WASHINGTON — The Food and Drug Administration halted the sale of four R.J. Reynolds cigarette products on Wednesday, saying a scientific review found that they were potentially more harmful than the company had claimed.The agency ordered retailers who sell any of the cigarettes — Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 — to stop selling them immediately and to dispose of them within 30 days or face financial penalties or criminal prosecution.“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, director of the Center for Tobacco Products at the F.D.A., said in statement.Officials for R.J.R. were not immediately available for comment.Under a 2009 federal law, the F.D.A. can reject cigarettes and other tobacco products that its scientists believe pose greater public health risks than comparable products already on the market, a sharp departure from past practice, when tobacco companies could change existing products and introduce new ones at will.These four products were introduced during a grace period set up by the law. R.J.R. applied for so-called “substantial equivalence” status at that time. To be considered “substantially equivalent,” tobacco products must be shown to have the same characteristics as a predecessor product, or to have different ones that do not raise new questions for public health. Over the past two years, the agency has blocked products that were not the same as predecessors on a number of occasions.On Wednesday the F.D.A. ruled the four R.J.R. products were not the same as their predecessor brands, and ordered them removed from the market.The agency said it took the action against the four products because it concluded that the products had higher amounts of harmful ingredients, higher levels of menthol, or the addition of new ingredients that raised new questions for public health.“The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law.” Mr. Zeller said.Cowen and Company, a financial services firm, said in a research note that the products make up less than 1 percent of R. J. R’s total cigarette sales volumes, so is not likely to be a major financial issue for the company. It said the R.J.R. would likely file a legal injunction to get the action suspended, or pull the products and then contest the findings legally.
Source: F.D.A Orders R.J Reynolds to Stop Selling 4 Cigarette Products – The New York Times