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Tag: Blu

  • FDA Denies Marketing for blu Disposable E-Cigarette

    FDA Denies Marketing for blu Disposable E-Cigarette

    Today (August 19), the U.S. Food and Drug Administration (FDA) issued a Marketing Denial Order (MDO) for Fontem US, LLC’s blu Disposable Classic Tobacco 2.4% e-cigarette, prohibiting its marketing or sale in the United States. The decision bars the product due to insufficient evidence that it would help adult smokers quit cigarettes—and raises concerns about dual use increasing overall toxicant exposure. FDA emphasized that only e-cigarettes supported by robust evidence showing reduced harm or smoking cessation benefits have been granted market authorization.

    “While FDA-authorized e-cigarettes are a lower-risk alternative for adults who smoke cigarettes – especially if they completely switch – not all e-cigarettes are equal,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “FDA’s rigorous scientific review ensures authorized e-cigarettes provide a net benefit to public health.

    “In this case, the company did not provide sufficient evidence of a benefit that outweighs the risk, particularly given evidence that adults who smoke generally do not stop or significantly curtail consumption of cigarettes when using this product.”

    Tobacco products that receive an MDO from the FDA may not be introduced or delivered for introduction into interstate commerce and must be removed from the market. Manufacturers, distributors, and retailers who sell or distribute this product in interstate commerce are violating the law and are at risk of enforcement action. The company may submit a new application for the product subject to this MDO.

    Industry observers interpret today’s decision as part of an increasingly stringent FDA posture, where even incumbent market players face rejection unless they clearly demonstrate both consumer and public health benefits. FDA-authorized products to date are limited to those with compelling evidence, and remain largely within tobacco-flavored, closed-system formats

    Fontem joins smaller U.S.-based e-cigarette companies ECS Global, Texas Select Vapor, Fumizer, and American Vapor Inc. that received MDOs in the last month.

    See the FDA’s notification.

  • blu Vapes Help Smokers Cut Down, New Studies Find

    blu Vapes Help Smokers Cut Down, New Studies Find

    New research from Imperial Brands shows that its vape product, blu, is helping adult smokers reduce or quit smoking—even among those who had no plans to stop.

    Two behavioral studies tracked smokers who started using blu and found cigarette use dropped by nearly 30% within a week. At a six-month follow-up, up to 40% had significantly reduced or stopped smoking altogether. Flavors played a key role in the switch, with nearly 29% of users preferring fruit flavors, and 60% saying they’d keep using blu because of the flavor options.

    “This is potentially very positive news for public health,” said Elizabeth Clarke, Imperial’s Scientific Substantiation Lead.

    The findings will be presented at the Global Forum on Nicotine 2025 in Warsaw this week and submitted for academic publication later this year.

  • 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 Denies Marketing of Suorin, Blu Plus+

    FDA Denies Marketing of Suorin, Blu Plus+

    The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products. It also issued Fontem US, LLC MDOs for its Blu PLUS+ brand e-cigarette products.

    “Thorough scientific review of tobacco products applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It is the applicant’s responsibility to ensure that sufficient scientific evidence is included in an application to meet the necessary public health standard required by law. In these cases, such evidence was lacking.”

    The companies must not market or distribute these products in the United States or they risk FDA enforcement action. The companies may submit new applications for the products that are subject to these MDOs, according to an agency press release.

    The FDA denied Suorin Air refillable vaporizers in various colors and an empty refillable cartridge. The FDA stated that Suorin Air’s empty cartridges would allow consumers to fill the cartridge with an e-liquid purchased separately.

    “The applications submitted by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence regarding abuse liability, which is the ability of a tobacco product to promote continued use and the development of addiction and dependence,” the release states.

    SMOK recently had 22 products denied, including devices, pods, atomizers, and cartridges. It was the first time the agency has denied strictly hardware products from one company en mass. The products were denied because they were submitted without a specific e-liquid to be used with the devices, according to the FDA. 

    The denied Blu PLUS+ products include a battery and several prefilled e-liquid pods:   

    • blu PLUS+ Battery  
    • blu PLUS+ Carolina Bold 2.0%  
    • blu PLUS+ Classic Tobacco 1.2%  
    • blu PLUS+ Classic Tobacco 2.4%  
    • blu PLUS+ Gold Leaf 1.2%  
    • blu PLUS+ Gold Leaf 2.4%  
    • blu PLUS+ Menthol 1.2%  
    • blu PLUS+ Menthol 2.4%

    “Among other deficiencies in their applications, Fontem US, LLC failed to include sufficient ingredient information, harmful and potentially harmful constituent (HPHC) yield quantities, and abuse liability information.,” the FDA stated. “In addition, the applicant did not provide sufficient evidence demonstrating that the flavored 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.

    The FDA also issued MDOs for additional blu PLUS+ products not listed above. The regulatory only publicly names products that the FDA or the manufacturer has confirmed to be currently marketed to avoid the release of confidential commercial information.

  • Imperial Launches Blu 2.0 in U.K.

    Imperial Launches Blu 2.0 in U.K.

    Photo: Imperial Brands

    Imperial Brands has launched Blu 2.0, a new vaping device that replaces its existing Myblu system, in the U.K., reports The Grocer.

    According to Imperial Brands, the new product offers a smoother and richer vaping experience due to its ceramic heating pod technology, which replaces the previously used cotton wick option. It also features a longer-lasting battery and bigger 1.9 mL volume liquid pods.

    The new device also comes with a magnetic lock feature and “power tap,” which enables users to easily check the battery level.

    Imperial has also launched a new range of six flavored liquids for use with the system: Golden Tobacco, Polar Menthol, Fresh Mint, Berry Mix, Blueberry Ice and Fresh Mango. All come in 9 mg and 18 mg nicotine strength variants.

    “Through the launch of Blu 2.0, we’ve developed a product that looks better, tastes better and lasts longer than before to provide consumers with the next-generation vape product they’re looking for,” said Tom Gully, Imperial Tobacco’s head of consumer marketing for the U.K. and Ireland.