FDA Pulls Four RAI Products From Market
WINTSON-SALEM, N.C. — R.J. Reynolds Tobacco Co. will have to stop selling four cigarette products as a result of orders issued by the Food and Drug Administration (FDA).
The agency's evaluation found that Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes were not substantially equivalent (NSE) to their respective "predicate" products as identified by the manufacturer.
Predicate products were commercially marketed as of Feb. 15, 2007.
More specifically, the agency concluded the products have different characteristics than the predicate products and that R.J. Reynolds failed to show that the new products do not raise different questions of public health when compared to them.
As a result of the review, at this time, these products can no longer be sold, distributed, imported or marketed in interstate commerce.
"These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "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."
According to the FDA, the scientific basis for these four decisions include a failure to demonstrate that increased yields of harmful or potentially harmful constituents, higher levels of menthol, and/or the addition of new ingredients in the currently marketed products — when compared to the predicate products — do not raise different questions of public health.
In the case of Camel Crush Bold, a failure to demonstrate that the addition of a menthol capsule in the filter did not affect consumer perception and use also contributed to the decision, the agency added.
R.J. Reynolds is an operating company of Reynolds American Inc. (RAI), which is based in Winston-Salem. The tobacco company could not be reached for comment when contacted by CSNews Online.
According to Vivien Azer, director and senior research analyst at Cowen and Co., RAI is likely to file for a preliminary injunction to suspend this action, or pull the products and then contest these findings legally.
The four products represent 1 percent or less of RAI's total cigarette volumes, she added.
"Even if the company has to pull these products immediately, we do not expect this to have a material impact on RAI's results. Of the four, Camel Crush Bold is the biggest, but still only represents less than 1 percent of RAI's total cigarette volumes," Azer said.