The FDA says R.J. Reynolds had failed to show the four products that have been ordered off the market do not expose smokers to more harmful chemicals, higher levels of menthol or new ingredients.
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The action made by the FDA does not necessarily signify that the cigarettes and tobaccos sold by the company are more dangerous, but peculiar. “These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use”, Zeller said. “Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence”, said Jeffery Gentry, the company’s executive vice president for operations and chief scientific officer, in the statement.
The brands are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. R.J. Reynolds said in a written statement that it “strongly disagrees” with the FDA decision. Selling or distributing these brands could result in FDA enforcement action, including seizure, the agency said.
STEIN: Stores have 30 days to clear their shelves of the four R.J. Reynolds cigarette products being banned.
Meanwhile, Reynolds responded to the FDA allegations stating that the products satisfy the guidance laid down by the FDA related to manufacturing tobacco products. But the ban imposed Tuesday only applies to Camel Crush Bold and not to other flavors of Camel Crush cigarettes, the AP said. The FDA determined that this and other new features and ingredients raised new health concerns. The agency can evaluate new tobacco products for their health risks and ban those that raise uncertain health risks. The agency has also rejected 113 applications for new products.
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Congress gave the FDA authority to regulate cigarettes for the first time in 2009.
