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Its mechanism of action and discovery are described below: Identified nitrosamine impurities with carcinogenic (cancer-causing) potential include: Sources of nitrosamine impurities include: 6, 24, 25, 26 Nitrosamines can be grouped by cancer risk, as follows: Human studies demonstrating increased cancer risk posed by nitrosamine include the following: Research suggests NDMA and NDEA may increase risk of liver cancer, as follows: FDA regulatory limits on nitrosamine contaminants led to the following recalls: The FDA set safety limits on N-nitroso-varenicline found in Chantix, as follows: 6 Higher Limits and Risk : Agency scientists determined that higher intake levels, up to 185 ng/day (92.5 ppm), pose a slightly increased cancer risk compared to the 37 ng/day limit

(KCDC, Osong, Republic of Korea, 2020)

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