FDA Files MRTP Renewal Applications From 22nd Century Group Inc. and Opens Public Docket
On May 12, FDA filed two modified risk tobacco product (MRTP) renewal applications for scientific review. The applications moving to the scientific review stage were submitted by 22nd Century Group Inc. for the following products:
- VLN® King
- VLN® Menthol King
Both products are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.
In 2021, the FDA issued modified risk granted orders for these products. Such orders are valid for a fixed time period as stated in the orders; these MRTP orders expire in December 2026. To continue marketing these products with MRTP claims after the authorized time, the company submitted renewal applications to FDA.
In accordance with applicable laws, FDA has made some redacted application materials available online and will post more on a rolling basis. Any remaining application materials, including current and future amendments, will be posted to the CTP website as they are redacted until all application materials have been posted.
The Federal Register has also issued a notice opening the docket on regulations.gov to receive public comments. Starting May 13, 2026, anyone may submit research, data, or other public comments related to these MRTP applications to docket FDA-2019-N-0994 on regulations.gov.
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