TobaccoReporter logo

Tag: U.S. Food and Drug Administration

  • CTP Launches Webpage on Relative Risks

    CTP Launches Webpage on Relative Risks

    Photo: Farknot Architect

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has launched a new webpage aimed at educating the public about the relative risks of tobacco products. The CTP will continue to update the information on this new webpage based on the best available science.

    Coinciding with the launch, CTP Director Brian King co-authored a commentary in Nature Medicine, discussing considerations for healthcare providers around talking to adults about the relative risks of different tobacco products.

    The commentary reinforces that youth should not use any form of tobacco products. Among adults who smoke, it stresses the importance of using evidence-based cessation methods, including FDA-approved pharmacotherapies, as a first line treatment.

    For adults who smoke and have tried proven cessation methods with no success, medical providers may consider educating patients about the relative risks of tobacco products and the potential health benefits of switching completely to a lower-risk product.

    Among patients who smoke, the authors note it is critical to reinforce the importance of complete transitioning away from smoking to exclusive e-cigarette use. Further, eventual abstinence from all tobacco products should be the end goal, according to King.

  • FDA Denies Market Access to Yibo Products

    FDA Denies Market Access to Yibo Products

    Photo: Surendra

    The U.S. Food and Drug Administration on April 15 issued marketing denial orders (MDOs) to Shenzhen Yibo Technology Co. for 65 disposable e-cigarettes marketed as “MNGO Disposable Stick.”

    The products involved include flavors such as tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze, iced banana, and others, with each flavor offered in a range of nicotine concentrations from 2 percent to 6 percent.

    According to the 2023 National Youth Tobacco Survey (NYTS), disposable e-cigarettes were the most commonly used device among current e-cigarette users, and almost 9 out of 10 current e-cigarette users reported using flavored e-cigarettes with fruit flavors being the most popular.

    The MDOs also include several “Clear” flavor products that were described by the applicant as flavorless or unflavored. However, data submitted in the company’s applications showed these products contained ingredients that are flavor enhancers or are known to impart a menthol or mint flavor, according to the FDA. Based on the entirety of evidence, the agency determined that the products have a characterizing flavor.

    “The onus is on tobacco companies to provide the evidence demonstrating that the necessary public health standard has been met, and when they fail to do so, FDA will appropriately deny the marketing authorization of new tobacco products,” said Brian King, director of FDA’s Center for Tobacco Products, in a statement. “In this case, the applicant did not meet the necessary bar.”

  • Video: FDA Urged to Prioritize Access to Safer Alternatives

    Video: FDA Urged to Prioritize Access to Safer Alternatives

    Consumer advocates spoke out against what they describe as the U.S. Food and Drug Administration’s “alarming neglect” in facilitating access to safer nicotine alternatives for millions of adult consumers during a House Oversight hearing today.

    “Despite the bipartisan mandate of the Tobacco Control Act of 2009, the FDA’s performance has fallen short of expectations, leaving countless individuals without viable options to effectively transition away from combustible cigarettes,” the Consumer Choice Center wrote in a press note.

    “With over 26 million premarket tobacco product applications (PMTA) languishing in bureaucratic limbo, the FDA has only authorized fewer than 50 granted to just a handful of firms, completely disregarding the 180-day review deadline set imposed by Congress,” said Consumer Choice Center U.S. Policy Analyst Elizabeth Hicks.

    “Less than 10 unique devices are available on the regulated marketplace, all of which come from industry incumbents, not to mention the growing categories of nicotine alternatives such as heaters, pouches, toothpicks, and more.

    “This blatant failure highlights a systemic issue within the agency, where regulatory inertia trumps the urgent need to provide consumers with safer nicotine alternatives such as e-cigarettes which studies have shown to be 95 percent less harmful than combustible cigarettes. As a result, consumers are being pushed towards the illicit market, which does not adhere to regulatory standards, to find their preferred nicotine alternative products,” said Hicks.

    “Consumers are deeply troubled by the FDA’s abject failure to fulfill its obligations under the Tobacco Control Act. It is imperative that the FDA swiftly rectify this situation by implementing a transparent and expedited regulatory pathway that prioritizes access to scientifically validated, less harmful nicotine products,” she concluded.

    The Consumer Choice Center’s concern was echoed by Philip Morris International, which in an e-mailed statement expressed the hope that the hearing would spur the FDA into action to fully embrace the tobacco harm reduction principles enshrined in the Tobacco Control Act.

    “Today’s House Oversight hearing put a bright spotlight on the fact that the agency is failing to help millions of adult smokers access smoke-free options that are better alternatives to combustible cigarettes,” the company wrote. “More than 26 million premarket tobacco product applications have been submitted to the FDA for review, but the agency has authorized fewer than 50 of those applications, and none within the 180-day deadline set by Congress.

    “FDA’s goal to strike ‘an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes’ is far from the reality of its actions. To assist adult smokers’ transition away from cigarettes, the FDA must develop a fair, efficient and effective regulatory pathway to bring scientifically validated, less harmful products to market with the appropriate safeguards to ensure they do not appeal to youth.”

  • FDA Chief to be Grilled

    FDA Chief to be Grilled

    Robert Califf (Photo: FDA)

    The U.S. House Oversight and Accountability Committee will question U.S. Food and Drug Administration Commissioner Robert Califf as part of an investigation into the agency’s handling of tobacco and nicotine products regulation, among other issues, according to a press release.

    Last year, the committee announced an investigation into the FDA Center for Tobacco Products (CTP). “We have deep concerns that the CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Oversight Committee chairman James Comer in a letter for Califf. “Comments from FDA staff to RUF [the Reagan-Udall Foundation] … reflect such concerns.”

    Other members of Congress have also questioned the FDA’s commitment to fair regulation, with a bipartisan group of senators asking Califf in 2023 to explain the FDA’s premarket tobacco product application process.

    The hearing is scheduled for April 11 at 1 p.m. EDT. It will be live streamed on the committee website and on YouTube.

  • Retailers Warned Over Underage Zyn Sales

    Retailers Warned Over Underage Zyn Sales

    Photo: Swedish Match

    The U.S. Food and Drug Administration warned multiple retailers over sales of Zyn nicotine pouches to underage consumers.

    In a note posed on its website, the agency said it had issued 119 warning letters to brick-and-mortar retailers and had filed 41 civil money penalty complaints seeking more than $55,000 in total for underage sales of flavored Zyn nicotine pouches, including espressino, black cherry, lemon spritz, and cucumber lime.

    “There is no excuse for selling tobacco products to any underage person, and FDA will hold retailers accountable for those violations—especially those who continue to do so after being warned,” said Briang King, director of the FDA’s Center for Tobacco Products.

    The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. To achieve voluntary compliance, warning letter recipients have 15 working days to respond with the steps they will take to correct and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including civil money penalties.

  • Retailers Warned Over Unauthorized Vapes

    Retailers Warned Over Unauthorized Vapes

    Photo: Ljupco Smokovski

    The U.S. Food and Drug Administration has warned 61 brick-and-mortar retailers for selling unauthorized e-cigarette products. The offending businesses received warning letters citing the sale of disposable vapes marketed under the Elf Bar/EB Design and Lava brand names.

    Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar; in 2023, the manufacturer of Elf Bar began marketing the product under the name “EB Design.” In addition, the brand Lava was identified as popular or youth-appealing by the agency following review of retail sales data and emerging internal data from a survey among youth. 

    The retailers have 15 working days to respond with the steps they will take to correct the violation and to prevent future violations. Failure to promptly correct the violations, the FDA warned, can result in additional actions such as an injunction, seizure and/or civil money penalties.

  • Phelps to Lead CTP Policy and Partnerships

    Phelps to Lead CTP Policy and Partnerships

    The U.S. Food and Drug Administration’s Center for Tobacco Products has selected Natasha Phelps as the center’s associate director for policy and partnerships. She will assume her new role on May 6.

    Phelps comes to the CTP from The Center for Black Health & Equity, where she served as the director of equity-centered policies. Prior to this, Phelps spent five years at the Public Health Law Center, where she specialized in commercial tobacco law and policy.

    Phelps received her Bachelor of Arts degree in sociology and legal studies from the University of Wisconsin-Madison. She received her law degree from William Mitchell College of Law in St. Paul, Minnesota.

    According to the FDA, Phelps was selected after an extensive nationwide search, multiple interview panels that evaluated a well-qualified applicant pool, and clearance through agency ethics and security processes.

  • FDA Urged to Follow the Science

    FDA Urged to Follow the Science

    Photo: Pixel-Shot

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) should open the marketplace for electronic nicotine delivery systems to products with varied characteristics so that those interested in alternative nicotine products can access them, according to R Street resident senior fellow Jeffrey Smith.

    In a recently published analysis, Smith critiques the FDA’s disregard for the current research on ENDS, diving into new data that he says represents a “tectonic-shift in the academic medicine community” regarding the safety of ENDS for smoking cessation. 

    ”As evidence grows for the utility of ENDS and other potentially life-saving alternative products, the CTP continues to limit Americans’ access to these products,” writes Smith.

    “Though the CTP has received millions of applications for ENDS products, it has only allowed a few to be marketed legally in the United States. Of those that have received marketing clearance, only older closed systems have been approved—with tobacco as the only permitted flavor.”

    Arguing that a diverse range of ENDS products available to those who smoke and want to quit is critical to reducing the health burdens associated with smoking, Smith urges the CTP to revise its processes and procedures, and allow more cigarette alternatives on the market. Continued delay by the CTP, he says, will only lead to more unnecessary deaths and disease in the United States.

  • More FDA Warnings

    More FDA Warnings

    Photo: Ljupco Smokovski

    The violations involve products sold under the Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary brands.

    The U.S. Food and Drug Administration has warned five more online retailers for selling flavored disposable vaping products.

    On Feb. 28, the regulatory agency announced that the warning letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze and Cali Bars, according to a press release.

    “Protecting our nation’s youth from the harms of tobacco products is crucial to our center’s public health mission,” said Brian King, director of the FDA’s Center for Tobacco Products in a statement. “We’re committed to continuing to use a data-driven approach to identify and prevent the sale of unauthorized tobacco products and to take compliance and enforcement action when appropriate.”

  • Penalties for Unauthorized Elf Bars

    Penalties for Unauthorized Elf Bars

    Photo: mehaniq41

    On Feb. 26, the U.S. Food and Drug Administration announced the filing of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers for the sale of unauthorized Elf Bar e-cigarettes. The FDA previously issued each retailer a warning letter relating to their sale of unauthorized e-cigarettes. However, follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking the maximum penalty amount of $20,678 for a single violation from each retailer.

    Including these complaints, the FDA has filed more than 100 CMP complaints against retailers for the illegal sale of Elf Bar e-cigarettes. Data indicate these products are appealing to youth. According to the 2023 National Youth Tobacco Survey, Elf Bar was the most commonly used brand among U.S. youth e-cigarette users; among middle and high school students who reported using e-cigarettes in the past 30 days, more than half said they used Elf Bar products during that period.

    “These retailers have not adequately addressed the violations noted in previous warnings from FDA regarding the sale of unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products. “Their continued failure to comply with the law is inexcusable, and as is evidenced by today’s actions, we’re committed to holding them accountable for it.”

    As of Feb. 15, the FDA has issued more than 440 warning letters to and filed 100 CMP actions against retailers, including brick-and-mortar and online retailers, for selling unauthorized tobacco products. In addition to actions involving retailers, the FDA has issued more than 660 warning letters to manufacturers, importers and distributors for illegally selling and/or distributing unauthorized new tobacco products, including e-cigarettes. The agency has also filed CMP complaints against 50 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.