US: Tobacco Chief to Start Ruling on Product Backlog at FDA

Source from:  Bloomberg 06/07/2013

The top U.S. tobacco regulator said he's ready to make decisions on a backlog of 4,000 applications from companies that would determine which of their products can stay on the market and what new ones may be introduced.

The Food and Drug Administration is "very close" to ruling whether tobacco companies can sell new products they say have the same characteristics as existing ones, Mitch Zeller, appointed in March as head of the agency's Center for Tobacco Products, said today in an interview. There are 500 requests to approve products not currently sold, and 3,500 for products already in stores, he said.

The changing regulatory standards for cigarettes have created a backlog of applications from Altria Group Inc. (MO) and other companies, which Congress put under FDA oversight in 2009. That supervision came with an exception to rigorous new-product reviews by letting companies ask the FDA to determine that proposed products are "substantially equivalent" to those on the market and should receive less scrutiny.

The industry "has the greatest degree of concern" over products they can't currently sell, Zeller said. The agency plans to rule first on some of those requests before issuing decisions on the 3,500 products already being sold, he said.

Zeller declined to provide specifics on the timing of rulings.

Public Health

The FDA can allow products to be sold even if the agency determines they have different characteristics than existing ones, Zeller said. In those cases, the agency must consider whether the variances raise new questions about public health. If the FDA decides that the issues aren't different, it can rule the products as substantially equivalent, he said.

Companies such as Richmond, Virginia-based Altria and Winston-Salem, North Carolina-based Reynolds American Inc. (RAI), are regulated by the 2009 Family Smoking and Tobacco Control Act.

New tobacco products marketed after Feb. 15, 2007, must be cleared for sale by the FDA. A tobacco product marketed before March 22, 2011, can continue to be sold if the FDA issues an order that it is substantially equivalent to an older product or one that has been declared substantially equivalent.

Zeller, a former FDA tobacco regulator, took over from Larry Deyton as head of the FDA's tobacco center in March. Enditem