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Tobacco Products

FDA Issues New Warning Letters

August 13, 2013 

FDA Issues 10,000th Tobacco Retailer Warning Letter and Four Warning Letters for Cigarette or Roll-Your-Own Tobacco Labeled as “Pipe Tobacco” 

The U.S. Food and Drug Administration’s (FDA) tobacco compliance and enforcement program ensures that industry and retailers follow existing laws designed to reduce the health burden of tobacco use on the American public and protect America’s youth. To ensure compliance with the law, FDA works to prevent youth access to tobacco products and the influence of marketing by reviewing print and online advertising, monitoring promotional activities, and inspecting tobacco retail establishments. FDA takes action against retailers, manufacturers, distributors, and importers who do not comply with the law, such as by issuing warning letters for first-time violations. 

FDA recently issued its 10,000th tobacco retailer warning letter. Although most retailers are actively trying to keep tobacco away from kids, some continue to violate the law. In order to help reduce these violations, in 2009 CTP established a vigorous State Enforcement Program under which FDA awards contracts to states and territories to assist with inspections of tobacco retail establishments. As of July 31, 2013, we have contracts with 45 states, territories, and the District of Columbia and have conducted more than 189,000 inspections of tobacco product retailers. FDA also is working to help retailers comply with tobacco regulations by providing webinars and guidance documents to educate retailers and their employees about tobacco laws. 

Search our tobacco retailer warning letter database to see the results of inspections near you. 

In addition to this recent milestone, the FDA has also issued warning letters to three tobacco manufacturers and one tobacco retailer for promoting or selling illegal cigarette or RYO tobacco products labeled as “pipe tobacco.” These tobacco products were found to be subject to FDA regulation, and as such, the warning letters include violations for selling modified risk tobacco products without an order in effect and/or selling prohibited flavored cigarette tobacco products.  

View the four “pipe tobacco” warning letters

These efforts highlight FDA’s continued work to protect public health from the harms of tobacco use. 

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