Tag: FDA

  • Beard Vape Company Submits PMTAs for E-liquid Brands

    Beard Vape Company Submits PMTAs for E-liquid Brands

    Beard Vape Co. has officially submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). The company announced that it submitted data for 10 flavors, including five each from both its Beard and The One e-liquid brands.

    “We, like many in the industry, disagree with the PMTA process. However, we will be submitting our PMTA in September. This is a major step for a small company that
    began serving customers in a small shop in California,” a representative wrote in an email. “To shops, distributors, and customers. We hope that you will join us in the next chapter of the industry we have built together. We are grateful for all of your support over the years and plan to continue to serve you for as long as possible. To our international accounts, we will continue to serve you as well.”

  • AMV Holdings Receives First PMTA Acceptance Letter

    AMV Holdings Receives First PMTA Acceptance Letter

    AMV Holdings has received its first premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). AMV has filed an additional 104 PMTA submissions accounting for over 5,000 SKUs. All of these submissions reflect the same file and information structure as the PMTA for which AMV received the acceptance letter, according to a press release.

    Acceptance of a PMTA is the first step in a long approval process that, if positive, will end in a marketing order. AMV’s first PMTA will now be on to the substantive review phase to determine if the product is beneficial to public health.

    “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. “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 manufacturer and retailer of electronic nicotine delivery systems (ENDS) products in the U.S. and Europe. AMV currently operates 113 retail locations in the U.S. through a combination of corporate-owned, franchised and licensed stores. The company also has seven stores in Germany and Ireland.

    “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.”

  • Final Countdown: PMTAs Due to the FDA by 4pm Today

    Final Countdown: PMTAs Due to the FDA by 4pm Today

    The vapor industry is expected to look vastly different tomorrow. At 4pm today, all premarket tobacco product applications (PMTA) must be submitted to the U.S. Food and Drug Administration (FDA). Many industry players say that the regulatory rule will force more than 10,000 businesses to close and cause more than 100,000 jobs to be lost. It could also force millions of vapers back to smoking deadly combustible cigarettes.

    The vapor industry is not dead, however, as several manufacturers have announced that their PMTA submissions have been accepted and filed by the FDA. This allows those products to remain on the market while the FDA conducts its substantive review phase of the PMTA. During this period, the FDA will evaluate whether marketing a specific electronic nicotine delivery system (ENDS) product is appropriate for the protection of public health.

    If a company does not submit a PMTA by 4pm today, it must remove its products from the market. If the product was “verifiably” on the market prior to Aug. 8, 2016 (the FDA’s cutoff for new products) and submitted a PMTA application before Sept. 9 at 4pm, the product can stay on the market for up to a year or until the FDA approves or denies the PMTA. For any PMTA submitted after today’s deadline, a product may not be marketed until the FDA grants a marketing order, according to the FDA.

    The FDA has said that it will release a list of products that can legally remain on the market, although no timeframe was established for when that list would be available to retailers. Beyond all the major tobacco companies, which all have submitted PMTAs for vapor products, only a few other companies have publicly announced PMTA submissions to the FDA for their products.

    As of Aug. 31, the FDA had received applications for around 2,000 deemed products, of which around 40 percent have been resolved, according to Mitch Zeller, director of the agency’s Center for Tobacco Products. Only two brands have ever had a PMTA application approved, Swedish Match’s General snus products and Philip Morris International’s IQOS, HeatSticks and charger.

    AMV Holdings (Madvapes, Kure, Aloma), Avail Vapor, Beard Vape Co., Charlie’s Chalk Dust, Bidi Stick, E-Alternative Solutions (Leap, Leap Go), Innoken, Jarvis Vaping Supply, KangerTech, Nicopure Labs, Prism (511 Solutions), Smok, Smoore/Vaporesso, Turning Point Brands and Voom are just some of the vapor manufacturers that are not affiliated with a major tobacco company that have filed PMTAs. It is expected that this list will grow exponentially throughout the day as companies submit applications before the deadline. Several companies have said they have submitted PMTAs already but are waiting for acceptance letters from the FDA before making the announcement public.

    “We feel that we have met all documentation requirements in our over 3-million-page submission thus far,” wrote James Jarvis of Jarvis Vaping Supply in a press release. “We excited about the future opportunity to work with [the] FDA and the industry to achieve final authorization in the coming months.”

    Receiving a marketing authorization to sell vapor products isn’t the end of the process for manufacturers. The FDA requires companies to conduct post-market surveillance and studies to determine the impact of the marketing orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.

    These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the product does not have unintended consequences for youth use.

  • Turning Point Brands Submits PMTAs for 250 Products

    Turning Point Brands Submits PMTAs for 250 Products

    Photo: Bacho | Dreamstime

    Turning Point Brands (TPB) has submitted to the U.S. Food and Drug Administration (FDA) premarket tobacco product applications (PMTAs) for 250 products.

    The PMTAs cover a broad assortment of products in the vapor category including multiple proprietary e-liquid offerings in varying nicotine strengths, technologies and sizes. They also include proprietary replacement parts and components of open system tank devices, along with a closed system e-cigarette.

    According to TPB, the filings provide detailed scientific data to demonstrate that the products are “appropriate for the protection of public health,” as required by law.

    The applications are supported by five pharmacokinetics studies, a likelihood-of-use study, and a patterns-of-use study, in addition to a toxicological review. Data throughout the applications underline that TPB products do not appeal to never users, youth or former users; that an extremely small percentage of users are never users, youth, or former users; that a significant majority of users have completely ceased use of combustible cigarettes; that a low percentage of users engage in dual or poly use; and that the products are substantially less harmful than combustible cigarettes and comparable to other products in the vapor category.

    TPB has also provided a detailed marketing plan to illustrate how it will continue to prevent youth exposure to the products.

    “We look forward to engaging with the FDA as it reviews our submissions,” said Larry Wexler, president and CEO of TPB.

    The FDA deadline for submitting PMTAs is today.

  • Bidi Stick Disposable Vape Submits PMTA to U.S. FDA

    Bidi Stick Disposable Vape Submits PMTA to U.S. FDA

    Bidi Vapor, the manufacturer of the disposable vape pen Bidi Stick, has submitted its Premarket Tobacco Product application (PMTA) to the U.S. Food and Drug Administration (FDA). The announcement was made by Kaival Brands Innovations Group, a company focused on growing and incubating innovative and profitable products into mature, dominant brands, in a press release.

    “We are confident that, upon review, the FDA will authorize Bidi Vapor’s Bidi™ Stick for continued marketing in the United States,” said Niraj Patel, president and CEO of Kaival Brands. “It is a premium-quality product that adult smokers have discovered can be a viable alternative to combustible tobacco, and we look forward to meeting the increasing market demand for the innovative Bidi Stick.”

    The application detailed 11 flavored varieties with nicotine concentrations of 6 percent weight/volume. The Bidi Stick is a disposable pod system, similar to Juul. “Starting from a science-based foundation, Bidi Vapor has engineered its electronic nicotine-delivery system (ENDS) products using its own patented technology, ensuring quality control and assurance from the raw chemicals and components purchased through to the manufacturing process in a cGMP (current Good Manufacturing Practice) facility,” the release states.

    Bidi states that its product went through various in-vitro and in-vivo toxicity testing (including genotoxicity tests) at a GLP (Good Laboratory Practice) approved lab, as well as HPHC (Harmful and Potentially Harmful Constituents) analysis of both the aerosol and e-liquid in ISO 17025 certified labs. Also included in its PMTA submission, Bidi Vapor conducted three independent surveys and one “combined” consumer survey of people aged 21 and over.

    Bidi Vapor’s application was more than 285,000 pages, according to the release. “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 Patel. “We look forward to working with Bidi Vapor as they work with the FDA to construct its regulatory policy based on science and facts.”

  • Nicopure Labs has First PMTAs Accepted Quickly by US FDA

    Nicopure Labs has First PMTAs Accepted Quickly by US FDA

    Credit: Nicopure Labs

    The U.S. Food and Drug Administration has accepted Nicopure Labs first round of premarket tobacco product applications (PMTA). The application will now move into the substantive scientific review phase of the process, according to a press release.

    “I am extremely proud of all the hard work and dedication from the Nicopure Team that’s been put forth into our first round of applications. Over the next few days we will be filing additional applications and are very optimistic about Halo’s future,” said Jeffrey Stamler, CEO of Nicopure Labs. “Halo e-liquid flavors have been chosen by millions of vapors around the world as the Tobacco and Menthol e-liquids that vapers prefer.”

    The regulatory agency took just three day to accept and file the submissions for Tampa-based Nicopure Labs’ Halo Tribeca Tobacco e-liquid, Halo SubZero Menthol e-liquid and Halo Fusion e-liquid.

    “Halo’s 10-year history as a prominent brand, specializing in the tobacco-flavored e-liquid space has positioned the brand well for what is likely to come for the vaping industry. With California and New York becoming tobacco flavor-only markets, it is expected that more states will follow suit and Halo will be well-prepared with their award-winning tobacco flavors,” the release states. “Once accepted for filing, the final phase of the PMTA review process will be the FDA’s comprehensive evaluation of the scientific data supplied in the (PMTA) After all information has been fully evaluated and inspected, the FDA will make their final approval decision.”

  • Vapor Firms Request Delay of PMTA Deadline

    Vapor Firms Request Delay of PMTA Deadline

    Photo: Nmedia | Dreamstime.com

    Keller and Heckman has asked the U.S. Food and Drug Administration to postpone its Sept. 9 deadline for filing premarket tobacco applications (PMTAs) by six months because of the Covid-19 pandemic.

    On behalf of a group of small vapor product manufacturers, retailers and trade associations, the law firm filed a citizen petition asking the FDA to postpone the PMTA due date until March 8, 2021.

    Many of Keller and Heckman’s clients have experienced delays in preparing their applications because of the coronavirus. Without an extension, small vapor companies will either have to file incomplete PMTAs or forego submission altogether, according to Keller and Heckman. This would force them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes, the law firm said.

    The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017.

    The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the Sept. 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use.

     

     

  • Last Call: Vapor Industry Braces for Impact of PMTAs

    Last Call: Vapor Industry Braces for Impact of PMTAs

    vaper

    In just one week, the vapor industry could be drastically different. Thousands of businesses could close. Millions of products are most likely going to be removed from store shelves. Premarket tobacco product applications (PMTA) are due to the U.S. Food and Drug Administration (FDA) on Sept. 9 and the vapor industry is bracing for the impact the regulatory deadline will have on businesses and consumers alike.

    To date, only a small percentage of vapor product manufacturers have publicly announced that they submitted PMTAs that had been accepted by the FDA. All the major tobacco companies have filed PMTAs for electronic nicotine delivery systems (ENDS). Avail Vapor, E-Alternative Solutions, Charlie’s Chalk Dust and Prism are just a few smaller companies that have also publicly announced PMTA filings.

    The FDA has stated that there will not be a grace period for retailers to sell previously purchased product. This has confused vape shop owners who are wondering what products they will be able to sell on Sept. 10. On Aug. 25, this lack of clarity prompted a group of retailers to write a letter to the FDA urging the agency to release a list companies that filed a PMTA. The FDA then announced a week later that the agency would break from tradition and let retailers know what products can be sold, but when that list will arrive is still a question mark.

    In a press note on Aug. 31, director of the FDA’s Center for Tobacco Products, Mitch Zeller, wrote that the FDA “plans to make publicly available a list of the deemed new tobacco products” that are subject to the Sept. 9 deadline and were on the market as of Aug. 8, 2016. “However, before doing so, we will need to ensure that the publishing of any such information complies with federal disclosure laws and regulations as only certain types of product information from applications can be lawfully disclosed,” Zeller wrote.

    The FDA also states that it expects numerous PMTA submissions and the one-year review timeline may be exceeded. Zeller acknowledged “there are over a million deemed products” currently listed with the regulatory agency.

    “Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low, given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced,” Zeller wrote. “Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by Sept. 9, 2020 within the year.”

    The Vapor Technology Association (VTA), a vapor industry advocacy group, echoed the FDA in advising retailers to ask manufacturers for specific information on whether their products are covered by a PMTA. Numerous distributors have told Vapor Voice that they intend to buy back any product that their retailers will no be able to sell.

    “Each manufacturer may have a different method of providing you with evidence that it has filed PMTAs for its products, including, for example, a redacted version of its Cover Letter or proof of submission through the electronic filing portal,” said VTA Executive Director Tony Abboud. ”While FDA is not currently performing in-person inspections, they will likely resume soon after COVID-19 restrictions are lifted. So, if inspections resume before FDA publishes the list of products for which PMTAs have been filed, you can insulate yourself from potential exposure by having on hand documentation from your manufacturers regarding the product that you have on the shelves.”

    Policing retailers may prove difficult for the FDA in the short term, however. In March, due to Covid-19, the FDA temporarily postponed compliance checks and vape shop inspections. This suspension of in-person retail enforcement activity is likely to continue until Covid-19 restrictions begin to lift. However, the FDA has stated it plans to continue monitoring social media, industry-related websites and publications, and issue warning letters when required.

    It should also be noted that, in February of this year, the FDA outlined and reiterated its enforcement priorities. The FDA stated that it would focus enforcement efforts for flavored cartridge-based ENDS products; all other ENDS products for which the manufacturer has failed or fails to take adequate measures to prevent access or use by minors; any ENDS products that are targeted to minors or which are likely to promote use by minors; and manufacturers that have not filed PMTAs by the deadline.

    The most important thing for manufacturers is to get PMTAs submitted on time, according to Zeller. The FDA announced that if a PMTA has any deficiencies, the agency will address those issues in writing. “Although we expect high quality and complete applications to come in by Sept. 9, if we do find deficiencies, it is likely FDA will issue a Deficiency Letter with a 90-day deadline for companies to respond,” Zeller wrote. This would give companies an opportunity to solve those issues rather than the agency outright rejecting the application.

    The FDA stated that it would also devote as many resources as possible under the circumstances to help expedite the PMTA review process and the agency vows to treat all applications equally.

    “As always, FDA intends to be fair in allocating FDA resources to review applications from both small and large manufacturers and importers, and from applications received through different pathways,” Zeller stated. “Additionally, we intend to maximize the resources that we have to review the most products in the shortest timeframe … To help with this, we are refining our review processes to shorten the overall review time.”

  • Retail Groups Urge FDA to Release List of PMTA Filers

    Retail Groups Urge FDA to Release List of PMTA Filers

    Retailers are struggling to know what vapor products will be able to remain on the market after Sept. 9. That’s the deadline for manufacturers to file premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA).

    In a letter to the FDA, several retail associations are asking the regulatory agency to release a list of manufacturers that have PMTAs on file so retailers can know what electronic nicotine delivery system (ENDS) brands can remain on store shelves.

    “As the September deadline approaches, the PMTA List will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers, and retailers which ENDS products are being marketed legally in accordance with FDA’s compliance policy,” the group wrote. “Relatedly, such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline.”

    FMI (the Food Industry Association), the National Association of Convenience Stores, the National Association of Truckstop Operators, the Petroleum Marketers Association of America, and the Society of Independent Gasoline Marketers of America state that “unlike the confidentiality provisions that are afforded to applicants” of PMTAs, such restrictions are not applicable when the PMTA filing applies to a currently marketed product.

    “While FDA typically does not disclose the existence of a premarket product application (unless the applicant has publicly disclosed or acknowledged the existence of the application), the underlying rationale for non-disclosure does not apply in this situation,” the letter states. “Unlike PMTAs for products that have not yet been marketed, disclosing the existence of PMTAs submitted for ENDS products that have been on the market since at least August 8, 2016, through publication of the PMTA List, would not reveal any trade secret or (confidential commercial information).”

    In the 6-page letter to Matthew Holman, director, Office of Science for the FDA’s Center for Tobacco Products, the retail group also stated that if the FDA would require consent from the manufacturer before disclosure, the retail group could provide “recommendations on a streamlined process for obtaining such consent” quickly.

    “For example, FDA could ask for an applicant’s consent at the time of submission. To do so, [the] FDA could add a field in its submission portal notifying the applicant of the option to permit the agency to disclose the existence of its PMTA in a public list,” the group suggests. “Alternatively, in its initial acknowledgement letter, which provides the submission tracking number (STN) to applicants, FDA could ask for such consent. In both cases, the applicant would have the opportunity to provide affirmative consent.”

  • Vaporesso PMTA Quickly Accepted by the U.S. FDA

    Vaporesso PMTA Quickly Accepted by the U.S. FDA

    Credit: Vaporesso

    Vaporesso received an acceptance letter for its first round of premarket tobacco product applications (PMTAs) from the U.S. Food and Drug Administration (FDA) on Aug. 20, 2020.

    The acceptance letter came three days after the company submitted its PMTAs. The application received positive comments from the FDA on its preparation, according to the company’s U.S. scientific CRO agent.

    “A successful acceptance has boosted the confidence of Smoore to keep investing in bringing more vaping products into PMTA in the future,” the company wrote in its press release. “Our commitment to vapers in the USA remains the same: We will make vaping as easy as possible, and we will consistently provide high-quality vaping experiences for vapers all over the world. So the first round of application accomplished by Smoore is merely the start with more products to come.”