Tag: regulation

  • U.S. FDA Sends 10 Warning Letters for Targeting Youth

    U.S. FDA Sends 10 Warning Letters for Targeting Youth

    Today, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.

    The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.

    Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.

    “The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Even in the midst of the COVID-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”

    The following retailers and/or manufacturers or importers received a warning letter:

    • Vaprwear Gear, LLC (manufacturer, online retailer)
    • Vapewear, LLC (manufacturer, online retailer)
    • Wizman Limited (manufacturer, online retailer)
    • EightCig, LLC (online retailer)
    • Ejuicepack, LLC (online retailer)
    • Vape Royalty, LLC (online retailer)
    • VapeCentric, Inc. (online retailer)
    • Dukhan Store (online retailer)
    • VapeSourcing (online retailer)
    • Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer)

    The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.

  • RAI Files 2 New PMTAs for Vuse Products

    RAI Files 2 New PMTAs for Vuse Products

    Reynolds American Inc. (RAI) has submitted two new premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). RAI is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapor products, which would allow these products to remain on the market after the FDA’s deadline for PMTAs for electronic nicotine-delivery systems.

    The applications include a range of scientific studies for Vuse Vibe and Vuse Ciro using well-known methodologies, including the comparative assessment of cigarettes and associated health risks. Though the PMTAs themselves are considered commercially proprietary and are thus confidential, the data and information submitted to the FDA include the results of product analyses, nonclinical health risk information and human health and population information, including the impact to both users and nonusers of tobacco products.

    According to RAI, the results of these studies demonstrate that the continued marketing of the Vuse Vibe and Vuse Ciro products is appropriate for the protection of the public health. The FDA s expected to extend the PMTA deadline to from May 12 to Sept. 9.

    “I am incredibly proud of our diverse team of scientists, researchers and regulatory experts, who have worked tirelessly together to complete these applications well ahead of the FDA’s May deadline for ENDS products,” noted Reynolds’ executive vice president and head of scientific and regulatory affairs, James Figlar.

    The PMTAs for Vuse Vibe and Vuse Ciro are the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019.