Tag: warning letters

  • FDA Sends More Warnings                                              

    FDA Sends More Warnings                                              

    Image: Mucahiddin

    The U.S. Food and Drug Administration sent warning letters to seven online retailers for selling unauthorized e-cigarette products. The warning letters cite the sale of popular and youth-appealing disposable e-cigarette products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava.

    These warning letters were informed by the FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, according to the agency. Findings released last week from the 2023 National Youth Tobacco Survey found that more than half of current youth e-cigarette users reported using the disposable e-cigarette brand Elf Bar; earlier this year, the manufacturer of Elf Bar began marketing the product under the name EB Design. In addition, the brands Bang, Cali Bars and Lava were identified as popular or youth appealing by the agency following review of retail sales data and emerging internal data from a survey among youth.

    “FDA’s robust surveillance of the e-cigarette landscape helps us to identify youth-appealing products and to act quickly to protect public health,” said Brian King, director of FDA’s Center for Tobacco Products. “The goal is to identify, prevent and reduce these risks to our nation’s youth before they escalate further.”

    The retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack authorization from the FDA in violation of the Federal Food, Drug and Cosmetic Act. Warning letter recipients are given 15 working days to respond with the steps they’ll 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.

    To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. For retailers looking for information on which e-cigarettes are legal to sell, the FDA created a printable, one-page flyer of these authorized products. This information is also available on the FDA’s website.

  • FDA Sends More Warning Letters

    FDA Sends More Warning Letters

    Image: theerakit

    On Sept. 14, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. 

    According to the FDA, the youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the agency to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.

    “Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, director of the FDA’s Center for Tobacco Products. “They’re a critical component of our comprehensive surveillance toolbox, so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”