Tag: nicoventures

  • HTPs: EU Rulemaking Challenged in Court

    HTPs: EU Rulemaking Challenged in Court

    Photo: nmann77

    The European Commission will face a legal challenge over its attempt to restrict the sale of heated tobacco products (HTPs).

    On Nov. 3, 2022, the European Union published a directive banning flavored HTPs throughout the union. The ban, which covers all flavors except tobacco, officially took effect Nov. 23, 2022. EU member states were given until July 23, 2023, to transpose the rule into national legislation.

    When the Ireland did so, it was challenged in the Irish High Court by PJ Carroll & Co. and Nicoventures Trading. The nicotine companies argued that the European Commission had exceeded the powers delegated to it under tobacco products legislation approved by the European Council and the European Parliament. According to them, the Commission made its decision based on political grounds rather than legal grounds.

    In his judgment, Irish High Court Justice Cian Ferriter noted that the Commission had effectively prohibited “a category of tobacco product which was new on the market, which had not been in existence at the time of the enactment of the Tobacco Products Directive in 2014 and which had not been the subject of separate policy and health assessments…”.

    “It is at least arguable that this involved a political choice which was only open to the EU legislature and not to the Commission,” Ferriter said.

    According to Eureporter, the Dublin court will now refer the case to the European Court of Justice in Luxembourg.

    The nicotine companies and the Irish High Court are not the first to raise concerns about regulatory overreach. When the Commission adopted its directive in 2022, four EU member states objected that the directive involved “essential elements reserved for the European legislators.”

  • Nicoventures buys VIP

    Nicoventures buys VIP

    Nicoventures Retail (UK) will pay £11.9 million ($15.4 million) for the business and assets of VIP, a vapor company that went into administration earlier this year, reports Insider Media.

    VIP reported sales of £21 million and a pretax profit of nearly £600,000 in 2016. After HM Revenue & Customs demanded repayment of a tax liability totaling £2.3 million, VIP’s management team attempted to raise money to purchase the company, but were unsuccessful.

    This led to the appointment of FRP Advisory partners Anthony Collier and Geoff Rowley as administrators during the first quarter of 2017.

    All 265 jobs at VIP will be transferred over to Nicoventures Retail.

  • Regulatory authorization for nicotine inhaler

    The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted a product license for general sale to Kind Consumer’s Voke nicotine inhaler. The company will now submit a variation to the license to support full-scale commercialization by its commercial partner, Nicoventures.

    “We are pleased to announce that the Voke Inhaler has been licensed in the U.K. as a medicinal product after a detailed review process by the MHRA,” says Chris Moyses, chief medical officer, Kind Consumer.

    “It is a great achievement for the team to have successfully navigated the process to marketing authorization during which we have satisfied all questions raised by the MHRA. The technology contains no electronics, heat or combustion and will rival e-cigarettes and nicotine-replacement therapies when launched.”

    Voke is licensed for use to relieve and/or prevent craving and nicotine-withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.

    The marketing authorization application comprised pharmaceutical, non-clinical and clinical data on the Voke Inhaler, including a clinical pharmacokinetic study comparing the Voke Inhaler with a commercially available pharmaceutical product. In addition, the Voke Inhaler includes a CE-marked medical device.

    “It took over a decade to design and develop Voke, combining strict pharmaceutical safety standards while retaining the real consumer experience of the product,” says Alex Hearn, chief product officer, inventor of the technology and founder of Kind Consumer. “This invention, promises to make a real difference in offering smokers a safer alternative to smoking.”

    “Achieving the first authorization for the Voke Inhaler as a licensed medicine is a major milestone for the company,” says Kind Consumer CEO Paul Triniman. “The Voke Inhaler will be commercialized by Nicoventures Ltd., now engaged in ensuring that automated manufacturing capacity will be in place, as well as the marketing plans to bring this advance in nicotine technology to smokers.”