Four R.J. Reynolds cigarettes banned
FDA says brands have different characteristics
A Washington regulator halted sale and distribution of four R.J. Reynolds Tobacco cigarettes Tuesday, ruling the company hadn’t proved the products were substantially equivalent to previous products and raised new public health questions.
The orders by the U.S. Food and Drug Administration apply to Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.
R.J. Reynolds, the second-largest U.S. tobacco company, failed to show the new products didn’t pose different public health questions when compared to older brands the company identified as equivalents, the FDA said.
For instance, Camel Crush Bold cigarettes have a menthol capsule in their filters that wasn’t included in Kool Filter Kings Box cigarettes, the earlier product R.J. Reynolds cited for comparison, the FDA said.
Camel Crush Bold also contained new ingredients and provided users with higher levels of menthol, changes that “raised questions for us,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
The decision means the four cigarettes no longer may be sold, distributed, imported or marketed in interstate commerce, the regulator said.
The FDA plans to delay enforcement of the action for 30 days, giving retailers time to dispose of current stocks of the four cigarettes.
“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Zeller said.
Jeffery Gentry, the chief scientific officer for R.J. Reynolds, said the company believed “we effectively demonstrated substantial equivalence. We’re examining all of our options at this time.”
Reynolds also said the four brands represent less than a 0.4 share of its business. A research report by RBC Capital Markets separately predicted the FDA action would not have substantial impact on the company’s financial operations.
Reynolds American shares closed up 0.26% at $42.09.
Federal legislation that took effect in 2009 required tobacco companies to file applications of substantial equivalence to the FDA by March 2011 in an effort to show that new products were generally similar to older versions on the market as of February 2007. The FDA has issued 257 substantial equivalence approvals, while disapproving 113 applications.
However, Tuesday’s action marks the first time the regulator has pulled a major cigarette brand off the market, said Matthew Myers, president of the Campaign for Tobacco-Free Kids. He said the decision “sets an important precedent” that would likely apply to other brands.