US: Hearing Set for Smokeless-tobacco Petition

Source from:  Winston-Salem Journal 12/14/2012

A petition filed by R.J. Reynolds Tobacco Co. may represent the boldest step to date in trying to market smokeless-tobacco products as a less harmful alternative to cigarettes.

The Food and Drug Administration will hold a hearing Monday in which it will hear petitions and comments on how it should monitor and regulate smokeless products and nicotine-replacement therapy (NRT) products.

The hearing is part of the agency's preparation for a long-awaited report to Congress on innovative products and treatments for tobacco dependence. The FDA began regulating tobacco products and marketing in June 2009, but it does not have the authority to ban nicotine or tobacco.

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 facing FDA scrutiny include not only moist snuff and snus products, but also dissolvable products being sold in trial markets by Reynolds and e-cigarettes.

A company that wants to market a lower-risk tobacco product in the United States must offer scientific proof to the FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole.

Reynolds spokesman David Howard said Wednesday its petition includes "a wide range of scientific studies regarding the comparative risks of cigarettes and smokeless tobacco products." Those 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 that the current wording of the warning label in question continues to mislead the public by providing information that is incomplete and misleading."

According to Bill Godshall, executive director of SmokeFree Pennsylvania, 15 of the 23 people scheduled to testify at the FDA hearing are tobacco harm-reduction advocates, including himself, while eight are advocates for the pharmaceutical and NRT sector.

The stances of those testifying is important since some NRT advocates view smokeless tobacco as potential competition as smoking-cessation products.

Some anti-tobacco advocates are concerned that a rise in use of smokeless-tobacco products will only contribute to "dual use" consumers – those who smoke where they can and use smokeless products where they can't.

The long-term effectiveness of NRT products was called into doubt by a January study released by researchers at the Harvard School of Public Health and the University of Massachusetts-Boston.

The study of 787 adult smokers in Massachusetts found that the products, specifically nicotine patches and gum, "are no more effective in helping people stop smoking cigarettes in the long term than trying to quit on one's own," said Hillel Alpert, a research scientist with the Harvard group and the study's lead author.

Gregory Connolly, director of the Center for Global Tobacco Control at Harvard, said the study shows the FDA "needs to approve only medications that have been proven to be effective in helping smokers quit in the long term and to lower nicotine in order to reduce the addictiveness of cigarettes."

Godshall said he supports the Reynolds petition and label change "because it truthfully informs consumers that cigarettes are more hazardous than smokeless tobacco."

"The FDA should also require a warning on all cigarette packs that inform smokers that smokeless tobacco, e-cigarettes, nicotine gums and lozenges are far less hazardous alternatives to cigarettes." Enditem