Tag: manufacturing

  • BRS Expanding Manufacturing and Regulatory Services

    BRS Expanding Manufacturing and Regulatory Services

    Blackbriar Regulatory Services (BRS), a firm specializing in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market, is expanding.

    The company announced today that it is growing its facility and services to meet increasing client demand. Immediate expansion efforts include adding cleanroom manufacturing space, increasing its analytical capabilities and expanding regulatory service offerings.

    “With the [U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) deadline approaching within weeks for existing nicotine-based vaping products currently on the market, we are now seeing an increase in PMTA demand for new, innovative nicotine-based vaping products,” said Russ Rogers, CEO at BRS. “The FDA rightly worked with the industry to pause and take a look at the appropriateness of the products on the market, and those companies who understand how to make the highest-quality products are in a position to start working on applications for next generation technologies that should create dramatically improved user experiences and step-wise safety improvements.”

    BRS was established to address challenges such as those that the PMTA process creates for manufacturers and brand holders. Its unique business model and capabilities provide numerous cost and speed advantages to clients who are looking for solutions to keep their products on the market in the United States, according to Rogers.

    BRS is under contract to file more applications before the Sept. 9, 2020, deadline for several U.S. and international customers, and is now starting to prepare PMTA submissions for next generation nicotine-based vaping products for companies that are seeking to revitalize their product portfolio after the recent industry-wide focus on obtaining approval for legacy products.

    Post Market Surveillance is an integral and mandatory commitment manufacturers must make to the FDA as part of their PMTA submission. BRS has also expanded its capabilities in this area to service clients both domestic and international to help them remain compliant in this regard, according to Rogers.

  • Avail Earns PMTA Acceptance Letter From FDA for E-liquids

    Avail Earns PMTA Acceptance Letter From FDA for E-liquids

    Credit: Avail

    Avail Vapor announced today that it has received its first premarket tobacco product application (PMTA) acceptance letter from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. While the company would not say what flavors or how many flavors, it was confirmed that the mixed-berry flavored Mardi Gras was a submitted flavor.

    Blackbriar Regulatory Services led the regulatory process for Avail’s submission. The application now moves to the substantive scientific review where the FDA will determine if Avail has scientifically proven that its nicotine vaping products are appropriate for the protection of public health.

    This is one of numerous applications that Avail plans to file prior to the September 9, 2020 deadline which will provide a wide-ranging flavor portfolio to meet the needs of adults seeking alternative choices to combustible tobacco products, according to James Xu, chairman of Avail.

    James Xu

    “We started mapping out our regulatory framework and PMTAs in 2015, before nicotine vaping products became subject to the FDA’s tobacco authority,” said Xu. “We couldn’t be more pleased that the years of hard work, investment and dedication have gotten us to this point. Our end goal is to seek an FDA marketing order which would allow us to continue to keep our products on the market for those adult smokers looking for alternatives to traditional tobacco products.”

    In order for nicotine vaping products to remain on the market after the FDA’s September 9, 2020 PMTA submission deadline, companies must submit a viable PMTA with the intent of seeking an FDA marketing order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.

  • FDA Gives EAS Acceptance and Filing Letters for PMTA

    FDA Gives EAS Acceptance and Filing Letters for PMTA

    The U.S. Food and Drug Administration (FDA) has issued Acceptance and Filing letters for E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands for its Leap and Leap Go vapor products. This notification moves the EAS products to the Substantive Review phase of the Premarket Tobacco Product Application (PMTA) process.

    “This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS. “FDA Acceptance and Filing Letters are a testament to the strength and thoroughness of our applications, which we believe will meet FDA’s requirements. We want to thank FDA for the prompt turnaround on these materials given the challenging circumstances, and we look forward to partnering with the Agency as we move forward in the process.”

    Jacopo D’Alessandris

    The Acceptance letters follow the administrative review of EAS’s filings to ensure that the submissions met the baseline criteria for review. The Filing Letters are the result of a preliminary scientific review that ensures that the applications include the necessary ingredients and health analyses. FDA will now conduct a Substantive Review to assess whether the Leap and Leap Go products are appropriate for the protection of public health. If successful, this phase will result in Marketing Orders from FDA authorizing the continued marketing and sale of these products.

    “The Substantive Review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health,” said Chris Howard, Vice President, General Counsel and Chief Compliance Officer at EAS. “We are looking forward to continued collaboration with FDA in the weeks and months to come and remain optimistic that the PMTA process will result in Marketing Orders.”

  • Smoore Tallies $918 Million in Hong Kong IPO

    Smoore Tallies $918 Million in Hong Kong IPO

    Photo: Timonthy Donahue

    Smoore International has raised $918 million in its initial public offering (IPO) at the Hong Kong Stock Exchange, reports Reuters. The deal is the largest IPO in Hong Kong since the start of 2020.

    The Shenzhen, China-based firm offered 574 million shares, according to the company’s prospectus, and had indicated the stock would be priced between HKD9.60 ($1.24) and HKD12.40 per share.

    The largest investors were Huaneng Trust, which took $80 million worth of stock, and Prime Capital which took $50 million, according to Smoore’s prospectus.

    In 2019, Smoore reported a profit of CNY2.17 billion ($307.8 million), up from CNY733.9 million one year earlier.

    Smoore is due to start trading on the Hong Kong Stock Exchange on Friday.

  • Pyxus to Delist From New York Stock Exchange

    Pyxus to Delist From New York Stock Exchange

    Photo: skeeze from Pixabay

    The New York Stock Exchange (NYSE) has commenced proceedings to delist Pyxus International. Trading in Pyxus’ common stock has been suspended.

    The NYSE determined that Pyxus is no longer suitable for listing under after the company filed for relief under Chapter 11 of the United States bankruptcy code. Pyxus does not intend to appeal the NYSE’s determination.

    Pyxus’ common stock began to be quoted on the OTC Pink marketplace on June 17, 2020, under the symbol PYXSQ. Investors can find quotes for the company’s common stock on. 

    Pyxus does not expect a transition to the OTC Pink marketplace to affect the company’s operations. 

    “The company can provide no assurance that its common stock will continue to trade on this market, whether broker-dealers will continue to provide public quotes of the company’s common stock on this market, whether the trading volume of the company’s common stock will be sufficient to provide for an efficient trading market or whether quotes for the company’s common stock may be blocked by OTC Markets Group in the future,” Pyxus wrote in a statement.

  • EAS Submits PMTA for Leap and Leap Go Vapor Products

    EAS Submits PMTA for Leap and Leap Go Vapor Products

    Credit: Timothy S. Donahue

    Finally, some positive news for the vapor industry. The much anticipated premarket tobacco product applications (PMTA) for the Leap pod system and Leap Go disposable were delivered to the U.S. Food and Drug Administration (FDA) on Tuesday. E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands, is seeking authorization for the marketing and sale of its wide-ranging portfolio of Leap and Leap Go vapor products.

    “We are pleased to take this important step in demonstrating our commitment to the vapor industry, retailers and adult smokers seeking an alternative to combustible cigarette smoking with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS.

    Jacopo D’Alessandris

    “At EAS, we have always held ourselves to high standards, from supplying adult consumers with products they can trust to consistently following ethical marketing practices. We are confident in the strong merits of our PMTAs and want to thank our compliance and research teams for developing and delivering thorough submissions.”

    The submission of PMTAs by EAS plays an integral role in supporting the proposition that Leap and Leap Go vapor products are appropriate for the protection of public health, according to a press release. The collective 75,000+ page PMTA submissions for Leap and Leap Go are the result of months of hard work and investigation that included an assessment of the stability of the products over time, toxicological formula reviews, toxicology testing, an assessment of abuse liability, label comprehension studies and behavioral studies.

    In addition, EAS undertook an extensive review of available literature on vapor products related to health effects, behavioral factors and toxicological end points. Further, an exacting risk assessment was conducted across many areas of potential risk for Leap and Leap Go products, according to the release.

    “Our PMTA submissions provide a robust analysis of the Leap and Leap Go products that will enable FDA to conclude these products are appropriate for the protection of public health,” said Chris Howard, vice president, general counsel and Chief Compliance Officer at EAS.

    Chris Howard
    Chris Howard

    “From an industry perspective, the PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith. Looking ahead, a robust collaboration with FDA will help build a strong future for both the vapor industry and adult consumers.”

    EAS continues to establish a leadership role in the creation of sensible industry standards and regulations as member of the Board of Directors of both the National Association of Tobacco Outlets (NATO) and the Vapor Technology Association (VTA), where EAS led the initiative to formulate the VTA marketing standards for membership, according to the release. The company continues to advance the interests of the industry’s consumers, manufacturers, wholesalers, small business owners, and entrepreneurs.

  • Lil Hybrid 2.0 Goes Nationwide in Korea

    Lil Hybrid 2.0 Goes Nationwide in Korea

    Photo: KT&G

    KT&G will expand the sales of its Lil Hybrid 2.0 heated tobacco cigarette to all cities in South Korea.

    The product debuted in February in major cities, such as Seoul, and expanded to 37 metropolitan areas in April.

    The expansion follows a series of inquiries from consumers in areas where the product had not yet been released, according to Lim Wang-seop, business director for next-generation products at KT&G.

    “Since the launch of the product, we have continued to expand our sales outlets,” Lim said. “We will continue to lead the e-cigarette market by strengthening product competitiveness and enhancing customer satisfaction through technological innovation.”

    Lil Hybrid 2.0 is equipped with a function that automatically warms up when a stick is inserted for the first time. An OLED display provides information on the battery charge, the cartridge level and the remaining number of puffs.  

    The recommended consumer price is KRW110,000 ($90.27).

  • Countermove: Altria Sues Reynolds Over Patent Infringement

    Countermove: Altria Sues Reynolds Over Patent Infringement

    Altria Group Inc.’s e-cigarette and smokeless tobacco divisions filed suit Thursday against competitor R.J. Reynolds Vapor Co. for patent infringement on e-cigarettes and associated products.

    Altria owns a 35 percent stake in e-cigarette industry leader Juul Labs Inc., a direct competitor of Reynolds’ Vuse brand of e-cigarettes.

    According to a lawsuit filed in the U.S. District Court for the Middle District of North Carolina, Reynolds Vapor, owned by Reynolds American Inc., violated nine patents held by Altria Client Services in producing its Vuse Vapor e-cigarette line, according to a story on Virginiabusiness.com. The suit contends that Reynolds’ Vuse brand of e-cigarettes — including the Vibe and Alto — uses heating technology, mouthpieces, batteries and liquid-filled pods covered by Altria’s patents for its Juul e-vapor products.

    Based in Winston-Salem, North Carolina, Reynolds American Inc. is owned by British American Tobacco plc, which is headquartered in London. “Reynolds Vapor has infringed on Altria’s intellectual property and we are seeking financial damages for each of these violations,” Altria Client Services spokesman George Parman said Thursday, according to the story.

    The suit comes weeks after Reynolds filed its own patent-infringement suit against Altria and Philip Morris International Inc. in Richmond’s federal court over its heat-not-burn cigarette line, Marlboro HeatSticks, a competitor of Reynolds’ Eclipse line.

    Altria seeks unspecified monetary compensation but asks for “treble damages” — in other words, triple the amount — for “defendant’s willful infringement” of the patents, as well as awards of compensation, supplemental damages after discovery cutoff and attorneys’ fees and expenses. The plaintiffs ask for a trial by jury. No hearing has been set.

     

  • Pyxus Reportedly in Talks About Bankruptcy

    Pyxus Reportedly in Talks About Bankruptcy

    Photo: Pyxus International

    Pyxus International has reportedly begun talks with creditors regarding a possible bankruptcy filing, according to an article in the Wall Street Journal.

    The filing is potentially related to declining cigarette consumption and the Covid-19 pandemic following the company’s struggle to make headway in the cannabis and vapor sectors.

  • PMI Gets ‘Brexit-Proof’ Patent Protection for IQOS

    PMI Gets ‘Brexit-Proof’ Patent Protection for IQOS

    Credit: iQOS

    Last week, a London judge granted Philip Morris International (PMI) an injunction prohibiting a Chinese competitor from putting an alleged “knock-off” of its smokeless tobacco-delivery device on the market in the U.K. because of European design protections.

    As part of his ruling, High Court Judge Anthony Mann granted the tobacco giant’s request for default judgment in the case since defendants Shenzhen Shunbao Technology Co. Ltd. had not participated in the proceedings. He also granted Philip Morris’ request to extend the intellectual property protections the company currently has for its product under a European Union registered community design so it will remain in effect in the U.K. after Britain leaves the bloc, according to information on law360.com.

    “I have satisfied myself that all of the relief included in the order, including the references to various Brexit matters, are forms of relief for which the claimants would be entitled, had they fully proved everything that they had pleaded in their particulars of claim,” Judge Mann said at the conclusion of a video conference hearing.

    The smoking device dispute wafts back to November 2018 when Phillip Morris first sued Shenzhen for infringement of its registered design. The product design is for a “smoke-free alternative to cigarettes,” according to Philip Morris, which markets the device under the trademark name IQOS, according to law360. The tobacco-delivery system includes tobacco “sticks and a rechargeable holder that heats up, the registered design relating specifically to that device.”

    Phillip Morris filed its claim in the U.K. shortly after discovering the rival company had created a “cheap knock-off” smokeless product called AMO, that was already being marketed in China, according to its written arguments to the court.

    No representative of Shenzhen was present at Monday’s hearing. “It is a straightforward case where the defendant has simply refused to engage with the proceedings,” Philip Morris told the court in its filing. Monday marked the second hearing Philip Morris had over its bid for a final injunction. A different judge determined in February that the tobacco company could serve Shenzhen and several individual company representatives by email.

    Philip Morris lawyer James Abrahams said his client was unable to deliver documents related to the proceedings to one individual, a Cherry Zhou, as the email sent was “kicked back” and she later informed Philip Morris’ Chinese legal representatives that she had left Shenzhen.

    The injunction granted by Judge Mann on Monday prohibits the Chinese competitor from marketing its infringing product. The order would also allow Philip Morris to pursue any profits Shenzhen made with its device in the U.K., although its written argument notes that “it does not currently appear proportionate to pursue an inquiry for damages or an account of profit.” The written filing also notes that a registered community design is seen as an EU right, so it currently only has effect in the U.K. pursuant to the Brexit Withdrawal Agreement. That will end in the U.K., “as things stand, at the end of the transitional period at the end of this year,” the filing says.

    And while a provision of the withdrawal agreement currently provides that at the end of the transition period, holders of registered designs “will enjoy an equivalent U.K. registered design,” Philip Morris asked for — and the court granted — permission to come back to the court if there are any unexpected changes to that as Brexit unfolds.

    “We do not know for certain how the law will change at the end of the transition period and the parties ought to be able to apply to the court to deal with such changes,” Philip Morris stated. In a written statement, Philip Morris’ counsel at Bird & Bird LLP emphasized that the injunction will continue to protect the design after Brexit.

    “The order granted suggests that the courts are ready and willing to grant Brexit-proof orders where needed,” the law firm said. “This will be a relief to litigants seeking as much certainty as possible with regard to the post-transition period arrangements.”
    Philip Morris is on the other end of infringement litigation over its IQOS system in the U.S. R.J.
    Reynolds Tobacco Co. is calling on the U.S. International Trade Commission to probe Philip Morris’ tobacco vaping product imports, claiming the tobacco heating system infringes patents covering R.J. Reynolds’ vaporizers.