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On Dec. 23, FDA authorized the marketing of 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 exposure modification orders 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.”
FDA previously authorized these products without the reduced exposure claims or disclaimer in December 2019 via the premarket tobacco product application (PMTA) pathway. Importantly, even with today’s action, these products are not safe nor "FDA approved"—there are no safe tobacco products.
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