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The Food and Drug Administration recommends that companies developing smoking cessation treatments assess their impact on smoking for a minimum of four weeks, though a 26-week assessment is typically considered the preferred period for a study to reliably predict long-term abstinence from cigarettes

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In September 2020, the FDA started reviewing premarket tobacco applications and has since issued marketing denial orders for 55,000 flavored ENDS products, on the grounds the applicants dont have sufficient evidence that the benefit to adult smokers outweighs the risk to youth