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FDA takes steps on tobacco products

RICHMOND — The Food and Drug Administration is taking a small step to whittle down a backlog of 4,000 tobacco-product applications, some of which have lingered for more than two years.

The federal agency said Tuesday that it has authorized two nonmenthol versions of Lorillard Inc.’s flagship Newport brand under a 2009 law that gave the FDA authority over tobacco.

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It also said it has rejected four applications submitted to the agency for review, but did not disclose the products.

In addition to regulating a number of aspects of tobacco marketing and manufacturing, the FDA’s Center for Tobacco Products must review new cigarettes and smokeless tobacco products.

An Associated Press review in December found that the agency had not ruled on thousands of those applications for more than a year, despite the 90-day review process the industry expected.

While only two products have been authorized to be marketed, the vast majority of those awaiting review are for products already being sold in the United States.

A grandfather clause in the law allows products introduced between February 2007 and March 2011 that are similar to those previously on the market to be sold while under review. They can be removed from stores if they don’t pass muster with the agency. But about 500 products submitted for review since March 2011 are being kept off the market.

According to data obtained by the AP, about 90 percent of the applications submitted to the FDA have been with the agency for more than a year.

The FDA had said the review process was taking so long because the applications from manufacturers lacked the information the agency deemed necessary to complete its analysis.

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