Today, the U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them. These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.

“Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.” 

The exposure modification orders specifically authorize the manufacturer to market “VLN King” and “VLN Menthol King” 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.” The FDA also recommends that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.” The manufacturer is also required to label the packages with one of four warning statements for cigarettes as required by the Federal Cigarette Labeling and Advertising Act; for example, “Surgeon General’s Warning: Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.”

Despite today’s action, these products are not considered safe or “FDA approved.” There are no safe tobacco products, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product. The exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers. These orders do not allow the company to market these products with therapeutic or cessation claims.

In the review of 22nd Century Group, Inc.’s MRTP applications, the FDA evaluated data from both the company and FDA testing and found that nicotine levels in tobacco and mainstream smoke of VLN cigarettes are at least 96% lower than the majority of marketed and market-leading conventional cigarette brands.

Furthermore, the FDA’s behavioral and clinical pharmacology review found that by exclusively smoking cigarettes with the same or similarly reduced nicotine content as VLN cigarettes, consumers could reduce their exposure to nicotine by approximately 95%. The data also showed it is reasonably likely that using these products reduces nicotine dependence, which is anticipated to lead to long-term reductions in exposure to the smoking-related toxicants associated with morbidity and mortality by reducing smoking. Published studies have shown that significantly reducing the number of cigarettes smoked per day is associated with lower risk of lung cancer and death, with greater reductions in cigarettes per day resulting in less risk. Additionally, as required for authorization, the FDA found that the applications supported consumer understanding of the claims that VLN cigarettes contain much lower levels of nicotine than other cigarettes.

The authorization for these products requires the company to conduct postmarket surveillance and studies to determine whether the authorization criteria for these exposure modification orders continue to be met, including assessing use among youth.

These products are also subject to the postmarket requirements and restrictions previously imposed in their December 2019 premarket tobacco product marketing granted orders. In particular, to limit youth access to the products and to limit youth exposure to advertising and promotion, the marketing granted orders placed stringent restrictions on how the products are marketed–especially via websites and through social media platforms—by including requirements that advertising be targeted to adults of legal age to purchase tobacco products.

The company must request and receive authorization from the FDA to continue marketing the products with the same modified exposure information after the initial exposure modification orders expire in five years. The FDA also may withdraw the initial, and any potential subsequent, exposure modification orders if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole; for example, as a result of an uptake in use of the products by youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.

In reaching today’s determination, the FDA considered both the current legal status of menthol cigarettes and the available science demonstrating that these particular products could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day. The FDA is committed to moving forward with the rulemaking process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to issue proposed rules in the spring of 2022.

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