Tag: RAI

  • RJ Reynolds Wants Enforcement of Disposables

    RJ Reynolds Wants Enforcement of Disposables

    Credit: Casimiro

    RAI Services Company submitted a citizen petition asking the U.S. Food and Drug Administration to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine delivery system” (ENDS) products.

    The petition was filed on Feb. 6 and posted by the FDA to Regulations.gov for public comment on Feb. 8.

    RAI Services and R.J. Reynolds Vapor Company, the maker of Vuse e-cigarettes, are owned by BAT. Vuse is the most popular brand in the c-store segment, according to Neilsen data.

    “As the Agency well knows, use of ENDS products in the United States has shifted to disposable products. And a new enforcement policy, one that is specifically directed at these disposables that are on the market illegally, is needed to better protect public health,” the petition states.

    Reynolds requested that the FDA prioritize enforcement for:

    • Any flavored disposable ENDS (except for tobacco- or menthol-flavored products);
    • Any disposable ENDS containing nicotine derived from any source other than tobacco that lacks premarket authorization;
    • Any disposable ENDS containing nicotine derived from tobacco that was not on the market as of August 8, 2016, or for which the manufacturer either failed to submit an application by September 9, 2020, or submitted a PMTA to FDA by that deadline, but received a negative action that is not being challenged in court;
    • Any disposable ENDS for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
    • Any disposable ENDS targeted to, or whose marketing is likely to promote use by, minors.

    Reynolds does not sell disposable vapes or vaping products in flavors other than tobacco or menthol. The U.S. Court of Appeals for the Fifth Circuit granted an administrative stay of an FDA marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.

    “Such a policy,” writes Reynolds regarding its desired enforcement priorities, “will close an existing loophole in FDA’s current tobacco enforcement efforts, especially when it comes to youth.”

  • 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.