FDA bans sales of four cigarette brands from RJ Reynolds
16 Sep 2015
The Food and Drug Administration yesterday banned sales of four cigarette brands from RJ Reynolds for not meeting the agency's safety review requirements.
Under FDA rules companies that launched cigarettes had to show the products were essentially the same as older products in terms of health risks. According to the agency, four brands from RJ Reynolds failed to show that they did not raise fresh safetey concerns.
Agency officials said they had engaged in a ''considerable back and forth'' with North Carolina-based RJ Reynolds before ordering the cigarettes off the market. The FDA's action did not explicitly mean that the products were more dangerous than older cigarettes, just different.
''All we have to conclude is that the different characteristics of these products raise different issues of public health,'' said FDA's tobacco director Mitch Zeller, on a call with reporters. ''In our mind, these changed features raised questions for us.''
The brands included Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.
The action yesterday meant it was illegal for retailers to sell or distribute the four cigarette brands. The agency would however not take action for 30 days to give stores and distributors time to dispose of the products.
The brands were introduced during a grace period set up by the law that ended in 2011. R J Reynolds applied for so-called substantial equivalence status at the time but to be considered substantially equivalent, tobacco products needed to be shown to have the same characteristics as a product already on the market or, if different, raised no new questions for public health.
''These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,'' Mitch Zeller, the director of the Center for Tobacco Products at the agency, said in statement.
The agency ruled the four products were not the same as their predecessor brands, which opened up the possibility that they were more harmful.
RJ Reynolds said in a statement that it ''strongly disagrees'' with the decision. Jeffery S Gentry, the company's executive vice president for operations and chief scientific officer, said in the statement, ''Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence.''
