Category: U.S. FDA

  • FDA Denies Marketing Applications for Vuse Menthol

    FDA Denies Marketing Applications for Vuse Menthol

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.

    Reynolds is expected to challenge the order.

    The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2, according to a statement. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. 

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.

    After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

    Specifically, the evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.

    In October last year, the FDA issued MDOs for several menthol-flavored vaping products marketed by Logic Technology Development. It was the first time the FDA issued MDOs for menthol products after receiving a scientific review.

    A few days after the order was issued, Logic obtained a court order from the U.S. Circuit Court of Appeals for the 3rd Circuit that temporarily stayed the order.

    The case continues.

  • FDA: 99 Percent of Applications Decided

    FDA: 99 Percent of Applications Decided

    Image: manonteravest | Adobe Stock

    In an update, the U.S. Food and Drug Administration said it has made determinations on more than 99 percent of the nearly 26 million deemed products for which applications were submitted. To date, the agency has authorized 23 new e-cigarette products.

    This includes determination on applications for nearly 6.7 million products received by the Sept. 9, 2020, deadline, more than 18 million products received after the Sept. 9 deadline, and applications for nearly 1 million nontobacco nicotine products submitted by May 14, 2022, in accordance with the new federal law passed in April 2022.

    Under a federal court order, manufacturers of deemed new tobacco products that were on the market as of the deeming rule’s effective date (Aug. 8, 2016) were required to submit premarket review applications by Sept. 9, 2020.

    On Feb. 21, 2023, the FDA issued a refuse-to-accept (RTA) letter to one applicant notifying the company that their premarket tobacco product applications, which are associated with approximately 17 million individual tobacco products, do not meet the acceptance requirements outlined in the FDA’s regulations. The applications were for a grouped submission of e-liquids in varying size, nicotine strength and flavor combinations, each of which was treated as an individual product application according to existing premarket review processes.

    During the acceptance phase of application review, the FDA reviews applications to ensure they meet a minimum threshold for acceptability for FDA scientific review. If required contents for acceptance are missing, the FDA refuses to accept the application. This company was issued an RTA letter because the company’s applications for these products lacked required environmental assessments. The company may submit a new application for these products at any time; however, the products may not be marketed unless the FDA reviews the applications and determines that marketing of the products is appropriate for the protection of the public health.

    The latest updates on actions taken on these applications can be viewed on the FDA’s tobacco products marketing orders page.

  • Health Advocates Urge FDA to Ban Flavors

    Health Advocates Urge FDA to Ban Flavors

    Image: chocolatefather | Adobe Stock

    Health advocates are urging the U.S. Food and Drug Administration to ban menthol cigarettes and flavored cigars, reports WGBO. The FDA issued draft measures to ban menthol in April 2022. Final regulations are expected later this year.

    “Menthol is an analgesic; it numbs the throat, so it lets the poison go down easier,” said Carol McGruder, co-chair of the African American Tobacco Control Leadership Council. “It dilates the alveoli in the lungs, the little sacs in your lungs, and so it allows the toxins to stay longer and deeper in the lungs.”

    Lincoln Mondy made a documentary called Black Lives/Black Lungs about the marketing of menthol cigarettes to Black communities, something many have pointed out as a trend in tobacco marketing.

    “We say predatory because it was indeed predatory; they went in neighborhoods like Detroit and New York and majority Black neighborhoods and gave out free cigarettes. They just handed out free cigarettes; they drove up in Newport vans and Kool vans and handed out free cigarettes,” Mondy said.

    As a result of this “predatory” marketing, 85 percent of Black smokers smoke menthol cigarettes. Some states like California passed laws banning flavors. However, McGruder says that the industry is still finding ways around such bans.

    “They’ve already introduced new products that have some chemicals in there that mimic menthol, but they’re not menthol, and they’re actually on the market right now in California, and so now we have to deal with that, and so, the industry will never stop. They are going to continue to recruit their new smokers to replace the folks who are dying,” McGruder said.

  • CTP Hires New Office of Science Director

    CTP Hires New Office of Science Director

    Matthew Farrelly (Credit: RTI International)

    The new director of the U.S. Food and Drug Administration’s tobacco science division is Matthew Farrelly, former chief scientist and director of the Center for Health Analytics, Media, and Policy for RTI International.

    In an announcement, the FDA’s Center of Tobacco Products (CTP) stated that Farrelly’s extensive work in the field of tobacco and nicotine science for more than 25 years, and being recognized internationally as an expert with proven leadership and organizational management skills will help him succeed as the director of the CTP’s Office of Science.

    “He has led or been involved with numerous scientific endeavors related to tobacco control policies and regulatory approaches, including those related to graphic health warning labels, excise taxes, smoke-free policies, quitlines, state tobacco control programs, retail advertising, and flavored tobacco products,” the release states. “He has also extensively researched the influence of mass reach health campaigns, including FDA’s The Real Cost.”

    Farrelly also has authored or co-authored over 120 articles in peer-reviewed scientific literature, according to the release. He earned his Ph.D. in Economics from the University of Maryland at College Park.

    Farrelly joins the CTP as the agency faces a series of major tobacco-related decisions, including a potential ban on menthol cigarettes, lowering nicotine levels, and the next step in its ongoing attempt to regulate Juul and other electronic cigarettes.

    Farrelly will replace Matt Holman, who left the position last year to join Philip Morris International. Holman was hired in 2017 and took over for David Ashley.

  • 22nd Century Submits CBD Drug Master File

    22nd Century Submits CBD Drug Master File

    Image: Tobacco Reporter archive

    22nd Century Group filed a U.S. drug master file (DMF) to the U.S. Food and Drug Administration for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group company, according to a company press release.

    “GVB Biopharma is widely recognized for the quality and consistency of its Cannabinoid extracts and ingredients,” said James A. Mish, CEO of 22nd Century. “We are now leveraging these capabilities with our DMF filing to meet the increasing regulatory demands of the supplements markets.”

    Additionally, 22nd Century and GVB Biopharma have entered into an agreement with Cannabinoid API Solutions (CAS) and Transo-Pharm for global sales, marketing and distribution of GVB’s Cannabinoid APIs. Transo-Pharm is a well-established supplier and distributor of pharmaceutical APIs to a broad portfolio of branded and generic finished drug product manufacturers, including more than 75 current active, ongoing development programs.

    “The partnership with Transo-Pharm will accelerate opportunities to supply our APIs to the largest and most innovative pharmaceutical and consumer goods manufacturers in the world,” said Mish.

  • FDA Launches Online Vaping Resource Center

    FDA Launches Online Vaping Resource Center

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has launched the Vaping Prevention and Education Resource Center, which provides free science-based, standards-mapped materials that teachers can use to help their students understand the risks associated with vaping and nicotine addiction. The Center for Tobacco Products also developed free materials for parents and teens.

    Teachers will find lesson plans, interactive tools, infographics and videos with tobacco facts and tips about how to teach teens about the dangers of vaping.

    Parents will find fact sheets, videos and resources to help them understand and recognize vapes, talk with their children and keep the conversation going over time.

    According to the FDA, students will find real-life stories and relatable content to help them understand vaping, nicotine addiction, common myths about vapes and how to say no to vaping.

    The resource center will be continuously updated, according to the FDA.

  • Menthol and Nicotine Timelines Accelerated

    Menthol and Nicotine Timelines Accelerated

    Image: pingebat | Adobe Stock

    The Biden administration released its Unified Agenda and Regulatory Plan for fall 2022, which includes moving forward the timeline for a federal ban on menthol-flavored cigarettes, reports The Winston-Salem Journal.

    There are eight rules that address the tobacco industry, and three have “notable changes” from the spring 2022 plan, according to Jain Gaurav, a Barclays analyst. These include: Rules on a menthol ban in cigarettes and flavored cigars have moved to the “final rule stage” versus the “proposed rule stage”; rules to ban characterizing flavors in cigars have also progressed to the final rule stage; and the nicotine cap proposed standard development has been moved from May to October.

    “We continue to believe the Food and Drug Administration’s focus is going to revolve around the evaluation of premarket tobacco [product] applications of deemed products, notably e-cigarettes, in the next few months,” Gaurav said.

    “The FDA intends to publish a final (menthol) rule by August 2023. We expect a two-[year] to three-year cycle from the day FDA passes any rule to the time such rule survives the inevitable court challenges.

    “We don’t expect a menthol cigarette ban from the FDA implemented (if it were to pass) at least until 2026.”

    A cigarette menthol ban could have negative impacts on tobacco stocks with a significant U.S. presence, according to Gaurav and other tobacco industry analysts. Menthol cigarettes account for 35 percent of cigarettes sold in the U.S.

    “While there is some risk, a federal ban on menthol cigarettes could reduce smoker initiation and potentially be a catalyst that prompts a number of smokers to quit, thereby having some negative impact on cig volumes,” said Bonnie Herzog, Goldman Sachs analyst, “we continue to believe a more likely scenario is for menthol cig users to convert to nonmenthol cig products or to reduced-risk products that have a menthol variant, such as e-vapor.”

    It is expected that the FDA will face lawsuits from tobacco manufacturers and anti-smoking groups if the ban goes through because Congress exempted menthol from banned flavorings in traditional cigarettes in the federal Tobacco Control Act in 2009.

    In June, the FDA issued its proposal to reduce nicotine content in traditional cigarettes to minimal and potentially nonaddictive levels as early as May 2023.

    “We think it will take a decade or longer for the FDA to introduce nicotine caps due to the long nine-step process at the FDA, the inevitable litigation and then the one year given to retailers to get rid of the excess inventory,” Gaurav said.

  • Bantam Receives PMTA Acceptance Letter

    Bantam Receives PMTA Acceptance Letter

    Image: Tobacco Reporter archive

    Bantam Vape received acceptance of its premarket tobacco product application (PMTA) submission from the U.S. Food and Drug Administration for its nontobacco nicotine e-liquids, according to a press release. Bantam’s application now moves to the next step in the PMTA process—a preliminary scientific review to confirm the application contains all required items to permit a substantive review by the FDA.

    Bantam submitted its application for its nontobacco nicotine e-liquids to the FDA on May 13, 2022, and is seeking marketing orders from the agency.

    “The receipt of this acceptance letter reflects Bantam’s efforts to provide adult consumers with high-quality, science-based e-liquids while upholding our responsibility to restrict youth access and use of these products,” said Bantam spokesperson Anthony Dillon. “Bantam remains supportive of the need for science-based regulation in the e-liquids industry and is proud of the progress of our various PMTAs. We remain confident in the quality and consistency of our products and the science behind them.”

    Prior to its nontobacco nicotine-focused submission, Bantam submitted a PMTA to the FDA in September 2020 for its tobacco-derived e-liquids. The application entered scientific review in August 2021, and, to date, remains under FDA review.

  • OSC Letter Describes FDA’s ‘Public Failure’

    OSC Letter Describes FDA’s ‘Public Failure’

    Image: David Mark | Pixabay

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns, according to an investigation conducted by the U.S. Office of Special Counsel (OSC). The OSC sent a letter to President Joe Biden and Congress outlining the findings.

    The investigation began after a leading CTP toxicologist-turned-whistleblower disclosed to the OSC that a 2019 memorandum issued to the CTP’s scientists revised the process for evaluating potentially harmful ingredients in substantial equivalence applications used for certain tobacco products. According to the whistleblower, the memo directed scientists to stop using objective, quantitative data to evaluate applications and to instead use an approach that was more akin to “eyeballing it,” resulting in unclear review standards and less reliable decisions, according to the CTP.

    The whistleblower also alleged that flaws in the CTP’s internal scientific dispute resolution process effectively prevented the whistleblower and several other concerned scientists from raising these issues within the agency. “This internal dispute process is intended to safeguard the integrity of CTP’s scientific evaluations, including consideration of certain tobacco products to ensure those authorized for market meet the applicable health and safety standards,” the CTP stated.   

    The OSC referred the whistleblower’s allegations for investigation. In response, the FDA convened an independent panel of scientific experts to evaluate allegations concerning the allegedly flawed tobacco application review process. The panel largely agreed with the whistleblower’s concerns, finding that the process lacked “quantifiable standards or criteria.” The expert panel made six recommendations, including a new process for resolving scientific discrepancies, which the agency largely adopted.

    In response, the whistleblower acknowledged the CTP’s progress in giving scientists discretion to consider quantitative data in reviewing potentially harmful chemical compounds in substantial equivalence applications for new tobacco products. The CTP also revamped its scientific dispute procedures and created a mandatory training program for all CTP staff involved in scientific decision-making. While supportive of these steps, the whistleblower stated that FDA scientists will still need courage to challenge a system that “discourages dissenting voices.”

    “The public depends on the FDA to vigorously implement and enforce our nation’s health and safety laws, especially when new tobacco products are being brought to market,” said Special Counsel Henry J. Kerner. “I am deeply troubled that FDA’s own scientific dispute process failed our whistleblower and fellow concerned scientists, and as a result failed the public. I commend the whistleblower for persevering in the face of these unnecessary obstacles. I also thank the FDA for taking the allegations seriously by convening an independent expert panel and for taking positive steps to repair its review process.”

  • Reagan-Udall Submits CTP Review to FDA

    Reagan-Udall Submits CTP Review to FDA

    The Reagan-Udall Foundation today submitted its recommendations to Robert Califf , commissioner of the U.S. Food and Drug Administration. The findings are what many in the industry are calling “meaningless” and “less than compelling.”

    The report concludes that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the Center for Tobacco Products (CTP), particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.

    The “Operational Evaluation of FDA’s Tobacco Program” was facilitated at Califf’s request. The announcement came as Califf attempted to push past several controversies that dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.

    The report did highlight several wide-ranging problems that the report states hinder its ability to regulate the industry and reduce tobacco-related disease and death. The report stated that the CTP should make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its program also has been affected by “changes in leadership and administrations.” In its first 13 years, CTP has operated under seven different commissioners in three different administrations, and recently hired a third CTP director, Brian King.

    “From the stakeholders’ perspective, policy shifts with broad impact on the industry occurred without notice. The Center has faced significant challenges in clearing its policies through the career and political infrastructure. It took years to establish requirements and standards governing application reviews, frustrating industry and creating problems for the Center itself when it received deficient applications,” the report states. “Issues in application reviews resulted in litigation necessitating re-review of some applications. The current environment reflects an unintended shift from what was structured by law as a pre-market authorization framework to the reality of a post-market regulatory environment, which is much more difficult to deal with given that there are few incentives for industry to come into compliance and many incentives for industry to delay the process.”

    The evaluation and resulting recommendations focused on four program areas: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders, according to the review. The review and recommendations are meant to assist the agency in making changes to better carry out its regulatory responsibilities; to strengthen its relationships with stakeholders

    The report identified several fundamental issues that the center needs to address and it states that the report offers “cross-cutting as well as program-specific recommendations to help CTP operate more effectively,” according to the authors of the review.

    The key points from the report can be summarized as follows:

    • The panel observes that CTP has been forced to operate primarily in a reactive mode, moving
      from one challenge to the next, mainly provoked by the outside forces. The Center should transition to becoming a more proactive and strategic program. With more substantial engagement with stakeholders and the public, CTP should take the time now to think strategically about where it is today and where it needs to go in the next several years.
    • Although CTP has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly, and transparently. This responsibility to function as an effective product regulator should be captured in the Center’s mission, vision, and goals and carried out to the best of the Center’s ability.
    • The panel recognizes that to improve the effectiveness of its application review, the Center should make process improvements and identify and address the policy and scientific questions that underpin its regulatory framework.
    • CTP needs to work with other entities on strategies to clear the market of illegal tobacco products more rapidly and provide more transparency to the public on its efforts to do so. This work is challenging but essential as CTP adopts a more strategic approach. While there is much the Center can do on its own, the panel notes that enforcement of the premarket requirements in the tobacco laws, particularly to help prevent youth use of tobacco products, requires the involvement and support of agencies other than FDA. The authors encourage the agency to elevate this issue and pursue a more comprehensive approach that leverages the resources of other agencies with a declared role in tobacco control.

    “Overall, the panel is confident that many of the concerns raised in this report can be addressed by CTP’s
    talented and dedicated staff, with the support of FDA leadership,” the report states.

    Numerous comments from purported staffers of the FDA for the Reagan Udall assessment claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research. One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs. The report fails to address these issues.

    The panel was comprised of former federal public health leaders, regulatory strategists, and process improvement specialists. Lauren Silvis, served as chair of the group, which included Jane Axelrad, Keith Flanagan, Charlene Frizzera, and Alberto Gutierrez.

    “The panel provided recommendations to help the Agency’s tobacco program strengthen its operations as it works to reduce the harm associated with tobacco use,” said Lauren Silvis. “The Center for Tobacco Products has made significant progress in establishing a regulatory program for tobacco products and our recommendations are intended to help the Center develop additional tools for achieving its public health objectives.”

    Through multiple listening sessions, interviews, and an online portal, the group received and carefully reviewed input from a range of stakeholders, including FDA staff and the public, according to the report. The author’s claim the report offers “cross-cutting and program-specific recommendations” for the FDA to consider, “focusing on regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders.”

    The report did not address tobacco policy issues, which are outside the scope of the evaluation, according to a Reagan-Udall Foundation.

    One industry stakeholder, who asked not to be named for fear of retribution from the FDA for its brands under PMTA review by the agency, said the report’s findings were “a joke” and “completely ignorant of the real problems at the CTP.”

    Califf said Monday he will review the recommendations with the aim of outlining the agency’s next steps by February.

    Earlier this month, Reagan-Udall delivered its food report that was commissioned at the same time as the tobacco report. The food response suggests the agency’s leadership be restructured to improve its response to emergencies, including the recent shortage of baby formula

    Reagan-Udall was created by Congress to help further FDA’s mission. The non-profit receives funding from both the FDA and the industries it regulates, including drugmakers.

    The report can be found at reaganudall.org.