FDA takes small step in tobacco product backlog

[June 26, 2013]  RICHMOND, Va. (AP) -- The Food and Drug Administration is taking a small step to whittle away a backlog of 4,000 tobacco product applications, some of which have lingered for more than two years.

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

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 also must review new cigarette or smokeless tobacco products.

An Associated Press review in December found that the agency hadn't 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 U.S.

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 store shelves 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 under a Freedom of Information Act request, 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.

On Tuesday, Mitch Zeller, the center's director, said the FDA recognizes the review process "has taken time, with a learning curve both for manufacturers and the agency."

"As all involved parties continue to gain more experience, FDA expects the process to move much more quickly," Zeller said in a conference call with reporters.

Zeller also said in a blog post on the agency's website that the review decisions do not reflect whether the FDA "considers a product to be safe."

Lorillard, the nation's third-biggest tobacco company, is pleased with the FDA's actions and believes the agency has "carried out is evaluation process in a deliberate manner reflecting sound science," CEO Murray Kessler said in a statement. Lorillard is based in Greensboro, N.C.

Kessler had previously criticized the agency's backlog, saying it wasn't "exercising common sense."

"These are cigarettes. They haven't changed in 50 years. They've had the most minor changes," Kessler had said in an interview with the AP. "I don't think the spirit of the law ever envisioned this type of cumbersome scrutiny."

[Associated Press; By MICHAEL FELBERBAUM]

Michael Felberbaum can be reached at http://twitter.com/MLFelberbaum.

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