Congresswoman Gwen Moore Adds Voice to Groundswell of Support for Reducing Nicotine in Cigarettes, Encourages HHS Secretary Becerra to Take Action to Save Lives and End Health Disparities - Seite 3

22nd Century’s VLN cigarettes were engineered to contain 95% less nicotine than traditional cigarettes, and VLN is the only combustible product that is in line with the FDA’s proposed nicotine cap. Numerous independent scientific studies, funded largely by the FDA, the National Institutes of Health (NIH), and other U.S. federal government agencies, have demonstrated that using reduced nicotine content tobacco cigarettes helps smokers reduce their nicotine exposure and dependence; smoke fewer cigarettes per day; increase their number of smoke-free days; and double their quit attempts – all with minimal or no evidence of nicotine withdrawal or compensatory smoking.

The Company believes that it is in the final stages of the FDA’s application process to obtain a Modified Risk Tobacco Product (MRTP) designation for VLN. The designation will allow 22nd Century to communicate key features of VLN King and VLN Menthol King, including a headline claim of “95% less nicotine.” Although it contains just 0.5 milligrams of nicotine per gram of tobacco, VLN tastes, smells, and smokes like a conventional cigarette. This disruptive product is an alternative to addictive, traditional cigarettes and will help adult smokers reduce their exposure to nicotine. 22nd Century is fully prepared and eager to launch its VLN cigarettes within 90 days of receiving authorization from the FDA and believes that an MRTP designation will serve as a catalyst for its VLN brand and tobacco franchise. The Company remains willing to licensing its technology to every cigarette manufacturer so that Big Tobacco can join in the effort to reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.

Reprint of the original letter below:

April 8, 2021

The Honorable Xavier Becerra
Secretary
U.S. Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue SW
Washington, DC 20201

Dear Secretary Becerra:

I write to request, as part of the Administration's commitment to use all available tools to combat the damage to our communities by tobacco use especially among our youth, that the Department of Health and Human Services (HHS) and Federal Drug Administration (FDA) use existing authority under the Tobacco Control Act to reduce the level of nicotine in tobacco products. Even during the current COVID pandemic, the Center for Disease Control and Prevention (CDC) continues to recognize that cigarette smoking is the leading cause of preventable disease, disability, and death in the United States. Smoking continues to kill and disable Americans because of the addictive nature of nicotine contained in tobacco products.