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  1. Compliance, Enforcement & Training

Manufacturing

The United States District Court has granted FDA’s request for an extension of the premarket review submission deadline for certain tobacco products, which FDA requested due to the COVID-19 pandemic. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.

FDA has compiled information and resources to assist with submission of premarket review applications.

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any "tobacco product," then you are considered a tobacco product "manufacturer." Importers of “finished tobacco products,” are regulated as tobacco product manufacturers, distributors, or both.

How Do I Comply with FDA's Tobacco Regulations?

If you are a tobacco product manufacturer, then you must, as applicable:



Additional Resources





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