For immediate release:

Today, the United States Food and Drug Administration cleared the smoked and filtered cigarettes “VLN King” and “VLN Menthol King” from 22nd Century Group Inc. as Modified Risk Tobacco Products (MRTP). , which help reduce exposure and consumption. of nicotine for smokers who use it. These are the first burnt cigarettes to be licensed as MRTP and the second total tobacco products to receive “modification of exposure” orders, allowing them to be marketed as having a reduced level or having reduced exposure to. a substance.

“Our mission is to find ways to stop tobacco-related illness and death. We know that three in four adult smokers want to quit, and data on these products shows they can help addicted adult smokers quit highly addictive burnt cigarettes, ”said Mitch Zeller, JD, director of the Center for Tobacco Products from the FDA. “Having options like these products licensed today, which contain less nicotine and are reasonably likely to reduce nicotine addiction, can help adult smokers. If adult smokers were less dependent on burnt cigarettes, they would likely smoke less and could be exposed to fewer harmful chemicals that cause tobacco-related illness and death.

The Exposure Variation 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 intake. “
  • “… Dramatically reduces your nicotine intake. “

When using any of the exposure reduction claims on the product’s label, labeling or advertisement, the company should include “helps you smoke less”. The FDA also recommends that labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause illness and death. The manufacturer is also required to label packages with one of the four warnings for cigarettes, as required by federal law on cigarette labeling and advertising; for example, “Surgeon General 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 are not currently using tobacco products should not start using them or using others. Exposure modification orders do not permit the Company to make any other modified risk claims or express or implied statements that convey or could mislead consumers into believing that the products are approved or approved by the FDA, or that the FDA considers the products to be safe for consumers. These prescriptions do not allow the company to market these products with therapeutic or withdrawal claims.

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

Additionally, the FDA’s Behavioral and Clinical Pharmacology Review found that by exclusively smoking cigarettes with the same or similar nicotine content as VLN cigarettes, consumers could reduce their exposure to nicotine by approximately 95%. %. The data also showed that it is reasonably likely that the use of these products will reduce nicotine dependence, which should lead to long-term reductions in exposure to smoking-related toxins associated with morbidity and disease. mortality by reducing smoking. Published studies have shown that a significant reduction in the number of cigarettes smoked per day is associated with a lower risk of lung cancer and death, with a greater reduction in the number of cigarettes per day resulting in a lower risk. Additionally, as required for clearance, the FDA found that the applications supported consumers’ understanding of the claims that VLN cigarettes contain much lower levels of nicotine than other cigarettes.

Authorization of these products requires the company to conduct post-market surveillance and studies to determine whether the authorization criteria for these exposure modification orders continue to be met, including assessment of the use in young people.

These products are also subject to post-market requirements and restrictions previously imposed in their orders granted in December 2019 for the marketing of tobacco products before market. In particular, to limit the access of young people to products and to limit the exposure of young people to advertising and promotion, orders granted by marketing placed strict restrictions on how products are marketed, in particular through websites and social media platforms, including requirements that advertising must be directed to adults of legal age to purchase tobacco products.

The company must seek and receive FDA clearance to continue to market products with the same modified exposure information after the original exposure modification orders expire in five years. The FDA may also withdraw initial and possible 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 adoption of the use of the products by young or former smokers, or a decrease in the number of current smokers who switch completely to the products.

To arrive at today’s decision, the FDA reviewed 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 advancing the rule-making process to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars and remains on track to release proposed rules to the FDA. spring 2022.

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The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.