The FDA has proposed mandatory registration and product listing for all foreign tobacco manufacturers to match domestic requirements.
The rule targets e-cigarette supply chain transparency by requiring disclosure of nicotine levels, flavors, and device technical specifications.
Foreign manufacturers must register and provide annual updates to help the FDA facilitate international site inspections.
The public comment period for Docket No. FDA-2025-N-7130 is open until September 14, 2026, on the Regulations.gov website.