Tag: FDA

  • FDA Authorizes IQOS Holder and Charger

    FDA Authorizes IQOS Holder and Charger

    The U.S. Food and Drug Administration (FDA) has issued a marketing order to Philip Morris Products authorizing the sale of the IQOS 3 system holder and charger, the agency announced on Twitter.

    The newly authorized version has minor design differences from the previous version authorized in April, including how the holder inserts into the charger, changes to the charging connectors and LED indicator lights, a new touch feedback feature, and an option to reduce the perceived heat from the tobacco aerosol inhaled by users.

    Data on product use suggest no differences among user populations from the previous version, including no new concerns regarding product initiation or use among youth and young adults.

    “The issuance of this marketing granted order confirms that you have met the requirements of section 910(c) of the FD&C Act and authorizes marketing of your new tobacco product,” the FDA wrote in a letter to Philip Morris Products.

    “Under the provisions of section 910, you may introduce or deliver for introduction into interstate commerce the tobacco product, in accordance with the marketing order requirements outlined in this order, including all appendices.”

    The agency stressed that the marketing order does not mean any version of the IQOS system holder and charger can be marketed as “safe” or “FDA approved.”

    “There are no safe tobacco products,” the FDA wrote.

    The previous version of the IQOS system holder and charger was initially allowed for sale in the U.S. following the FDA’s issuance of a marketing order in April 2019. The company later submitted another premarket tobacco application requesting to market an updated version of the device holder and charger.

    On July 7, 2020 the FDA authorized the marketing of the IQOS 2.4 tobacco heating system as a modified risk tobacco product with a reduced exposure claim. IQOS 2.4 is the first next-generation inhalable tobacco product to be authorized as a modified risk tobacco product.

    “Altria’s 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we’re excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets,” said Jon Moore, president and chief executive officer of PM USA, which has an exclusive agreement to commercialize the IQOS system in the U.S., in a statement.

    IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina markets.

  • Regulation of E-cigs as Tobacco Upheld

    Regulation of E-cigs as Tobacco Upheld

    Photo: jessica45 | Pixabay

    A U.S. federal appeals court has upheld the Food and Drug Administration’s (FDA) decision to regulate e-cigarettes as tobacco products, reports Westlaw Today.

    Several vape shops and e-liquid manufacturers, represented by the Pacific Legal Foundation, a conservative legal group, had challenged the FDA’s decision claiming it violated the Constitution (Moose Jooce et al v. FDA).

    They argued that the FDA’s then-associate commissioner for policy, Leslie Kux, who issued the 2016 rule deeming e-cigarettes to be tobacco products, lacked the authority to do so because she was a career employee, not a principal officer appointed by the president.

    The FDA countered that the authority had been delegated to Kux by the agency’s commissioner. Furthermore, it said, her authority did not matter because the rule was ultimately ratified by two different FDA commissioners, most recently FDA Commissioner Scott Gottlieb in April 2019.

    A unanimous panel of the D.C. Circuit U.S. Court of Appeals ruled that the regulation did not run afoul of the Constitution’s Appointments Clause.

    Jonathan Wood of the Pacific Legal Foundation said he and his clients were disappointed by the ruling and considering next steps.

  • U.S. Graphic Warnings Postponed Again

    U.S. Graphic Warnings Postponed Again

    Illustration: FDA

    A Texas federal court Wednesday further postponed the effective date of the U.S. Food and Drug Administration’s (FDA) new requirement for graphic warning labels on cigarette packs to January 2022, reports Law360.

    In his ruling, U.S. District Judge J. Campbell Barker sided with the tobacco industry, which argued that questions over the validity of the rule remain unanswered. A hearing for pending motions for summary judgment and motion for a preliminary injunction is scheduled for next week,

    In November, R.J. Reynolds Tobacco Co., Liggett Group and ITG Brands, along with cigarette retailers, asked for the postponement. The companies argued they would suffer irreparable harm if they were forced to spend millions of dollars to comply with a rule that will soon be invalidated.

    “These expenditures of resources for the purpose of meeting the rule’s requirements constitute irreparable harm because plaintiffs cannot recover money damages should the rule and/or the graphic-warning requirement in the Tobacco Control Act be invalidated,” the companies stated.

    Barker has already pushed the rule’s effective date back once due to the coronavirus pandemic, at the request of tobacco companies and the FDA. In a May 8 order, the judge delayed the effective date from June 18, 2021, to Oct. 16, 2021.

    In March, the FDA released a final rule requiring new graphic warnings for cigarettes that feature some of the lesser-known health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.

    The warnings include statements that tobacco smoke can harm children and that smoking can cause bladder cancer and neck and head cancer.

    In April, the cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

  • FDA Urged to Mandate Minimal Nicotine

    FDA Urged to Mandate Minimal Nicotine

    Photo: Martinmark – Dreamstime.com

    John Pritchard, 22nd Century’s vice president of regulatory science, has called on the U.S. Food and Drug Administration (FDA) to accelerate implementation of its comprehensive plan on tobacco and nicotine regulation, in particular to impose the mandate requiring all cigarettes sold in the United States to contain minimally or non-addictive levels of nicotine.

    The proposed rule was removed from the agency’s agenda late last year without significant explanation.

    “Despite the obvious harm of smoking, the staggering public health costs, and the millions of lives lost, we have never mustered the fortitude to enact policies that would make cigarettes less addictive and end this public health disaster, Pritchard wrote in a newsletter published by the global data intelligence company Morning Consult.

    “This is the perfect time to take that step.”

    22nd Century has invested heavily in nicotine-reduction technology, and the company stands to benefit greatly if the FDA mandates minimally addictive levels of nicotine.

    “Companies like the one where I work have developed technology to decrease the chances that future generations become addicted to cigarettes and to provide alternatives for smokers of highly addictive cigarettes,” Pritchard wrote.

    “Yet we continue to wait almost a year for a further authorization to allow us to communicate this breakthrough to adult smokers. The faster this can be achieved, the sooner and greater the public health benefit in the United States

  • FDA Accepts Bantam Vape PMTA

    FDA Accepts Bantam Vape PMTA

    Photo: Bantam Vape

    The U.S. Food and Drug Administration (FDA) has accepted the premarket tobacco product application (PMTA) submitted on Sept. 2, 2020, by Bantam Vape, a supplier of e-liquids based in North Carolina, USA.

    The filing letter signifies completion of FDA’s preliminary review of Bantam’s PMTA and the progression of its application into the formal substantive review phase. During this phase, FDA will conduct an in-depth evaluation of the scientific studies and other materials submitted in conjunction with Bantam’s application.

    “Bantam is pleased its PMTA has been formally filed and will be entering the scientific review phase of this process,” said Bantam spokesperson Anthony Dillon in a statement.

    “Bantam looks forward to engaging with FDA as it reviews the submission and scientific research provided in support of the filing. Bantam’s goal has always been to provide consumers with high-quality, science-based e-liquid products that can be enjoyed for years to come. News of the filing brings Bantam one step closer to reaching that goal.”

  • FDA Draft Guidance for Perception Studies

    FDA Draft Guidance for Perception Studies

    Photo: Jhvephotos | Dreamstime.com

    The U.S. Food and Drug Administration (FDA) has released a draft guidance for tobacco product perception and intention (TPPI) studies. The studies must be submitted as part of a modified risk tobacco product application, a premarket tobacco product application or a substantial equivalence report.

    The guidance is aimed at helping applicants design and conduct the studies that can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products.

    It is possible for a TPPI study to also include an actual use component (e.g., an actual product utilized in a simulated use setting or a real environment of use); however, a discussion of actual use research is beyond the scope of this draft guidance, according to the FDA.

    This draft guidance addresses the following scientific issues for applicants to consider as they design and conduct TPPI studies to support tobacco product applications:

    • Developing TPPI study aims and hypotheses
    • Designing quantitative and qualitative TPPI studies
    • Selecting and adapting measures of TPPI study constructs
    • Determining TPPI study outcomes
    • Selecting and justifying TPPI study samples
    • Analyzing TPPI study results

    The agency is accepting public comments related to the draft guidance through Dec. 28. The application deadline was Sept. 9 for deemed new tobacco products that were on the market as of Aug. 8, 2016, and the FDA said it intends to make a public list of what products were submitted on time. 

  • Zeller to Present at FDLI Conference

    Zeller to Present at FDLI Conference

    Photo: David Parker

    Mitchell R. Zeller, director of the Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA), will provide an update on the FDA’s comprehensive plan for tobacco and nicotine products at the Food and Drug Law Institute’s (FDLI) Tobacco and Nicotine Products Regulation and Policy Conference on Oct. 21, 2020, at 11:15 a.m. Eastern time. 

    This year’s conference brings together a diverse group of stakeholders, including public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies and others to discuss effective regulation across the broad spectrum of tobacco and nicotine products in the United States.

    Panelists will examine the public health impact of regulating nicotine content across the broad spectrum of tobacco and nicotine products; the ways in which policies can help minimize users’ health risks; and the mitigation of potential unintended consequences.

  • FDA Outlines Steps After PMTA deadline

    FDA Outlines Steps After PMTA deadline

    The U.S. Food and Drug Administration (FDA) has outlined the next steps for products with a submitted premarket tobacco product application (PMTA) now that the Sept. 9 deadline has passed.
     
    According to the FDA, the process will consist of three phases. Phase one is acceptance of the application. Phase two is notification or filing, and phase three consists of review and action. The FDA website notes that “the PMTA process also includes a fourth phase for post-market reporting.”
     
    The FDA plans to prioritize enforcement against electronic nicotine-delivery system (ENDS) products that are still being sold and that don’t have PMTAs submitted as well as any other “deemed new tobacco product” that does not have a submitted PMTA.
     
    The FDA will not enforce the premarket review requirement for premium cigars.

  • Marketing Authorization Requested for Bidi Stick

    Marketing Authorization Requested for Bidi Stick

    Photo: Kaival Brands Innovation Group

    Bidi Vapor has submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) for its Bidi Stick, according to Kaival Brands Innovations Group, the exclusive worldwide distributor of the Bidi Stick.
     
    The application details 11 flavored varieties with nicotine concentrations of 6 percent weight/volume as part of the company’s proprietary e-liquid formulation.
     
    Bidi Vapor’s application runs more than 285,000 pages, providing science-based evidence demonstrating that Bidi Sticks are “appropriate for the protection of public health.” The applications further support the public need to provide options to adult smokers of combustible tobacco products.
     
    “Both Kaival Brands and Bidi Vapor fully support proper regulation of the category so that all ENDS products meet the highest manufacturing, safety and marketing standards for adult smokers, with the ultimate goal of improving the public health,” said Niraj Patel, president and CEO of Kaival Brands. “We look forward to working with Bidi Vapor as they work with the FDA to construct its regulatory policy based on science and facts.”
     

  • FDA Accepts PMTA from AMV Holdings

    FDA Accepts PMTA from AMV Holdings

    Photo: Tobacco Reporter archive

    The U.S. Food and Drug Administration (FDA) has accepted a premarket tobacco product application (PMTA) from AMV Holdings.

    Since receiving the notification, AMV has filed an additional 104 PMTA submissions accounting for more than 5,000 stock keeping units.  All these submissions reflect the same file and information structure as the PMTA for which AMV has already received its acceptance for review notification.

    Mark Kehaya

    “We are proud of our team and their achievement in completing a significant step in a rigorous regulatory process and look forward to the FDA’s review of all our products,” said Mark Kehaya, chairman of AMV Holdings, in a statement.

    “We view this multi-year effort as another milestone in leading with science and quality in the vapor industry. We hope that the FDA’s PMTA process will increase consumers’ trust in the industry and the products we offer give combustible tobacco users a reliable alternative.”

    AMV Holdings, which includes the brands Alohma, Kure, Madvapes, ELB Labs, and Wholesale Vaping Supply, is a leading manufacturer and retailer of electronic nicotine delivery systems in the United States and Europe.

    AMV currently operates 113 retail locations in the United States through a combination of corporately owned, franchised and licensed stores and a further seven stores in Germany and Ireland. AMV manufactures e-liquids through ELB Labs, to distribute to their brick and mortar vape stores, online (B2C) e-commerce platforms, and third-party vape stores for consumers who want to switch from smoking cigarettes to vaping/e-cigarettes.

    “It’s exciting to know that we will be able to continue to offer our guests Prime e-liquids in all our retail locations,” said Sam Salaymeh, president of AMV Holdings. “The process with the FDA has enabled us to document our philosophy of providing high-quality standards and superior chemistry of our Prime e-liquid line, that is something we are all proud of. We look forward to providing our guests with the best service and products in the industry for many years to come.”