UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 1, 2025

22nd Century Group, Inc.

(Exact Name of Registrant as Specified in Charter)

Registrant’s telephone number, including area code: (716) 270-1523

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities Registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 1.01 Entry into a Material Definitive Agreement.

On January 1, 2025, 22nd Century Group, Inc. (the “Company”) entered into a Master Services Agreement and Addendum #1 (collectively, the “Agreement’) with Smoker Friendly International, LLC (“SF”). Pursuant to the Agreement, the Company will be the exclusive licensee and manufacturer of SF’s cigarette brands for a period of five years. The Agreement includes 11 SF brands currently sold in the Smoker Friendly network of retail stores and dealers in the United States, plus another eight new SF brands. The Agreement also allows the parties to add other tobacco products to the Agreement via addendum including filtered cigars and reduced nicotine content cigarettes. The Company will pay SF a royalty for each carton of cigarettes manufactured and sold to distributors.

The Company and SF were previously parties to a Private Label Manufacturing Agreement that was set to expire.

The foregoing summary of the terms of the Agreement is subject to, and qualified in its entirety by, the Agreement, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K.

Item 7.01 Regulation FD Disclosure.

On January 7, 2025, the Company issued a press release regarding the Agreement with Smoker Friendly, which press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this item (including the exhibit) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of Section 18, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent, if any, expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.