“Helps You Smoke Less”: First Combusted Cigarettes Authorized as Modified Risk Tobacco Products

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The US Food and Drug Administration (FDA) authorized marketing for “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs). MRTPs help reduce exposure to, and consumption of, nicotine for smokers who use them. These are the first combusted cigarettes to be authorized as MRTPs.

“Our mission is to find ways to stop tobacco-related disease and death. We know that 3 out of 4 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, JD, director of the FDA’s Center for Tobacco Products.

These combusted, filtered cigarettes are also the second tobacco products overall to receive “exposure modification” orders. This allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance. The orders specifically authorize “VLN King” and “VLN Menthol King” manufacturers to market the products with reduced exposure claims regarding nicotine.

Reduced exposure claims include:

-“95% less nicotine.”

-“Helps reduce your nicotine consumption.”

-“...Greatly reduces your nicotine consumption.”

The company must include “Helps you smoke less,” when using any of the reduced exposure claims in the product label, labeling, or advertising. Additionally, the FDA recommends the labeling and advertising state that, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”

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 5 years.

“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,” Zeller said further.

Reference

1. FDA authorizes marketing of tobacco products that help reduce exposure to and consumption of nicotine for smokers who use them. US Food and Drug Administration. News release. December 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-tobacco-products-help-reduce-exposure-and-consumption-nicotine-smokers-who?utm_medium=email&utm_source=govdelivery