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22nd Century Group Inc. Modified Risk Tobacco Product (MRTP) Applications

On December 23, 2021, FDA issued exposure modification orders to 22nd Century Group Inc. for VLN® King and VLN® Menthol King combusted, filtered cigarettes. The orders specifically authorize the manufacturer to market these products with certain reduced exposure claims regarding nicotine.

See the Modified Risk Granted Orders webpage for order letters and decision summaries relevant to these actions.

Please sign up to receive email alerts when any MRTP application materials are made publicly available or check this webpage regularly. The latest set of application materials from 22nd Century Group Inc. were updated on February 22, 2021.

The application materials below have been redacted in accordance with applicable laws.

Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.

Originally Submitted Application:

Note: The FDA is required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make MRTP applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications.

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