22nd Century Group, Inc.
22nd Century Group Calls on HHS Secretary Kennedy, Acting FDA Commissioner Diamantas and CTP Director Koplow to Enact and Implement the Reduced Nicotine Content Standard
Administration's Reported Move to Accelerate Vape and Nicotine Pouch Authorizations Addresses Only Part of the Continuum of Risk
MOCKSVILLE, N.C., Sept. 24, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company focused on reducing the harms of smoking through nicotine reduction, today called on political leaders and the U.S. Food and Drug Administration ("FDA") to enact and implement the proposed "Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products," 90 Fed. Reg. 5032 (Jan. 16, 2025) ("Proposed Rule"), which remains pending more than eight years after the FDA first announced its intent to act and more than a year after the public comment period closed.
The Company's call follows a Wall Street Journal report published Wednesday that the Trump administration plans to change federal rules to speed the authorization of tobacco products such as flavored vapes and nicotine pouches, with the FDA expected to announce in coming days that it will revisit the 2021 rule governing premarket review of new tobacco product applications ("U.S. Regulators Plan Major Move to Speed Authorizations of Vapes, Tobacco Pouches," WSJ, Sept. 23, 2026). 22nd Century supports those efforts and believes they represent only one component of a comprehensive continuum-of-risk strategy to address the harms of tobacco.
The Proposed Rule would establish a maximum nicotine level of 0.70 milligrams per gram of total tobacco in cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars and pipe tobacco, a level low enough to no longer create or sustain addiction. The FDA first issued an advance notice of proposed rulemaking on the subject on March 16, 2018 (83 Fed. Reg. 11818). The Proposed Rule was issued on January 15, 2025, and the comment period closed on September 15, 2025. To date, there is no final rule, no published timeline and no public update from the agency.
What 22nd Century Is Asking Of Federal Policymakers
HHS Secretary Kennedy: Direct FDA to prioritize the pending standard, consistent with your stated commitment to tobacco harm reduction and to delivering results for the American people.
Acting FDA Commissioner Diamantas: Place the rule back on the FDA's entry into the Unified Agenda and establish a clear timeline for transmitting a final rule.
CTP Director Koplow: Convene the Tobacco Products Scientific Advisory Committee (TPSAC) to review the standard, as FDA stated it intended to do, and complete that step publicly.
The Trump Administration: Clear interagency and OMB review rather than allowing the rule to remain undecided and apply the same acceleration to combusted products that it is applying to non-combusted alternatives and to make mandatory that all retailers that sell combustible cigarettes immediately make available, space on their shelves to carry VLNC products.
Congress: Members of the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee, from both parties, should request a status update from FDA and hold the agency to the 180-day review framework Congress established in the Tobacco Control Act of 2009. Senators who have consistently championed tobacco policy, including Senators Durbin and Merkley, have pressed the agency on the youth implications of its recent flavor decisions; that same scrutiny should extend to finishing a standard FDA itself projects would prevent 48 million young Americans from starting to smoke.