Modified-Risk Marketing Orders for 22nd Century

    Photo: 22nd Century Group

    The U.S. Food and Drug Administration has authorized the marketing of 22nd Century Group 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, director of the FDA’s Center for Tobacco Products, in a statement.

    “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 percent 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.”

    Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers.

    Mitch Zeller, director, FDA Center for Tobacco Products

    In the review of 22nd Century Group’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 percent 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 percent. 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 post-market 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 post-market 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.

    22nd Century Group welcomed the FDA decision. “Today’s decision to authorize VLN’s MRTP application places the FDA and 22nd Century together at the vanguard of transforming the tobacco industry,” said James A. Mish, chief executive officer at 22nd Century Group, in a statement.

    “With 60 percent of adult smokers in our U.S. market research telling us they are likely to try VLN, this is a complete game-changer for 22nd Century, the tobacco industry, public health, and adult smokers looking to change their relationship with nicotine–the addictive chemical found in all tobacco products.

    “This is the first, and most likely will be the only, combustible cigarette to ever carry the FDA’s MRTP designation. The FDA’s decision to require the additional headline claim ‘Helps You Smoke Less’ alongside our requested headline claim of ’95 percent Less Nicotine’ gives adult smokers a crystal-clear reason to replace their conventional and highly addictive cigarettes with VLN.”