit tobacco promotions seen by minors. Following the referendum, the government had to adjust Switzerland’s tobacco product law to incorporate the proposal.

    The new law will come into force from mid-2026 and will also strengthen restrictions on packaging and advertising on tobacco and e-cigarettes due to take effect from next year.

    In the future, no advertising for tobacco products or e-cigarettes will be allowed in print media, shops or events that can be visited by minors. In addition, sponsorship of events that people under 18 attend will be banned. Online advertising will still be permitted provided that age control systems are in place.

    The tobacco industry will also be made to collectively disclose its advertising expenditure, but companies will not be required to individually reveal this information. The government believes advertising plays an important role in the decision to start smoking.

    Smoking remains relatively widespread in Switzerland with 9,500 people dying prematurely every year as a result of tobacco consumption, according to the government. In 2022, 6.9 percent of Swiss 11-year-olds to 15-year-olds had smoked cigarettes in the past 30 days while 5.7 percent of youths aged 15 to 24 had used electronic cigarettes at least once a month, the government said.

    Switzerland is home to several tobacco multinationals, including Philip Morris International and Japan Tobacco International.