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Tag: alternative nicotine products

  • Netherlands Calls for EU ‘Market Freeze’ on New Nicotine Products

    Netherlands Calls for EU ‘Market Freeze’ on New Nicotine Products

    Dutch Health Minister Sophie Hermans is calling on the European Commission to prevent new products containing nicotine or nicotine-like substances from entering the EU market, as part of a joint proposal with seven other member states. The countries are also seeking mandatory plain packaging for nicotine products, an EU-wide flavor ban, stricter requirements for social media platforms to remove tobacco advertising, and tighter controls on cross-border purchases.

    The initiative comes as the Netherlands prepares to further restrict domestic tobacco sales, with specialty tobacco shops set to become the only legal retail outlets for tobacco from 2032. Hermans also wants tighter rules on advertising in tobacco shops, while the Dutch regulator has raised concerns about tobacco companies providing financial support for specialty-store renovations that could promote nicotine products.

  • FDA Changes PMTA Structure

    FDA Changes PMTA Structure

    On May 8, the FDA issued updated guidance outlining its current enforcement approach for electronic nicotine delivery systems (ENDS) and nicotine pouch products without premarket authorization, emphasizing that its policies are nonbinding and reflect the agency’s current priorities. The guidance indicates that while unauthorized products remain illegal, the FDA does not intend to prioritize enforcement against products with pending and sufficiently complete applications under scientific review, allowing the agency to better allocate resources.

    The document also clarifies that enforcement will focus on products with higher public health risks, including those appealing to youth or lacking required safety features, while encouraging manufacturers to provide transparency around application status. The FDA said it will maintain a public-facing list of products under review, as part of efforts to improve visibility for stakeholders and streamline regulatory oversight.

    “For four years, nicotine pouch manufacturers, suppliers, and retailers like Nicokick.com have been patiently waiting for authorization decisions, and this guidance finally gives them the ability to stop operating in a grey area of regulation,” said Laura Leigh Oyler, Vice President of Regulatory Affairs for Nicokick.com. “For an agency that typically operates without much clarity, this is mind-blowingly clear — file a PMTA for your product that includes everything the FDA has explicitly listed they expect to see, wait 180 days, and then you can launch your product in the market. This is a ground-breaking announcement for American consumers who deserve a wealth of options as they try to leave cigarettes behind.”