Category: Regulation

  • ‘We Vape, We Vote’ Movement Descends on D.C. for Rally

    ‘We Vape, We Vote’ Movement Descends on D.C. for Rally

    Credit: UVA

    This weekend’s “We Vape, We Vote” movement descended on D.C. to advocate for continued access to vapor products as an alternative to deadly combustible cigarettes.

    Organized by United Vapers Alliance (UVA), advocates protested to show the world that “We Vape, We Vote” is a movement that has the influence to disrupt the upcoming election with millions of potential votes up for grabs. The organizers and attendees vowed to continue to push elected officials to “reject prohibitionist policies that threaten access to life-saving vapor products,” according to a UVA press release.

    “If President Trump does not deliver on real reform at FDA, he is not only risking the destruction of an American industry, but he will be also be creating a situation where millions of adult ex-smokers could return to deadly combustible cigarettes,” said Dimitris Agrafiotis, who serves as executive director of the Tennessee Smoke-Free Association. “HHS Secretary Alex Azar has pledged PMTA reform, but he failed to deliver. Now, it is up to President Trump to stop the FDA from destroying 99 percent of the industry and leaving 160,000 Americans unemployed in the middle of the Covid-19 pandemic.”

    Over 20 vaping consumer advocates shared life-changing stories during the rally on their journey to vaping and how it has positively impacted their friends and family since switching to a tobacco-free lifestyle. They were also joined by featured speakers and leaders in the industry Dimitris Agrafiotis, executive director of the Tennessee Smoke-Free Association; Amanda Wheeler, president of Rocky Mountain Smoke-Free Alliance; and Gregory Conley, president of American Vaping Association.

    Wheeler says the FDA’s PMTA rules are too burdensome for small business owners (Wheeler owns five vape shops across three states. “The costs associated with PMTA will force Jvapes’ five locations in Arizona, Colorado, and Oklahoma to close doors,” she said.

  • Philippine Bill Aims to Regulate Next-Generation Products

    Philippine Bill Aims to Regulate Next-Generation Products

    The trade and industry committee of the Philippine House of Representatives has
    approved a bill that aims to regulate the manufacture, sale and distribution of electronic
    nicotine-delivery systems (ENDS) and electronic nonnicotine-delivery systems (ENNDS).

    Panel chairman Wes Gatchalian said the approval would pave the way for the regulation
    of the reported rampant proliferation of ENDS, ENNDS and heated-tobacco products
    that have been sold even to minors. “We would like to emphasize that this bill will serve
    to regulate, and not ban, the sale of these products,” he said, noting that lawfully
    registered vape shops have suffered unfair competition from an estimated 800
    unregistered stores.

    Under the proposed legislation, ENDS and ENNDS would be regulated by the Department of Trade and Industry. The bill sets a minimum purchase age of 18 and restricts flavors. It also mandates child-resistant and tamper-resistant e-liquid receptacles. The sale or distribution of ENDS/ENNDS and heated-tobacco products would be prohibited within 100 meters from schools and other locations
    frequented by minors.

  • Reynolds American Files Final 6 PMTAs for Vuse Products

    Reynolds American Files Final 6 PMTAs for Vuse Products

    Reynolds American, a subsidiary of BAT, filed its final round of premarket tobacco product application (PMTA) submissions with the U.S. Food and Drug Administration (FDA) on Friday.

    The move will allow its Vuse and Velo brands to remain on the market in the United States for at least one year while the applications are reviewed. The process allows the FDA to evaluate whether the products should remain on the market as part of the FDA’s public health mission.

    The filing concludes an 11-month process for Reynolds which has the industry’s broadest portfolio of alternative nicotine products, according to a press release. Reynolds has filed six applications for its Vuse Solo, Vuse Ciro and Vuse Vibe vapor products, as well as for its Velo nicotine lozenge and modern oral pouch products. The Vuse Alto-branded device PMTA includes 12 cartridges in various flavors and nicotine strengths in menthol, two tobacco-flavored products and mixed berry.

    Across the six applications, over 530,000 pages of scientific data and more than 8,600 scientific documents have been submitted as part of the filings.

    “The U.S. is the world’s largest vaping market and so the completion of our PMTA filings is a really important step for us as we transform our organisation, drive a step change in our New Categories business, and increase our non-combustible consumer base and revenues. Our transformation is progressing very well and in the first six months of 2020 we attracted an additional 2.7million new non-combustible consumers compared to the same time last year,” Kingsley Wheaton, chief marketing officer for BAT said. “Globally, we now have nearly 12 million regular non-combustible consumers and the U.S. will play a large part of our ambition to grow this number to at least 50 million by 2030.”

  • Voom Submits PMTA to U.S. FDA for Refillable System

    Voom Submits PMTA to U.S. FDA for Refillable System

    The manufacturers of the Voom refillable vaping device have submitted a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA). The Voom also has a closed-pod version, but that device was not mentioned in the PMTA announcement.

    In an email to Vapor Voice, a Voom Labs representative only stated that a PMTA had been submitted to the FDA, no other information was included.

    The Voom open system has the exact same specifications of its closed-pod cousin, only with a refillable pod. The Voom closed-pod system may have the closest representation to the draw of an analog cigarette of any device on the market, according to a review in Vapor Voice.

    “Speaking of the draw, the VOOM may be the closest representation of an analog cigarette to date. The airflow is very restricted, resulting in a satisfying draw with rich flavor that doesn’t incorporate any harshness or spitback,” the review states. “Additionally, the soft plastic material and thin design work well for hands-free vaping. Although the body is made of metal, the overall device is light enough to carry between the lips or teeth, depending on personal preference.”

  • 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.”

  • Saudi Arabia Ends Unlicensed Imports of E-cigarettes

    Saudi Arabia Ends Unlicensed Imports of E-cigarettes

    Credit: Yasmine Arfaoui

    Saudi Customs have banned the import of shisha, e-cigarettes and all vapor accessories through shipping companies and individuals’ websites.

    In the event that they are imported, they would be confiscated, a fine imposed, and a record of seizure will be registered. Companies licensed by the Saudi Food and Drug Authority (SFDA) are allowed to import such products in commercial quantities, according to an article posted on albawaba.com.

    Saudi Customs also announced three avenues that enable a licensed importer to claim a refund of customs duties. “Re-exporting foreign goods abroad, goods that had a material error, technical errors or errors in evaluation; and goods for which an industrial exemption decision was issued”, via the portal “Faseh.”

    According to the mechanisms for exempting goods returned for export abroad, Saudi Customs have stipulated five reasons for reimbursement of their duties. “Re-exporting them within a calendar year from the date of payment of customs duties, the claim for refund of customs duties is made within six months from the date of re-export, the goods should be from one consignment, it should not be used locally, the value of the taxes levied is not less than SR18,750 ($5,000), and the exporter is also the importer or any other person when it is proven to the Saudi Customs that he has purchased them.”

    The owners of the goods in which a material error, technical errors, or errors in the evaluation occurred, will be able to apply for the refund of customs duties by “obsolescence”. Saudi Customs confirmed that the application for refund of customs duties for goods for which an industrial exemption decision has been issued requires that “the unified importer’s number in the customs declaration is identical with the unified importer’s number mentioned in the exemption decision.”

  • U.S. FDA Will Publish List of E-cigarette PMTA Applicants

    U.S. FDA Will Publish List of E-cigarette PMTA Applicants

    The U.S. Food and Drug Administration (FDA) will release a list to help support retailers. The regulatory agency now says it will break protocol and publish the names of manufacturers and products that have accepted premarket tobacco product applications (PMTAs) on file by the Sept. 9 deadline.

    In a press note on Monday, 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.

    “And for which a premarket application is submitted by Sept. 9, 2020,” Zeller wrote. “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.”

    The news comes just one week after several retail groups submitted a letter to the agency asking for a published list of applicants. The Vapor Technology Association, a vapor industry advocacy group, asked the FDA more than a month ago for a published list.

    The FDA also noted that while the deadline is on September 9, 2020, it will take FDA some time for the agency to compile and confirm that the list is accurate before publication. “The fact that FDA will be publishing such a list is dramatic change from their prior practice,” wrote VTA Executive Director Tony Abboud in an email. “In the meantime, we will do our best to inform you of VTA members which are participating in the process.”

    Zeller stated that the agency requests patience from stakeholders as the agency works through the appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, Zeller stated that retailers and other interested parties should refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted.

  • Charlie’s Chalk Dust Files First of ‘Multiple’ PMTAs

    Charlie’s Chalk Dust Files First of ‘Multiple’ PMTAs

    Charlie’s Holdings, parent to the Charlie’s Chalk Dust e-liquid brand, has submitted its initial premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA).

    “Today’s submission marks the first of multiple applications that Charlie’s Chalk Dust (CCD) intends to take through FDA’s approval process as it seeks to create a long-term, robust product portfolio. This is a day we’ve long awaited for in our industry,” stated Charlie’s Holdings’ Chief Operating Officer Ryan Stump in a press release. “After spending nearly $5 million over the past two years on our PMTA preparation and submission, we are extremely excited about the application we filed with the FDA.”

    The release states that Stump believes “that a significant amount of our competitors will not have the resources, desire, and/or expertise to complete the extensive and costly PMTA process.” However, once approved, CCD’s marketing orders would allow the company “to benefit from being one of only a select group of companies responsibly operating in the flavored nicotine product space.”

    The company also announced that it was performing human clinical trials on its products to help detect the biomarkers of exposure associated with smoking combustible cigarettes and determine the nicotine delivery efficiency of CCD products via pharmacokinetic studies.

    “A large team of doctors, scientists, biostatisticians, and data analysts are conducting these time intensive clinical trials,” the release states. “We believe that this kind of study will significantly set our application apart from those that are relying solely on the literature-based approach to this critical ‘in human’ assessment of product performance.”

  • 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.”