Tag: FDA

  • 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.

  • 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.

    Joe Murillo, chief regulatory officer, Juul Labs

    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.

  • FDA Grants $3.9 Million to Study Effects of Flavors

    FDA Grants $3.9 Million to Study Effects of Flavors

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration has given the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on smoking behaviors of current adult smokers, according to News Medical Lifesciences.

    The study will be co-led by Theodore Wagener, director of Ohio State’s Center for Tobacco Research, and Tracy Smith from the Medical University of South Carolina Hollings Cancer Center.

    Wagener says, “the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.”

    “The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data,” Wagener said. “Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers.”

    The national, randomized, controlled trial will recruit up to 1,500 cigarette users from across the country, and researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior. Combination nicotine-replacement therapy will be used as a comparator to determine potential increased benefit of e-cigarettes versus nicotine-replacement therapy.

    “If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision-making,” Wagener said.

  • Chemular Adds Carignan as Chief Commercial Officer

    Chemular Adds Carignan as Chief Commercial Officer

    Jason Carignan

    Jason Carignan has joined Chemular, an FDA regulatory consultancy group, as its chief commercial officer.

    Carignan will lead the company’s revenue generation initiatives, strategic partnerships, and intellectual property monetization strategies across its diverse portfolio of business units, according to a press release.

    “Carignan brings a wealth of experience and expertise to Chemular, having held various leadership positions in the tobacco and nicotine industry. He most recently served as president of Phillips & King and the Total Product Expo (TPE), both part of the Kretek International Inc. family of companies,” the release states. “Prior to that, he served as president of DRYFT Sciences, overseeing the successful development of the DRYFT line of nicotine pouches before selling the company to British American Tobacco in late-2020.”

    With an impressive track record of driving growth and creating strategic alliances, Carignan is well-positioned to play a pivotal role in expanding Chemular’s market presence and further establishing the company as a leader in FDA regulatory matters.

    Kevin Burd, CEO of Chemular. said he is thrilled to welcome Carignan to the Chemular team. “His deep industry knowledge and proven leadership in revenue generation and partnership strategies will be instrumental in driving our growth and expanding our client base,” said Burd. “We believe Jason’s appointment will advance our mission of providing comprehensive regulatory solutions to our clients and partners.”

    Carignan will work closely with Chemular’s executive team to develop and execute business development strategies, identify new revenue opportunities, and forge strategic partnerships that enhance the company’s market position, according to the release.

    Carignan said he was excited to join the Chemular team.

    “Chemular has established itself as a trusted and innovative partner for clients navigating the complex landscape of FDA regulations,” Carignan said. “I look forward to leveraging my experience and expertise to drive revenue growth, establish impactful partnerships, and contribute to Chemular’s continued success.”

  • New York City Accuses Vape Distributors of Racketeering

    New York City Accuses Vape Distributors of Racketeering

    Credit: Maria Kray

    New York City has filed a lawsuit in federal court charging four vaping product distributors and six persons associated with the companies for illegally selling flavored vaping products other than tobacco in the city. It is possible more companies will be added to the suit.

    The civil lawsuit, filed Monday in the U.S. District Court for the Southern District of New York, claims the defendants violated “nearly every federal, New York State and New York City law applicable to the marketing, distribution, and sale of flavored e-cigarettes, the sales of which are prohibited under laws enacted by all three jurisdictions.”

    Named in the suit are Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. Also named were Matthew Glauser, Donald Hashagen, Russell Rogers, Nikunj Patel, Devang Koya and Nabil Hassen. The suit also mentions Puff Bar, Elf Bar and Hyde products, however, those manufacturers were not named in the suit.

    The lawsuit alleges the defendants committed mail and wire fraud, alongside violations of New York City’s Administrative Code, New York State Public Health Law, and the federal Tobacco Control Act. The city also accuses the companies of violating both the federal Racketeering Influenced Corrupt Organizations (RICO) Act and the Prevent All Cigarette Trafficking (PACT) Act.

    The suit centers on disposable flavored vapes. However, the suit alleges that is seeking relief for any type of flavored e-cigarette product on the market. This would suggest the suit could grow into anyone entity that has sold flavored vaping products in the city.

    “Although this action speaks principally about (flavored disposables), the favorite type of electronic
    nicotine delivery system among youth and the most intentionally directed to that market, the City
    seeks relief for defendants’ violation of laws applicable to e-cigarettes regardless of the type of
    device with which the violation is committed,” the suit states. “Any non-FDA approved [the FDA authorizes for marketing; it does not approve products] e-cigarette containing a flavored e-liquid is governed by the laws under which the City’s claims are brought and the City seeks relief with respect to all such devices.”

    The city says it “seeks to recover monetary damages and civil penalties from the defendants, potentially totaling millions,” according to a press release. The suit also alleges the sales of disposable flavored vapes created a youth use crisis. The suit alleges the largest increase in youth use ever. The claim is unsupported by any facts.

    “By distributing devices that provide larger than normal doses of nicotine in a mild aerosol formulated to reduce or eliminate the harshness of burning tobacco and tasting pleasantly of fruit, candy or desserts, FDV manufacturers and distributors have triggered the largest increases in youth nicotine use ever seen,” the suit claims.

    The lawsuit states the city will seek triple the damages awarded at trial under the RICO law guidelines.

  • U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    U.S. FDA Drops MDO on Myblu Menthol E-Cigarettes

    The U.S. Food and Drug Administration has issued a marketing denial order (MDO) for myblu Menthol 2.4%. Fontem US, a subsidiary of Imperial Brands, is banned from marketing or distributing the product in the United States, or they risk enforcement action by FDA.

    The company may resubmit a new application to address the deficiencies of the product subject to this MDO, according to an FDA press release.

    “Thorough scientific review of tobacco applications is a key pillar under FDA’s role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products. “This application lacked the scientific evidence needed to demonstrate that the product provided a net benefit to the public health that outweigh the known risks.”

    The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the impact of the product on the population as a whole, including benefits (i.e., complete transitioning to the product or significant reduction in combustible cigarette use among adults who smoke) and risks (e.g., initiation among youth).

    “After reviewing the company’s PMTA, FDA determined that the application lacked sufficient evidence to demonstrate that permitting the marketing of the product would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act,” the release states. “For example, among other deficiencies, the application did not present sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”

    The FDA has not authorized for sale of any flavored vaping product other than tobacco. Fontem is expected to challenge the denial order in court.

    In April of last year, The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu.

  • Ninth Circuit Denies Lotus Vaping MDO Review

    Ninth Circuit Denies Lotus Vaping MDO Review

    Entrance to United States Court of Appeals for the Ninth Circuit . Headquartered in San Francisco, California, the Ninth Circuit is by far the largest of the 13 courts of appeals. (Credit: Eric BVD)

    A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit on Friday ruled 3-0 to deny Lotus Vaping Technologies’ petition for review of a marketing denial order (MDO) for its flavored e-liquid products. The company could now ask for an en banc rehearing with all Ninth Circuit judges

    The FDA issued marketing denial orders for Lotus’ flavored products, finding that the petitioners’ applications lacked sufficient evidence showing that the flavored products would provide a benefit to adult users that outweighs the risks such products pose to youth.

    The panel held that the text of the Family Smoking Prevention and Tobacco Control Act (TCA) authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids, the judges wrote in the denial that is not considered an opinion.

    The panel also held that the FDA did not arbitrarily or capriciously deny Lotuss’ applications and that “any error the agency committed by failing to comparisons of flavored e-liquids to tobacco-flavored e-liquids.” The panel also held that the FDA did not arbitrarily or capriciously deny Lotus’ applications and that any error the agency committed by failing to consider Lotus’ marketing plans was harmless

  • FTC Drops Action Against Altria for Juul Purchase

    FTC Drops Action Against Altria for Juul Purchase

    Credit: Ascannio

    The U.S. Federal Trade Commission dismissed a complaint against NJOY parent Altria Group and e-cigarette maker Juul Labs that was brought after Altria bought a 35 percent stake in Juul Labs.

    The agency also said on Monday it would vacate an FTC administrative law judge’s decision in favor of the companies in February 2022. Since it has been vacated, it cannot be cited as precedent, the agency said in the statement announcing it was dropping the litigation.

    The FTC said in 2020 that Altria’s $12.8 billion investment violated antitrust law because the company acquired the position rather than continuing to compete against Juul in the market for closed-system e-cigarettes, according to Reuters.

    Altria had exited the stake earlier this year and had asked the FTC to drop the challenge. As of December, its share of Juul was valued at $250 million, down from $12.8 billion in 2018.

    Altria said on Monday it was pleased by the FTC dropping its complaint.

    Separate from the FTC action, Juul Labs has fought with the U.S. Food and Drug Administration over whether it could sell its Juul e-cigarettes in the United States.

    Altria’s MarkTen was at one point the second most popular e-cigarette maker, according to the FTC.

    In May, Altria said that it would pay $235 million to settle at least 6,000 lawsuit.

  • CTP Touts Progress Addressing Reagan-Udall Goals

    CTP Touts Progress Addressing Reagan-Udall Goals

    Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), published a statement summarizing the CTP’s progress in addressing the recommendations from the Reagan-Udall evaluation.

    At the request of FDA Commissioner Robert Califf, the Reagan-Udall Foundation evaluated the CTP’s operations. In December, the foundation submitted its report, which identified several problems hindering the agency’s ability to regulate the industry and reduce tobacco-related disease. Among other recommendations, the foundation urged the CTP to make process improvements and increase transparency.

    According to King, the CTP has made significant strides in putting its plans for improvement into action. The agency, he said, is on track to issue proposed goals this summer, and to release the final plan by December 2023. The CTP intends to hold a public meeting in the summer of 2023 to seek stakeholder feedback about the strategic plan.

    Meanwhile, said King, the CTP Ombuds Office is leading the creation of an operational strategy to improve transparency and information sharing across all programmatic areas, including establishing transparency liaisons. Externally, the center is planning for upcoming public meetings to gather stakeholder input. CTP also published a webpage of all the tobacco products-related citizen petitions received by the center to provide the public with information about such citizen petitions that is easy to access and user-friendly.

    According to King, the center has reviewed 99 percent of tobacco product applications submitted over the past three years, authorizing 23 tobacco-flavored e-cigarette products and devices. The CTP is planning a public meeting in fall 2023 regarding the application review process.

    Meanwhile, the center is in the process of finalizing rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.

    CTP also recently proposed new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.

    King also highlighted the CTP Office of Science leadership’s participation in conferences and external meetings. For example, representatives from the Office of Science recently presented at the Food and Drug Law Institute’s Nicotine Product Regulatory Science Symposium, the E-Cigarette Summit and the TMA annual meeting (see Todd Cecil’s TMA presentation here).

    “I am proud of the significant progress the center has made to date in addressing the external evaluation recommendations, and I am confident that we’ll continue to make important strides in continuing to build and strengthen FDA’s tobacco program in the future,” said King.

    A comprehensive list of CTP status updates for each Reagan-Udall Foundation recommendation is available here.