Category: U.S. FDA

  • CTP Updates Compliance Website

    CTP Updates Compliance Website

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has announced an enhancement to its website, which will more easily present information about tobacco compliance check outcomes.

    The agency noted in a statement that the database is designed to be a resource for various audiences, including the general public, public health groups and the tobacco industry.

    The new database offers the ability to search for various compliance and enforcement outcomes among brick-and-mortar and online retailers, including warning letters, civil money penalties and no-tobacco-sale orders.

    Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from the FDA’s compliance and enforcement efforts of retailers in one centralized location, according to reports.

    This centralized database will be updated monthly with the latest compliance check outcomes. “The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.

  • Top Court to Hear Triton PMTA Denial Order Suit

    Top Court to Hear Triton PMTA Denial Order Suit

    supreme court of USThe U.S. Supreme Court agreed on Tuesday to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

    The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.

    Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.

  • Swedish Match Presents to FDA on General Snus

    Swedish Match Presents to FDA on General Snus

    Image: Tobacco Reporter archive

    Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.

    The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.

    Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.

    Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.

    In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.

    “As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.

    During the meeting, representatives from Swedish Match and committee members discussed a range of scientific, technical and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented evidence and research demonstrating low levels of use by unintended populations.

    General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).

    “We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”

    The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.

    Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.

  • Durbin Decries Menthol Vape Order

    Durbin Decries Menthol Vape Order

    Senator Dick Durbin
    Credit: Dick Durbin

    When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Senator Dick Durbin was disappointed. He said the agency should have done better. The move marks the first nontobacco-flavored e-cigarette products to be authorized by the FDA.

    “Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”

    Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a committee hearing titled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use and the role that flavors—such as menthol—play in youth use of tobacco products and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.

    Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s hearing, said he applauds the FDA’s decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.

    “The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern—the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.

    “Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”

  • FDA Rescinds Juul Marketing Denial Order

    FDA Rescinds Juul Marketing Denial Order

    Photo: steheap

    The Food and Drug Administration Thursday rescinded its 2022 ban on Juul Labs’ e-cigarette products. However, the agency has not yet made a final decision on whether Juul can remain on the U.S. market. The move does open the door for Juul to receive marketing authorization from the regulatory agency.

    In 2022, the FDA ordered Juul to stop its sales, but later paused the order while the vaping company appealed. The agency announced that it would reinitiate a scientific review of Juul’s products, essentially returning them to their regulatory status before the initial ban.

    In the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA stated in a release. “Some of these court decisions establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law.”

    Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The FDA’s regulations significantly limit what the agency can disclose regarding the content of pending applications.

    Juul Labs welcomed the move. “We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products, the company wrote in a statement. “We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”

     

  • Swedish Match MRTP Comments Due July 5

    Swedish Match MRTP Comments Due July 5

    The U.S. Food and Drug Administration posted the final set of application materials related to renewing existing modified-risk tobacco product (MRTP) orders for Swedish Match U.S.A.’s General Snus products.

    The agency announced a deadline for public comments. To ensure they receive consideration by FDA, the applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024.

    The application materials, redacted in accordance with applicable laws, can be found on the FDA’s website. “Before making a final determination on an MRTP application, FDA considers all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC),” a release states.

    The FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

    Written submissions may be made to the contact person on or before June 20, 2024.

  • PMTA Filed for Njoy ACE 2.0 With Age Check

    PMTA Filed for Njoy ACE 2.0 With Age Check

    Njoy, a subsidiary of Altria, submitted a supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device.

    The new device includes access restriction technology designed to prevent underage use. This is achieved through Bluetooth connectivity, which authenticates the user before unlocking the device. The company has also re-submitted PMTAs for blueberry- and watermelon-flavored pod products, which are exclusively compatible with the Njoy ACE 2.0 device.

    “Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products,” said Njoy President and CEO Shannon Leistra in a statement. “Njoy ACE 2.0 includes critical technology features to prevent underage access to flavored Njoy products while also responsibly providing flavored options for adult smokers and vapers.”

    The Njoy ACE is the only pod-based vaping product currently with marketing authorization from the FDA. In the first quarter of 2024, Njoy announced it had broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end.

    Njoy also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space.

    “Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, senior vice president of regulatory affairs of Altria Client Services. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”

    The Njoy had previously received marketing denial orders for its blueberry (2.4% and 5% nicotine strengths) and watermelon (2.4% and 5% nicotine strengths) pods.

    Njoy believes its latest applications sufficiently address the FDA’s concerns regarding underage use by incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco-flavored vaping product.

  • FDA Denies Marketing of Flavored Blu Products

    FDA Denies Marketing of Flavored Blu Products

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem U.S. for four Blu disposable products and one MyBlu e-cigarette product.

    The denied products include a closed menthol e-liquid and several flavored disposable e-cigarettes. As a result, the company may not legally market or distribute these products in the United States. However, the company may submit new applications for the products that are subject to these MDOs.

    The products that received MDOs are Blu Disposable Menthol 2.4 percent; Blu Disposable Vanilla 2.4 percent; Blu Disposable Polar Mint 2.4 percent; Blu Disposable Cherry 2.4 percent; and MyBlu Menthol 1.2 percent.

    After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. 

    More specifically, the FDA said the application lacked sufficient evidence regarding harmful and potentially harmful ingredients in the aerosol for one product and battery safety for several products. Additionally, the applicant did not present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth, according to the agency.

  • FDA Warns More Sellers of Flavored Vapes

    FDA Warns More Sellers of Flavored Vapes

    The U.S. Food and Drug Administration has again issued warning letters to several small business owners for selling flavored disposable vaping products.

    The regulatory agency issued letters to 14 online businesses for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products marketed under brand names, including Elf Bar/EB Design, Lava Plus, Funky Republic/Funky Lands, Lost Mary, Cali Bars, Cali Plus, and Kangvape.

    “These warning letters were informed by FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, an agency press release states. “Findings from the 2023 National Youth Tobacco Survey found that more than 50 percent of youth who use e-cigarettes reported using the disposable e-cigarette brand Elf Bar; in 2023, the manufacturer of Elf Bar began marketing the product under the name EB Design.”

    In addition, the brands Lava Plus, Funky Republic/Funky Lands, Kangvape, Cali, and Breeze were identified as popular or youth-appealing by the agency following a review of retail sales data and emerging internal data from a survey among youth, according to the agency.

    Retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack marketing authorization from the FDA violate the Federal Food, Drug, and Cosmetic Act.

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

    As of Jan. 30, 2024, FDA issued more than 440 warning letters and 88 CMPs to retailers for the sale of illegal e-cigarettes, including through a series of nationwide inspection efforts of brick-and-mortar retailers, according to the release.

    Earlier this week, the FDA issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.

    In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency now seeks the maximum penalty of $20,678 from each retailer.

  • Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor Appeals MDO of Tobacco Bidi Stick

    Bidi Vapor will appeal the U.S. Food and Drug Administration’s January 2024 decision to deny the company’s premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick electronic nicotine-delivery system.

    Bidi Vapor has asked the U.S. Court of Appeals for the 11th Circuit to review the marketing denial order (MDO), which Bidi Vapor believes violates the Administrative Procedure Act. Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.

    “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Bidi Vapor founder and CEO Niraj Patel in a statement. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”

    With its recent legal challenge, Bidi Vapor hopes to build on its record of successfully contesting adverse FDA decisions. In August 2022, the 11th Circuit set aside the original MDOs issued for its 10 nontobacco-flavored products. That ruling put the 10 PMTAs back into scientific review and allowed those flavors to remain available for sale pursuant to the FDA’s compliance policy for deemed tobacco products. During this evaluation period, the 10 nontobacco-flavored products are still under FDA enforcement discretion.