FDA Authorized MRTP for Reduced Nicotine Cigarettes…


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The FDA granted a long-awaited authorization earlier than Christmas.

WASHINGTON — America Meals and Drug Administration (FDA) stated that Buffalo, N.Y.-based twenty second Century Group can start advertising their proprietary lowered nicotine cigarettes below the modified threat tobacco product (MRTP) regulatory pathway approved by the Obama-era Tobacco Management Act of 2009.

“Our mission is to find ways to stop tobacco-related disease and death,” stated Mitch Zeller, the director of the FDA’s Heart for Tobacco Merchandise, in a press assertion on December 23, 2021.

“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,” stated Zeller. “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.”

On December 23, 2021, the Meals and Drug Administration approved the advertising of twenty second Century Group’s VLN King and VLN Menthol King combusted, filtered cigarettes as modified threat tobacco merchandise. The FDA’s Heart for Tobacco Merchandise (CTP) stated that they discovered scientific proof that the lowered nicotine cigarettes will help scale back publicity to and the consumption of nicotine for people who smoke who intend to make use of the merchandise.

“This order authorizing the marketing of these modified risk tobacco products does not mean FDA “approved” the merchandise,” states a letter from the FDA despatched to twenty second Century Group management. “Nicotine is addictive. Less nicotine does NOT

mean safer. All cigarettes can cause disease and death.”

“With 60% 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,” stated James A. Mish, chief government officer at twenty second Century Group on Dec. 23.


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