FDA to consider petition on ‘lower risk’ labeling for some products

A petition filed by R.J. Reynolds Tobacco could represent the boldest step to date in trying to market smokeless-tobacco products in theUSas less harmful alternatives to cigarettes, according to a story by Richard Craver for the Winston-Salem Journal.

The US Food and Drug Administration is due to hold a hearing on 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.

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 theUSmust 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.

The full story is at: http://www.journalnow.com/business/business_news/local/article_ea77073e-44d0-11e2-81b1-001a4bcf6878.html.