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

FDA previously issued modified risk granted orders (MRGOs) in December 2021 authorizing 22nd Century Group Inc. to market the following products as modified risk tobacco products (MRTP):

  • VLN® King
  • VLN® Menthol King

The exposure modification orders specifically authorized the manufacturer to market these products with certain reduced exposure claims regarding nicotine, including:

  • “95% less nicotine.”
  • “Helps reduce your nicotine consumption.”
  • “...Greatly reduces your nicotine consumption.”

When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, “Helps you smoke less.” FDA also recommended that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”

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

On May 12, 2026, FDA filed for scientific review MRTP renewal applications submitted by 22nd Century Group Inc. for VLN® King and VLN® Menthol King.

The original modified risk granted orders issued in 2021 are valid for the fixed time period specified in the order. To continue marketing an MRTP after the term of an order, the company may submit an MRTP renewal application for FDA to determine that the product still satisfies the requirements in section 911 of the Federal Food, Drug, and Cosmetic Act. Renewal applications may cross-reference an applicant’s original MRTP application as well as postmarket annual reports submitted in accordance with marketing order requirements for both the premarket tobacco application (PMTA) and MRTP application. Annual reports for MRTPs contain the cumulative results from the postmarket surveillance and studies that all companies are required to conduct as part of a modified risk granted order.

Starting on May 13, 2026, public comments on these MRTP renewal applications may be submitted on regulations.gov to docket number FDA-2019-N-0994. Currently, there is no deadline for public comments. Once all materials from these MRTP renewal applications are posted, FDA will announce the closing date for the comment period. 

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 May 12, 2026.

Materials and Related Documents

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.

VLN® King and VLN® Menthol King – MRTP Renewal Applications

Part 1 Executive Summary (PDF – 2.9 MB) – posted July 19, 2019

Part 2 Published Literature (zip – 1 MB) posted August 28, 2019

Part 3 IND Reports (zip – 330 MB) posted August 28, 2019

Part 1 Descriptive Information (zip – 3.2 MB) updated February 22, 2021

Part 2 Clinical Reports (zip – 55 MB) posted August 28, 2019

Part 3 Published Literature (zip – 13 MB) posted August 28, 2019

Part 4 U.S. Government Publications (zip – 195 KB) posted August 28, 2019

Part 1 Labels (zip – 33 MB) posted August 28, 2019

Part 2 Consumer Perception (zip – 6.7 MB) posted August 28, 2019

Part 3 U.S. Government Publications (zip – 2.6 MB) posted August 28, 2019

Part 2 U.S. Government Publications (zip – 2.7 MB) posted August 28, 2019

Part 3 Public Interest Group Publication (zip – 343 KB) posted August 28, 2019

Part 1 Summary of All Research Findings (zip – 343 KB) posted August 28, 2019

Part 2 Clinical Reports (zip – 370 MB) posted August 28, 2019

Part 3 Consumer Perception Reports (zip – 6.9 MB) updated November 21, 2019

Part 4 Population Modeling Reports (zip – 2.8 MB) posted August 28, 2019

Part 5 Published Literature (zip – 343 KB) posted August 28, 2019

Part 6 U.S. Government Publications (zip – 15 MB) posted August 28, 2019

Part 1 Scientific Studies Analyses - Background Product Analysis (zip – 4.6 MB) updated October 26, 2020

Part 2 Scientific Studies - Non-Clinical (zip – 11 MB) posted October 1, 2019

Part 3 Scientific Studies - Population Modeling (zip – 8 MB) posted October 1, 2019

Part 4.1 Scientific Studies - Clinical (zip – 12 MB) posted November 19, 2019

Part 4.2 Scientific Studies - Clinical (zip – 5 MB) posted November 19, 2019

Part 4.3 Scientific Studies - Clinical (zip – 523 MB) posted November 19, 2019

Part 4.4 Scientific Studies - Clinical (zip – 651 MB) posted November 19, 2019

Part 4.5 Scientific Studies - Clinical (zip – 279 MB) posted November 19, 2019

Part 4.6 Scientific Studies - Clinical (zip – 224 MB) posted November 19, 2019

Part 4.7 Scientific Studies - Clinical (zip – 225 MB) posted November 19, 2019

Part 4.8 Scientific Studies - Clinical (zip – 224 MB) posted November 19, 2019

Part 4.9 Scientific Studies - Clinical (zip – 256 MB) posted November 19, 2019

Part 4.10 Scientific Studies - Clinical (zip – 234 MB) posted November 19, 2019

Part 4.11 Scientific Studies - Clinical (zip – 217 MB) posted November 19, 2019

Part 4.12 Scientific Studies - Clinical (zip – 200 MB) posted November 19, 2019

Part 4.13 Scientific Studies - Clinical (zip – 95 MB) posted November 19, 2019

Part 4.14 Scientific Studies - Clinical (zip – 6 MB) posted November 19, 2019

Part 4.15 Scientific Studies - Clinical (zip – 1.5 MB) posted November 19, 2019

Part 4.16 Scientific Studies - Clinical (zip – 4 MB) posted November 19, 2019

Part 5.1 Scientific Studies - Consumer Perception (zip – 4 MB) posted November 19, 2019

Part 5.2 Scientific Studies - Consumer Perception (zip – 14 MB) posted November 19, 2019

Part 5.3 Scientific Studies - Consumer Perception (zip – 41 MB) posted November 19, 2019

Part 5.4 Scientific Studies - Consumer Perception (zip – 67 MB) posted November 19, 2019

Part 5.5 Scientific Studies - Consumer Perception (zip – 344 MB) posted November 19, 2019

Part 5.6 Scientific Studies - Consumer Perception (zip – 330 MB) posted November 19, 2019

Part 5.7 Scientific Studies - Consumer Perception (zip – 299 MB) posted November 19, 2019

Part 5.8 Scientific Studies - Consumer Perception (zip – 3 MB) posted November 19, 2019

Part 5.9 Scientific Studies - Consumer Perception (zip – 566 MB) posted November 19, 2019

Part 5.10 Scientific Studies - Consumer Perception (zip – 286 MB) posted November 19, 2019

Part 5.11 Scientific Studies - Consumer Perception (zip – 670 MB) posted November 19, 2019

Part 5.12 Scientific Studies - Consumer Perception (zip – 7.5 MB) posted November 19, 2019

Part 5.13 Scientific Studies - Consumer Perception (zip – 252 MB) posted November 19, 2019

Part 5.14 Scientific Studies - Consumer Perception (zip – 74 MB) posted November 19, 2019

Part 5.15 Scientific Studies - Consumer Perception (zip – 319 MB) posted November 19, 2019

Part 5.16 Scientific Studies - Consumer Perception (zip – 108 MB) posted November 19, 2019

Part 5.17 Scientific Studies - Consumer Perception (zip – 261 MB) posted November 19, 2019

Part 5.18 Scientific Studies - Consumer Perception (zip – 45 MB) posted November 19, 2019

Part 5.19 Scientific Studies - Consumer Perception (zip – 290 MB) posted November 19, 2019

Part 5.20 Scientific Studies - Consumer Perception (zip – 100 MB) posted November 19, 2019

Part 5.21 Scientific Studies - Consumer Perception (zip – 256 MB) posted November 19, 2019

Part 5.22 Scientific Studies - Consumer Perception (zip – 47 MB) posted November 19, 2019

Part 5.23 Scientific Studies - Consumer Perception (zip – 292 MB) posted November 19, 2019

Part 5.24 Scientific Studies - Consumer Perception (zip – 93 MB) posted November 19, 2019

Part 5.25 Scientific Studies - Consumer Perception (zip – 233 KB) posted November 19, 2019

Part 5.26 Scientific Studies - Consumer Perception (zip – 335 KB) posted November 19, 2019

Part 5.27 Scientific Studies - Consumer Perception (zip – 342 KB) posted November 19, 2019

Part 5.28 Scientific Studies - Consumer Perception (zip – 256 KB) posted November 19, 2019

Part 5.29 Scientific Studies - Consumer Perception (zip – 26 MB) posted November 19, 2019

Part 5.30 Scientific Studies - Consumer Perception (zip – 3.7 MB) posted November 19, 2019

Part 5.31 Scientific Studies - Consumer Perception (zip – 163 MB) posted November 19, 2019

Part 1 - All Documents Related to Research Findings (zip – 72 MB) updated October 26, 2020

Part 2 - All Documents Related to Research Findings  (zip – 43 MB) updated October 26, 2020

Part 3 - All Documents Related to Research Findings  (zip – 106 MB) posted October 26, 2020

Part 4 - All Documents Related to Research Findings  (zip – 197 MB) posted October 26, 2020

Part 5 - All Documents Related to Research Findings  (zip – 217 MB) posted October 26, 2020

Part 1 Section X Postmarket Surveillance Program (zip – 229 KB) posted October 29, 2019
Part 2 Clinical Study (zip – 12 MB) posted October 29, 2019
Part 3 Published Literature (zip – 4 MB) posted October 29, 2019
Part 4 Government and Public Interest Group Publications (zip – 31 MB) posted October 29, 2019

March 10, 2020 Amendment:  Correction to Tables VI.F-1, VI.G-1 and VI.G-2 in Section VI. Environmental Assessment (zip – 263 KB) posted April 8, 2020
March 2, 2020 Amendment: Submission of Tabular Index of Referenced Citations (zip – 150 KB) posted March 16, 2020
September 13, 2019 Amendment: Response to September 9, 2019, FDA Information Request (zip – 3 MB) posted January 28, 2020
August 28, 2019 Amendment: Response to August 26, 2019, FDA Information Request (zip – 1.5 MB) posted October 29, 2019
August 7, 2019 Amendment: Response to August 2, 2019, FDA Information Request (zip – 18 MB) posted December 23, 2019
July 18, 2019 Amendment: Submission of 6-week Clinical Study Part One (zip – 81 MB) posted December 23, 2019
July 18, 2019 Amendment: Submission of 6-week Clinical Study Part Two (zip – 7 MB) posted December 23, 2019
June 25, 2019 Amendment: Submission of 12-month Storage Stability and Water Activity Study Results (zip – 7 MB) posted October 29, 2019
May 23, 2019 Amendment: Update to Section V. Labels, Labeling, and Advertising (zip – 800 MB) posted October 29, 2019

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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