Tag: news

  • U.S. Congress Committee to Discuss CBD Thursday

    U.S. Congress Committee to Discuss CBD Thursday

    A U.S. congressional committee is scheduled to talk about hemp this week as lawmakers presumably will increase pressure on the U.S. Food and Drug Administration to establish guidelines to regulate the CBD market.

    A hearing set for 2 p.m. Thursday will look at “Hemp in the Modern World: The Yearslong Wait for FDA Action.”

    The House Oversight and Accountability Subcommittee on Health Care and Financial Services session is open to the public and also may be viewed online, according to Hemp Today.

    The session is also likely to address what some say is a lack of regulatory clarity and concern about the safety of synthetic delta-8 THC products.

    The oversight committee, chaired by Rep. James Comer, is investigating the FDA’s failure to regulate hemp-derived CBD products as dietary supplements.

    Lawmakers and the FDA have danced around CBD for nearly five years, with Congress repeatedly calling on the agency to set rules for the unregulated products, which emerged beginning late last decade and grew into a flourishing gray market.

    “We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction,” said Rep. Lisa McClain, who serves on the committee.

    “Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market,” McClain said.

  • Michigan Recalls THC Vapes for Banned Chemical

    Michigan Recalls THC Vapes for Banned Chemical

    The Cannabis Regulatory Agency in Michigan is recalling certain THC vape cartridges due to the possible presence of banned chemical residue exceeding the established limits, the agency announced.

    The vape cartridges — manufactured under the name “FLIGHT LIVE RESIN DISPOSABLE” — were manufactured by the Mount Morris-based marijuana processor Sky Labs near Flint and include three batches called “Grease Monkey,” “Space Ether” and “Bubblegum,” according to the Detroit Free Press.

    More than 13,000 of these vape cartridges have been sold, David Harns, a spokesperson for the CRA said, and about 2,200 of them are currently available for sale at 59 dispensaries.

    The banned chemical residues that are possibly in the products include Bifenthrin (an insecticide), Myclobutanil (a chemical used as a fungicide), Bifenazate (a pesticide), Paclobutrazol (an organic compound used as a plant growth retardant and fungicide) and Permethrin (an insecticide), he said.

  • Study Linking Vaping and Liver Disease Retracted

    Study Linking Vaping and Liver Disease Retracted

    A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research after the authors failed to reply to concerns about the researchers’ methods and findings, reports Filter.

    The retraction stated that “concerns have been raised regarding the article’s methodology, source data processing, including statistical analysis, and reliability of conclusions.” The study was published in June 2022.

    A letter was sent to the editor raising concerns, and the authors were given time to respond but failed to do so. “As is our journal and publisher’s policy, because there was no response or rebuttal from the authors, the manuscript was retracted, and the letter to the editor was not published,” said Robert Wong, editor-in-chief of Gastroenterology Research. “Typically, if there is an author response or rebuttal, we publish both the letter to the editor and the response.”

    “This is a greater problem than just one study,” said Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, noting a 2020 retraction by the Journal of the American Heart Association of a study connecting vaping to heart attacks. The 2020 retraction letter to the journal was made public, but the issue with the Gastroenterology Research paper is less clear because “there is silence around why it was retracted,” said Conley.

    It’s gratifying that the journal took the step to retract the paper. There’s just a lot of things going on with this study that make it seem kind of weird.

    Ray Niaura, epidemiology professor at New York University’s School of Global Public Health

    The 13 co-authors of the study drew from the National Health and Nutrition Examination Survey and analyzed participants’ responses for associations between liver disease and the use of cigarettes or vaping products.

    They claimed the results showed “e-cigarette users … were associated with higher odds of having liver disease compared to nonsmokers.”

    “I already have a bunch of questions just off the top of my head, basically, just looking at this paper,” said who studies tobacco dependence and treatment. He said there were issues with the data, noting that the only survey question on vaping is broad, asking “Have you ever used an e-cigarette?” Questions on combustible tobacco included “Do you now smoke cigarettes?” and if someone has smoked “at least 100 cigarettes” in their life. 

    “That’s kind of a weak variable,” Niaura said. “What does it mean? It doesn’t mean much.”

    The data also didn’t allow for analysis around timing, which means it’s not possible to tell whether liver disease was developed before or after smoking/vaping. “What’s the resolution of the information in studies like this?” Niaura asked. “It’s tricky.”

    “It’s gratifying that the journal took the step to retract the paper,” he said. “There’s just a lot of things going on with this study that make it seem kind of weird.” 

  • Bangladesh Mayors Commit to Smoke-Free Future

    Bangladesh Mayors Commit to Smoke-Free Future

    Mayors from Bangladesh’s municipalities met for a two-day summit with national and international tobacco control experts, where they pledged to aim for Prime Minister Sheikh Hasina’s vision of a tobacco-free Bangladesh by 2040, reports the Dhaka Tribune.

    The goal of the summit was to discuss implementation of tobacco control laws and local government guidelines. The country’s tobacco control law was enacted in 2005 after ratification of the World Health Organization Framework Convention on Tobacco Control. The law was amended in 2013, introducing pictorial health warnings and including smokeless tobacco. It took over three years to put the law into practice, and during that time, the health ministry drafted an amendment banning vaping products, lifting the provision of designated smoking zones to prevent secondhand smoke and controlling point-of-sale advertising. The draft is pending Cabinet approval.

    Tobacco use is not declining as expected, according to anti-tobacco activists. The latest data shows that 35.3 percent of adults ages 18 and older used tobacco in any form in 2017. Experts warn that if the trend continues, the tobacco-free goal will not be met.

    “The key is to have strong local leadership in terms of policy development, policy implementation and mobilizing funds at the local level for the prevention of tobacco use and noncommunicable diseases,” said Tara Singh Bam, regional director of The Union Asia Pacific, who spoke at the summit. “Mechanisms need to be established that ensure mayors are held accountable for safeguarding the development and implementation of public health policies from the undue influence of unhealthy commodity industries.”

    “We, the Ministry of Local Government, issued tobacco guidelines for all the municipalities and cities to assist them,” said Joint Secretary Jasim Uddin. “We have distributed these guidelines.” He noted that the mayors attending the summit are “very committed” to preventing tobacco-related diseases and deaths.

    The guidelines direct the mayors to improve tobacco control law enforcement, build public awareness, allocate funds for tobacco control and limit the availability of tobacco products.

  • BAT Launches New Vuse 800 Disposable in Korea

    BAT Launches New Vuse 800 Disposable in Korea

    BAT Rothmans, the Korean unit of BAT, debuted Vuse 800 in Korea, marking the first launch in Asia, according to The Korea Herald.

    The battery-powered e-liquid cigarette product allows up to 800 puffs without charging. There are four flavor options available.

    In the U.S., Vuse accounts for nearly half the market.

    Vuse’s U.S. market share declined from 42.2 percent to 41.8 percent, compared with Juul declining from 26.1 percent to 26 percent.

    In March of this year, Altria Group announced it had entered into an agreement to acquire Njoy Holdings for approximately $2.75 billion in cash.

    Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for IQOS. 

    A day before the Njoy announcement, Altria Group announced it had exchanged its entire investment in Juul Labs for a non-exclusive, irrevocable global license to certain of Juul’s heated tobacco intellectual property.

  • China Releases Guideline for Vaping Product Exports

    China Releases Guideline for Vaping Product Exports

    Credit: Zapp 2 Photo

    China’s State Tobacco Monopoly Administration released the Guidelines for Promoting the Building of Quality Assurance Systems for Exported Electronic Cigarette Products on July 20, according to 2Firsts, which published a translated version of the release.

    The guidelines consist of 18 articles covering the following:

    1. clarifying that enterprises are the main responsible entities for the building of quality assurance management systems for exported electronic cigarette products;
    2. specifying the main content for the building of quality assurance management systems for exported processes, allocation of production resources, the establishment of sound systems, standardization of product packaging, traceability of logistics and transportation, and export declaration and registration requirements; and
    3. specifying the requirements for the building of quality assurance management systems for exported electronic cigarette products.

    The guidelines are interpreted by the State Tobacco Monopoly Administration (STMA). The guidelines “shall be implemented” from the date of issuance, according to the STMA.

  • FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

    Credit: FDA

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on the five-year plan it developed to advance its mission.

    As part of its response to the Reagan-Udall Foundation evaluation, the CTP plan includes five proposed goal areas that are interconnected with the themes of health equity, science, transparency and stakeholder engagement.

    The proposed goals and the questions that the CTP would like commenters to address are on the agency’s virtual listening session event page.

    Following receipt and consideration of public input, the CTP intends to publish its strategic plan by the end of 2023.

    After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan.

    Request to verbally provide open public comment must be submitted by Aug. 14 at 11:59 p.m. Eastern Time.

    In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted and written comments must be postmarked by Aug. 29.

  • Lawmakers File Bills To Address FDA CBD Regulation

    Lawmakers File Bills To Address FDA CBD Regulation

    Courtesy: US FDA

    Four U.S. senators separately filed legislation on Thursday that would remove regulatory barriers that the U.S. Food and Drug Administration claims prevent it from allowing CBD sales in the food supply or as dietary supplements.

    The Hemp Access and Consumer Safety Act, which was also introduced last Congress but did not advance, would exempt “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from certain federal restrictions while permitting officials to enact labeling and packaging rules, according to media reports.

    Now lawmakers are gearing up to address FDA’s inaction at the subcommittee hearing formally.

    A congressional committee has scheduled a hearing for next week focused on the FDA’s refusal to enact regulations to allow for the marketing of hemp-derived CBD products. And bipartisan and bicameral lawmakers have separately reintroduced a bill to fill the regulatory gap.

    The House Oversight and Accountability Subcommittee on Health Care and Financial Services scheduled the hearing—titled “Hemp in the Modern World: The Years long Wait for FDA Action”—for July 27.

    Rep. James Comer, who chairs the full committee, has sharply criticized FDA after the agency announced in January that it would not be developing CBD regulations, stating that there is not an available pathway to create such rules and it would require congressional action.

    Meanwhile, Comer said in April that his panel would be launching an investigation into the matter, and he requested that the FDA turn over documents related to its decision not to regulate the cannabinoid. Even before the agency made that decision, the congressman expressed his intent to address the lack of rules.

    Jonathan Miller, general counsel to the U.S. Hemp Roundtable, will be among those testifying at the meeting, the organization announced in a press release on Thursday.

  • Call for Proposals to Improve Doctors’ Understanding of THR

    Call for Proposals to Improve Doctors’ Understanding of THR

    Image: Tobacco Reporter archive

    The Foundation for a Smoke-Free World (FSFW) has issued a call for proposals to further analyze the findings of its Sermo survey on doctors and propose programs that would help improve doctors’ fluency about smoking cessation and tobacco harm reduction (THR), according to a press release.

    The FSFW funded research carried out in 2022 by Sermo, an independent platform and leader in actionable healthcare professional insights that surveyed more than 15,000 doctors online in 11 countries, including China, Germany, Greece, India, Indonesia, Israel, Italy, Japan, South Africa, the United Kingdom and the United States. A significant majority of the surveyed doctors mistakenly attributed the negative health effects of smoking to nicotine. 

    An average of 87 percent of doctors agreed, at least moderately, that helping patients quit smoking is a priority; however, 74 percent mistakenly believe nicotine causes a range of illnesses, including lung cancer and chronic obstructive pulmonary disease (COPD).

    The misperception about nicotine could account for an average of 55 percent of the doctors recommending over-the-counter nicotine-replacement therapies to help patients reduce or quit smoking.

    “It is imperative that doctors get the proper training to learn the facts about nicotine and tobacco harm reduction options that can help their smoking patients quit,” said Muhammad Ahmed, director of health and science research at the FSFW. “With more than 7 million smokers dying annually from smoking-related diseases worldwide, many lives can be saved if doctors become more knowledgeable about the cessation tools available.” 

    “Patients look to doctors for trusted health advice,” said Jed Rose, president and CEO of Rose Research Center and co-inventor of the nicotine patch. “Therefore, it is vital that doctors provide accurate, current advice to smokers about the health risks of smoking cigarettes compared to using products that deliver nicotine without combustion.”

    The survey on doctors showed that 74 percent of doctors on average at least moderately agree that nicotine causes lung, bladder and head/neck/gastric cancer; in the United States, this figure is 70 percent; in Germany, this figure is 78 percent; in China, this figure is 86 percent; in Japan, this figure is 85 percent; 78 percent of doctors on average at least moderately agree that atherosclerosis is caused by nicotine; and 76 percent of doctors on average at least moderately agree that COPD is caused by nicotine.

    On average, 81 percent of the physicians surveyed are at least moderately interested in training focused on smoking cessation and tobacco harm reduction.

    The survey also found that while doctors’ conversations with patients who smoke focus on the health benefits of cutting down or quitting (73 percent on average globally) and the health risks of continuing (73 percent on average globally), a comparatively small number of physicians—just over half (56 percent on average globally) on average—recommend cutting down on the amount of smokable tobacco products, and less than half of doctors (48 percent on average globally) help patients develop a plan to quit.

    Researchers interested in submitting a proposal to further analyze these findings should contact support@smokefreeworld.org.

  • Smoore International Issues 2023 Profits Warning

    Smoore International Issues 2023 Profits Warning

    Smoore International Holdings issued a profit warning for the six months ended June 30, 2023.

    The company’s board of directors expects the group’s comprehensive income for the period to be between RMB717.3 million ($100.1 million) and RMB792.8 million, representing a decrease of between 42.7 percent and 48.2 percent from the income reported for the comparable period in 2022.

    The adjusted net profit will be approximately RMB741.4 million to RMB816.9 million, representing a decrease of approximately 43.1 percent to 48.4 percent from the prior-year period.

    Smoore attributed the decline to a decrease in revenue of 9.4 percent. Revenue from the Mainland China market for the period dropped approximately 96.3 percent, and its proportion to total revenue decreased from approximately 30 percent in the 2022 period to approximately 1.2 percent in the most recent six months.

    Although the revenue from Mainland China in the second quarter of 2023 has significantly increased compared with the first quarter of 2023, it is still far below the same period last year.

    During the period, the group’s revenue from overseas markets was approximately RMB5.06 billion, representing a steady growth of approximately 28 percent year-on-year. Among them, the revenue from the U.S. market was approximately RMB2.22 billion, representing a year-on-year increase of approximately 26.9 percent.

    With the strengthening of supervision and enforcement of noncompliant products, compliant products are expected to gain more room for sustainable growth in the U.S. market.

    Revenue from Europe and other markets was approximately RMB2.85 billion, representing a year-on-year increase of approximately 28.8 percent. The group launched disposable products with a better experience under the compliance framework in this market, which were well received by clients and users, and the revenue from this market continued to grow.

    The increase in revenue from overseas were insufficient to offset the declines in Mainland China.