[INVNT GROUP]™ Bets Big on Live; Enhances Live Brand Storytelling Capabilities with Newly Formed ITP LIVE, in the Strategic Acquisitions of InSync Production Services, Thunder Audio and Morpheus Lights.

Introducing ITP LIVE: An Integrated Production Services Division of INVNT®

New York, Dec. 29, 2021 (GLOBE NEWSWIRE) — [INVNT GROUP] THE GLOBAL BRANDSTORY PROJECT™ announces the strategic acquisitions of four historied live event production companies: ITP LIVE, InSync Production Services, Thunder Audio, and Morpheus Lights.

Led by President and CEO, Scott Cullather, [INVNT GROUP] represents a growing portfolio of complementary disciplines designed to help forward thinking brands everywhere, impact the audiences that matter anywhere.

“This deal is a key pillar of our integrated vertical growth strategy as [INVNT GROUP] THE GLOBAL BRANDSTORY PROJECT. The dedicated search for these four companies has been in development for over 18 months. We sought leaders in the technical and production aspects of the live events industry, who were delivering premier production services to legacy brands and many of the world’s biggest peforming artists. These acquisitions will expand our innovation capabilities, allowing INVNT, our live events business, to offer our customers the ultimate in live events and experiential activations.”

Scott Cullather, President and CEO,  [INVNT GROUP]

[INVNT GROUP] consists of modern brand strategy firm, Folk Hero; creative-led culture consultancy, Meaning; branded content studio and content marketing agency HEVĒ; collegiate events and experiences, INVNT Higher Education, the original global live brand storytelling agency, INVNT and now ITP LIVE consisting of: InSync Production Services, Thunder Audio and Morpheus Lights.

For more than twenty-five years, these production companies have supported the design and execution of experiential and live entertainment programs for many of the largest corporations, trade associations, sports franchises, governmental agencies (including the White House), and some of the most successful artists in the world: Bruce Springsteen, Snoop Dog, Lady Gaga, Lionel Richie, Billy Joel, Diana Ross, Metallica, Post Malone, Tyler Perry and more.

The companies will continue to operate under their current names and will service their existing roster of clients, seek new clients, and providing services to synergistic INVNT opportunities and projects.

“Historically, producing live events has often required a great deal of outsourcing on virtually every project. Through these strategic acquisitions we will have end-to-end control over every aspect of our live events – especially quality and cost, continuing to deliver world-class service and at the very best value. The merging of resources and networks also gives us geographical spread across North America. Our anticipation is to continue growing these resources in other territories around the world. This is only the beginning.”

Kristina McCoobery, COO [INVNT GROUP] and CEO INVNT

Rooted in experiential marketing, [INVNT GROUP]’s expansion comes as part of a strategic, yet natural evolution. This business partnership creates a unique offering in the market, and enhances the group’s abilities to fulfill creative, technological, and strategic designs in dynamic new ways.

“When [INVNT GROUP] approached us about the idea of coming together and amplifying our resources, I was instantly drawn to the group’s commitment to impactful storytelling. Their award-winning work aligns with our vision of the newly formed ITP LIVE, that includes Insync Production Services, Thunder Audio and Morpheus Lights,. We’re excited by the incredible synergies created through our partnership and welcome a new chapter in designing the best events on the planet.”


This transaction was structured by Wolf Karbe, CFO of [INVNT GROUP] and represented by Evergreen Advisors Capital and Center Rock Advisors. Financial terms of the transaction were not disclosed.


[INVNT GROUP] was established in 2020, as an evolution of the founding global live brand storytelling agency INVNT in 2008, with a vision to provide consistent, meaningful, well-articulated BrandStory across all platforms. With offices in New York, Sydney, London, Singapore, San Francisco, Sydney, Stockholm, Detroit, and Washington D.C.; headed by President and CEO, Scott Cullather, [INVNT GROUP], THE GLOBAL BRANDSTORY PROJECT™ represents a growing portfolio of complementary disciplines designed to help forward-thinking organizations everywhere, impact the audiences that matter, anywhere. The GROUP consists of modern brand strategy firm, Folk Hero; creative-led culture consultancy, Meaning; branded content studio and content marketing agency HEVĒ, INVNT Higher Ed; events for colleges and universities, and the original live brand storytelling agency, INVNT. For more information about [INVNT GROUP], visit: www.invntgroup.com.


Founded in 2008 by Scott Cullather and Kristina McCoobery, INVNT uses the craft of live brand storytelling to create and produce live experiences that excite and unite physical and virtual audiences, globally. The company’s ‘challenge everything’ positioning statement helps clients including General Motors, PepsiCo, Merck, Microsoft, Pfizer, and Samsung share their stories with every audience that matters. INVNT’s offices are strategically located in New York, London, Sydney, Detroit, San Francisco, Washington D.C., Stockholm and Singapore. For more information about INVNT, visit: www.invnt.com.


ITP Live – Ideas. Technology. People. was Founded by Pat Hand (CEO) and Paul Mullen (COO) who collectively have over 60 years of experience in event design and production management.  Pat Hand, former CEO, PRG Mid-Atlantic and Paul Mullen former President and CEO, Greyhound Exposition Services have created, managed, and integrated world class companies and were forerunners of providing end to end, turnkey production solutions. Their strategy spans from concept through execution with a true 360 production approach. Pat and Paul will oversee management for InSync, Thunder Audio and Morpheus Lights, to ensure smooth integration and growth while fully maximizing production synergies with INVNT creating significant cost savings while ensuring best in class production support services.   For more information about ITP LIVE, visit: www.itplive.com


An iconic show production company, founded over 25 years ago in Las Vegas, the entertainment capital of the world, powering the Indy 500, Super Bowl and supporting clients that include L’Oreal, Dell Computers, Nissan, Verizon and Wells Fargo. Built around the broadcast video landscape, a creative leader leveraging LED technology. For more information about Insync Production Services, visit: www.insyncproductionservices.com.


Thunder Audio, a family owned business for over 42 years, has amplified some of the largest musical artists in the world including: Billy Joel, Post Malone, Elton John, Lionel Ritchie, Metallica, Diana Ross, and Earth Wind and Fire. Thunder Audio design and produce dynamic audio services for live experiences of all varieties and scales. Thunder Audio has always been a part of supporting touring, music festivals, corporate events, broadcast, sporting and governmental events. Providing the finest technology with premier manufacturers in the industry. For more information about Thunder Audio, visit: www.thunderaudioinc.com.


Morpheus Lights has staked a global claim in the art and science of performance illumination in live events. For over 25 years, the company has counted on top-tier technology partners like AYRTON, Martin/Harmon, and Clay Paky to support lighting design and execution on  tours and performances for Bruce Springsteen, Ringo Starr, and Lady Gaga. The company uses an eco-conscious approach to all projects, constantly researching for the most environmentally friendly products. For more information about Morpheus Lights, visit: www.morpheuslights.com.



Jhonathan Mendez de Leon

La FDA autorise la commercialisation des cigarettes VLN® de 22nd Century Group en tant que produit du tabac à risque modifié

    • VLN® est la première et la seule cigarette combustible au monde à recevoir la désignation MRTP de la FDA
    • La FDA ajoute une allégation principale fondée sur des preuves « Vous aide à fumer moins » aux allégations demandées par l’entreprise
    • Les cigarettes à teneur réduite de 95 % en nicotine VLN® seront lancées aux États-Unis d’ici 90 jours
    • VLN® sera lancée en dehors des États-Unis au cours du premier trimestre 2022

BUFFALO, New York, 29 déc. 2021 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq : XXII), une société de biotechnologie agricole de premier plan axée sur la réduction des méfaits du tabac, la réduction du tabac à nicotine et l’amélioration de la santé et du bien-être grâce à une science des plantes moderne, a annoncé aujourd’hui que la Food and Drug Administration (FDA) des États-Unis a autorisé la commercialisation des cigarettes VLN® King et VLN Menthol King de la société en tant que produits du tabac à risque modifié (MRTP). Ce faisant, l’agence a conclu que VLN®, qui se fume, a le goût et l’odeur d’une cigarette conventionnelle mais contient 95 % moins de nicotine que les cigarettes conventionnelles hautement addictives, « contribue à réduire l’exposition et la consommation de nicotine pour les fumeurs qui les utilisent ».

« La décision prise aujourd’hui d’autoriser la demande MRTP de VLN® place la FDA et 22nd Century à l’avant-garde de la transformation de l’industrie du tabac. Avec 60 % des fumeurs adultes qui, dans le cadre de notre étude de marché aux États-Unis, nous ont dit qu’ils sont susceptibles d’essayer VLN®, il s’agit d’un produit totalement révolutionnaire pour 22nd Century, l’industrie du tabac, la santé publique et les fumeurs adultes cherchant à changer leur relation avec la nicotine, la substance chimique addictive que contiennent tous les produits du tabac. C’est la première et ce sera très probablement la seule cigarette combustible à porter la désignation MRTP de la FDA. La décision de la FDA d’exiger l’allégation principale supplémentaire « Vous aide à fumer moins » parallèlement à notre demande de titre « 95 % de nicotine en moins » donne aux fumeurs adultes une raison claire de remplacer leurs cigarettes conventionnelles et hautement addictives par VLN® », a déclaré James A. Mish, président-directeur général de 22nd Century Group.

« Notre mission consiste à trouver des moyens de mettre fin aux maladies et aux décès liés au tabac. Nous savons que trois fumeurs adultes sur quatre souhaitent cesser de fumer et les données sur ces produits montrent qu’ils peuvent aider les fumeurs adultes dépendants à abandonner les cigarettes fortement toxiques », a déclaré Mitch Zeller, J.D., directeur du Center for Tobacco Products de la FDA. « Disposer d’options telles que les produits autorisés aujourd’hui, qui contiennent moins de nicotine et sont raisonnablement susceptibles de réduire la dépendance à la nicotine, peut aider les fumeurs adultes. Si les fumeurs adultes étaient moins dépendants des cigarettes combustibles, ils fumeraient probablement moins et pourraient être exposés à moins de produits chimiques nocifs qui sont responsables des maladies et des décès liés au tabac. »

« Après avoir obtenu ce décret de mise sur le marché de la FDA, nous sommes fin prêts à lancer VLN® avec des partenaires de vente au détail et marketing sélectionnés sur nos marchés pilotes aux États-Unis dans les 90 prochains jours et sur le premier de plusieurs marchés mondiaux d’ici la fin du premier trimestre 2022. Nous sommes également en pourparlers avec d’autres partenaires commerciaux, marketing et stratégiques pour augmenter les ventes de VLN® aux États-Unis et à l’international, notamment par le biais d’une licence potentielle de notre technologie pour faciliter la transition plus large de l’industrie vers les produits RNC. Nous fournirons des détails supplémentaires sur les partenaires stratégiques et le déploiement de VLN® au cours des prochains mois », a déclaré M. Mish.

La FDA a autorisé la commercialisation de VLN® avec les allégations MRTP suivantes :

  • « Vous aide à fumer moins. »
  • « 95 % de nicotine en moins. »
  • « Aide à réduire votre consommation de nicotine. »
  • « …Réduit considérablement votre consommation de nicotine. »

La décision de la FDA d’autoriser les allégations MRTP de la société et d’exiger l’allégation supplémentaire « Vous aide à fumer moins » sur chaque paquet de cigarettes VLN® et dans chaque publicité sur VLN® où l’une des autres allégations autorisées est également utilisée reposait sur un vaste corpus scientifique composé de dizaines d’études scientifiques et cliniques indépendantes utilisant les cigarettes de tabac à teneur en nicotine réduite (RNC) de 22nd Century. Ces études, qui ont été financées en grande partie par la FDA, les National Institutes of Health (NIH) et d’autres agences gouvernementales fédérales des États-Unis, ainsi que des études financées par 22nd Century, montrent que les fumeurs qui utilisent des cigarettes RNC – même ceux qui n’avaient pas l’intention d’arrêter de fumer au début des études – réduisent leur exposition et leur dépendance à la nicotine, fument moins de cigarettes par jour, augmentent leur nombre de jours sans fumer, et doublent leurs tentatives d’abandon – le tout avec des symptômes minimaux ou inexistants de manque de nicotine ou de tabagisme compensatoire.

Dans l’annonce de sa décision aujourd’hui, la FDA a expliqué : « Les données ont également montré qu’il était raisonnablement probable que l’utilisation de ces produits réduise la dépendance à la nicotine, et entraîne des réductions à long terme de l’exposition aux substances toxiques liées au tabagisme associées à la morbidité et à la mortalité en réduisant le tabagisme. Des études publiées ont montré que la réduction significative du nombre de cigarettes fumées par jour est associée à un risque plus faible de cancer du poumon et de décès, une réduction plus importante du nombre de cigarettes par jour entraînant un risque moindre. En outre, comme l’exige l’autorisation, la FDA a estimé que les demandes étayaient la compréhension par les consommateurs des allégations selon lesquelles les cigarettes VLN® contenaient beaucoup moins de nicotine que les autres cigarettes. »

VLN® est également la première et la seule cigarette combustible à arriver sur le marché qui est conforme au plafond de nicotine proposé par la FDA pour les cigarettes conventionnelles dans son Comprehensive Plan for Tobacco and Nicotine Regulation (Plan complet de réglementation du tabac et de la nicotine), ainsi qu’au mandat de réduction de la teneur en nicotine récemment proposé par la Nouvelle-Zélande.

« Nous sommes convaincus que l’annonce faite aujourd’hui par la FDA illustre clairement ses progrès dans son plan pour lutter contre les méfaits incroyables causés par le tabagisme. Ce plan prévoit l’autorisation de produits du tabac moins toxiques tels que les cigarettes électroniques et d’autres produits non combustibles, ainsi qu’un plafond de 0,5 mg de nicotine par gramme de tabac dans les produits du tabac combustibles. Ce niveau de nicotine, que la FDA a décrit comme étant “faiblement ou non addictif”, a déjà été atteint par 22nd Century dans ses produits VLN® », a déclaré M. Mish.

La FDA a réitéré aujourd’hui dans son annonce qu’elle est « engagée à faire avancer le processus d’élaboration de règles visant à interdire le menthol en tant qu’arôme caractéristique dans les cigarettes et tous les arômes caractéristiques dans les cigares et reste sur la bonne voie pour publier des projets de règles au printemps 2022 » et le fait que les cigarettes VLN® King et VLN® Menthol King « pourraient aider les fumeurs de cigarettes dépendants à réduire leur consommation de nicotine et le nombre de cigarettes qu’ils fument par jour ».

« Alors que la FDA cherche également à interdire le menthol dans les cigarettes hautement addictives, nous nous attendons à ce qu’elle autorise nos cigarettes VLN® Menthol, qui offrent peu d’attrait pour les jeunes et les anciens fumeurs en raison de leur teneur réduite en nicotine, à rester sur le marché pour fournir une rampe de sortie aux fumeurs adultes de cigarettes mentholées », a ajouté M. Mish.

La décision de la FDA s’appuie en outre sur des recherches projetant qu’une norme de produit de l’industrie visant à abaisser la teneur en nicotine dans les cigarettes à des niveaux minimaux ou non addictifs modifierait considérablement la trajectoire de la dépendance à la cigarette, qui est la principale cause de maladies et de décès évitables aux États-Unis. Environ cinq millions de fumeurs adultes arrêteraient de fumer dans un délai d’un an seulement après sa mise en œuvre, plus de 33 millions de personnes éviteraient de devenir des fumeurs réguliers, et plus de huit millions de décès prématurés dus au tabac pourraient être évités. Avec près d’un demi-million d’Américains mourant du tabagisme et plus de 300 milliards de dollars dépensés chaque année pour lutter contre les maladies liées au tabagisme, il est évident et urgent de procéder à des changements substantiels dans l’industrie du tabac.

22nd Century est prête à approvisionner le marché en tabac RNC et en produits finis tels que VLN® afin de permettre à la fois à 22nd Century et à d’autres fabricants de se conformer aux capsules de nicotine proposées aux États-Unis, en Nouvelle-Zélande et dans d’autres pays, alors qu’ils adoptent cette approche innovante et hautement efficace de réduction des effets nocifs du tabac initialement proposée par l’OMS en 2015. La technologie et les produits à base de plantes de 22nd Century sont supérieurs aux technologies d’extraction coûteuses et aux technologies de dénicotinisation similaires, car ces technologies utilisent généralement des produits chimiques qui éliminent non seulement la nicotine, mais également les composés de saveur et d’arôme, résultant en un produit qui a été jugé inacceptable pour les fumeurs car il ne procure aucune satisfaction de fumer. En revanche, le tabac à teneur réduite en nicotine de 22nd Century se développe naturellement avec de très faibles niveaux de nicotine, créant des produits qui se fument, ont le goût et l’odeur de cigarettes conventionnelles mais contiennent 95 % de nicotine en moins que les cigarettes conventionnelles hautement addictives. Ceci est essentiel pour créer une solution acceptable et une « rampe de sortie » pour les fumeurs actuels qui cherchent à changer leur relation avec la nicotine.

22nd Century reste déterminée à octroyer des licences pour sa technologie et ses produits à chaque fabricant afin de permettre la conformité à l’échelle de l’industrie avec les capsules de nicotine proposées.

À propos de 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq : XXII) est une entreprise de biotechnologie agricole de premier plan axée sur la réduction des méfaits du tabac, la réduction du tabac à nicotine et l’amélioration de la santé et du bien-être grâce à la science des plantes. Avec des dizaines de brevets lui permettant de contrôler la biosynthèse de nicotine dans la plante de tabac, la société a développé des plantes de tabac et des cigarettes brevetées à teneur réduite en nicotine (RNC), qui sont devenues la pierre angulaire du Plan global de la FDA visant à lutter contre la mortalité et les maladies généralisées causées par le tabagisme. Dans les plantes de tabac, de chanvre/cannabis et les plants de houblon, 22nd Century utilise des technologies modernes de reproduction végétale, y compris le génie génétique, l’édition génique et la reproduction moléculaire, pour fournir des solutions aux industries des sciences de la vie et des produits de consommation en créant de nouvelles plantes brevetées avec un alcaloïde optimisé et des profils de flavonoïdes ainsi que des rendements améliorés et des traits agronomiques précieux.

Apprenez-en plus sur xxiicentury.com, sur Twitter @_xxiicentury, et sur LinkedIn.

Pour en savoir plus sur VLN®, rendez-vous sur tryvln.com.

Mise en garde concernant les déclarations prospectives
À l’exception des informations historiques, toutes les déclarations, attentes et hypothèses contenues dans ce communiqué de presse sont des déclarations prospectives. Les déclarations prospectives contiennent généralement des termes tels que « anticiper », « croire », « considérer », « continuer », « pourrait », « estimer », « s’attendre », « explorer », « prévoir », « objectif », « orientation », « avoir l’intention », « probable », « peut », « planifier », « potentiel », « prédire », « préliminaire », « probable », « projet », « prometteur », « chercher », « devrait », « sera », « voudrait » et des expressions similaires. Les résultats réels peuvent différer sensiblement de ceux explicites ou implicites dans ces déclarations prospectives. Les facteurs importants qui pourraient entraîner des écarts importants avec les résultats réels sont énoncés dans la section « Risk Factors » (Facteurs de risque) du rapport annuel de la société sur le formulaire 10-K déposé le 11 mars 2021. Toutes les informations fournies dans le présent communiqué de presse sont valables à la date du présent communiqué, et la société n’assume aucune obligation et n’a pas l’intention de mettre à jour ces déclarations prospectives, sauf si la loi l’exige.

Contact auprès des investisseurs et des médias :
Mei Kuo
Directrice des communications et des relations avec les investisseurs
22nd Century Group, Inc.
(716) 300-1221

Une photo accompagnant cette annonce est disponible à l’adresse https://www.globenewswire.com/NewsRoom/AttachmentNg/f2454099-23c6-4b74-a46b-28fbb97124d5

FDA autoriza a comercialização do VLN® do 22nd Century Group como Produto de Tabaco de Risco Modificado

  • O VLN® é o primeiro e único cigarro combustível do mundo a receber a designação MRTP da FDA
  • FDA inclui a afirmação “Ajuda você a fumar menos” às afirmações solicitadas pela empresa
  • Cigarros VLN® com 95% de teor reduzido de nicotina a serem lançados nos EUA dentro de 90 dias
  • O VLN® será lançado fora dos EUA no primeiro trimestre de 2022

BUFFALO, N.Y., Dec. 29, 2021 (GLOBE NEWSWIRE) — O 22nd Century Group, Inc. (Nasdaq: XXII), uma empresa líder em biotecnologia agrícola focada na redução de danos causados pelo tabaco, tabaco com baixo teor de nicotina e melhoria da saúde e bem-estar através da fitotecnologia moderna, anunciou hoje que a Food and Drug Administration dos EUA (FDA) autorizou a comercialização dos cigarros com baixo teor de nicotina VLN® King e VLN® Menthol King da empresa como produtos de tabaco de risco modificado (MRTPs). Ao fazer isso, a Agência descobriu que o VLN® – com fumaça, gosto e cheiro do cigarro convencional, mas com 95% menos nicotina do que os cigarros convencionais altamente viciantes – “ajuda a reduzir a exposição e o consumo de nicotina dos fumantes”.

“A decisão de hoje de autorizar a aplicação de MRTP do VLN® une a FDA e o 22nd Century na vanguarda de transformar a indústria do tabaco. Com 60% dos fumantes adultos da nossa pesquisa de mercado nos EUA nos dizendo que é provável que eles experimentem VLN®, este é um divisor de águas completo para o 22nd Century, a indústria do tabaco, a saúde pública e os fumantes adultos que procuram mudar sua relação com a nicotina – a substância química viciante encontrado em todos os produtos de tabaco. Este é o primeiro e, provavelmente, será o único cigarro combustível a ter a designação MRTP da FDA. A decisão da FDA de exigir a declaração adicional da afirmação “Ajuda você a fumar menos”, juntamente com a solicitada afirmação de “95% menos nicotina”, proporciona aos fumantes adultos um motivo claro para substituir o cigarro convencional e altamente viciante pelo VLN®”, disse James A. Mish, diretor executivo do 22nd Century Group.

“Nossa missão é encontrar maneiras de parar as doenças e mortes relacionadas ao tabaco. Três em cada quatro fumantes adultos querem parar de fumar e os dados sobre esses produtos mostram que eles podem ajudar os fumantes adultos viciados a fazer a transição para deixarem de fumar cigarros combustíveis altamente viciantes”, disse Mitch Zeller, J.D., diretor do Center for Tobacco Products da FDA. “Opções como essas dos produtos autorizados hoje, que contêm menos nicotina e são razoavelmente propensos a reduzir a dependência da nicotina, pode ajudar os fumantes adultos. Os fumantes adultos menos viciados em cigarros combustíveis provavelmente fumariam menos e estariam menos expostos a substâncias químicas nocivas que causam doenças e mortes relacionadas ao tabaco.”

“Com a obtenção da autorização de marketing da FDA, estamos prontos para lançar o VLN® com parceiros de varejo e de marketing selecionados nos nossos mercados-piloto nos EUA nos próximos 90 dias e nos primeiros mercados globais até o final do primeiro trimestre de 2022. Também estamos em discussões com parceiros adicionais de varejo, marketing e estratégicos para escalar as vendas do VLN® nos EUA e em outros países, inclusive por meio de um possível licenciamento da nossa tecnologia para facilitar a transição mais ampla da indústria para os produtos da RNC. Daremos mais detalhes sobre os parceiros estratégicos e a implantação do VLN® nos próximos meses”, disse Mish.

A FDA autorizou a comercialização do VLN® com as seguintes afirmações de MRTP:

  • “Ajuda você a fumar menos”.
  • “95% menos nicotina”.
  • “Ajuda você a reduzir o consumo de nicotina”.
  • “…Reduz muito o consumo de nicotina”.

A decisão da FDA de autorizar as afirmações de MRTP da Empresa e exigir a afirmação adicional de “Ajuda você a fumar menos” em cada embalagem e anúncio do VLN® onde qualquer uma das outras afirmações autorizadas também sejam usadas, teve por base um extenso conjunto de dezenas de estudos científicos e clínicos independentes sobre o uso de cigarro de tabaco de teor reduzido de nicotina (RNC) do 22nd Century. Esses estudos, financiados em grande parte pela FDA, pelo National Institutes of Health (NIH) e por outras agências governamentais federais dos EUA, bem como estudos financiados pelo 22nd Century, mostram que os fumantes que usam cigarros RNC – mesmo aqueles sem intenção de parar no início dos estudos – reduzem sua exposição e dependência à nicotina, fumam menos cigarros por dia, aumentam seu número de dias sem fumar e dobram suas tentativas de parar – todos com pouca ou nenhuma evidência de sintomas de abstinência de nicotina ou tabagismo compensatório.

No anúncio da sua decisão hoje, a FDA explicou: “Os dados também mostraram que é razoavelmente provável que o uso desses produtos reduza a dependência da nicotina, o que deve levar a reduções de longo prazo na exposição aos tóxicos relacionados ao tabagismo associados à morbidade e mortalidade, levando à redução do tabagismo. Estudos publicados indicam que a redução significativa do número de cigarros fumados por dia está associada ao menor risco de câncer de pulmão e morte, com maiores reduções de cigarros por dia, resultando em menor risco. Além disso, conforme exigido para autorização, a FDA descobriu que os pedidos tiveram por base a compreensão do consumidor sobre as alegações de que os cigarros VLN® contêm níveis muito mais baixos de nicotina do que outros cigarros.”

O VLN® também é o primeiro e único cigarro combustível a chegar ao mercado estando em conformidade com o limite de nicotina proposto pela FDA para cigarros convencionais no seu Plano Abrangente para Tabaco e Nicotina, bem como o recentemente proposto mandato de teor reduzido de nicotina da Nova Zelândia.

“Acreditamos que o anúncio de hoje da FDA seja uma indicação clara de que a FDA está avançando com seu Plano para lidar com os incríveis danos causados pelo tabagismo. Este plano inclui a autorização de produtos de tabaco menos tóxicos, como cigarros eletrônicos e outros produtos não combustíveis, juntamente com um limite máximo de 0,5 mg de nicotina por grama de tabaco nos produtos de tabaco combustíveis. Este nível de teor de nicotina que a FDA descreveu como sendo “minimamente ou não viciante”, já foi alcançado pelo 22nd Century nos seus produtos VLN®”, disse Mish.

A FDA reiterou no seu anúncio de hoje que está “comprometida em avançar com o processo de criação de regras para proibir o mentol como sabor caracterizante em cigarros e todos os sabores característicos em charutos, e está no caminho certo para emitir regras propostas em meados de 2022” e que os cigarros VLN® King e VLN® Menthol King “ podem ajudar os fumantes de cigarros viciados a reduzir o consumo de nicotina e o número de cigarros que fumam por dia.”

“Como a FDA também está tentando proibir o mentol em cigarros altamente viciantes, esperamos que a FDA permita que o nosso cigarro VLN® Menthol, que oferece pouco apelo para jovens e ex-fumantes devido ao seu teor reduzido de nicotina, sejam autorizados pela FDA a permanecer no mercado como uma rampa de saída para fumantes adultos de cigarros mentolados”, acrescentou Mish.

A decisão da FDA tem por base ainda pesquisas que projetam que um padrão de produto da indústria para redução do teor de nicotina nos cigarros a níveis mínimos ou não viciantes mudaria significativamente a trajetória do vício em cigarros, que é a principal causa de doenças e mortes evitáveis nos EUA. Aproximadamente cinco milhões de fumantes adultos desistiriam de fumar dentro de apenas um ano após a sua implementação, mais de 33 milhões de pessoas evitariam se tornar fumantes regulares e mais de oito milhões de mortes prematuras por tabaco poderiam ser evitadas. Com quase meio milhão de americanos morrendo de tabagismo e mais de US $ 300 bilhões gastos por ano com doenças relacionadas ao tabagismo, há uma necessidade clara e urgente de mudanças substanciais na indústria do tabaco.

O 22nd Century está pronto para fornecer ao mercado produtos de tabaco e acabados de RNC, como o VLN®, para permitir que tanto o 22nd Century quanto outros fabricantes estejam em conformidade com os limites de nicotina propostos nos EUA, Nova Zelândia e outros países, com a adoção dessa abordagem inovadora e altamente eficaz para a redução dos danos do tabaco, proposta pela OMS em 2015. A tecnologia e os produtos à base de plantas do 22nd Century são superiores a tecnologias caras de extração e de desnicotinização semelhantes porque essas tecnologias normalmente usam substâncias químicas que removem, além da nicotina, os compostos de sabor e aroma, resultando em um produto considerado inaceitável pelos fumantes não gostam do produto final. Por outro lado, o tabaco com teor reduzido de nicotina do 22nd Century cresce naturalmente com níveis muito baixos de nicotina, resultando em produtos com fumaça, gosto e cheiro de cigarro convencionais, porém com 95% menos nicotina do que os cigarros convencionais e altamente viciantes. Isso é fundamental para a criação de uma solução aceitável e de saída para os fumantes que estejam querendo mudar seu relacionamento com a nicotina.

O 22nd Century continua empenhado em licenciar sua tecnologia e produtos a todos os fabricantes para viabilizar a conformidade da indústria com os limites propostos para a nicotina.

Sobre o 22nd Century Group, Inc.
O 22nd Century Group, Inc. (Nasdaq: XXII) uma empresa líder em biotecnologia agrícola focada na redução de danos causados pelo tabaco, tabaco com baixo teor de nicotina e melhoria da saúde e bem-estar através da fitotecnologia moderna. Com dezenas de patentes para controle da biossíntese da nicotina na planta de tabaco, a Empresa desenvolveu plantas e cigarros proprietários de tabaco com teor reduzido de nicotina (RNC), que se tornaram a pedra angular do Plano Abrangente da FDA para abordar a morte e doenças generalizadas causadas pelo tabagismo. Nas plantas de tabaco, cânhamo/cannabis e lúpulo, o 22nd Century usa tecnologias modernas de aprimoramento das plantas, incluindo engenharia genética, edição genética e aprimoramento molecular para fornecer soluções para as indústrias de ciências da vida e produtos de consumo, criando plantas novas e proprietárias com perfis otimizados de alcaloides e flavonoides, bem como de rendimentos aprimorados e características agronômicas valiosas.

Saiba mais em xxiicentury.com, no Twitter @_xxiicentury, e LinkedIn.

Saiba mais sobre o VLN® em tryvln.com.

Nota de advertência sobre declarações de previsão
Com exceção das informações históricas, todas as declarações, expectativas e suposições contidas neste comunicado de imprensa são declarações de previsão. As declarações de previsão geralmente contêm termos como “antecipar”, “acreditar”, “considerar”, “continuar”, “poderia”, “estimar”, “esperar”, “explorar”, “prever”, “objetivo”, “orientação”, “pretende”, “provável”, “pode”, “planeja”, “potencial”, “prevê”, “preliminar”, “provável”, “projeto”, “promissor”, “busca”, “deve”, “vai”, “faria” e expressões semelhantes. Os resultados reais podem ser substancialmente diferentes dos resultados explícitos ou implícitos nas declarações de previsão. Fatores importantes que podem fazer com que os resultados reais sejam substancialmente diferentes podem ser encontrados nos “Fatores de Risco” do Relatório Anual da Empresa no Formulário 10-K protocolado em 11 de março de 2021. Todas as informações fornecidas nesta versão são válidas a partir da presente data e a Empresa não assume nenhuma obrigação e não pretende atualizar essas declarações de previsão, exceto conforme exigido por lei.

Relações com Investidores e Contato com a Mídia:
Mei Kuo
Diretor, Comunicações e Relações com Investidores
22nd Century Group, Inc.
(716) 300-1221

Foto deste comunicado disponível em https://www.globenewswire.com/NewsRoom/AttachmentNg/f2454099-23c6-4b74-a46b-28fbb97124d5

UNHCR Ethiopia: Operational Update (December 2021)


Documentation of Eritrean refugees: In Addis Ababa, UNHCR, in collaboration with the Refugees and Returnees Service (RRS) continues to locate, through biometric verification, registered refugees who had been displaced from the former Shimelba and Hitsats camps and other locations in the Tigray region. Between 4 August and 25 November, a total of 14,266 families composed of 17,172 persons were verified and issued new ID cards; 6,415 refugees under age of 14 were issued proof of registration documents. The three-year documents will enable refugees to access assistance, protection and services, and open bank accounts. UNHCR has started transferring a one-off cash assistance on the bank accounts of those already verified to cover their basic needs for three months.

Over 9,000 Somali refugees registered in 2021: So far this year, UNHCR registered 9,391 new arrivals from Somalia who entered Ethiopia through the Dollo Ado and other border crossing points. Most have been relocated to different refugee camps in the Melkadida area, including 730 over the past couple of weeks. All of the new arrivals were provided with basic humanitarian supplies to help them rebuild their lives in the refugee camps, while those still at the Dollo Ado Reception Center are being offered basic assistance and services such as health and water, sanitation and hygiene (WASH). Meanwhile, UNHCR and the Refugees and Returnees Service (RRS) are working on a plan to relocate nearly 9,000 new arrivals from South Sudan currently at the Pagak Reception Centre.

16 Days of Activism: The 16 Days of Activism Against Gender Based Violence was marked in different refugee camps in the country, with a series of activities that are aimed to raise awareness and promote gender equality through the participation in the campaign of both female and male members of the refugee and host communities. Launched on 25 November under the theme “Let peace prevail, End Violence Against Women and Children Now!”, the campaign has featured several events such as panel discussions, Q&As and cultural performances. A photo exhibition by refugees in Gure-Shembola camp, Benishangul-Gumuz region, organized in the camp, was opened at the conclusion of the campaign on 10 December 2021, coinciding with the Human Rights Day. Entitled “This is Our World”, the exhibition consists of 20 photographs taken by young refugees who have been given hands-on photography training. The photos reflect their everyday life in the camp, highlighting their hopes for a better future. The exhibition will be closed on 20 December.

Operationalization of the One-Stop-Shop in Bambasi camp: The One-Stop-Shop (OSS) in Bambasi refugee camp in the Benishangul-Gumuz region has started to provide all services that are essential for the protection of refugees. The services include new birth registrations, renewal and issuance of proof of registration documents and ID cards, and registration of refugees who had missed the comprehensive registration conducted in all refugee camps from 2017 to 2019. OSS Bambasi is one of the 27 facilities across Ethiopia that are aimed to serve both the refugee and local communities surrounding the camp and that are at different stages of construction.


Source: UN High Commissioner for Refugees

WFP Ethiopia Market Watch, November 2021


  • Inflation: Headline inflation which was recorded as the highest in a decade hitting 34.8 percent in September, slightly declined to 34.2 percent in October 2021. The food inflation that was standing at 42 percent in September, the highest in ten years, slightly reduced to 40.7 percent in October. The measure of change in price of cereals and bread, fats and oils, registered a significant increase in October 2021, far above the food inflation in the month. The domestic price increase for these essential household commodities is in part driven by the depreciation of Birr against US Dollar.
  • Exchange Rate: Over the past 12 months (October 2020 – October 2021), the official exchange rate of the Birr has lost its value by 25 percent against US dollar. In October alone, the Birr has been eroded by 0.03 Birr per day against USD on average. The difference between the official exchange rate and the parallel markets has been around 28 percent in September and October. The Government of Ethiopia continues to call for the Ethiopian diaspora to transfer remittances through the legal channel to overcome the impending forex crunch.
    Market dynamics in Conflict-affected Areas of Tigray and Amhara: Markets in Tigray and Amhara continue to operate below normal with the escalation of the blocking off road network due to insecurity and thereby affecting supply chain – as such, retail prices of common food commodities have increased. The price of teff has increased by 39 percent in the last six-week period due to limited supply to the Dessie market. Significant price increase has been observed on industrial processed food commodities in Dessie market such as rice, sugar, and vegetable oil which are very high in the conflict-affected markets when compared with Addis Ababa markets. Wheat grains are far cheaper in the conflict affected markets of Tigray and Amhara, reflecting the increased availability of this item which may be attributed to the sale of in-kind food, being provided for the response.
  • Food price trends in surplus producing areas: Prices of key staples, after reaching record high levels in the previous months between July and August, showed slight decline in October in most of the surplus producing areas of the country. The availability of these food items is also improving seasonally with the new harvest becoming available in the market. However, underpinned by the macro-economic challenges the country is facing and the ongoing conflict that impede agricultural and trading activities, prices are still far above the previous year and five-year average for the month
  • Terms of Trade (TOT) (Shoat to wheat flour): In the dry season of Hagaya between July and September, the ToT dipped and the downward trend continued through October. This is attributable to the poor performance (below average) Deyr rains that limited the availability of pasture in Somali region. The ToT of shoat to rice, which indicates how much imported rice a pastoralist can buy after selling an average sized goat/sheep, plunged in July and early August mainly due to the fact that Birr lost value against US dollar in the parallel market which showed slight recovery in September and October.
  • Market and food security outlook: Prices of cereals may continue decline in the upcoming months until the new harvest becomes available in the market. The possible reduction in the yields from meher harvest in connection with the ongoing conflict may drive the prices of staples in affected areas upwards. The wide differential of the Birr against USD in the parallel market means imported staple cereals (pasta, rice, wheat flour) in Somali region will remain expensive. This will continue to jeopardize the food security status of poor households that rely on markets to access food and other essential needs.


Source: World Food Programme

IOM Northern Ethiopia response: 06 – 19 December 2021

OM’s multi-sectoral response in northern Ethiopia was initiated in November 2020, with quick actions taken to support conflict-affected populations in collective displacement sites and host communities. Since then, IOM has significantly scaled up its response in Tigray, Amhara, and Afar regions and provided over 1.1 million instances of multi-sectoral assistance to people in need in 2021 to date [945,000 in Tigray; 127,000 in Amhara; 32,000 in Afar].

Some of the key achievements in 2021 to date include:

  • 8 Emergency Site Assessment (ESA) reports have been published — identifying 2.1 million displaced people across Tigray, Amhara, and Afar regions — supporting all humanitarian partners with their planning and response. The latest report is available here
  • 317,000 individuals supported with CCCM services [254,000 in Tigray; 63,000 in Amhara]
  • 308,000 individuals supported with primary and mental health & psychosocial support (MHPSS) services [290,000 in Tigray; 11,000 in Amhara; 6,700 in Afar]
  • 264,000 individuals supported through the Rapid Response Fund (e.g. shelter, NFIs, cash, CCCM) [205,000 in Tigray; 34,000 in Amhara; 25,000 in Afar]
  • 109,000 individuals with emergency shelter and NFIs [94,000 in Tigray; 14,000 in Amhara]
  • 103,000 individualssupported with access to clean water, sanitation, and hygiene services [98,000 in Tigray; 3,800 in Amhara; 650 in Afar]
  • 3,000 individuals supported with protection assistance [1,700 in Tigray; 800 in Amhara; 450 in Afar]


Source: International Organization for Migration

Women’s Integrated Sexual Health: WISH2ACTION Consortium – Value for Money: Efficiency (Ethiopia, Somalia, South Sudan, Uganda, July 2021)

Executive Summary

A Value for Money (VfM) analysis was conducted by IRC to assess the cost-efficiency of family planning services in Ethiopia, Somalia, South Sudan, and Uganda between 2019 and 2020 under the Women’s Integrated Sexual Health (WISH2ACTION) project funded by FCDO. The analysis revealed that:

  • The cost-efficiency of family planning services delivered through WISH2ACTION was on average £43 ($55) per couple-year of protection (CYP) against unwanted pregnancy. Investments in community engagement and service provider training in Uganda and Somalia resulted in a relatively high uptake of long-acting methods, which are particularly cost-effective.
  • Costs per CYP were significantly higher in Somalia and South Sudan because these were new programmes implemented in less established health systems and could not piggyback on existing systems and structures, as was the case in Ethiopia and Uganda.
  • While the cost per CYP may be higher than average for underserved communities, meaningful increases in efficiency over time are expected, as family planning services become more established, acceptance of family planning goes up, and more CYPs can be delivered.
  • Conflict, insecurity, and access issues may constrain programme efficiency and result in high costs per CYP, since basic staffing and operating costs (e.g. salaries) must still be paid during programme disruptions, although clients may not be receiving services.


Source: International Rescue Committee