Author: Staff Writer

  • 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.

  • Juul Labs Seeks FDA Authorization for Juul2 System

    Juul Labs Seeks FDA Authorization for Juul2 System

    Credit: Juul Labs

    Juul Labs has submitted a premarket tobacco product application (PMTA) for its next-generation vapor platform to the U.S. Food and Drug Administration. The company says its submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18 mg/mL nicotine concentration, as well as information on novel, data-driven technologies to restrict underage access.

    “Our company DNA is product innovation,” said Chief Product Officer Kirk Phelps in a statement. “With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products. This is only the beginning of new tech being developed and refined for the U.S. market and abroad to eliminate combustible cigarettes and combat underage use.”

    Launched initially in the U.K. in 2021 as the JUUL2 System, the new vapor platform delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products and incorporates age-verification technology capabilities.

    Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization.

    According to Juul, features of the next-generation platform include:

    • A more consistent vapor experience that better competes with combustible cigarettes
    • A Bluetooth-enabled device with a larger, long-lasting battery and a “smart light system” that communicates battery life and e-liquid level to the user
    • Newly designed, tamper-resistant pods that enable improved aerosol delivery
    • An innovative heating element that improves product performance and temperature-control precision
    • A unique Pod ID chip that, among other tech capabilities, prevents the use of illicit counterfeit and compatible pods with the next-generation device
    • A mobile and web-based app that enables age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections

    Initial behavioral research of the new platform in the U.K. has demonstrated compelling adoption and switching among adult smokers. Over 32 percent of JUUL2 System users had switched completely from combustible cigarettes six months after purchasing the product. While the currently marketed Juul System has switched over 2 million adult smokers in the U.S., the company looks forward to bringing this new technology to over 28 million adult smokers in the country who continue to smoke combustible cigarettes.

    “Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization,” said Juul Chief Regulatory Officer Joe Murillo. “We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity.”

    Juul said it continues to pursue its administrative appeal of the FDA’s stayed decision for the Juul System and believes that it too will receive marketing authorization once a decision is made on science and evidence.

  • PMI to Aquire Medical Marijuana Inhaler Company

    PMI to Aquire Medical Marijuana Inhaler Company

    Syqe Inhaler (CNW Group/Syqe Medical)

    Philip Morris International plans to acquire Syqe Medical, an Israeli company, according to Calcalist. The deal could reach $650 million.

    Syqe’s main product is a metered-dose inhaler for pain reduction using medical marijuana.

    PMI will initially invest $120 million to aid in the process of obtaining U.S. Food and Drug Administration approval for Syqe’s inhaler. If approval is received, PMI will purchase all shares of Syqe for $650 million.

    PMI subsidiary Vectura will conduct the transaction.

    In 2016, PMI invested $20 million in Syqe.

  • Health Ministry in India Warns 15 for Online Sales

    Health Ministry in India Warns 15 for Online Sales

    Credit: K Kolosov

    The Union Health Ministry in New Delhi, India, has sent warnings to 15 websites for selling e-cigarettes and ordered them to stop selling and advertising the items. The websites were not announced.

    If those sites do not comply with the law, they will face legal consequences. The government has its eyes on six more websites that may also receive notices soon.

    The Ministry is monitoring online media to ensure that no one is violating the ban on e-cigarettes that was put in place in 2019.

    The notice states that “it has been discovered that your platform is displaying, broadcasting, and sharing information related to the sale of e-cigarettes, which is against the law,” according to The News Agency.

    Four websites have already acknowledged the warning and taken action, while the rest are yet to respond.

    Those who fail to do so within 36 hours may be subjected to fines as stipulated by the IT Act and/or the Electronic Cigarette Prohibition Act.

  • Retailers: More Work Needed to Curb Black Market

    Retailers: More Work Needed to Curb Black Market

    Credit: Steheap

    After New York City moved to ban flavored vape products three years ago, Sheriff Edgar Domenech says some distributors continue to sell illegal products.

    “This is organized criminal activity at the forefront,” he said.

    More needs to be done to address the sale of illegal flavored vape products in the state, according to retailers and former law enforcement officials.

    Earlier this month, New York City Mayor Eric Adams moved to sue four vape distributors he alleges are illegally targeting minors by continuing to sell the now-banned products.

    The suit against the four distributors was praised by Domench as a potential path forward for addressing the issue.

    “It’s a model that other states should basically replicate to go after these distributors who are selling counterfeit vape products that are endangering the lives of our children,” Domenech said.

    The proliferation of illegal vape products can be damaging to small businesses that are following the law, he added, according to Spectrum News.

    “Mom-and-pop operators want to do it the right way,” he said. “They are paying the tax on the tobacco products. They’re only selling a legitimate product.”

    New York Association of Convenience Stores President Kent Sopris says the lack of enforcement has hurt business owners.

    “You don’t want folks to go to another store, but you especially don’t want folks going to another store because they’re selling the illegal products you can’t sell,” he said.

    But more work is needed to address existing laws for flavored vape products in New York, Sopris said. The push comes as New York is working to crack down on the sale of unlicensed marijuana as the legal marketplace has struggled to get off the ground.

    “What it takes is some coordination,” Sopris said. “The infrastructure is there. The will, the funding and the coordination have to be provided.”

  • Jean Gonnell Joins Troutman Pepper Tobacco Team

    Jean Gonnell Joins Troutman Pepper Tobacco Team

    Jean Gonnell, a regulatory attorney with a significant focus cannabis and tobacco law, has joined Troutman Pepper’s Regulatory Investigations, Strategy and Enforcement (RISE) practice group. Resident in the firm’s Charlotte office, Gonnell joins from her private practice, Gonnell Law.

    Gonnell began her legal career in Colorado, where she was at the forefront of cannabis legislation before the larger movement to legalize the drug. Over the course of her career, she has represented more than 100 clients in the cannabis industry, including approximately 15 percent of all licensed cannabis businesses in Colorado. With a deep commitment to her clients and dedication to the flourishing cannabis field, she continues to expand her practice and make a positive impact in the evolving landscape of cannabis law.

    “Jean’s addition to the firm will deepen the expertise of the firm’s established tobacco and nicotine and cannabis law practices,” said John West, chair of the business litigation department, in a statement. “Her extensive experience will enhance the innovative solutions we provide for our existing cannabis-focused clients as well as expand the services we can offer to potential new clients in the space.”

    “With the possibility of North Carolina passing a new medical marijuana regulatory regime, the timing of Jean joining our Charlotte office could not be better,” said Jason Evans, managing partner of the Charlotte office. “We welcome her and are confident that her guidance will help to expand our reach in providing service to clients.” Gonnell is the second partner to join the Charlotte office in recent months, following the arrival of white-collar partner Matt Orso in May.

    Gonnell is licensed to practice in Arizona, Colorado and North Carolina.

    “I’m thrilled to join Troutman Pepper due to its strong regulatory presence,” said Gonnell. “I chose the firm because it allows me to maintain top client service while also giving me the network to expand my practice to new fronts. I’m excited to continue working with my clients in Colorado while also expanding my client base here in North Carolina.”

  • Study: Support with Flavors Helps Smokers Quit

    Study: Support with Flavors Helps Smokers Quit

    no smoking
    Image: Tobacco Reporter archive

    A new study has found that smokers who get help picking flavored e-cigarettes and receive supportive text messages are more likely to quit smoking, reports The Guardian.

    The study was led by London South Bank University (LSBU), and it explored in what settings vapes could help smokers quit. After three months, about 25 percent had quit and a further 13 percent reduced cigarette consumption by more than half.

    Those who received help choosing a vape flavor and got supportive texts were 55 percent more likely to quit smoking in three months.

    “Smoking kills approximately 8 million people worldwide every year, and even some of the often most effective treatments have little effect on reducing the number of smokers,” said Lynne Dawkins, professor of nicotine and tobacco studies at LSBU. “From this treatment, 24.5 percent were smoke-free after three months and a further 13 percent had reduced their cigarette consumption by more than 50 percent.

    “The simplicity of tailored support through flavor advice and supportive messages could have a huge impact in helping people lead smoke-free lives.”

    The research examined: tailored advice on which product, nicotine strength or flavor to buy; brief information on vaping harms relative to smoking; and text message support. Some people received all of these, others received none and some received some but not all.

  • Dragbar Launches B6500 Disposable Device in U.S.

    Dragbar Launches B6500 Disposable Device in U.S.

    Credit: Dragbar

    Dragbar announced it launched its latest disposable vaping device, Dragbar B6500 in the U.S. market.

    The B6500 offers a variety of juicy flavors. In order to create flavors that are more popular with American consumers, Dragbar’s senior oil blenders conducted local research in the U.S.. They introduced 20 popular flavors based on fruit to develop products that fit local tastes and cultural characteristics, according to a press release.

    The design of the mouthpiece has also been upgraded to fit the user’s lips better, using food-grade TPU soft rubber material, a more ergonomic design, allowing consumers to feel more comfortable when vaping, according to the release.

    The device also features an upgraded mesh coil “providing a rich and juicy flavor to every puff, with a highly reducible taste and an irresistible freshness,” the release states.

    During internal testing, Dragbar B6500 can support 6500 puffs at maximum. The actual number of puffs will be affected by personal vaping habits,” according to the release.