The
'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
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
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
Furthermore, the
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
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.
The FDA, an agency within the
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