Category: Featured

  • FDA Accepts Application for CLEW Pouches

    FDA Accepts Application for CLEW Pouches

    Image: Nevcore Innovations

    The U.S. Food and Drug Administration has accepted a premarket tobacco product application for Nevcore Innovations’ CLEW modern oral nicotine pouches.

    According to the manufacturer, CLEW pouches are manufactured in state-of-the-art cGMP- and HAACP-certified facilities that comply with strict quality protocols and ensure products meet the highest safety standards.

    “At the core of CLEW lies our unwavering commitment to delivering an unparalleled experience, by blending cutting-edge technology with the finest ingredients,” said Nevcore Innovations’ founder and chairman, Nutesh Singla, in a statement.

    “Crafted with precision and passion, CLEW nicotine pouches are formulated at the top laboratories in the USA and contain pharmaceutical-grade nicotine and carefully selected flavorings, ensuring a gratifying sensation with every use.”

    “CLEW nicotine pouches herald a new era in nicotine indulgence, and we are confident they will set the new global benchmark for white nicotine pouches the world over,” said Nevcore Innovations’ global CEO, Waqas Khan.

    “We have listened to the needs and desires of consumers and have developed a product that not only meets but exceeds their expectations and are confident that they will play a significant role in global harm reduction efforts. With CLEW, we are reimagining what it means to enjoy nicotine, providing a solution that is both convenient and satisfying.”

    CLEW nicotine pouches will be available in flavors such as mint, fruit and tobacco, and in strengths of 3 mg, 5 mg, 6 mg, 9 mg, 10 mg, 12 mg, 15 mg and 20 mg.

  • FDA Rescinds Juul Marketing Denial Order

    FDA Rescinds Juul Marketing Denial Order

    Photo: steheap

    The Food and Drug Administration Thursday rescinded its 2022 ban on Juul Labs’ e-cigarette products. However, the agency has not yet made a final decision on whether Juul can remain on the U.S. market. The move does open the door for Juul to receive marketing authorization from the regulatory agency.

    In 2022, the FDA ordered Juul to stop its sales, but later paused the order while the vaping company appealed. The agency announced that it would reinitiate a scientific review of Juul’s products, essentially returning them to their regulatory status before the initial ban.

    In the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA stated in a release. “Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”

    Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.

    Juul Labs welcomed the move. “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products, the company wrote in a statement. “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”

     

  • Malawi Prices Up a Quarter Over Last Year

    Malawi Prices Up a Quarter Over Last Year

    Photo: Taco Tuinstra

    Malawi tobacco growers have sold 64.7 million kg of tobacco for $182 million in the seven weeks since the marketing season opened, reports The Nyasa Times.

    Tobacco Commission spokesperson Telephorus Chingwenembe said the average price, at $2.81 per kg, was 26 percent above that fetched during the same period during last year’s selling season.

    “We are happy to note that the progress of the selling season underway has triggered people’s interest to grow the crop,” he was quoted as saying. “This aligns very well with our goal to increase our annual production to 200 million kg by 2028 because in the recent years, we have been failing to meet the trade demand. The demand is higher than what we are currently producing.”

    Chingwenembe also praised the high quality of leaf being brought to the sales floors.

  • Hong Kong Mulls New Anti-Smoking Measures

    Hong Kong Mulls New Anti-Smoking Measures

    Photo: ChenPG

    Hong Kong announced several new anti-tobacco policies on June 6, reports The Standard.

    Among other measures, the city plans to introduce a new duty-paid labeling system, ban “smoke-and-queue” behavior in public, and prohibit all flavored cigarettes and alternative products including vapes and heated cigarettes.

    The rules are meant to help the government lower smoking prevalence to 7.8 percent by 2025 and ultimately achieve a “Tobacco-free Hong Kong” after the completion of a public consultation exercise launched last year.

    Other measures include raising the maximum penalty for evading tobacco duty to a HKD2 million ($256,082) fine and seven years’ imprisonment; a ban on providing cigarettes to underage teens and children; and continuous reviews on the adjustment of tobacco duty.

    The government will also maximize the area reserved for health warnings on cigarette packaging to 100 percent; expand non-smoking areas and increase fines for violations.

    Secretary for Health Lo Chung-mau said the government strives to table the new policies to the Legislative Council before the end of this year and expects they will be passed within this legislative year.

    More than 90 percent of respondents to the public consultation agreed with further lowering the smoking prevalence.

    There are more than 570,000 daily smokers in Hong Kong and the latest prevalence stands at 9.1 percent, according to Director of Health Ronald Lam Man-kin.

  • Pyxus Completes Strong Fiscal 2024

    Pyxus Completes Strong Fiscal 2024

    Photo: Pyxus International

    Pyxus International reported sales and other revenue of $2 billion in fiscal year 2024, up 6.1 percent over its 2023 results. The company attributed this growth to “consistent execution” and an increase in average pricing of 10.5 percent, partially offset by slightly lower volume of 4.4 percent compared to fiscal 2023. Operating income increased 46.3 percent to $137.2 million, reflecting a more favorable business mix as well as improved operating efficiencies.

    “We achieved strong fiscal year 2024 results through our continued identification and capture of opportunities for growth, acceleration of our operating cycle times, improved working capital efficiency and increased availability of our total liquidity,” said Pyxus’ President and CEO Pieter Sikkel in a statement.

    “Our discipline is enabling a significant reduction of long-term debt that strengthens our capital structure and demonstrates our ability to achieve near-term operating and financial objectives while ensuring that the business remains positioned for long-term success.”

    For fiscal 2025, Pyxus anticipates sales to range between $2.1 billion and $2.3 billion and adjusted EBITDA to range between $165 million and $185 million. The company believes it is well positioned to successfully navigate an industry operating environment for fiscal 2025 that, due to the El Niño weather phenomenon, is generally expected to have a short-term negative impact on margins. 

  • Shareholders Approve Hotels Demerger

    Shareholders Approve Hotels Demerger

    Timon Schneider/Wirestock

    Shareholders on May 6 approved ITC’s plan to demerge its hotels business, reports Reuters.

    The company, which has a substantial cigarette business, announced the demerger plan in July last year and later said that the new entity would be tentatively listed.

    In May, proxy advisory firms Stakeholders Empowerment Services and InGovern Research Services asked shareholders to support the proposal, while Institutional Investor Advisory Services opposed the move.

    The hotels business contributed 4 percent to ITC’s fiscal year 2024 revenue, while its mainstay consumer staples business made up 71 percent of the topline.

  • Leaf Sales Down

    Leaf Sales Down

    Photo: Taco Tuinstra

    Contracted and self-financing growers had earned more than US$600 million by Day 56 of Zimbabwe’s 2024 tobacco selling season, down from $722 million earned by the same day last year, reports The Herald.

    The most recent season was impacted by an El Nino-induced drought, which caused the season to start late and end early.

    Tobacco Industry and Marketing Board statistics revealed that farmers had cumulatively sold 173.76 million kilograms of tobacco worth $607.08 million by Day 56 under both the auction and contract systems. This represents a 16 percent decline in earnings from the comparable 2023 period.

     In volume terms, the leaf sold was 27 percent below the 239.56 million kg sold last season. The average auction price was $0.12 higher than that at the contract floors.

    Some stakeholders remained positive about the remainder of the season. “On the back of an El Niño-ravaged season, we need to celebrate the 174 million kilograms achieved to date,” said Paul Zakariya, secretary general of the Zimbabwe Farmers Union. “The marketing season is still underway and we expect more tobacco to come through. We may not necessarily reach the desired target, but we will not totally be out of range .”

    Others were less optimistic. Tobacco Farmers Union Trust Vice President Edward Dune said it was highly unlikely that the 240 million kilogram target would be reached in the wake of the drought.

    “Deliveries should definitely be declining now that the marketing season is almost coming to an end. Firewood cutting and nursery preparations are the major farmer activities currently taking place on farms,” he said.

  • Swedish Match MRTP Comments Due July 5

    Swedish Match MRTP Comments Due July 5

    The U.S. Food and Drug Administration posted the final set of application materials related to renewing existing modified-risk tobacco product (MRTP) orders for Swedish Match U.S.A.’s General Snus products.

    The agency announced a deadline for public comments. To ensure they receive consideration by FDA, the applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024.

    The application materials, redacted in accordance with applicable laws, can be found on the FDA’s website. “Before making a final determination on an MRTP application, FDA considers all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC),” a release states.

    The FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

    Written submissions may be made to the contact person on or before June 20, 2024.

  • Tax Hike Diverted Cigarette Sales: LUMS

    Tax Hike Diverted Cigarette Sales: LUMS

    Image: alexlmx

    Pakistan’s 2023 federal excise duty (FED) hike on tobacco products has diverted rather than reduced cigarette consumption, reports The News International, citing recent research.

    In 2023, the government announced a significant cigarette tax hike, prompting tobacco companies to more than double their cigarette prices.

    The fiscal measure aimed to boost revenue and discourage smoking. However, a recent study conducted by the Lahore University of Management Sciences (LUMS), suggests it has achieved neither objective.

    Instead of lowering smoking rates, the increased prices have prompted consumers to source their cigarettes from informal sources, a development that will likely cause the government to miss PKR300 billion ($1.08 billion) in tax earnings this year, according to LUMS.

    The LUMS study found that the share of duty-paid cigarettes shrank to 42 percent over the past two years.

    “Government has implemented various initiatives to address the extent of illicit sector to bring more companies and illicit sector under tax net,” said LUMS Associate Professor of Economics Kashif Zaheer Malik. “These, however, have not been successful in reducing illicit trade in Pakistan.”

    In light of Pakistani smokers’ profound price sensitivity, the LUMS report urged the government to reconsider its excise tiers. It also said the success of Pakistan’s track-and-trace system would depend on an all-encompassing rollout and consistent enforcement.

    Only a handful of Pakistan’s cigarette manufacturers have implemented the new system.

    In related news, the government of Pakistan’s Khyber Pakhtunkhwa (KP) province announced a 400 percent tobacco tax increase.

    Civil society groups welcomed the measure. “This substantial increase is projected to generate over PKR2 billion annually, which will be dedicated to enhancing health facilities across KP,” Blue Veins and the Provincial Alliance for Sustainable Tobacco Control wrote in joint statement.

    Tobacco growers warned the tax hike would destroy the sector. “The farmers can’t afford this and will stop growing tobacco,” Pakistan Tobacco Board member Rustam Khan was quoted as saying by The News International.

    “Tobacco crop is the only cash crop of the province. And around 1.2 million people in the province depended on it,” said Khan, adding that more than 75,000 farmers were involved in tobacco cultivation.

    Tobacco taxation has been a contentious topic in Pakistan recently. In May, market leader Pakistan Tobacco Co. threatened to cease operations in the country if the government further increases cigarette taxes.

  • Vietnam Trade Ministry Supports Vapes Ban

    Vietnam Trade Ministry Supports Vapes Ban

    Photo: Holger

    Vietnam’s Ministry of Industry and Trade supports a ban on e-cigarettes, reports The VN Express

    The ministry has requested the government to halt the review of its proposed bill on regulating e-cigarettes after the health ministry officially published a report highlighting their negative effects.

    “The Ministry of Industry and Trade supports making changes in the law to ban e-cigarettes as the Ministry of Health has affirmed that they are harmful,” Trader Minister Nguyen Hong Dien told lawmakers on June 5.

    No business have been licensed to trade e-cigarettes in Vietnam.

    The share of Vietnamese aged 13-15 using e-cigarettes has increased from 3.5 percent in 2022 to 8 percent in 2023, official data shows.