Category: News This Week

  • Warnings After ‘Refuse to Accept’ Notices

    Warnings After ‘Refuse to Accept’ Notices

    Photo: Marcus Krauss

    The U.S. Food and Drug Administration issued 29 warning letters to firms that manufacture and sell unauthorized electronic nicotine-delivery systems (ENDS) products in August. The recipients failed to submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020, deadline. Collectively, the firms have listed more than 268,000 products with the FDA.

    In addition, the agency issues two warning letters to two companies for manufacturing and offering for sale or distribution ENDS products without a marketing authorization order. Vapor Boss and Kaleidoscope Custom Vapor Lounge have continued to sell ENDS products after receiving “Refuse to Accept” (RTA) determinations from the agency. These are the first warning letters issued for an application that was submitted by the Sept. 9, 2020, deadline that subsequently received RTA determination, according to the FDA.

    Companies that receive an RTA determination must remove any products currently on the market or risk enforcement by the FDA. Companies may submit a complete application for these products at any time but may not market the products unless they receive a marketing order.

    The FDA also issued the first warning letter to a company that submitted a PMTA for some but not all of its products. Maduro Distributors, which does business as The Loon, submitted an application covering 18 products, but it manufactures and sells additional products not covered by the PMTA.

    From January through August 2021, the FDA has issued 169 warning letters to firms selling more than 17 million unauthorized ENDS products by the Sept. 9, 2020, deadline.

  • Calls for Action Against Noncompliant Products

    Calls for Action Against Noncompliant Products

    Photo: auremar

    The U.K. Vaping Industry Association (UKVIA) is calling for tough action against resellers of noncompliant disposable vape products.

    During an investigation, the trade group found that there are significant numbers of noncompliant products entering the U.K. and being sold in particular by convenience shops and on major online marketplaces.

    “We are calling upon regulators and the online marketplaces to robustly enforce current regulations and do much more in order to ‘clean up’ the disposable vapes market,” said John Dunne, director general at the UKVIA, in a statement.

    The disposable vape sector has enjoyed a significant revival in recent years, appealing as an entry point for adult smokers looking to quit conventional cigarettes. However, an investigation by the UKVIA has identified that illegal products are re-entering the U.K. market. The problem, according to the group, lies with some distributors who are flouting U.K. regulations and managing to get these products imported into the country and sell them on to traders and retailers as well as a lack of proper scrutiny on major online marketplaces.

    Disposable vapes are pre-filled with e-liquids and cost around £6 ($8.27) each. U.K. regulations stipulate that they should contain no more than 20 mg/mL of nicotine, yet evidence collected by the UKVIA reveals that some listed as this amount contain higher concentrations of nicotine, and some products are being openly sold with 50 mg/mL strength. Furthermore, product packaging is often missing warnings about the nicotine content, which is a legal requirement.

    The UKVIA has been in discussions with the Medicines & Healthcare Products Regulatory Agency (MHRA), which regulates vape products and trading standards, to address the situation. In a major crackdown on unscrupulous suppliers, the association is providing guidance on official distributors and disposable vape products to its members as well as looking at the idea of licensing vape shops to fund enforcement. It’s also working with manufacturers of disposable vapes to ensure they are doing all that is possible to monitor and audit their distributors.

    “Robust enforcement of the current regulations is the only answer, and it’s needed now,” said Dunne. “We can provide support to the regulators and educate the industry on how to distinguish between what’s a compliant product or not, and we are in the process of doing this. However, we are not in a position to come down heavy on those breaking the law; that lies with the regulators.

    “The vaping sector’s reputation, [which] the industry has taken years to build up and which has made it one of the most successful business markets in the 21st century to date, is being threatened by a minority intent on making a quick buck out of a popular product, and we will not stand back and just watch it happen. Disposables have a major role to play in the vape market, but like all products, they need to adhere to the legislation.”

  • Multimillion Dollar Verdict in Engle Case

    Multimillion Dollar Verdict in Engle Case

    Photo: BillionPhotos.com

    A Florida jury returned a $43 million verdict against Philip Morris on Aug. 3 after finding the company responsible for the cancer death of a woman who had smoked the company’s Virginia Slims cigarettes, reports the Courtroom View Network.

    The verdict includes $15 million in compensatory damages and $28 million in punitive damages for the 1993 lung cancer death of Norma Lipp.

    Lipp had smoked between one and two packs of cigarettes a day for decades, including those of the Virginia Slims brand for 15 years.

    Her family claims Philip Morris conspired to hide the dangers of smoking, hooked her to nicotine and caused her fatal cancer.

    The case is among thousands that stem from Engle v. Liggett Group Inc., a 1994 Florida class-action lawsuit against the nation’s tobacco companies that led to a plaintiffs’ verdict at trial.

    The state’s supreme court later decertified the class but ruled that “Engle progeny” cases may be tried individually.

  • Alarm About Illicit Cigarettes in Ghana

    Alarm About Illicit Cigarettes in Ghana

    Photo: Dietmar Temps

    One in every five cigarettes in Ghana is illicit, reports Business Ghana, citing research conducted by Arti Singh, a faculty member of the School of Public Health at the Kwame Nkrumah University of Science and Technology.

    The study revealed that close to half of illicit tobacco products originate in neighboring Togo. In the border town of Aflao, more than 90 percent of packs studied turned out to be illicit.

    Singh attributed the prevalence of illegal stock to porous borders and low awareness among stakeholders, among other factors.

    Out of 384 retailers interviewed, close to half were unaware of illicit tobacco. A third was unaware of tobacco control laws on illicit products.

    The study recommended the implementation of a track-and-trace system, enforcement of restrictions on single-stick sales and the implementation and enforcement of an illicit tobacco protocol. Ghana is in the process ratifying the WHO Framework Convention on Tobacco Control, according to Olivia Agyekumwaa Boateng, head of the country’s tobacco and substance abuse department at the food and drugs authority.

    The study also suggested educational campaigns to inform retailers on tobacco control laws and illicit tobacco products.

    The illicit tobacco trade study was carried out as part of the Tobacco Control Capacity Program, which aims to improve research capacity in low-income and middle-income countries and conduct high-quality studies that will generate evidence on how to reduce morbidity and mortality caused by tobacco use. 

    Led by Professor Linda Bauld from the University of Edinburgh, the program is funded by a grant from Research Councils U.K.

  • Ceylon Tobacco Names Finance Director

    Ceylon Tobacco Names Finance Director

    Photo: Negro Elkha

    Ceylon Tobacco Company (CTC) has appointed Syed Muhammad Ali Abrar to the position of finance director, reports The Daily Mirror of Colombo. 

    Ali joined BAT Pakistan in 2005 and has held leadership functions for the company in South Asia, the South Pacific, the Middle East and BAT’s global business services hub in Malaysia. He has experience in corporate finance, commercial finance and supply chain finance. 

    Ali holds a bachelor’s degree from the National University of Science and Technology, Pakistan, and holds a Master of Business Administration degree from the Institute of Business Administration, Pakistan. 

    He will report to managing director/CEO Nedal Salem,

    Earlier this year, CTC appointed Suresh Kumar Shah as its chairman.

  • ‘Menthol Ban Would Save 650,000 Lives’

    ‘Menthol Ban Would Save 650,000 Lives’

    David Levy

    Banning menthol flavors in cigarettes could reduce smoking by 15 percent by having smokers giving up tobacco products altogether or switching to e-cigarettes and other nicotine vaping products—avoiding 16,250 tobacco-related deaths per year by 2060, according to a new University of Michigan study.

    The report supports the April 2021 announcement by the U.S. Food and Drug Administration of its intention to ban menthol cigarettes and cigars nationwide. The menthol ban would not affect e-cigarettes or other flavored products. Published in Tobacco Control, the study notes that additional measures such as increasing taxes on cigarettes and cigars could further reduce smoking and related deaths.

    “This work is the culmination of a series of sequential projects aimed to assess the impact that a menthol ban could have on smoking, tobacco use and downstream health effects,” said Rafael Meza, one of the authors of the study and a professor of epidemiology at the University of Michigan’s School of Public Health. “Our findings show that a menthol ban could result in considerable health gains and highlight the urgency for final approval and implementation of the ban.”

    The study is based on the data analysis and computational modeling infrastructure that the researchers have assembled as part of the Center for the Assessment of Tobacco Regulations. Researchers used the Smoking and Vaping Model, a simulation model they had previously developed to reflect recent cigarette and vaping products and incorporated current trends in the use of menthol and nonmenthol cigarettes.

    Then, the researchers developed a scenario with a menthol ban starting in 2021, informed by expert assessment of the potential impacts, and estimated the public health impact as the difference between smoking and vaping attributable deaths and life-years lost in the current and the menthol ban scenarios, between 2021–2060.

    They found that with a menthol ban, combined menthol and nonmenthol cigarette smoking would decline by 15 percent by 2026. Deaths attributable to smoking and vaping were estimated to fall by about 5 percent and life-years lost by 8.8 percent—translating to 16,250 deaths per year averted and 11 million life-years gained (almost 300,000 per year) over a 40-year period.

    “Recent evidence finds that a menthol ban would likely increase smoking cessation, with more limited evidence of reducing smoking initiation and switching from smoking to other products like e-cigarettes,” said David Levy, professor of oncology at Georgetown University and lead author of the paper.

    The researchers said that the effects of a menthol ban will also depend on other tobacco control policies. In particular, higher cigarette taxes would reduce smoking initiation and increase cessation, and increased enforcement of age 21 purchase laws would likely reduce smoking initiation. However, a menthol ban is likely to be very effective as a standalone policy, they said.

    The work was conducted by the Center for the Assessment of Tobacco Regulations, one of nine Tobacco Centers for Regulatory Science funded by the FDA/NIH.

  • Opponents Dig in Ahead of New Products Debate

    Opponents Dig in Ahead of New Products Debate

    Photo: Prism6 Production

    Opponents and proponents of vaping are ramping up pressure as Hong Kong’s legislative council prepares to take up the Smoking (Public Health) (Amendment) Bill 2019, which aims to ban e-cigarettes and heated-tobacco products.

    According to a report in South China Morning Post, the government wants the legislative council to approve the law before the end of its session in October, and it could be in force as early as April.

    On Sept. 3, the Heated-Tobacco Concern Group released a study showing that 90 percent of 882 surveyed heated-tobacco product users would turn to traditional cigarettes in the event of a total ban. The remaining 10 percent said they would continue to use heated-tobacco products but buy them on the black market.

    But Judith Mackay, director of the Asian Consultancy on Tobacco Control, said all forms of tobacco use were harmful and no level of exposure was safe. “These new products offer a new, trendy, exciting way of using tobacco and nicotine, accompanied by appalling advertising directed at children,” Mackay said. “Once the genie is out of the bottle, it cannot be put back.”

    Lawmakers have been mulling a crackdown on alternative tobacco products since 2014, but with the city’s largest political party indicating it will back the bill, a ban now appears more likely than before.

  • Additional Products Denied Market Access

    Additional Products Denied Market Access

    Photo: chase4concept

    The U.S. Food and Drug Administration on Sept. 3 issued another round of marketing denial orders to 31 companies. “After issuing marketing denial orders (MDOs) to three companies for their flavored ENDS products last week, @FDATobacco issued MDOs to an additional 31 companies for approximately 300,000 flavored ENDS products from Aug. 27 through Sept. 2,” the agency tweeted.

    Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. The regulatory agency did not release the names of the companies.

    According to its website, the FDA plans to release the names of the companies that received MDOs. Previously, the agency gave the names only of the first three manufacturers to receive MDOs for vapor products. “FDA understands that the public may be interested in the specific names of the currently marketed products subject to the negative decisions,” the FDA wrote. “However, before releasing this information, FDA needs to ensure the agency is not releasing the applicant’s commercial confidential information. Given the large number of products involved, sharing this information requires additional time and resources. Accordingly, FDA is actively exploring options related to this issue.”

    In a release, the FDA wrote that companies receiving these MDOs may have submitted premarket applications for other products “(such as ENDS devices, tobacco-flavored ENDS or menthol-flavored ENDS),” and those products, if still pending, remain under review at FDA.

    “FDA continues to make substantial progress reviewing the unprecedented number of applications received by the Sept. 9, 2020, court-ordered deadline for submission of premarket applications for deemed new tobacco products,” the agency stated. “The aggregate information on these actions will be provided within our regular updates on the ‘Tobacco Product Applications: Metrics and Reporting’ page.”

    As of Sept. 3, the FDA website lists 27 companies that have been issued MDOs:

        Great American Vapes

        JD Nova Group LLC

        Vapor Salon

        Big Time Vapes

        J-Vapor LLC dba North Shore Vapor

        SS Vape Brands Inc. dba Monster Vape Labs

        Custom Vapors

        The Vaping Tiger

        Gothic Vapor

        TrendSetters E-liquid LLC

        SWT Global Supply

        Diamond Vapor

        American Vapor Group

        MV Enterprises

        Planet of the Vapes

        CITTG dba Orgnx E Liquids

        Vapors of Ohio Inc. dba Nostalgic Vapes

        Buckshot Vapors Inc.

        Royalty Premium E Juice

        Imperial Vapors

        Midwest Vape Supply

        Dominant Vapor

        Mountain Vaporz

        Sir Vapes -A-Lot

        Loveli Design LLC dba

        Alice in Vapeland

        Nicquid

    The first MDOs were announced on Aug. 26. According to the FDA, JD Nova Group, Great American Vapes and Vapor Salon didn’t provide adequate information to show their rejected products offered enough benefit to adult smokers sufficient to overcome the public health threat posed by the “well-documented, alarming levels” of youth use of such products.

    The FDA has received applications from over 500 companies covering more than 6.5 million tobacco products. The agency refused to file more than 4.5 million applications from the JD Nova Group alone. The agency has until Sept. 9, 2020, to decide on the remaining PMTAs.

  • Indonesia Plans Cigarette Tax Hike

    Indonesia Plans Cigarette Tax Hike

    Photo: Taco Tuinstra

    The Indonesian government is planning to raise the nation’s cigarette excise tax rates in an effort to reduce smoking prevalence, particularly among children, reports Tempo. The amount of the increase has not yet been determined.

    “If we look at the data in 2019, it (the smoking prevalence among children) was still 9.1 percent. So there’s still quite a lot to be dropped,” said Titik Anas, the Finance Ministry’s special staffer for sectoral fiscal policy.

    “The price of cigarettes in Indonesia is actually higher compared to the Philippines, Thailand and Vietnam. But if we compare it with Singapore and Malaysia, it is still relatively cheap.” Titik also warned that the government must be careful in increasing the cigarette excise tax as it will potentially spur illicit cigarette trade.

  • Filter: FDA Denies Additional 800 Products

    Filter: FDA Denies Additional 800 Products

    Photo: Boki

    The Food and Drug Administration on Aug. 31 denied the premarket tobacco product applications for 800 vaping products from three e-liquid manufacturers, according to Filter. The marketing denial orders have not been published on the agency’s website.

    Earlier in August, the FDA announced its first outright denial of 55,000 flavored vaping products from three other companies. Prior to that, the FDA refused to file 4.5 million of the 6.5 million applications sent to the agency because the company that put them together did not include appropriate environmental assessments for each product.

    All of the products rejected on Aug. 31 were flavored, and consumer advocates and manufacturers are worried that the FDA is moving toward an effective flavor ban.

    According to industry consultant Dimitris Agrafiotis, the applications he helped the three companies file were unfinished. The companies had intended to send more data piecemeal to the agency as substantial product stability testing wrapped up. Just last week, his clients drafted a letter to the FDA, stating that they would be sending further information.

    Agrafiotis said that each company he represents is now moving into the synthetic nicotine space, a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

    The FDA has until Sept. 9 to determine the legality of other vaping products, though the agency has signaled it will rule on the major players but not complete the process for everybody else by then.