Tag: Myblu

  • FDA Denies Marketing of Myblu Menthol

    FDA Denies Marketing of Myblu Menthol

    Image: Tobacco Reporter archive

    The U.S. Food and Drug Administration on July 10 issued a marketing denial order (MDO) for Myblu Menthol 2.4 percent, an e-cigarette product made by Fontem US. The order prohibits the company from marketing or distributing this product in the United States.

    “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 outweighs the known risks.”

    Among other shortcomings, the application presented insufficient scientific evidence to show that the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes, according to the FDA.

    Fontem US may resubmit a new application to address the deficiencies for the product subject to this MDO.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. Last year, the FDA issued MDOs to Fontem US for several other Myblu products, which are the subject of ongoing litigation.

  • 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.

  • Court Refuses to Suspend Fontem MDO

    Court Refuses to Suspend Fontem MDO

    A U.S. appeals court denied Fontem US’ request to suspend the Food and Drug Administration’s marketing denial orders (MDO) for certain Myblu products.

    On April 8, the FDA rejected several of the company’s premarket tobacco product applications on the basis that they lacked sufficient evidence to show that permitting the marketing of those products would be appropriate for the protection of public health.

    The court rejected Fontem’s July 12 request for a stay, saying that the e-cigarette company had waited too long to file the motion.

    “Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote.

    The court also stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO on merits.

    “The court ruling does not affect our progress through the FDA’s administrative appeals process, through which we intend to convince the agency that approval should be granted for Myblu products,” said a spokesperson for Fontem US.

    “In the meantime we continue to supply Myblu to the majority of retailers. The MDO does not apply to Blu disposables which constitute 50 percent of Blu share in the U.S. market.”

  • FDA Denies Market Access to Myblu

    FDA Denies Market Access to Myblu

    Photo: Alex Kalmbach

    The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem US for several Myblu electronic nicotine delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health.

    According to a notice published on the FDA’s website, the currently marketed products receiving MDOs include Myblu Device Kit, Myblu Intense Tobacco Chill 2.5% and Myblu Intense Tobacco Chill 4.0%.

    In reviewing premarket applications for tobacco products, the FDA evaluates the risks and benefits of those products to the population as a whole, including users and nonusers of the tobacco product, and considers, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.

    Based on the information submitted by Fontem US for these Myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the FDA. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, the agency said.

    Tobacco products subject to an MDO may not be offered for sale, distributed or marketed in the U.S.