Tag: FDA

  • FDA: New Joint Task Force to Combat Illegal Vapes

    FDA: New Joint Task Force to Combat Illegal Vapes

    Credit: Heidi

    The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration announced today the establishment of a federal multi-agency task force to combat the distribution and sale of illegal vaping products, including disposable e-cigarettes.

    “Enforcement against illegal e-cigarettes is a multi-pronged issue that necessitates a multi-pronged response,” said Brian King, director of the FDA’s Center for Tobacco Products. “This ‘All Government’ approach – including the creation of this new Task Force – will bring the collective resources and experience of the federal government to bear on this pressing public health issue.”

    Along with the FDA and DOJ, the task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth. Additional agencies may join the task force in the coming weeks and months.

    “Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans – particularly children and adolescents – across the country,” said Acting Associate Attorney General Benjamin Mizer. “This interagency Task Force is dedicated to protecting Americans by combatting the unlawful sale and distribution of these products. And the establishment of this Task Force makes clear that vigorous enforcement of the tobacco laws is a government-wide priority.”

    The federal task force will focus on several topics, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions under the PACT Act; the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA); and other authorities.

    “The U.S. Marshals Service Asset Forfeiture Division stands ready to work with our Task Force partners in the seizure of unauthorized e-cigarettes from domestic distributors seeking to sell them unlawfully,” said Ronald Davis, director of the U.S. Marshals Service.

    According to a press release, violations of these statutes can result in felony convictions, significant criminal fines, and civil monetary penalties. They can also result in seizures of unauthorized products, which can help make illegal e-cigarettes less accessible, including to young people. Through their participation in the task force, USMS will help the FDA and the Department effectuate seizures of unauthorized e-cigarettes within the United States.

    “The Justice Department is committed to enforcing the laws that prevent the sale and distribution of unlawful e-cigarettes,” said Principal Deputy Assistant Attorney General Brian Boynton, head of DOJ’s Civil Division. “We will work closely with our Task Force partners to address this crisis with all of the enforcement tools available to us.”

    The Federal Trade Commission (FTC), which releases reports about cigarette, smokeless tobacco, and e-cigarette marketing and enforces various statutory and regulatory prohibitions on false and misleading advertising, will support the task force’s activities, including by sharing its knowledge about the marketplace for vaping products.

    “We look forward to sharing our experience with this rapidly changing, multi-billion dollar market through this important Task Force,” said Samuel A.A. Levine, director of the FTC’s Bureau of Consumer Protection.

  • Consumer Group Welcomes Juul Ban Rescission

    Consumer Group Welcomes Juul Ban Rescission

    Photo: Juul Labs

    The potential return of Juul to U.S. store shelves would represent a win for consumers and tobacco harm reduction, according to the Consumer Choice Center (CCC).

    On June 6, the U.S. Food and Drug Administration rescinded its 2022 marketing denial order. While the move it neither an authorization nor a denial, it places the company’s premarket tobacco product application back into scientific review, meaning it could potentially be authorized at some point.

    “This is a step in the right direction for consumers who want more nicotine alternatives to combustible tobacco,” said CCC U.S. Policy Analyst Elizabeth Hicks.

    The FDA said in its June 6 statement that it had “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology” and that their change of course is based on a “review of information provided by the applicant” plus new case law based on court decisions involving MDOs for e-cigarette products.

    “With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency. Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes,” said Hicks.

    The FDA decision opens the door for Juul to return to the market in the future, and allow U.S. consumers the same choice as those in the U.K. and Canada.

    “We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” concluded Hicks.

  • Reversal: FDA Rescinds Juul Marketing Denial Order

    Reversal: FDA Rescinds Juul Marketing Denial Order

    Credit: Jet City Image

    The US FDA reversed a marketing denial order issued to Juul Labs for its vaping products.

    By VV staff

    Juul is allowed back on the market, but a final decision has yet to be made. On June 6, the U.S. Food and Drug Administration rescinded its 2022 ban on Juul Labs’ e-cigarette products, paving the way for the company to potentially receive marketing authorizations from the regulatory agency.

    “The FDA rescinded its June 2022 marketing denial orders (MDOs) for the Juul system and placed our applications back into scientific review,” Juul Labs stated in a release. “We appreciate the FDA’s decision and now look forward to reengaging with the agency on a science[-based] and evidence-based process to pursue a marketing authorization for Juul products.

    “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.

    These products (the Juul device and Virginia tobacco and menthol Juul pods in 5 percent and 3 percent nicotine concentration) will remain on the market during this review.”

    In 2022, the FDA ordered Juul to stop its sales but later paused the order while the vaping company appealed. The agency announced that it would reinitiate a scientific review of Juul’s products, essentially returning them to their regulatory status before the initial ban.

    “In the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA stated in a release. “Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”

    In the 2022 MDO, the FDA stated that Juul Labs’ premarket tobacco product applications (PMTAs) “lacked sufficient evidence regarding the toxicological profile of the products” and that some of the “study findings raised concerns due to insufficient and conflicting data.”

    Soon after receiving its MDO in 2022, Juul Labs published its administrative appeal of the MDO, which explained the company’s position, “based on science and evidence,” that the MDO was substantively and procedurally flawed. The appeal, referred to as a 10.75 appeal, presumably led to the MDO being rescinded.

    In late June 2022, the U.S. Court of Appeals for the D.C. Circuit told retailers they could continue to sell Juul products after it issued a stay of the MDO. In its 2022 court filing challenging the FDA ruling, Juul said the agency had overlooked more than 6,000 pages of data that the company had submitted on the aerosols that users inhale. Juul also suggested that the FDA’s decision was influenced by political pressure.

    The American Lung Association stated in a release that it was “deeply troubled” by the FDA’s announcement and urged the agency to deny all Juul products. It cited Juul Labs’ role in the “youth e-cigarette epidemic” from 2017 to 2019. “These products and its manufacturer clearly do not meet the standard for protecting the public health,” Erika Sward, the association’s assistant vice president of nationwide advocacy, stated.

    Anne Melzer, vice chair of the American Thoracic Society (ATS) Tobacco Action Committee, said she was disappointed with the decision. “FDA’s announcement that they are reconsidering the Juul application adds further delay and uncertainty to the already poorly regulated and chaotic e-cig market,” Melzer stated in a post on an X account for the ATS.

    Elizabeth Hicks, U.S. policy analyst at the Consumer Choice Center, called the FDA’s reversal “a step in the right direction” for consumers who want more nicotine alternatives to combustible tobacco. “With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency,” said Hicks. “Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes.”

    Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, said the MDO reversal will have little impact since Juul products never actually left the market.

    “A pause and a rescission of an MDO are differences without much distinction,” explained Conley. “Since the pause of the MDO enforcement, Juul has been able to market their products, and nothing about this move has made it harder or easier for them to continue to do so.”

    At the end of last year, Juul Labs announced it was seeking FDA approval for new menthol-flavored pods, the Juul2 pods, which require age verification.

    This announcement followed an announcement in July 2023 for a vaporizer with a unique pod ID chip to prevent the use of counterfeit cartridges and restrict underage access.

    The July 2023 application included a proposal for tobacco-flavored pods.
    The vaporizer is already on sale in the U.K. after its launch in 2021 as the Juul2 system. The menthol pod contains a secure microchip that requires age verification before use.

    Users can lock the device at any time to prevent unauthorized usage.
    So far, the FDA has authorized only 23 e-cigarette products for sale in the United States, all of them tobacco-flavored. The agency has denied menthol e-cigarette applications from several high-profile manufacturers, including BAT, which is appealing those decisions.

    Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied, according to the FDA. Rescission of the MDOs returns the PMTAs to pending status, under substantive review by the FDA.

    The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.
    Hicks said that she hopes that the move to rescind the Juul MDOs shows that the agency may be moving toward a more fair and logical approach to the PMTA review process.

    “We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” she said.

  • CTP Office of Management Gets Brandt as Director

    CTP Office of Management Gets Brandt as Director

    Credit: Otseira

    The U.S. Food and Drug Administration’s Center For Tobacco Products (CTP) is pleased to announce that Erin Brandt will serve as director of CTP’s Office of Management.

    Brandt currently holds the position of deputy director in CTP’s Office of Management.

    “Brandt has more than a decade of experience working in leadership positions in administrative management,” the CTP stated in a release. “She has extensive experience overseeing a wide range of administrative services, including human capital, information technology, financial management, administrative management, acquisitions and grants, ethics, facilities, and risk management and analysis.”

    Brandt joined CTP in 2013 as the Office of Management’s Management analysis officer, and became the deputy director in 2014, a position she held until assuming her current role as acting director.

    Before joining FDA, Brandt was a management analyst at the National Institutes of Health (NIH) and worked for several non-profit organizations, including Global Philanthropy Alliance, World Resources Institute, and Habitat for Humanity as an AmeriCorps VISTA.

    She earned a master’s of Public Policy from the University of Minnesota Humphrey School of Public Affairs and holds a bachelor’s of Science in Political Science from the University of Wisconsin-Eau Claire.

    Brandt was selected after an extensive nationwide search, multiple interview panels that evaluated a substantial and well-qualified applicant pool, and clearance through important FDA ethics and security processes. CTP is excited for Ms. Brandt to continue her service with CTP, with an effective date of June 16th.

  • US FDA Updates ‘Red List’ for Illegal Vaping Products

    US FDA Updates ‘Red List’ for Illegal Vaping Products

    Credit: Eduardo Barraza

    The U.S. Food and Drug Administration updated its import alert on May 23, which includes a “red list” of manufacturers, distributors, and brands of vapor products that may be detained “without physical examination,” the agency announced.

    The alert authorizes U.S. Customs and Border Protection (CBP) 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 full 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 states. “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 (FD&C Act).”

  • PMTA Filed for Njoy ACE 2.0 With Age Verification

    PMTA Filed for Njoy ACE 2.0 With Age Verification

    Credit: Kristina Blokhin

    Njoy, a subsidiary of Altria, submitted a supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device.

    The new device includes access restriction technology designed to prevent underage use. This is achieved through Bluetooth connectivity, which authenticates the user before unlocking the device. The company has also re-submitted PMTAs for blueberry- and watermelon-flavored pod products, which are exclusively compatible with the Njoy ACE 2.0 device.

    “Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products,” said Shannon Leistra, president & CEO of Njoy. “Njoy ACE 2.0 includes critical technology features to prevent underage access to flavored Njoy products while also responsibly providing flavored options for adult smokers and vapers.”

    The Njoy ACE is the only pod-based vaping product currently with marketing authorization from the FDA. In the first quarter of 2024, Njoy announced it had broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end.

    Njoy also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space, according to a press release.

    “Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, senior vice president of Regulatory Affairs of Altria Client Services. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”

    Njoy had previously received marketing denial orders for its blueberry (2.4% and 5% nicotine strengths) and watermelon (2.4% and 5% nicotine strengths) pods, noting that “…Rather, for flavored Electronic Nicotine Delivery System (ENDS), only the most stringent mitigation measures – specifically device access restrictions – have such mitigation potential.”

    Njoy stated that it believes these applications sufficiently address the FDA’s concerns regarding underage use by incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco-flavored vaping product.

  • 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.

  • FDA: 14 More Warning Letters for Flavored Vape Sales

    FDA: 14 More Warning Letters for Flavored Vape Sales

    The U.S. Food and Drug Administration announced on May 1 that it had sent warning letters to 14 online retailers. The reason for the warning letters was that these retailers were selling unauthorized e-cigarette products.

    The warning letters specifically mentioned the sale of disposable e-cigarette products marketed under various brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary, according to press release.

    The retailers receiving these warning letters sold or distributed e-cigarette products in the United States that lack authorization from FDA, in violation of the Federal Food, Drug, and Cosmetic Act.

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties.

    The agency announced on April 30 that the U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California.

    The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.

  • U.S. Marshals Seize $700,000 in Unauthorized Vapes

    U.S. Marshals Seize $700,000 in Unauthorized Vapes

    Photo: APchanel

    The U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California. The seized products were mostly flavored, disposable e-cigarette products, including brands such as Puff Bar/Puff, Elf Bar/EB Design, Esco Bar, Kuz, Smok and Pixi.

    “FDA has been unequivocally clear that we are committed to using the full scope of our enforcement tools—including seizures—to hold those who peddle unauthorized e-cigarettes accountable,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “The writing is on the wall for those in the tobacco product supply chain who fail to heed the law.”

    This action represents the first time the U.S. Food and Drug Administration and the Department of Justice (DOJ) have seized tobacco products in coordination with the U.S. Marshals Service.

    The seizure initially targeted products being held and sold by MDM Group, a distributor doing business as Eliquidstop.com. FDA issued a warning letter to MDM Group in May 2023, for offering unauthorized, flavored e-cigarette products for sale or distribution. In January 2024, FDA conducted a follow-up inspection of the firm and determined that it continued to commercially market its illegal products. While conducting the seizure at MDM’s facility, the agencies were informed that several firms may have an ownership interest in the unauthorized e-cigarettes seized.

    As of April 2024, the FDA had issued approximately 670 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and issued more than 550 warning letters to retailers for the sale of unauthorized e-cigarettes. The agency has also filed civil money penalty complaints against more than 50 e-cigarette manufacturers and more than 100 retailers for manufacture and/or sale of unauthorized new tobacco products, as well as complaints for permanent injunction against seven e-cigarette manufacturers.

  • Florida has First-in-Nation Disposable Vape Registry

    Florida has First-in-Nation Disposable Vape Registry

    Credit: Ball Studios

    Florida’s governor, Ron DeSantis, has signed legislation intended to crack down on the sale of unauthorized vapes that the state deems attractive to children.

    The new law (HB 1007), however, only targets disposable vaping products not authorized by the U.S. Food and Drug Administration. The rules will be enforced beginning Oct. 1.

    Unlike other state registry lists, Florida is the first state in the nation to include a carve-out for refillable pod systems and open-system vaping products, as well as bottled e-liquids.

    Florida Smoke Free Association president and vape shop owner Nick Orlando was the driving force behind getting the open system exemption.

    In its original form, the bill would have prohibited sales of any vape products that had not yet received FDA approval, according to media reports.

    The law now directs the state’s Department of Legal Affairs to develop and maintain a directory listing all single-use nicotine vapes it deems attractive to minors. The department must make the list publicly available on Jan. 1, 2025, and regularly update it.

    Once a product is added to the list, retailers and wholesalers in Florida have 60 days to sell or remove it from their inventory. Any products left in circulation will be subject to seizure and destruction.

    Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors that ship products into Florida.

    Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.