Update on Tobacco Warning Letters

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Welcome to the first monthly update on FDA's enforcement over regulated tobacco products. This update will examine trends in Warning Letters, and cover some unique Warning Letters and enforcement actions that have occurred in the previous month. As the first post regarding tobacco products, we will begin with a summary of tobacco related Warning Letters issued by the FDA to date.

Overall, there have been 1,370 Warning Letters issued by the Center for Tobacco Products since the Family Smoking Prevention and Tobacco Control Act was passed in 2009. The majority of Warning Letters were issued as the result of state contract inspections of retailers. The remaining 45 Warning Letters were issued directly by the Center for Tobacco Products to Internet retailers and manufacturers.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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