22nd Century Group Highlights VLN As Only FDA-Authorized Reduced Nicotine Cigarette Compliant With Proposed Federal Standard

22nd Century VLN® products are the only combustible cigarettes authorized by the FDA as a reduced nicotine content product that comply with the FDA proposed rule

MOCKSVILLE, N.C., July 29, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction, today commented on responses provided to the U.S. Food and Drug Administration to date as part of its open comment period on the proposed new Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.

"In the United States, smoking causes more than 480,000 deaths and costs over $600 billion annually and reduces life expectancy by 10 years. The US government and our federal courts have issued countless warnings concerning nicotine, the effects of nicotine addiction, and the harms caused by smoking since the early 1950's. Implementation of the proposed FDA standard, which would require that all combusted tobacco products sold in the U.S. contain less than 0.7mg of nicotine per gram of tobacco, would directly combat the public health issues resulting from nicotine and nicotine dependence, as outlined by the American Academy of Family Physicians," said Larry Firestone, Chief Executive Officer of 22nd Century Group.

Comments published from the American Academy of Family Physicians (AAFP), which represents more than 128,300 family physicians and medical students across the country, recommend the FDA finalize the proposed mandate as the new standard, including:

• Establishing a maximum nicotine yield of 0.7 milligrams per gram of total tobacco in cigarettes and other combusted tobacco products
• Extending the standard to other forms of nicotine consumption, such as e-cigarettes and vapes, as a means to protect children and support quitting. It's letter states: "Establishing a maximum nicotine yield is a vital step towards curbing nationwide tobacco dependence."

The full comment submission can be read on the AAFP webpage found here.

"The commercial launch of our low nicotine VLN® products which include partner brand products such as Smoker Friendly VLN® and Pinnacle VLN®, demonstrate the commercial viability for cigarettes which are already compliant with the new standard. If licensed from, or produced by 22nd Century, VLN® products can be quickly produced, marketed and sold under the wide array of brands in the tobacco industry," said Larry Firestone, Chief Executive Officer of 22nd Century Group.