Category: Nicotine

  • Lifting the Fog

    Lifting the Fog

    Photo: Andrii

    An official acknowledgement of nicotine pouches’ comparatively low risk clears the way for appropriate regulation in Germany.

    By Stefanie Rossel

    The news was a minor sensation given German authorities’ reluctance to acknowledge the reduced harm potential of novel tobacco products. On Oct. 7, 2022, the Federal Institute for Risk Assessment (BfR), a scientific institution of the German government, published a statement in which it confirmed that tobacco-free nicotine pouches could reduce the health risks compared to smoking.

    Jan Muecke | Photo: German Association of the Tobacco Industry and Novel Products

    The risk profile of modern oral nicotine products, as they are also called, is comparable to that of medical nicotine-replacement products such as nicotine patches, the institute wrote in its evaluation, which was published in several scientific journals, including Tobacco Control. Carried out by BfR scientists in August 2022, they study showed that aside from nicotine, the pouches contain no substances that present health concerns. In some samples, researchers detected traces of tobacco-specific nitrosamines, which are also found in medical nicotine-replacement products. According to Jan Muecke, chief executive of the German Association of the Tobacco Industry and Novel Products, this problem is solvable, however.

    To protect consumers, the BfR recommended regulation of the manufacture, presentation and sale of nicotine pouches. Tobacco harm reduction advocates hope the findings will prompt German authorities to finally regulate modern oral nicotine products as tobacco products.

    Nicotine pouches comprise small sachets with a mixture of cellulose fibers, flavorings, water, humidifying and gelling agents along with preservatives and artificial sweeteners. Since their introduction in Germany, they have existed in a regulatory gray area. Because the products contain nicotine, authorities decided that sales require monitoring. However, since the products are tobacco-free, the German tobacco product law does not apply.

    Following several assessments and court rulings, German regulators classified modern oral nicotine products as food, making it subject to European food law. However, the European Union prohibits the use of nicotine as a food, food ingredient, food additive or food flavor, which means nicotine pouches classified as food may not be sold in the trade bloc. In March 2021, the administrative court in Hamburg confirmed that the sale of modern oral nicotine products was illegal. Other German courts have followed suit.

    According to Muecke, the classification of nicotine pouches as food has been problematic because it misleadingly implies that the products are being eaten. “This is nonsense,” he says. “The products are consumed by putting the pouch between the upper lip and gum and leaving it there while the nicotine and taste is being released. After use, the complete pouch is disposed of. This makes them comparable to toothpaste or floss—no one would think of declaring these products as food.”

    Regulation Protects Consumers

    By classifying nicotine pouches as food, Germany is an outlier. In the 16 EU member states where modern oral products are available, they are regulated either as tobacco or as a consumer product. Demark and the Czech Republic have even created a new product category for nicotine pouches, defining them as tobacco surrogates and allowing the sale to adults.

    Muecke welcomes the opportunity that the BfR assessment offers Germany to change its classification. “The BfR statement contains all data that are required for appropriate regulation of nicotine pouches,” he says. “Scientific studies have confirmed that if nicotine content is limited to a maximum of 20 mg per pouch, nicotine blood levels will not be higher than when smoking a combustible cigarette. We therefore hope that the government will take the request of the consumer protection conference of the federal states seriously who in 2021 had called for regulation of nicotine pouches under tobacco law.

    “In the current state of legal uncertainty, modern oral nicotine is nevertheless on the German market—consumers buy their nicotine pouches online from abroad. These products often do not stick to nicotine limits, and child and youth protection cannot be efficiently controlled. Adequate regulation of nicotine pouches as tobacco products would hence protect consumers and youths.”

    A chance for a change is already in sight: Under a delegated directive from the European Commission, the German government has until July 2023 to revise the country’s rules for heated-tobacco products (HTPs). “HTPs will be more strictly regulated in Germany in the future,” Muecke explains. “Therefore, it would make sense to find legal regulation for nicotine pouches during the same legislative process, which for HTPs will have to be concluded in the first half of 2023. To wait for a new version of the EU Tobacco Products Directive (TPD) that won’t be translated into national law until 2025 or 2026 would be wrong as unregulated online purchases of modern oral nicotine products with excessive levels of nicotine would continue to endanger consumers.”

    The European Commission intends to publish a draft of the revised TPD in 2024. While the wording is still unknown, the public has an opportunity to share its views through a consultation. Muecke encourages all stakeholders to take part, for example through the German-language website dein-ding.de.

    While it would technically be possible to regulate nicotine under the revised TPD, this is not Muecke’s preferred solution. “The products are on the market right now and available in 16 EU member states, especially in most of our neighboring countries, hence Germany shouldn’t be an island of prohibition,” he says. Muecke suggests regulators use the TPD’s e-cigarette regulations as guidelines for modern oral nicotine products.

    Muecke is confident that appropriate regulation for the novel oral nicotine products will be implemented in Germany. “A ban of nicotine pouches would not be in accordance with the principle of risk minimization,” he says. “The government must create a possibility for consumers to buy such reduced-risk products at retailers—it’s an absolute necessity.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • 22nd and Core-Mark and Eby-Brown Partner

    22nd and Core-Mark and Eby-Brown Partner

    Photo: 22nd Century Group

    22nd Century Group has established new distribution partnerships with Core-Mark International and Eby-Brown Company, two of the largest convenience store (c-store) distributors in the United States.

    “22nd Century’s new partnership agreements with two of the largest, most respected convenience store distributors in the United States make possible the launch of VLN cigarettes in virtually every key U.S. market we are targeting in our state-by-state, region-by-region rollout strategy,” said John Miller, president of tobacco products for 22nd Century Group, in a statement. “We are proactively working with highly recognized retail chains that want to add VLN to their cigarette sets, many of which are already customers of Core-Mark and/or Eby-Brown, thus streamlining the rollout process.”

    The new partnerships provide nationwide distribution capabilities for VLN via 31 Core-Mark and Eby-Brown warehouses. Additionally, 22nd Century will attend 11 regional trade shows sponsored by the distributors in 2023, providing 22nd Century with the opportunity to introduce VLN to thousands of Core-Mark’s and Eby-Brown’s independent retail and chain store operators.

    “Approximately 70 percent of the estimated 39 million adult U.S. smokers want to stop smoking, though only a tiny fraction are able to quit each year,” explained James A. Mish, CEO of 22nd Century Group. “22nd Century’s proprietary reduced-nicotine tobacco technology has enabled us to develop a truly revolutionary VLN product designed to help smokers smoke less. The c-store channel is the largest point of purchase for cigarette products, and we look forward to partnering with Core-Mark, Eby-Brown and other distributor partners to continue placing our reduced-nicotine content cigarettes in a growing number of stores.”

  • 22nd Welcomes New Menthol Timeline

    22nd Welcomes New Menthol Timeline

    Image: nanzeeba

    22nd Century Group is poised to greatly benefit from the recent advancement of the U.S. Food and Drug Administration’s proposed ban on menthol as a flavoring agent in combustible cigarettes to final rule status, the company wrote in statement published on its website today.

    “The most recent updates to the Biden administration’s Unified Agenda on Regulatory and Deregulatory Actions include major advancements in the FDA’s proposed tobacco harm reduction policies in 2023,” said John Miller, president of tobacco products for 22nd Century Group. “Advancement of FDA’s proposed menthol ban could position VLN Menthol King as the only combustible menthol tobacco cigarette on the market, providing a critical off-ramp to the estimated more than 15 million menthol smokers in the U.S.”

    Menthol cigarettes account for an estimated $26 billion in retail sales. Menthol is also known to enhance nicotine’s addictive effects, making it more difficult to quit, and a disproportionate amount of menthol smokers are members of minority groups, particularly African Americans, 22nd Century wrote on its website.

    “FDA’s proposed menthol policy specifically contemplates exempting certain products from the ban, such as our MRTP authorized VLN cigarettes, providing a critical off-ramp opportunity for adult menthol smokers,” stated John Pritchard, vice president of regulatory science for 22nd Century Group. “Without an off-ramp product, both research and real-world experience show the vast majority of menthol smokers would simply transition to traditional combusted cigarettes. 22nd Century’s MRTP authorization documents how VLN products can help people to smoke less, leading to a true reduction in smoking in line with FDA’s important public health goals.”

    Advancement of FDA’s proposed menthol ban could position VLN Menthol King as the only combustible menthol tobacco cigarette on the market.

    John Miller, president of tobacco products, 22nd Century Group

    The Unified Agenda also indicates that the FDA intends to advance its transformative reduced nicotine content standards later in 2023, which seeks to limit the nicotine levels in all cigarettes to a level considered “minimally or non-addictive.” Both of these standards are considered game changers for public health and could be extremely favorable for 22nd Century Group due to VLN’s 95 percent reduced nicotine content.

    22nd Century has been expanding sales of VLN cigarettes across five states with anchor partners including Circle K and Smoker Friendly. Following the company’s stated growth strategy to expand to 12-15 states during 2023, 22nd Century is actively engaged with multiple industry leading distribution partners and retail store chains wanting to introduce VLN products to adult smokers in both existing and new markets.

    “The proactive and forward-thinking policies of the FDA have the power to reduce the harms of smoking and save millions of lives,” said Miller. “22nd Century Group continues to fully support these policies, and VLN® reduced nicotine content products demonstrate that these programs are 100 percent achievable.”

    22nd Century Group’s VLN brand cigarettes are the only combustible cigarettes that the FDA has authorized as modified risk tobacco products. The company’s VLN King and VLN Menthol King brands contain 95 percent less nicotine than traditional addictive cigarettes.

    A final decision on the menthol ban is expected in August 2023.

  • Korea to Crack Down on E-liquid Tax Evaders

    Korea to Crack Down on E-liquid Tax Evaders

    Photo: makistock

    South Korea plans to crack down on traders who try to evade taxes on e-liquids by falsely claiming that their products contain synthetic nicotine rather than tobacco-derived nicotine, reports The Korea Bizwire.

    On Nov. 10, the Korea Customs Service announced it has developed a highly accurate method to identify whether the nicotine contained in e-liquid is extracted from tobacco leaves or created in a laboratory. 

    This method uses derivatization technology to increase the detection sensitivity by a factor of 30. 

    Classified as cigarettes under tax laws, e-liquids containing natural nicotine are subject to an inland duty of KRW1,799 ($1.32) per mL. 

    By contrast, e-cigarettes containing synthetic nicotine are classified as manufactured goods and are therefore exempt from cigarette consumption taxes. 

  • 22nd Century Welcomes Reduced Nicotine Study

    22nd Century Welcomes Reduced Nicotine Study

    Photo: 22nd Century Group

    22nd Century Group welcomed the results of a recent study that found switching to reduced-nicotine content (RNC) cigarettes “reduces toxicant exposure and increases smoking cessation without worsening mental health among smokers with mood or anxiety disorders.”

    According to 22nd Century, the study conclusively dispelled a common misconception that RNC’s may exacerbate general health and mental health problems. The study also concluded that a national nicotine reduction policy for cigarettes will likely result in reduced nicotine absorption and likely result in greater smoking cessation from smokers with mood and anxiety disorders.

    The study examined adult smokers with a current or lifetime anxiety or unipolar mood disorder. The participants were randomly assigned to smoke conventional cigarettes or 22nd Century’s RNC research cigarettes. Adult smokers who were assigned to smoke 22nd Century’s RNC cigarettes had significantly lower cigarette consumption, lower cigarette dependence, lower plasma cotinine (metabolite of nicotine) and lower exhaled carbon monoxide than smokers assigned to the conventional group.

    At the end of the study, despite having selected only participants not intending to stop smoking, those randomized to the group using 22nd Century’s RNC cigarettes were more likely to have quit smoking.

    “Study after study, reduced-nicotine cigarettes are shown to be beneficial to adult smokers. The combination of reduced-nicotine cigarettes and a proposed nicotine standard have the potential to forever change the trajectory of public health by helping adult smokers smoke less,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.

    “Based on last week’s comments from FDA’s [U.S. Food and Drug Administration’s] Center for Tobacco Products Director, Dr. Brian King, we are confident the FDA will use its existing authority to advance both a reduced nicotine policy and a menthol ban. These policies and 22nd Century’s reduced-nicotine cigarettes are expected to save millions of lives and increase the chances that current smokers quit. Our VLN reduced-nicotine content cigarettes are backed by clear science and evidence, which support FDA’s proposed product standards, and are the only FDA-authorized combustible product able to meet the stringent reduced nicotine levels determined by the FDA to be ‘minimally or nonaddictive.’”

  • VLN Debuts in “Four Corners” States

    VLN Debuts in “Four Corners” States

    Photo: 22nd Century Group

    22nd Century Group is launching its VLN reduced-nicotine content in the “Four Corners” states—Arizona, Utah and New Mexico. The company will leverage both existing partners and new distribution networks. VLN was previously introduced in Colorado and Illinois.

    “With the addition of three more states, we are moving ahead with our plans to rapidly make our innovative products available to a much larger portion of the adult smoker population in the United States,” said John J. Miller, president of 22nd Century’s tobacco business, in a statement.

    “This is a massive market in need of new solutions to help adult smokers smoke less. Every 1 percent share of the U.S. market equates to approximately $800 million in sales at the register, which is about $500 million in revenue to a premium cigarette manufacturer.

    “These four states will demonstrate our scalable and repeatable state launch blueprint for VLN, which we are now leveraging to rapidly put our product in front of an ever-growing population of adult smokers looking for a way to smoke less.

    “Additionally, we have the benefit of favorable MRTP excise tax structures for tobacco products sold in Utah and New Mexico, similar to the beneficial programs in Colorado, that can assist us in getting the word out to adults who can benefit from our products.

    22nd Century Group’s proprietary VLN cigarettes smoke, smell and taste like a cigarette but contain approximately 95 percent less nicotine than conventional cigarettes, a level shown to be nonaddictive, according to 22nd Century Group.

  • Nicotine-Degrading Bacteria Identified

    Nicotine-Degrading Bacteria Identified

    Photo: Paulista

    Chinese and U.S. scientists have identified a bacteria in the human stomach that can degrade nicotine, reports the Xinhua News Agency, citing a new study published in Nature.

    A colony of gut bacteria was found to have reduced intestinal nicotine concentrations in nicotine-exposed mice. 

    Nicotine is known to activate an intestinal molecule called AMPKα. These molecules contribute to the progression of nonalcoholic fatty liver disease (NAFLD), according to the study. 

    The authors suggest that Bacteroides xylanisolvens can help reduce smoking-exacerbated NAFLD progression.

    The study involved researchers from Peking University, Zhejiang University, Fudan University, the First Affiliated Hospital of Wenzhou Medical University and the U.S. National Institutes of Health.

  • FDA Completes 95 Percent of Synthetic Nicotine Applications

    FDA Completes 95 Percent of Synthetic Nicotine Applications

    Photo: pixelrobot

    As of Oct. 7, the U.S. Food and Drug Administration has issued refuse to accept (RTA) letters for more than 889,000 non-tobacco nicotine (NTN) products in premarket tobacco product applications (PMTAs) that do not meet the criteria for acceptance, the agency announced on its website.

    The agency has accepted over 1,600 applications, with the vast majority being for e-cigarette or e-liquid products.

    “While the application review is ongoing, FDA remains vigilant in overseeing the market and will continue to use our compliance and enforcement resources to curb the unlawful marketing of [non-tobacco nicotine] NTN products,” the FDA wrote. “To date, FDA has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar. The manufacturer warning letters include those for products for which an application had been submitted but where the agency has taken a negative action, such as a [RTA].”

    The FDA has also issued over 300 warning letters to retailers for violations in relation to their sale of NTN products to underage purchasers, and imposed civil money penalties against two retailers for sales of NTN products to underage purchasers.

    “To date, the FDA has not authorized any NTN products. Therefore, all NTN products on the market are marketed unlawfully and risk FDA enforcement action,” the FDA stated. “It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty.”

  • Malaysia Removes NRT from Poisons List

    Malaysia Removes NRT from Poisons List

    Photo: dalaprod

    Malaysia’s Health Ministry has categorized nicotine-replacement products as nonpoisons to make them more accessible to consumers, reports The New Straits Times.

    Minister Khairy Jamaluddin said the move was done by granting an exemption to nicotine under the Poisons Act 1952 for products in the form of patches or gum registered under the Control of Drugs and Cosmetics Regulations 1984.

    “This exception is expected to help smokers, who are motivated to quit smoking, in dealing with the withdrawal symptoms,” said Khairy.

    At present, smokers who want to quit smoking have limited access to nicotine-replacement products as they are regulated under the Poisons Act 1952.

    Under the law, nicotine is classified as a “Group C poison” and can be dispensed only by licensed pharmacists or registered medical practitioners.

    The New Straits Times article made no mention of nicotine vapor products, which tobacco harm reduction advocates consider to be the most effect nicotine-replacement products on the market.

    Malaysian lawmakers are currently considering the Control of Tobacco Product and Smoking Bill 2022, which, among other measures, would ban the sale of tobacco products, including e-cigarettes, to anyone born after 2007.

  • 22nd Century Partners With Eagle Rock

    22nd Century Partners With Eagle Rock

    Photo: 22nd Century

    22nd Century Group will start placing its VLN reduced-nicotine cigarettes in thousands of stores across Colorado with Eagle Rock Distributing Co. With more than 90 years of history, Eagle Rock Distributing Co. is a leading beverage distributor of premium alcoholic beverages servicing license retailers across Georgia and Colorado.

    “We’re thrilled to partner with Eagle Rock as we open VLN sales across Colorado. In addition to our existing retail partnerships from our Chicago pilot, we now have access to nearly 7,000 prospective new locations through Eagle Rock’s network, to include both on-premise and off-premise locations,” said John J. Miller, president of 22nd Century’s tobacco business, in a statement.

    “We are excited to partner with 22nd Century Group to market VLN across the state of Colorado,” said Michael Economos, president of Eagle Rock Distributing Co. “We want Colorado to be the first state to have a combustible cigarette brand that meets the U.S. Food and Drug Administration[‘s]

    and Biden administration’s proposed nicotine cap broadly available to adult smokers across the state to truly help them smoke less. We have had similar ‘nonalcoholic’ adult beverage offerings for decades, and we are way overdue for adult cigarette smokers to have an analogous option.”

    22nd Century also partners with Circle K, one of the largest convenience chains in North America, and Smoker Friendly, a leading pioneer in the cigarette and tobacco store category with more than 800 independently owned and operated retail stores.