WASHINGTON — The Food and Drug Administration on Tuesday ordered tobacco giant R.J. Reynolds to pull several types of its cigarettes from the market, the latest example of the agency exercising powers it received under a 2009 tobacco control law.

Before Congress passed the far-reaching legislation, which gave the FDA authority to regulate everything from cigarettes to smokeless tobacco, companies could introduce new products without the blessing of federal regulators. But since the law’s passage, companies must prove that any new products they sell are “substantially equivalent” to what already was on the market years ago.

The FDA said Tuesday that Reynolds hadn’t adequately made that case for four of its cigarette brands: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. Agency officials said those cigarettes “have different characteristics than the predicate products” and, therefore, could raise a different set of public health concerns.

For instance, in some cases the products contained higher loads of potentially harmful ingredients, higher menthol levels or new ingredients altogether. In its applications for approval, Reynolds failed to prove that such changes don’t raise new public health questions, the agency said.

“These decisions were based on a rigorous, science-based review designed to protect the public from harms caused by tobacco use,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in announcing the action.

Reynolds is not alone in wrestling with the intricacies of the new tobacco legislation. The FDA said that since the law’s enactment, it has received thousands of applications for products that companies claimed were “substantially equivalent” to ones already on the market.

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Tuesday’s decision is significant because it marks the first time the FDA has ordered a company to pull a major brand off the market, namely Camel Crush Bold, said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

The FDA’s action is a critical step in preventing the introduction of tobacco products that may be more appealing to youth, more addictive or more harmful,” Myers said in a written statement. Ne noted that Camel was among the most popular cigarette brands among youth smokers, according to a 2013 government-funded survey.

Camel Crush Bold, in particular, has a capsule in its filter that releases menthol when crushed. The FDA cited that feature in its order, saying it made the product different in potentially significant ways from its predecessor.

Tuesday’s order means that the four Reynolds brands can no longer be legally sold or distributed in the United States. The FDA said that because some retailers might have difficulty disposing of products already on their shelves, the agency doesn’t intend to take enforcement actions for 30 days.

Representatives for Reynolds could not immediately be reached for comment.


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