Category: PMTA

  • Riot Squad Receives PMTA Acceptance Letter from FDA

    Riot Squad Receives PMTA Acceptance Letter from FDA

    riot squad e-liquid
    Credit: Riot Squad

    The U.S. Food and Drug Administration (FDA) has given an acceptance letter to the UK-based e-liquid manufacturer Riot Squad for its premarket tobacco product application (PMTA), the company confirmed today.

    “We continue to move through the PMTA process and are very happy to get to this stage”, said Ben Johnson Riot Labs CEO. “We remain committed to working with the FDA throughout the process. With our award-winning products and flavors we continue to provide better alternatives to combustible tobacco products and look forward to working in this industry for many more years to come.”

    The company confirmed that it had submitted PMTAs for seven flavors in three freebase nicotine strengths (0mg, 3mg and 6mg) and 2 nicotine salt strengths (20mg Hybrid and 48mg). The flavors submitted include:

    • Pink Grenade
    • Sub Lime
    • Tropical Fury
    • Blue Burst
    • Cherry Fizzle
    • Rich Black Grape
    • Ultra peach Tea

    “Receipt of this acceptance letter is a significant milestone, which confirms that Riot Labs products have now met the statutory and regulatory requirements for a PMTA submission, based on Section 910 of the FD&C Act,” a press release states. “The application is now under preliminary scientific review, before going forward to substantive review by the FDA.”

    The FDA requires applicants to show their products are appropriate for the protection of public health. Riot Labs began building its PMTA data in 2018. The process has taken over 2 years, with 7 applications and over 1.8 million pages of scientific data submitted, according to Johnson.

    Riot Labs was established in 2016 by Johnson who has an extensive background in pharmaceuticals. He set out to build ‘Riot Squad’ into an innovative brand, with the aim of encouraging consumers to find the confidence to give up smoking and engage in a healthier alternative. Riot Squad products are now available in over 86 countries.

  • FDA Approves PMTA for IQOS 3 Sales in U.S. Market

    FDA Approves PMTA for IQOS 3 Sales in U.S. Market

    IQOS 3
    Credit: Altria Group

    The U.S. Food and Drug Administration (FDA) has authorized the commercialization of the IQOS 3 heated tobacco product. Today, the Altria Group said the authorization follows review of the IQOS 3 premarket tobacco product application (PMTA) submitted by Philip Morris International Inc. (PMI).

    Philip Morris USA (PM USA), under an exclusive agreement with PMI, commercializes the IQOS system in the U.S. with three HeatStick variants. Unlike cigarettes, the IQOS system heats but does not burn tobacco. IQOS 3 offers several enhancements to the IQOS 2.4 currently being sold in select U.S. markets, including a longer battery life, faster re-charging time, a side opening mechanism, and magnetic closure, according to a press release.

    “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 CEO of PM USA.

    IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina markets. With PMTA authorization of IQOS 3, PM USA expects to begin quickly marketing the IQOS 3 device to U.S. adult smokers once the regulatory and U.S. importation logistics have been satisfied.

    To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

    On March 30, 2020, PMI submitted a supplemental PMTA to the FDA for the IQOS 3 tobacco heating system device. The original IQOS 2.4 device was authorized by the FDA for commercialization in the U.S. on April 30, 2019.

  • Bantam Vape Moves to FDA’s Substantive Review Phase

    Bantam Vape Moves to FDA’s Substantive Review Phase

    Bantam e-liquids
    Bantam is seeking marketing orders from FDA for its suite of e-liquid products. Credit: Bantam Vape

    Bantam Vape has received a filing letter for its premarket tobacco product application (PMTA). 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. Bantam is seeking marketing orders from FDA for its suite of e-liquid products.

    During this phase, the U.S. Food and Drug Administration (FDA) will conduct an in-depth evaluation of the scientific studies and other materials submitted in conjunction with Bantam’s application. Bantam, a provider of high-quality, science-based e-liquid products submitted its PMTA to FDA on Sept. 2 and received its initial acceptance notification from the agency the following month.

    “Bantam is pleased its PMTA has been formally filed and will be entering the scientific review phase of this process. Bantam looks forward to engaging with FDA as it reviews the submission and scientific research provided in support of the filing,” said Bantam spokesperson Anthony Dillon. “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.”

    Bantam has invested significant resources into the PMTA process and remains confident that the content and quality of materials in its submission will result in the receipt of the necessary marketing orders from FDA, according to a press release.

  • New U.S. FDA Draft Guidance for Perception Studies

    New U.S. FDA Draft Guidance for Perception Studies

    fda

    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 (MRTP), a premarket tobacco product application (PMTA) or a substantial equivalence report (SE 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 administration 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. 

  • USA Vape Lab Gets Filing Letter From FDA for PMTA

    USA Vape Lab Gets Filing Letter From FDA for PMTA

    Credit: Naked 100

    USA Vape Lab, one of the largest e-liquid manufacturers in the world, announced that it received its filing letter from the U.S. Food and Drug Administration (FDA). The filing letter acknowledges that the company’s premarket tobacco product applications (PMTAs) for their Naked 100 products are sufficiently complete, advancing the brand’s application forward to the substantive review phase.

    During the substantive review phase, the FDA evaluates the scientific studies and data presented in the applications submitted to ensure that the products are appropriate for the protection of the public health (APPH).

    “We are excited to be advancing further through the PMTA process. Our team has dedicated time and resources to ensure we have the data, research, and necessary components needed for our applications,” said Huy Nguyen, CEO of USA Vape Lab. “We are optimistic that our applications will continue to advance and result in the FDA granting USA Vape Lab with marketing orders.”

    The company says it continues to maintain the highest standards of regulatory compliance and is committed to working with the FDA as its applications undergo review.

  • Air Factory, Charlie’s Chalk Dust Get PMTA Filing Letters

    Air Factory, Charlie’s Chalk Dust Get PMTA Filing Letters

    My Vape Order, Inc. (MVO) announced that on October 9, 2020, the U.S. Food and Drug Administration (FDA) issued a Filing Letter notifying MVO that the Air Factory’s premarket tobacco product application (PMTA) met the FDA’s requirements and was moving forward into the regulatory agency’s substantive scientific review phase.

    Charlie’s Chalk Dust e-liquids have also received a filing letter and moved on to substantive review. “It is with great pleasure that we can announce to our customers that the FDA’s Center for Tobacco Products has informed us that our PMTA is sufficiently complete to enter the Substantive Review phase of the process,” wrote Brandon Stump, CEO of Charlie’s Chalk Dust. “This news is worthy of celebration as it highlights our progress towards achieving full regulatory compliance and providing our customers with a trusted product portfolio. It is a reflection of our relentless hard work and meticulousness in the pursuit of precision. We are confident that during the Substantive Review process the FDA will recognize that our submission is both distinguished and suitable for approval.”

    Kyle Godfrey, MVO’s CEO, said the FDA will review the extensive scientific data and research submitted with the PMTA to determine whether the Air Factory products are appropriate for the protection of public health. “The Air Factory PMTA was the culmination of years of planning and extensive toxicological testing and scientific research,” he said. “We look forward to working with FDA on its review of the Air Factory products, with the ultimate goal of obtaining FDA marketing orders for the products.”

  • Humble Juice Co. Receives Filing Letter for PMTA

    Humble Juice Co. Receives Filing Letter for PMTA

    The Humble Juice Co. is moving on to the scientific review stage of its premarket tobacco product application (PMTA). The leading e-liquid company with a humble beginning, announced that it had received a filing letter from the U.S. Food and Drug Administration (FDA). The letter indicates the FDA has completed its preliminary review of Humble’s PMTA, advancing the brand’s application forward in the review process.

    Humble submitted its PMTA to the FDA on Sept. 3.

    “We were excited to receive a filing letter from the FDA just days after being notified of our PMTA’s acceptance,” said Humble CEO Daniel Clark. “To my knowledge, there are a limited number of e-liquid companies that have moved forward to this phase of the PMTA process thus far. We hope our application continues to advance in a timely manner and we remain committed to working with the FDA in order to achieve this.”

    A filing letter from the FDA is a result of a preliminary scientific review of a PMTA. This review ensures an application includes the necessary components and scientific analyses. FDA will now conduct a Substantive Review of Humble’s application to evaluate the scientific information and data submitted within its PMTA. If successful, this phase will result in the FDA granting marketing orders, authorizing the continued marketing and sale of Humble’s products.”

  • Bantam E-Liquids Garners Acceptance Letter for PMTA

    Bantam E-Liquids Garners Acceptance Letter for PMTA

    The legal e-liquid market continues to grow. Bantam Vape announced yesterday that it had received an acceptance letter for its premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). The brand’s application now moves to the next step in the PMTA process—a preliminary scientific review to ensure the application contains all required items to permit a substantive review by the FDA.

    Bantam submitted its application to the FDA on Sept. 2.

    “Bantam has been anticipating and planning for these regulations since entering the e-liquids category,” said Bantam spokesperson Anthony Dillon. “The receipt of this acceptance letter is a significant milestone for Bantam. It reiterates a commitment to providing adult-use consumers with high-quality, science-based and compliant e-liquid products that can be enjoyed for years to come.”

    In preparation for its submission, Bantam worked with highly-qualified labs to conduct the in-depth product-specific and non-product specific testing needed for its PMTA, including: storage and stability testing; toxicity testing; and pharmacokinetic and topography studies. Bantam also submitted an extensive review of available literature on electronic nicotine delivery systems (ENDS) products.

    “Bantam has always supported the need for science-based regulation for the e-liquids industry. And while the PMTA process is complex and resource intensive, it is necessary to establish much needed standards and oversight across the board,” said Dillon. “Bantam is confident in the content and quality of materials prepared by its hardworking team of experts, and remains committed to working with the FDA throughout the PMTA process.”

  • PMTA Filing Letter Received for Disposable MNGO

    PMTA Filing Letter Received for Disposable MNGO

    Credit MNGO

    The makers of the disposable MNGO e-cigarettes and disposables announced today that it has advanced received a filing letter for its premarket tobacco product application (PMTA). The U.S. Food and Drug Administration will now conduct a scientific review.

    “Our goal has always been to provide adults with the highest quality alternative products that are affordable and taste great,” said a spokesperson for the company. “While [the] PMTA represents a major investment of time and resources for MNGO, we actually welcome the work. We want the industry to comprise of only companies that respect quality and customer safety as much as we do. We believe that the PMTA process is an important regulatory step for the vapor industry, and we are committed to working together with the FDA and remain optimistic about receiving a marketing order.”

    MNGO states that its PMTA was a global effort, with teams working around the world to support the document-intensive application. The submission included thousands of pages of scientific research and other supporting data.

    “We believe our products are appropriate for the protection of public health,” the spokesperson added. “We have always been committed to creating products for adult smokers seeking an alternative to combustible cigarette smoking and hold ourselves to higher standards.”

    MNGO, which has been on the US market since 2015, is already preparing further PMTAs for new products in early 2021 as part of an effort of sustainability within an ever-changing and advancing industry, according to a press release.

  • Zlab Receives PMTA Filing Letter for 78 Products

    Zlab Receives PMTA Filing Letter for 78 Products

    Credit: Zlab

    Shenzhen Yibo Technology Co. has received a filing letter from the U.S. Food and Drug Administration (FDA) for its premarket tobacco product application (PMTA). The company submitted the PMTA before the Sept. 9 deadline.

    The company is now allowed to market its ZLab brand of pods, disposable e-cigarettes and e-juice for up to 1 year or until the FDA takes action on its PMTA submission. On the market since 2015, Zlab’s PMTA includes 13 flavors in six different nicotine strengths totalizing 78 different SKUs, according to a press release.

    ZLab has over 20,000 points of sale in the US market. They currently have offices in 12 countries with revenues close to $300 million a year, according to the release. ZLab states that it is planning to submit 120 more PMTA applications in 2021, including an application for a new pod system, which should be launched at the beginning of 2022.