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

To Comment on the 22nd Century Group Inc. MRTP Applications
You may submit comments including data, research, and other related information to docket FDA-2019-N-0994. There is currently no deadline for public comments.

Once all materials from these MRTP applications, including amendments, are posted, FDA will announce the closing date for the comment period, which will be both at least 180 days after posting the first application materials and at least 30 days from the date the last application materials are posted.

On July 19, 2019, FDA filed for substantive scientific review two Modified Risk Tobacco Product (MRTP) Applications from 22nd Century Group Inc. for VLNTM King and VLNTM Menthol King combusted, filtered cigarettes. The company describes these tobacco products as “very low nicotine content” cigarettes.

Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted or check this webpage regularly. The latest set of application materials from 22nd Century Group Inc. were added on February 12, 2020.

The following application materials have been redacted in accordance with applicable laws:

Originally Submitted Application:

We anticipate making amendments received thus far publicly available over the next several months, and amendments received in the future will be made publicly available as they are redacted.

The Tobacco Products Scientific Advisory Committee will meet on February 14, 2020, to discuss these applications and provide their recommendations to the FDA. Requests to present an oral comment at the meeting must be received by January 30, 2020. Written comments related to the TPSAC meeting must be received by February 7, 2020. More instructions on how to submit a public comment to TPSAC are in the Federal Register notice.

Temporary Compliance Waiver Notice

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.

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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