Tag: news

  • FDA Posts 2 Regulatory Science Memos for Vapes

    FDA Posts 2 Regulatory Science Memos for Vapes

    Credit: Araki Illustrations

    FDA posted the following two regulatory science policy memos related to the agency’s review of premarket tobacco product applications (PMTAs) for new e-cigarette products: 

    • June 03, 2024: Genotoxicity Hazard Identification and Carcinogenicity Tiering of Constituents in ENDS Premarket Tobacco Product Applications
    • June 03, 2024: Calculating Excess Lifetime Cancer Risk in ENDS Premarket Tobacco Product Applications

    In general, the science policy memos provide a snapshot of FDA’s internal thinking on a specific topic at a certain point in time. Therefore, the information contained in the memos is subject to change, for example, based on changes in policy, the regulatory framework, or regulatory science, according to a press release.  

    FDA’s review of tobacco product applications is based on the specific facts presented in each application and is documented in reviews particular to each application. The memos posted today should not be used as a tool, guide, or manual for the preparation of applications or submissions to FDA.

    For applicants seeking to market new tobacco products, FDA has issued final regulations, such as the PMTA final rule that describes the required content, format, and review procedures for PMTAs, as well as guidance documents. FDA also regularly posts additional resources, such as webinars and application tips, on CTP’s website and social mediaExternal Link Disclaimer.  

    In April, FDA resumed the posting of regulatory science policy memos, with a subsequent release in May. The release of these latest memos reflects the CTP’s ongoing commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation.

  • Discount Brands Boost Revenue, Income at Vector

    Discount Brands Boost Revenue, Income at Vector

    Photo: Mind and I

    Vector Group reported consolidated revenues of $371.9 million for the second-quarter of 2024 financial results, up 1.7 percent compared to the prior-year period.

    Tobacco segment wholesale market share increased to 5.7 percent from 5.4 percent in the prior-year period, and retail market share remained at 5.8 percent, unchanged from the prior-year period.

    Montego wholesale and retail market share both increased to 4.1 percent from 3.4 percent and 3.5 percent, respectively, in the prior-year period.

    Operating income was $97.8 million, up 36.5 percent, or $26.1 million, compared to the prior-year period.

    Tobacco segment operating income was $102.9 million, up 37 percent, or $27.8 million, compared to the prior-year period.

    Adjusted EBITDA was $103.3 million, up 9.7 percent, or $9.2 million, compared to the prior-year period.

    Tobacco adjusted EBITDA was $104.4 million, up 10.2 percent, or $9.7 million, compared to the prior-year period.

    “Vector Group delivered strong performance in the second quarter, bolstered by the impressive growth of our Montego brand,” said Vector Group President and CEO Howard M. Lorber in a statement.

    “Montego’s continued expansion as the largest discount brand in the U.S. highlights the effectiveness of our strategic approach, expert market analysis and proven execution. We are confident in our ability to sustain our momentum in the second half of the year and to drive long-term value for our stockholders.”

  • Activists Slam IQOS Maker for Cellulose Heat Sticks

    Activists Slam IQOS Maker for Cellulose Heat Sticks

    Photo: Kuznyechova Yevgenia

    Anti-tobacco activists contend Philip Morris International is trying to circumvent the Dutch ban on flavored tobacco and vape products with its Levia heat sticks, reports Dutch News.

    Made with cellulose rather than tobacco, Levia heat sticks are considered an herbal product and are thus not covered by country’s tobacco legislation. The sticks retail online for €6.60 ($7.21) per pack of 20 and are sold in two flavors—”island beat,” which is menthol, and berry-flavored “electro-rouge.”

    The Netherlands banned menthol in cigarettes in May 2020 and outlawed flavored vape products in early 2024.

    Campaign group Rookvrije Generatie says Levia “a trick” to keep on selling smoking products with flavor. “They might not contain tobacco but they are packed with addictive nicotine,” spokesman Dave Krajenbrink was quoted as saying.

    Legislators are reportedly considering an amendment that would extend the flavor ban to tobacco-free nicotine products.

  • Vape Manufacturer Ispire Partners With Hidden Hills

    Vape Manufacturer Ispire Partners With Hidden Hills

    Photo: Africa Studio

    Ispire Technology and Aspire North America have signed a global licensing agreement with the U.S. lifestyle brand Hidden Hills Club.

    Under the agreement, Ispire will globally manufacture, distribute and commercialize Hidden Hills’ branded nicotine products, including reduced-risk e-cigarettes. The initial Hidden Hills nicotine products are scheduled to roll out in the United Arab Emirates and South Africa in the coming weeks, followed by the United Kingdom and European Union over the next few months.

    “Our partnership with Hidden Hills Club enables us to bring more innovative and reduced-risk nicotine products to a global audience,” said Ispire Co-CEO Michael Wang.

    “The 30-year exclusive license will allow us to make significant investments in the Hidden Hills brand, ensuring robust distribution and a deep product portfolio that captures the essence of this iconic lifestyle brand. Hidden Hills’ popularity as a lifestyle brand—encompassing apparel, clothing and cannabis and hemp products—has grown at an exponential rate over the last two years. Partnering with Hidden Hill will help Ispire to capture this west-coast culture and energy, and infuse it into its nicotine product offerings globally, under the Hidden Hills brand flag.”

    “Teaming up with Ispire was a strategic decision for us,” said Hidden Hills Club CEO Dre Liang. “Ispire’s expertise in vaping technology and its global distribution network provide the perfect platform to expand our brand into the nicotine products market. We believe this collaboration will redefine the market with products that reflect our brand’s commitment to quality and innovation.”

  • Thailand: Critics Call for Targeted Vaping Laws

    Thailand: Critics Call for Targeted Vaping Laws

    Photo: Looker Studio | Carsten Reisinger

    Thailand should create a law specifically targeting vaping, Deputy Public Health Minister Thanakrit Jitareerat told the National Health Commission Office on Aug. 1, according to a report in The Taiger.

    With various agencies independently enforcing measures based on different laws, Thailand has been unable to halt the spread of vaping, according to the minister.

    “The measures we have rolled out to date have proved ineffective, so a specific law on the matter must be drafted as soon as possible, describing vaping as a serious threat to society,” Jitareerat was quoted as saying.

    National Health Commission Office Chairman Banjerd Singkaneti countered that the government should refine existing laws to provide clearer guidelines for authorities.

    “In the long run, possession of e-cigarettes should be clearly prohibited by law so that the police will have no excuse not to pursue legal action,” Banjerd said.

    The Office of the Consumer Protection Board seized 100,000 illegal e-cigarettes in 2023, up from 27,000 in 2020.

  • Fifth Circuit Cites Triton to Vacate 5 Denial Orders

    Fifth Circuit Cites Triton to Vacate 5 Denial Orders

    Fifth Circuit Court of Appeals

    The 5th Circuit Court of Appeals granted petitions for review to five vaping companies, citing its own decision in the Triton Distribution case as precedent.

    The court sent the company’s marketing denial orders (MDOs) back to the U.S. Food and Drug Administration for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco applications (PMTAs), or until the Supreme Court takes action.

    “Specifically, the court determined that (1) FDA did not give e-cigarette manufacturers fair notice of the rule requiring long-term studies for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance,” the 5th Circuit wrote in its ruling.

    Five companies, Cloud House, Paradigm Distribution, SWT Global Supply, Vaporized and SV Packaging first challenged their MDOs in court in October 2021. The court consolidated the five cases, and in November 2021, all petitioners were granted stays pending review.

    In January, the 5th Circuit found in favor of Wages and White Lion Investments (doing business as Triton Distribution) in the e-liquid manufacturer’s appeal of an MDO. The FDA later petitioned the Supreme Court to review the 5th Circuit’s ruling, and last month the Supreme Court agreed to hear the agency’s appeal.

    The FDA challenged the Triton decision, and the U.S. Supreme Court agreed to hear that case. “But now another panel of the Fifth Circuit has applied the same rationale as in Triton to hold that these five, small-business manufacturers prevail for the same reason: FDA pulled a surprise switcheroo,” wrote the United States Vaping Association on X.

    The 5th Circuit found that the recent petitions posed the same issues as Triton’s. “Petitioners spent substantial time and resources preparing their PMTAs based on FDA guidance that they would not need to submit long-term clinical studies,” the court wrote.

    “Nevertheless, FDA rejected their PMTAs using the same boilerplate language it used for the Wages petitioners’ denials, as well as those of thousands of other e-cigarette manufacturers. Accordingly, for the reasons amply explained by the en banc court in Wages, we hold that FDA acted unlawfully here as well by denying Petitioners’ PMTAs based on the absence of long-term clinical studies.”

  • Quarterly Revenue and Profit up at Japan Tobacco

    Quarterly Revenue and Profit up at Japan Tobacco

    The JT Group reported revenue of ¥1.6 trillion ($10.63 billion) for the second quarter of 2024, up 12.7 percent over the comparable 2023 period. Profit increased by 6.3 percent to ¥305.2 billion.

    “The JT Group posted another strong set of results for the first half, driven by continued market share gains and solid pricing in the tobacco business,” said President and CEO Masamichi Terabatake in a statement.

    “Total volume increased by 2 percent year-on-year, with combustibles growing 1.7 percent and RRP [reduced risk products] up by a strong 25.5 percent. RRP volume was mainly driven by Ploom in the HTS segment, our investment priority, resulting in RRP-related revenue increasing by approximately 29 percent year-on-year.

    “In the Japanese market, Ploom volume increased approximately 36 percent year-on-year, growing at a faster pace than total HTS demand in the market. Additionally, the geo-expansion of Ploom has now reached 21 markets, with sales volumes in markets outside Japan also steadily increasing.

    “For the full-year performance forecast, we have revised our adjusted operating profit at constant FX [foreign exchange rates] upward, reflecting the positive momentum in the first half. On a reported basis, we have also revised our forecast upward, considering the continued impact of the current positive foreign exchange trend.”

  • Turning Point Announces Second Quarter Results

    Turning Point Announces Second Quarter Results

    Photo: David

    Turning Point Brands (TPB) announced financial results for the second quarter ended June 30, 2024.

    Total consolidated net sales increased 2.8 percent to $108.5 million compared to the previous year period. Zig-Zag product net sales increased 8 percent. Stoker’s product net sales increased 18.5 percent. Creative Distribution Solutions (CDS) net sales decreased 33 percent. Gross profit increased 2.6 percent to $53.8 million. Net income increased 31 percent to $13 million. Adjusted net income increased 12.2 percent to $17.2 million. Adjusted EBITDA increased 6.9 percent to $27 million.

    “We were pleased by our second-quarter results,” said President and CEO Graham Purdy in a statement. “We achieved our highest quarterly EBITDA since the second quarter of 2021. We believe Zig-Zag is on a sustainable growth trajectory, and Stoker’s MST continues to grow market share. In addition, sales of FRE, our modern oral nicotine pouch, grew 76 percent sequentially as we continue to expand our national footprint.”

    The company is increasing its previous full-year 2024 adjusted EBITDA guidance from $95 to $100 million to $98 to $102 million, which excludes CDS.

    For the second quarter, CDS net sales were $15.3 million, gross profit was $3.4 million and gross margin was 22.5 percent.

  • Warning Letters for 5 Online Illegal Vape Retailers

    Warning Letters for 5 Online Illegal Vape Retailers

    Credit: Marcus Krauss

    The U.S. Food and Drug Administration has again  issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products marketed under the brand names Geek Bar, Lost Mary, and Bang. It’s the second wave of warning letters issued in July.

    The retailers included Smoke and Vape Company, LLC d/b/a Smoke and Vape Co.; Smoking Vibes LLC d/b/a Smoking Vibes; Cavalry Industries d/b/a Select Vape; HTXW LLC d/b/a FOMO Culture; and Global Supply Allies Inc. d/b/a Vapor Grab.

    These warning letters were a result of FDA’s ongoing monitoring of multiple surveillance systems, including a review of various data, to identify emerging products of particular concern that are popular among youth or have youth appeal, according to an agency press release. For example, emerging data showed that Geek Bar – a Chinese-owned and manufactured brand – has recently seen an uptick in sales and can appeal to youth.  

    Warning letter recipients are given 15 working days to respond with the steps they will take to address the violation(s) cited in the warning letter and to prevent future violations. Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalties. 

    FDA holds retailers accountable for selling unauthorized tobacco products, particularly those popular with youth. To date, FDA has issued over 680 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, issued more than 690 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against 64 manufacturers and more than 140 retailers for distribution and/or sale of unauthorized tobacco products. 

    As of August 1, 2024, the FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products can be lawfully marketed and sold in the U.S. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement.

  • PMI Urges More Collaboration Against Illicit Trade

    PMI Urges More Collaboration Against Illicit Trade

    Photo: PMI

    International collaboration, stringent regulation and enforcement are the cornerstones in the fight against illicit trade, according to Rodney van Dooren, head of illicit trade prevention at Philip Morris International.

    Speaking at a trademark and brand protection conference, held in Delhi, July 23-24, van Dooren pointed out how prohibition has not been a viable option, while regulation and enforcement would be the solution to curb illicit trade.

    “Approximately 12 percent of the global cigarettes consumed are illicit, which impacts governments across the globe to the tune of $40.5 billion in tax losses, van Dooren said.

    “According to the Euromonitor report, one in four cigarettes consumed in India is illicit which translates to close to $2 billion in tax losses. There are various smuggling routes around the world for both counterfeit and contraband products, making this challenge not a domestic but a transnational issue that requires transnational solution.”

    Van Dooren urged authorities to better leverage the existing free trade agreements and provisions within the World Trade Organization to raise awareness with transit and source countries.

    “The next recommendation is to promote harmonization of existing gold standard regulations around ASEAN, supported by implementing rules, including the law enforcement agency that has jurisdiction and the related penalties,” he noted.

    “The adoption of the regulation requires manufacturers and exporters to ensure that the goods being exported comply with the destination market regulation. Additionally, in transshipment, adopt regulation that allows for inspection of suspicious shipments and exercise jurisdiction by Customs or any appropriate law enforcement agency on IP-infringing violations. Lastly, strengthen domestic enforcement effectiveness by enhanced cooperation with the legal industry and inter-law enforcement agency cooperation.”