Tag: Imperial Brands

  • Fontem US Receives Marketing Denial Orders for Myblu

    Fontem US Receives Marketing Denial Orders for Myblu

    The FDA has issued marketing denial orders (MDOs) to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US. 

    “On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.

    Credit: blu

    The currently marketed products receiving MDOs include:

    • myblu Device Kit
    • myblu Intense Tobacco Chill 2.5%
    • myblu Intense Tobacco Chill 4.0%
    • myblu Intense Tobacco 2.4%
    • myblu Intense Tobacco 3.6%
    • myblu Gold Leaf 1.2%
    • myblu Gold Leaf 2.4%

    Based on the information provided in the applications submitted by Fontem US, for these myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the agency. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.

    Generally, the submission of a premarket application and intent to commercially market a new tobacco product that has never been marketed would be considered confidential commercial information (CCI) that the FDA would not disclose, according to the FDA. However, the agency determined that the named products are currently marketed based on communication with the applicant during the development of the publicly available Deemed New Tobacco Product Application List, and therefore the applicant has acknowledged the submission of these premarket applications.

    “FDA is issuing MDOs for additional myblu products that do not appear on the publicly available list,” the agency stated. “FDA has publicly named only products that the FDA or the manufacturer have confirmed to be currently marketed to avoid potential CCI issues.”

  • Imperial to Test its Heated Tobacco Product in Greece

    Imperial to Test its Heated Tobacco Product in Greece

    Photo: Imperial Brands

    Imperial Brands has stepped up market testing of its heated tobacco products through a national rollout in Greece.

    Insights from Greek consumers on the Pulze device and iD heat sticks will help inform the potential for further launches in a focused number of European markets. Earlier this month, Imperial Brands launched a pilot trial for its tobacco heating products in the Czech Republic.

    Building a targeted and sustainable next generation product (NGP) business is a key part of Imperial’s new strategy and its commitment to make a meaningful contribution to harm reduction.

    According to the company, heated tobacco is an established NGP category in a number of European territories, including where Imperial already has a strong route to market for its traditional tobacco products.

    “Heated tobacco continues to gain traction among adult smokers in Greece, and we see significant growth opportunities for our promising products in this category,” said Imperial Brands’ chief consumer officer, Anindya Dasgupta, in a statement.

    “The valuable consumer insights we gain from the pilot initiatives in Greece and the Czech Republic will inform the scale and pace of further market rollouts.”

    Heated tobacco currently accounts for more than 10 per cent of the total tobacco sector in Greece, with further strong growth anticipated.

    The Pulze device heats but doesn’t burn ‘iD heat sticks’ to provide nicotine and tobacco aromas containing fewer and substantially lower levels of the harmful chemicals found in combustible cigarette smoke.

    Unlike other heated tobacco products, the Pulze device does not require a charging case, offering up to 20 consecutive uses. It is available in copper and silver colors.

    ID tobacco consumables are being made available in Greece in four flavors: Rich Bronze, Balanced Blue, Capsule Polar, and Ice.

  • Imperial Launches Tobacco-Heating Products in Czechia

    Imperial Launches Tobacco-Heating Products in Czechia

    Photo: Imperial Brands

    Imperial Brands has launched its heated-tobacco products in the Czech Republic.

    The launch is the first of two planned European pilot trials for the company’s Pulze device and iD heat sticks.

    Imperial is investing in heated-tobacco opportunities in a focused number of markets in Europe as part of its new strategy to build a targeted and sustainable next-generation product (NGP) business.

    The Czech pilot is the first step in Imperial’s approach of entering markets where the category is already established and where the business is able to leverage an existing strong route to market.

    “Heated-tobacco offers significant growth opportunities in Europe where, in many territories, it is the biggest NGP category and the fastest growing,” said Joerg Biebernick, Imperial Brands’ president of the European region, in a statement. “Detailed market testing will allow us to quickly expand our consumer insights and inform the potential to launch validated heated-tobacco products in further European markets.”

    Heated-tobacco currently accounts for around 10 percent of the total nicotine sector in the Czech Republic, with further strong growth anticipated.

    The Pulze device heats rather than burns iD heat sticks to provide nicotine and tobacco aromas containing fewer and substantially lower levels of the harmful chemicals found in cigarette smoke.

    Unlike other heated-tobacco products, the Pulze device does not require a charging case, offering up to 20 consecutive uses. It is available in copper and silver colors.

    iD heat sticks are being made available in five flavors: Rich Bronze with rich tobacco flavor and triple flow filter technology, Balanced Blue, Mint Polar Green, Mint Ice and Capsule Polar.

  • Imperial Opinion: New Zealand Vapor Sales

    Imperial Opinion: New Zealand Vapor Sales

    Credit: Dan Freeman

    Dr Grant O’Connell, Strategic Science and Policy Engagement Director, Imperial Brands, explains why Imperial Brands decided to sell vaping products in New Zealand ahead of new legislation designed to legalize the next generation of nicotine products in an opinion piece with Scoop, a New Zealand independent news outlet.

    For the past five years, New Zealand smokers have been embracing the new generation of less harmful alternatives such as e-cigarettes. The number of adult smokers vaping in New Zealand is growing along with new devices, flavours and nicotine levels that suit the very individual habits of smokers.

    These dramatic shifts in smoker behaviour, and the maturing of the vape category itself, occurred at a time of great uncertainty. No one knew the legal status of these products. The Government now accepts the scientific consensus that vaping is significantly less harmful than smoking, so getting more smokers to transition is a desirable public health goal. This mature policy objective has been praised by public health experts here and overseas.

    That should not be surprising, as public health experts have accepted the “harm reduction” approach to diseases and addictions for some decades now. Harm reduction involves a range of pragmatic policies, regulations and actions that either reduce health risks by providing safer forms of products or substances or encourage less risky behaviours.

    It was initially developed for adults with substance abuse problems where abstinence was not practically achievable. It has successfully reduced teen pregnancies, sexually transmitted diseases, and risky alcohol use. Harm reduction strategies have reduced morbidity and mortality.

    Harm reduction is at the heart of the Government’s planned legislation on vaping. The aim is to utilise the appeal and accessibility of vape products to transition adult smokers. The only practical challenge is that vaping products need to be sold publicly, like many other “R18” things. That creates a small challenge to prevent vaping being used regularly by youth and those who never have smoked or are unlikely to smoke.

    This is the challenge being wrestled with by the Health Select Committee looking at the Bill. They are weighing the evidence and personal testimony of hundreds of vapers, retailers, manufacturers and public health experts. It is exactly the same challenge we faced when we decided to launch our global vaping brand myblu in New Zealand.

    Without legislation and regulations to guide us, we had to consider advantages to public health, practicalities of availability and restrictions on sale, and consumer safety parameters. We deliberated what the product should look like, where it should be available, and how it should be advertised or promoted in store. And importantly, who it shouldn’t be available to.

    Underpinning all of these discussions and the decisions we made, was that we would apply our global best practice in lieu of any regulatory framework. The approach we’ve taken achieves the regulatory balance the Select Committee is looking for.

    Our vaping products are as available for smokers to purchase as our combustible ones. Myblu is available for sale at our network of dairies and convenience stores throughout New Zealand and we do this because familiarity of the retail store and convenience for access are necessary for adult smokers to transition.

    Store managers are equipped with information so they can talk to smokers, to help them understand the reduced risk potential with vaping and how to begin their transition. We offer a small but varied range of flavours and strengths and our products are clearly labelled in English and Maori with warning messages describing the addictiveness of nicotine.

    Like many in the industry, we self-imposed an R18 age restriction on all sales of myblu. Marketing and advertising do not target youth or seek to glamorise vaping. Every message communicated describes the relative health, price and physical appearance advantages of vaping compared with smoking.

    Our team of over 300 scientists, engineers and innovators work to ensure myblu’s vaping products are made to the highest safety and quality standards and are supported by the best-in-class science. Myblu is a closed pod, ‘tamper proof’ system. We purposely chose a closed pod system to restrict opportunities for people to misuse or mix illicit ingredients into the liquids.

    We use pharmaceutical grade nicotine, propylene glycol and glycerol and high-quality flavour ingredients in our e-liquids. All of our blu vaping products, their ingredients and the vapour produced undergo thorough scientific assessment prior to manufacture and sale.

    The work that has gone into consumer safety and product design is necessary to guarantee the quality of myblu and for smokers to have confidence in our product. We have learnt much in the past 10 months in New Zealand. We know that convenient access, reliable information and confidence in the quality and satisfaction of vape products are the critical success factors for smokers to quit smoking.

    Our approach to selling and marketing myblu is based on the principles of having restrictions in proportion to the risk posed by the product relative to cigarettes. It is our hope that this experience, and indeed that of many vape manufacturers and retailers, guides the Committee’s thinking for a harm reduction framework in regulation that makes vaping a more appealing option for smokers.

    Dr Grant O’Connell, Strategic Science & Policy Engagement Director, Imperial Brands.