Tag: U.S. Food and Drug Administration

  • FDA Updates Vaping Products ‘Red List’

    FDA Updates Vaping Products ‘Red List’

    Photo: xy

    The U.S. Food and Drug Administration has updated its import alert, which includes a “red list” of vapor products that may be detained “without physical examination,” the agency announced.

    The alert authorizes U.S. Customs and Border Protection to detain new tobacco products that do not have the required marketing authorization under the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products.

    The list of products now includes Chinese manufacturers and distributors as well as U.S. importers and distributors.

    The FDA announced last week that it is taking stronger enforcement actions against unauthorized e-cigarettes. The agency is seeking civil money penalties (CMP) against nine brick-and-mortar retailers and one online retailer for selling unauthorized Elf Bar brand vaping products. The FDA is seeking a penalty of more than $20,000 from each retailer.

    “In order to remove a firm’s product from the red list, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation,” the FDA wrote. “The purpose of this is so that the agency will have confidence that future shipments/entries will be in compliance with the Federal Food, Drug and Cosmetic Act.”

  • Retailers Fined for Selling Elf Bar

    Retailers Fined for Selling Elf Bar

    Photo: Gevorg Simonyan

    The U.S. Food and Drug Administration  is seeking civil money penalties (CMPs) from nine brick-and-mortar retailers and one online retailer for selling Elf Bar products.

    The FDA previously issued warning letters to these retailers for selling unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency is now seeking a CMP of $20,678 from each retailer.

    “The $20,678 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including February and April of this year,” the FDA stated.

    The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.

  • Agencies Urged to Remove Unauthorized Products

    Agencies Urged to Remove Unauthorized Products

    Photo: ksena32

    Seventy-eight U.S. public health and other organizations urged the U.S. Food and Drug Administration, the U.S. Department of Justice and the U.S. Customs and Border Protection to utilize all the enforcement tools at their disposal to clear the market of unauthorized e-cigarette products, including flavored products.

    To date, the FDA has authorized the sale of only 23 tobacco-flavored e-cigarette products.

    “This means that virtually the entire e-cigarette market consists of unauthorized, illegal products, including a wide variety of flavored products—largely disposables—that FDA has found to be highly appealing to youth,” the groups wrote in a letter addressed to all three agencies.

    “This is a wholesale failure to enforce the Family Smoking Prevention and Tobacco Control Act by FDA and other government enforcement agencies. There must be an intensified and coordinated, multi-agency federal effort to enforce the law against these illegal products in an effective and equitable manner.”

    The groups urged the adoption of several concrete changes in tobacco enforcement policies and activities, including more frequent use of enforcement tools, such as civil monetary penalties; and prioritization of efforts to stop illegal importation of unauthorized products.

     “The failure to adequately enforce the law against unauthorized products has real, and significant public health consequences. We urge FDA, DOJ and CBP to respond with an ‘all hands on deck’ strategy that will use all enforcement tools at their disposal to protect the public health, and particularly the health of our young people, from the flood of illegal, unauthorized e-cigarettes,” the letter writers concluded.

  • Verbeten to lead CTP Compliance Office

    Verbeten to lead CTP Compliance Office

    Image: Tada Images

    John Verbeten will be the new director of the U.S. Food and Drug Administration Center for Tobacco Products’ Office  of Compliance and Enforcement, effective June 16.

    Verbeten has more than 20 years of experience leading field operations, compliance and enforcement, and national-level program management. In his latest role within Office of Import Operations, Verbeten served as the principal advisor to the Office of Regulatory Affairs’ (ORA) leadership on import operations and enforcement activities, and oversaw the FDA’s field import operations, which includes a staff of more than 700 people.

    He also provided leadership in the development, implementation and evaluation of new laws, regulations and policies related to ORA’s global and national programs and activities.

    Most recently, he led the agency’s development of a memorandum of understanding between the FDA and U.S. Postal Service (USPS), which established a framework that provides a basis for the development of bilateral data exchange and provides the FDA access to the USPS advanced electronic data for imported mail shipments.

  • MRTP Renewal Application Filed

    MRTP Renewal Application Filed

    Photo: elenavah

    The U.S. Food and Drug Administration on May 9 filed for scientific review modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products for the following IQOS products: 

    • IQOS 2.4 System Holder and Charger
    • IQOS 3.0 System Holder and Charger
    • Marlboro Amber HeatSticks (formerly named Marlboro HeatSticks)
    • Marlboro Green Menthol HeatSticks (formerly named Marlboro Smooth Menthol HeatSticks)
    • Marlboro Blue Menthol HeatSticks (formerly named Marlboro Fresh Menthol HeatSticks)

    In 2020 and 2022, the FDA issued modified risk granted orders for products. These orders are valid for a fixed time period. To continue marketing the MRTPs after the authorized term, the company submitted MRTP renewal applications to FDA.

    Starting May 10, 2024, people may submit public comments on these applications on regulations.gov to docket FDA-2021-N-0408 for the IQOS 3.0 device and docket FDA-2017-D-3001 for the IQOS 2.4 device and the Marlboro HeatSticks products.

    The FDA will post application documents, including amendments; given that the documents will need to be redacted for any confidential information, they will be posted on the Center for Tobacco Products’ website on a rolling basis.

    Once all materials for these MRTP applications, including amendments, have been made publicly available, FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials.

  • FDA Updates Authorized Products Database

    FDA Updates Authorized Products Database

    Photo: Andrey Kuzmin

    The U.S. Food and Drug Administration has uploaded the first update to its recently created Searchable Tobacco Products Database, which provides an overview of tobacco products and vapor products that may be legally marketed in the United States.

    Due to timing factors associated with the initial launch, the products included in this update cover a longer time period (January through mid-April 2024) than will typically be included in the future. The agency intends to update the database every month.

    The current database updates include the addition of several tobacco products that were issued a substantial equivalence or exempt order, a number of tobacco products that were determined to be preexisting tobacco products through voluntary submissions, and links to redacted and 508-compliant order letters, decision summaries and other documents for various authorized products that were already in the database.

    The database is available here.

  • 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.