FDA to Hear Public Input on Smoking Cessation Products

SILVER SPRING, Md. -- On Monday, the Food and Drug Administration (FDA) is set to hear public comments on smoking cessation products.

The hearing, titled "FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing; Request for Public Comments," is part of the FDA's preparation work for its report to Congress on innovative products and treatments for tobacco dependence.

In a related note, R.J. Reynolds Tobacco Co. has filed a petition to market smokeless tobacco products as a less harmful alternative to cigarettes. The petition asks the agency to adjust one of four warning labels for smokeless tobacco products from "WARNING: This product is not a safe alternative to cigarettes," to "WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes." The petition is not on Monday's agenda; however, it could be mentioned during the public discussion, according to the FDA.

Reynolds spokesman David Howard told the Winston-Salem Journal that its petition includes "a wide range of scientific studies regarding the comparative risks of cigarettes and smokeless tobacco products." This includes reports from Britain's Royal College of Physicians, the World Health Organization and the Strategic Dialogue on Tobacco Harm Reduction Group.

"The petition also cites research showing that the public -- including tobacco consumers -- does not accurately understand the risks associated with smokeless tobacco use as compared to cigarette smoking," Howard said. "The petition says the current wording of the warning label in question continues to mislead the public by providing information that is incomplete and misleading."

Just as the FDA takes another step toward regulating tobacco products -- a task it was granted by the Family Smoking Prevention and Tobacco Control Act in 2009 -- an Associated Press review has found that the agency's process for reviewing new tobacco products has not only slowed, but actually grinded to a halt.

The news outlet reported that in the past 18 months, tobacco companies have introduced almost no new cigarette or smokeless tobacco products in the United States.

Since June 2009, the tobacco industry has submitted nearly 3,500 product applications, according to data obtained by the Associated Press under a Freedom of Information Act request. While none have been ruled upon, the vast majority of these products are already being sold. A grandfather clause in the law allows products similar to those already on the market as of February 2007 to be sold while under review. However, 400 products submitted for review since then are being kept off the market.

FDA reviews are supposed to take 90 days, but in some cases, they are dragging on for years, the AP investigation found.

In an interview with the news outlet, Dr. Lawrence Deyton, director of FDA's Center for Tobacco Products, said the agency is working with companies to get more information about products and hopes the industry will be more transparent about its reasoning that product changes don't affect public health.

This summer, Lorillard Inc. raised concerns about the snail's pace of the review process, as CSNews Online reported then. Regulatory obstacles have prevented Lorillard from bringing several new products to the marketplace. At the Morgan Stanley Global Consumer & Retail Conference in New York last month, though, CEO Murray Kessler said the lines of communication between the tobacco company and the FDA are open once again.


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