FDA to Hear R.J. Reynolds' Smokeless Tobacco Petition

Changes in regulation could be coming to smokeless tobacco products. On Monday, the Food and Drug Administration (FDA) will hear the petition filed by R.J. Reynolds Tobacco Co. to market smokeless tobacco products as a less harmful alternative to cigarettes.

The tobacco company's petition is just one of several petitions and comments the agency will hear on how it should monitor and regulate smokeless products and nicotine-replacement therapy (NRT) products. These hearings are part of the FDA's preparation work for its report to Congress on innovative products and treatments for tobacco dependence, according to the Winston-Salem Journal.

Reynolds' petition asks the FDA to adjust one of four warning labels for smokeless 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."

Smokeless products currently under FDA's microscope include moist snuff, snus, dissolvable products and electronic cigarettes.

Reynolds spokesman David Howard told the newspaper that its petition includes "a wide range of scientific studies regarding the comparative risks of cigarettes and smokeless tobacco products." This include 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."

According to the news report, 15 of the 23 people scheduled to testify at Monday’s FDA hearing are tobacco harm-reduction advocates, while eight are advocates for the pharmaceutical and NRT sector. The stances of those testifying is important since some NRT advocates view smokeless tobacco to be potential competition to smoking cessation products.

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.