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  • Bottleneck Broken in Cultivated Meat

    Bottleneck Broken in Cultivated Meat

    Photo: BioBetter

    BioBetter, an Israeli biotech firm, is using tobacco plants to significantly reduce the cost of cultivated meat and advance it rapidly to scale-up.

    As numerous cultivated meat start-ups move beyond the proof-of-concept phase, they run against one of the biggest challenges facing this budding industry. Developing a scalable and cost-effective production platform to make cultured meat affordable for the mass market has proven to be a primary stumbling block.

    Cell-derived meat requires a culture medium composed of a mix of amino acids, nutrients, and—most importantly—growth factors (GF’s) without which cells cannot multiply. Currently, such media are costly due to the complexity of producing GF’s. For example, insulin and transferrin GFs are collected from livestock, making it difficult to obtain large quantities. Some can be attained via fermentation of yeast or bacteria, but those methods require expensive facilities. The purification process also is complicated and expensive.

    “The Good Food Institutes determined that approximately a 100-fold reduction in insulin and transferrin costs is required to make cultivated meat economically viable,” explains Dana Yarden, co-founder of BioBetter, in a press note. “It is estimated that growth factors and cell-culture media can constitute 55 to 95% of the marginal cost in manufacturing cell-based foods.”

    BioBetter harnessed the inherent advantages of tobacco plants by turning them into bioreactors for expression and large-scale production of the proteins. Plant bioreactors use renewable energy (sunlight) and fixate CO2. They are self-forming, self-sustaining, and biodegradable. BioBetter uses open-field plantations to enable fast, efficient, and flexible response to market needs.

    “There are multiple advantages to using Nicotiana tabacum as a hardy vector for producing GFs of non-animal origin,” says Amit Yaari of BioBetter. “It is an abundant crop that has no place in the food-and-feed chain due to its extremely bitter taste and content of undesirable alkaloids. The global trend for reducing tobacco smoking also is raising concerns among tobacco growers that the crop might eventually become obsolete. Yet the tobacco plant has huge potential to become a key component in the future of food.” Tobacco plants can achieve up to four growth cycles annually and be harvested all year. This translates to more voluminous outputs per square meter of growing space.

    BioBetter says its uniqueness lies in refining and highlighting the advantages of the tobacco plant platform for production on a huge scale. The start-up applies a proprietary protein extraction and purification technology that enables it to exploit nearly the entire plant, and at the same time deliver a high purity product at broad scale production. The company currently sources tobacco plants from local growers but the goal is to eventually source the raw material from tobacco growers globally. Based on cultivation in open fields and BioBetter’s proprietary purification technology, the cost of growth factors production is dramatically reduced, bringing cost efficiency to cultured meat production.

  • Walmart to Limit Tobacco Sales

    Walmart to Limit Tobacco Sales

    Photo: Sundry Photography

    Walmart will stop selling cigarettes in select stores across the U.S., reports AP.

    Cigarettes will be removed from some stores in California, Florida, Arkansas and New Mexico; however, Walmart did not make it clear how many of its stores will remove tobacco entirely.

    In place of cigarettes, the chain has added more self-checkout registers and items like candy and grab-and-go foods in some of these stores.

    Decisions on removing cigarettes will be made on a store-by-store basis according to the business and particular market, Walmart said. “We are always looking at ways to meet our customers’ needs while still operating an efficient business.”

  • SWM and Neenah Paper Agree to Merge

    SWM and Neenah Paper Agree to Merge

    Photo: Mikael Damkier

    Neenah Paper and Schweitzer-Mauduit International (SWM) have agreed to merge, creating a specialty materials company with a combined $3 billion in sales. The new company does not have a name yet.

    The combined company would be headquartered in Alpharetta, Georgia, USA. Neenah President and CEO Julie Schertell will lead the new company while SWM CEO Jeff Kramer will take a role as a strategic advisor. Five SWM board members and four Neenah board members will make up the combined company’s board of directors.

    The two companies expect to trim at least $65 million from their operating costs over the next two to three years. It will do so through production synergies and “highly complementary technologies, geographies and product portfolios in specialty materials,” the companies said in a news release. The new company would have strong market share in growing categories like healthcare and wellness, protective and adhesive solutions, industrial solutions, packaging paper and specialty paper.

    “This merger is an exciting next step on our journey and one that will deliver significant shareholder value,” said Kramer. “The combination with Neenah is a continuation of our strategic intent to solve our customers’ most complex design challenges. We are excited by the numerous benefits of this merger, including the significantly broadened customer base, product lines and technical expertise.”

    “This combination is a unique opportunity to accelerate our growth strategy and continue the transformation of our business, creating a global leader in specialty materials with strong and defensible positions in attractive end markets,” said Schertell. “Merging our two companies enhances our ability to grow and solve the needs of our customers for demanding, innovative products that address global challenges, such as the necessity for clean water and air, sustainable alternatives, and enhanced health and wellness.”

    The deal has been approved by both companies’ boards but still must be approved by shareholders for both companies and regulators.

    Neenah was founded in 1873. It was acquired by Kimberly-Clark in 1902 and operated until Kimberly-Clark spun off its regular paper-making operations under the Neenah name in 2004. Schweitzer-Mauduit is also a former division of Kimberly-Clark that was spun off as an independent company in 2015.

  • What’s Next for Synthetic Nicotine

    What’s Next for Synthetic Nicotine

    Nveed Chaudhary (Photo: Broughton)

    Broughton’s Nveed Chaudhary explains how the FDA’s new powers to regulate synthetic nicotine will impact the industry.

    Contributed

    In mid-March, the U.S. Congress moved to close the loophole on the use of synthetic nicotine in electronic nicotine-delivery systems (ENDS) in the United States, bringing it into line with tobacco-derived nicotine products. In this article, Nveed Chaudhary, chief scientific and regulatory officer at Broughton, an independent life sciences contract research organization, explains what this regulatory change means for the next-generation nicotine-delivery industry in the U.S. market.

    What has happened in the U.S., and when will the changes take effect?

    The U.S. Congress has extended the Food and Drug Administration’s authority over tobacco products to include synthetic nicotine in products such as vapes, heated products and oral nicotine pouches. This will bring these products into line with tobacco-derived nicotine next-generation nicotine-delivery products. The new regulation was passed as part of a U.S. lawmaker’s long-term spending bill signed into law by President Joe Biden on March 15. It takes effect immediately, and manufacturers of synthetic nicotine vapes and oral nicotine pouches have 60 days from March 15 to submit a premarket tobacco product application (PMTA) dossier to keep their products on the U.S. market.  

    Was the industry expecting this regulatory change?

    The ENDS industry had been watching U.S. regulators with interest around this issue for some time and expected a change to come at some point. The speed with which it has been passed took the industry by surprise. It was included in a long-term spending bill that contained hot-button issues like funding for Ukraine, Covid support and regular government running expenses, enabling it to be passed without debate or amendment. That being said, U.S. lawmakers would possibly argue that ENDS manufacturers have had almost two years since the PMTA regulations were published to start collecting data on their products.

    What is synthetic nicotine?

    Synthetic nicotine, also called tobacco-free nicotine, is a synthesized form of nicotine produced via a chemical process instead of extraction from tobacco. Recent improvements in manufacturing processes have enabled producers to mimic the enantiomeric ratio of tobacco-derived nicotine. Synthetic nicotine is not new, with it first synthesized in 1904, but the production on a mass scale is relatively recent. Most e-cigarette manufacturers do not use synthetic nicotine because it tends to be more expensive than tobacco-derived nicotine. There is also far less infrastructure to create synthesized nicotine from scratch than the well-established facilities for harvesting nicotine from tobacco plant materials.

    Why have U.S. regulators chosen to close the synthetic nicotine loophole now?

    Previously, the FDA defined “any product made or derived from tobacco and intended for human consumption, including any component, part or accessory of a tobacco product” as a tobacco product. Under this description, e-cigarettes containing tobacco-derived nicotine e-liquids were subject to the PMTA regulatory framework while those containing tobacco-free nicotine were not. However, some U.S. lawmakers and nonprofit organization lobbyists have long discussed closing this loophole because it enabled manufacturers to introduce tobacco-free nicotine products to the market without regulatory oversight. Following the publication of the recent National Youth Tobacco Survey (NYTS) data, there is particular concern about the youth usage of synthetic nicotine disposable vape products, e-liquid flavors and marketing, which the FDA has had no authority to challenge. As we saw with tobacco-derived nicotine ENDS products, there is rightly intense scrutiny around products that are found to be attractive to youth, and this has become an area of significant political focus in the U.S. The fact that it appeared that some manufacturers were using the loophole to get around regulatory control is likely to have increased the speed with which lawmakers felt they had to act.

    What can synthetic nicotine manufacturers do now?

    If a product is already on the market in the U.S., manufacturers have 60 days to file a PMTA. If a manufacturer was in the process of commercializing a new synthetic nicotine product in the U.S., they have a 30-day window to launch the product and then 30 days to file their PMTA. This 60-day deadline for data submission will be very challenging for most tobacco-free nicotine ENDS manufacturers to meet but may not be impossible. At Broughton, we are currently in discussions with several clients about the regulation and what they will need to do to submit a PMTA within the timeframe allowed.

    Is it possible to prepare a PMTA dossier within this short timeframe?

    We believe it is, but manufacturers need to act immediately, and there are no guarantees of success. Especially as many of the manufacturers who submitted PMTA dossiers for their tobacco-derived nicotine ENDS products still don’t know if they have passed the FDA requirements to be awarded a marketing authorization. The first question is how much data a synthetic nicotine ENDS manufacturer already has available about their product and then to build analytical studies to fill gaps to file an adequate submission in the timeframe available. There is always a possibility that the FDA wants to close this NGP (next-generation product) market area completely, but that seems unlikely. It’s more likely they want to ensure that tobacco-free nicotine products are regulated in the same way tobacco-derived nicotine products are. Responsible manufacturers should welcome this opportunity to prove their product’s quality, safety and efficacy in relation to tobacco harm reduction objectives.

    What will be the long-term impact of FDA authority over synthetic nicotine products?

    The industry has been debating how governments will respond to regulating synthetic nicotine products for some time. It isn’t made from tobacco, but how else could lawmakers regulate it? It’s a classic dilemma for regulators; needing to respond to a technical innovation quickly, having less information than the industry it’s regulating, and then relying on existing regulation to act quickly and fill the gap. This has been the problem for the entire next-generation product category. We believe that all nicotine-containing products, regardless of tobacco-derived nicotine or synthetic-derived nicotine, should be treated in the same way. Regardless of where the nicotine comes from, the impact on population health needs to be measured in a consistent way. Synthetic nicotine is still not cost-effective to manufacture, and only a few companies currently produce synthetic nicotine due to patents around the manufacturing process. It’s estimated that synthetic nicotine is up to 13 times more expensive to manufacture than tobacco-derived nicotine. It will be interesting to see if ENDS manufacturers now abandon using synthetic nicotine because of the regulatory change or stick with it. A large part of this may be decided by how the FDA evaluates the PMTA submissions they receive and if there appears any difference in how synthetic nicotine and tobacco-derived nicotine PMTA applications are evaluated.

    This article was contributed by Broughton, an independent life sciences contract research organization.

  • Health Groups Urge FDA Action on Top Vape Brands

    Health Groups Urge FDA Action on Top Vape Brands

    Photo: Dmytro

    Health groups are urging the U.S Food and Drug Administration to make haste in addressing the remaining premarket tobacco applications (PMTA) for leading e-cigarette brands such as Juul, Blu, Vuse (Alto) and NJOY, which make up 75 percent of the U.S. market and are among the most popular with youth.

    “We are grateful to see movement again by the FDA on the e-cigarette pre-market approval process under Dr. Califf’s leadership and the recognition of the risks these products pose to America’s youth while assessing the public health benefit for adult smokers,” wrote Robin Koval, president and CEO of the Truth Initiative, in a statement following the FDA’s authorization of Logic Technology Development’s tobacco-flavored e-cigarettes. Logic, however, makes up a small percentage of the U.S. e-cigarette market, with just over 1 percent according to retailer scanner data.

    The Truth Initiative also expressed concern about the FDA’s failure to deny marketing applications for Logic’s menthol e-cigarettes, which remain under review. “According to the latest NYTS data, nearly 30 percent of young people who use e-cigarettes reported using a menthol flavor,” wrote Koval. “As the FDA prepares to issue a proposed rule removing menthol cigarettes from the market, we continue to urge the FDA to remove all flavored tobacco products, including menthol to protect our nation’s youth.”

    Meanwhile, tobacco harm reduction advocates, took the approval of Logic, which is ultimately owned by Japan Tobacco International, as further evidence that the PMTA process favors deep-pocketed tobacco multinationals.

    “It’s mildly gratifying to hear FDA say out loud the obvious and simple truth that vaping is helping Americans quit smoking,” Amanda Wheeler, president of the American Vapor Manufacturers Association told Filter. “But meanwhile in the bureaucratic shadows, they are strangling the life out of our entire innovative, entrepreneurial industry.”

    “The FDA should be thoroughly embarrassed that the only vaping products with PMTAs are ones that have been rejected by adult consumers,” Greg Conley, the president of the American Vaping Association, told Filter. “If JTI did not have cigarette sales to subsidize their minimal effort offerings in next-gen products, market forces would have caused them to stop selling these products years ago.”

  • South Africa: Concern Over New Vaping Rules

    South Africa: Concern Over New Vaping Rules

    Photo: Adrian | Adobe Stock

    The Free Market Foundation is concerned that the South African government’s plans for regulating vaping products will push more people back toward smoking combustible cigarettes and buying from the black market, reports BusinessTech.

    “The South African government argues that e-cigarette and vaping products are harmful and warrant regulation,” the Free Market Foundation said. “However, e-cigarettes and vaping innovations are tobacco harm reduction products aimed at mitigating the adverse health impacts associated with combustible tobacco products.”

    “The total excise duty to be levied on nicotine and a non-nicotine solution, e-cigarettes and vaping, will range from ZAR33.30 [$2.28] to ZAR346. Therefore, poorer communities suffering disproportionately from tobacco-related diseases would be more incentivized to continue smoking cigarettes than pick healthier alternatives.”

    “In reality, smokers may simply opt for illicit products, which are cheaper and constitute 42 percent of the informal market for cigarettes. Additionally, illicit goods are more harmful since production standards are not adhered to.”

    The illicit cigarette market in South Africa grew substantially during a temporary ban on tobacco and it has yet to shrink to pre-lockdown volumes.

    “National Treasury’s proposals to tax e-cigarette solutions that contain no tobacco or nicotine may, in particular, be questioned by some stakeholders as it does not necessarily support the government’s stated policy intention of reducing the consumption of tobacco products,” said Webber Wentzel, a legal firm. “It also could stimulate the illicit trade in e-cigarettes as has happened in the tobacco sector.”

    The proposed tax would go into effect Jan. 1, 2023, if passed.

  • Zimbabwe: Farmers Reject Local Currency

    Zimbabwe: Farmers Reject Local Currency

    Photo: Taco Tuinstra

    Tobacco farmers in Zimbabwe have requested to receive 100 percent of their proceeds in U.S. dollars as opposed to partially in foreign currency and partially in local currency, reports The Independent. The farmers cited input costs rising due to high inflation and exchange rate volatilities.

    The Reserve Bank of Zimbabwe said that tobacco farmers would be paid 75 percent of their sales proceeds in foreign currency. The remaining 25 percent would be paid in the local currency, converted at the prevailing auction exchange rate on the day of sale.

    “Expectations are that we retain 100 percent United States dollars (USD). Input costs were very high. Everything was paid in USD, including labor,” Commercial Farmers Union of Zimbabwe President Shadreck Makombe said.

    “Contractors need to improve funding per hectare. The dry spell has affected most late crops, and most farmers will have challenges in repaying loans.”

    The Zimbabwe Tobacco Association (ZTA) said in its latest newsletter that the forex retention level of 75 percent “will sadly negate all the anticipated positives for the season, hence diversification and identification of alternate crops to tobacco remains key for all growers.”

    “Demand for Zimbabwe’s flavor tobacco remains very high. However, it is poor, inconsistent monetary policies that are hurting the local industry and impeding its growth,” the ZTA said.

    “We have had a situation last year where contractors failed to pay farmers,” said George Seremwe, president of the ZTA. “To date, some of the farmers have not been paid. We do not expect that situation to happen. We don’t expect the same contractors to be buying tobacco this season until they fulfill last year’s obligations.”

    “We expect the grading and pricing system to be uniform. We cannot have one contractor paying one grade higher than the other. We want that to be addressed as well.”

    The marketing season officially begins on March 30.

  • ‘Medicago and PMI Talk About Disinvestment’

    ‘Medicago and PMI Talk About Disinvestment’

    Photo: Leigh Prather

    Medicago is talking to its shareholder Philip Morris about disinvesting to clear the way for the biopharmaceutical company’s Covid-19 vaccine, reports The Globe and Mail, citing Canada’s innovation minister, Francois-Philippe Champagne.

    In a briefing last week, the World Health Organization suggested it would reject Medicago’s Covifenz inoculation because of the company’s ties to the tobacco industry. Philip Morris Investments owns about one-third of the Canadian biopharmaceutical company.

    Earlier, Health Canada approved Covifenz for use in adults 18 to 64 years of age.

    On March 24, a WHO spokesperson told The Globe and Mail that Medicago’s request for an emergency use listing has been denied. He said the decision was made “because of the linkage with the tobacco industry and WHO’s strict policy on not engaging with companies that promote tobacco.”

    An emergency use listing is required in order for vaccines to be used by COVAX, a global initiative to share vaccines with low-income and middle-income countries.

    The WHO Framework Convention on Tobacco Control prohibits collaboration with the tobacco industry. According to The Globe and Mail, Health Canada believes the treaty does not preclude investment in vaccine development.

    But according to the WHO’s treaty implementation guidelines, signatories shouldn’t let any branch of government accept contributions from the tobacco industry or those working with it. The implementation guidelines also state that signatories should not “endorse, support, form partnerships with or participate in activities of the tobacco industry described as socially responsible.”

    The WHO will punish industry by preventing sale of less hazardous products and declining distribution of a vaccine tangentially connected to a tobacco company, both of which will inevitably cause even more disease and death.

    Martin Cullip

    Tobacco harm reduction advocates were aghast by the WHO’s rejection of Covifenz. Cameron English of the American Council on Science and Health described the global health body’s attitude as “shameless moral preening” that potentially puts many millions of people at risk.

    Cameron noted that the tobacco industry has a long history of investing in companies that sell smoking cessation aids. “Is the WHO going to publicly oppose the use of nicotine gum because cigarette makers have a vested interest in selling it?”

    Martin Cullip, an international fellow at The Taxpayers Protection Alliance’s Consumer Center, said the WHO is engaged with points-scoring against industry rather than saving people from dying of the disease in low-income and middle-income countries.

    “Their unethical and depraved reasoning seems to be that because cigarettes have caused so much harm, the WHO will punish industry by preventing sale of less hazardous products and declining distribution of a vaccine tangentially connected to a tobacco company, both of which will inevitably cause even more disease and death,” he wrote for Townhall.

  • U.K. Acknowledges Vaping’s THR Role

    U.K. Acknowledges Vaping’s THR Role

    Photo: ink drop

    The U.K. Department for Health and Social Care’s (DHSC) has acknowledged the role of vaping in smoking harm reduction, according to the U.K. Vaping Industry Association (UKVIA).

    In its review of the Tobacco and Related Products Regulations (TRPR) laws, which was published on March 25, the DHSC noted existing TRPR regulations “met their original objectives” and that they “could not be better achieved through alternative regulatory measures.”

    The government has set itself a target of reducing the amount of U.K. smokers to just 5 percent of the population in the next eight years with the TRPR and other developments, such as the yet to be published Tobacco Control Plan (TCP), set to play a major role in helping to realize that ambition.

    “While at first glance this appears to be ‘status quo,’ I see this as a win for the U.K’s vaping sector as the review clearly states the positive impact that vaping can have in helping people to quit smoking,” said John Dunne, director general of the UKVIA.

    “As part of the TRPR consultation we submitted a whole raft of proposals aimed at creating a better commercial and regulatory environment to make it easier for the industry to help people trying to give up smoking and it is good to see those acknowledged.”

    I see this as a win for the U.K’s vaping sector as the review clearly states the positive impact that vaping can have in helping people to quit smoking.

    John Dunne, director general, UKVIA

    The UKVIA, which promotes vaping as a much less harmful alternative to smoking and its significant impact in helping smokers quit, as well as dispelling the misinformation on vaping that exists, submitted a landmark package of recommendations to the TRPR consultation, including:

    • The use of government-approved expert health claims on products to address misinformation leading to misperceptions on vaping, and therefore encourage smokers to switch
    • Greater opportunities to engage with smokers, as current regulations restrict vaping’s ability to provide smokers with evidence-based knowledge to make informed decisions when looking to quit
    • The extension of certain regulations to cover additional vaping products, such as non-nicotine e-liquids, thereby ensuring a highly responsible and safe industry.

    “What this tells me is that the industry is doing its job in bringing to the fore some of the things that have been holding back vaping’s ability to support the government’s smokefree targets to full effect,” said Dunne.

    “We have to remember this is only a review of all points made and some initial positions the government is taking; our hope now is that those proposals and recommendations are carried forward and manifested in the Tobacco Control Plan.

    “So, while in some respects it is disappointing that the government hasn’t taken forward the measured, evidence-based reviews put forward by the UKVIA, there is still positivity that in addition to forthcoming TCP, our recommendations can also inform and influence the Health Disparities White Paper and independent review into tobacco control policies.”

  • RAI Announces Site Closures

    RAI Announces Site Closures

    Photo: RAI

    Reynolds American Inc. (RAI) will reduce its U.S. manufacturing footprint and close of some sites to position the company for future growth, the company announced.

    The decision follows a detailed strategic review of the company’s operations.

    Guy Meldrum

    “These decisions are never easy,” said RAI President and CEO Guy Meldrum in a statement. “We are focused on delivering long-term, sustainable growth in a rapidly evolving environment. While these changes are necessary to support the future of our business, they will be extremely difficult for our employees at the manufacturing sites that are closing and today we are focused on providing support to them through this transition.”

    Beginning next month and progressing through 2024, Santa Fe Natural Tobacco Co.’s operations in Oxford, North Carolina, and American Snuff Co.’s operations in Winston-Salem, North Carolina will move to Tobaccoville, North Carolina. ASC’s Traditional Oral operations in Memphis, Tennessee, will move to Clarksville, Tennessee.

    More than half of employees across the closing facilities will have the opportunity to transfer sites. These changes will reduce the company’s full-time employee workforce by approximately 350 roles by 2025.

    “After our review, it became clear that we had to align our manufacturing footprint with our growth strategies,” said Bernd Meyer, executive vice president of operations at Reynolds. “Many of our employees will be given the opportunity to transfer sites. Our employees displaced through this process will receive a comprehensive severance and benefits package, including outplacement support to help as they transition to the next phase of their careers.”