US: FDA Authorizes Two New Lorillard Cigarette Brands

Source from:  The Wall Street Journal  06/26/2013

The Food and Drug Administration authorized the sale of two new cigarette brands, in the first such move since Congress gave the federal agency power to do so in 2009.

The agency said it would allow Lorillard Inc.'s Lorillard Tobacco Co. unit to sell two new cigarettes, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, under a standard that allows introduction of new cigarette products that are similar to what is already on the market. The FDA said it also turned down four other applications by tobacco manufacturers, but under the law can't disclose its specific reasons.

FDA Commissioner Margaret A. Hamburg said in a media briefing that the agency's goal still is "reducing preventable disease and death caused by tobacco." However, the agency said it would allow new products if it finds them "substantially equivalent" to existing cigarette products. Such a step doesn't represent FDA approval, but simply recognizes the products don't raise new questions of public health.

The decision is roughly akin to those made by the FDA's medical-device center, which often clears products for the U.S. market because they're considered equivalent to those already in use.

"We are encouraged by the agency's fulfillment of its obligation," Lorillard Chairman and Chief Executive Murray Kessler said in a statement. "We look forward to continuing productive engagement with the agency moving forward."

The FDA's move was regarded positively by Wall Street, which had speculated the FDA might reject all new applications under the view that such clearances wouldn't benefit public health.

"It is important to recognize that to date this is one of the agency's very few affirmative tobacco-related decisions," a Morgan Stanley analyst report said. "This makes the decision broadly more encouraging."

Mitch Zeller, director of the FDA's Center for Tobacco Products, characterized the decision as "just the first of many forthcoming product review actions to be issued." He said the agency has formally withdrawn 136 tobacco-product applications at the request of companies making the applications. The agency said such withdrawals are allowed if a manufacturer can't meet FDA standards, or for other , director of the FDA's Center for Tobacco Products, characterized the decision as "just the first of many forthcoming product review actions to be issued." He said the agency has formally withdrawn 136 tobacco-product applications at the request of companies making the applications. The agency said such withdrawals are allowed if a manufacturer can't meet FDA standards, or for other business reasons.

An FDA spokeswoman said there are about 4,000 other pending applications for "substantial equivalence" status for tobacco products. The FDA has refused to accept 20 requests for exemptions from the standard. An exemption would normally be available for minor modifications to a tobacco product, such as when the only change is to an additive.

The Morgan Stanley note said the wording of the FDA's analysis of the newly authorized products may be a bad sign for new products that add menthol to an old product because it "could be consistent with the view that the addition of menthol to a non-menthol product could raise a new issue of public health." Enditem