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In May 2022, the FDA issued an update to their guidance regarding nitrosamine in varenicline, indicating the FDA is now confident in manufacturers ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agencys acceptable intake limit of 37 ng per day. (11)

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For the same period in 2019, that number was 311,974,000

The types of tobacco and alternative nicotine products covered by the new law include cigarettes