Latest FDA News suggests that the second largest tobacco company of America is in trouble. According to an order issued by the Food and Drug Administration (FDA) on Tuesday, Reynolds American Inc. cannot sell four cigarette products including Camel Crush Bold any longer in the United States. This is because experts at the government body feel that those four brands might be more perilous than other older cigarettes.
According to the Tobacco Control Act of 2009, every new cigarette must be reviewed by the US FDA before it hits the market. No product launched after February 15, 2007, can impose higher health risk than a previously launched “predicate” product. However, the FDA came to know that four Reynolds products, Pall Mall Deep Set Recessed Filter Menthol, Vantage Tech 13, Pall Mall Deep Set Recessed Filter, and Camel Crush Bold, showcase features that are different from their predicates; this finding has given first to fresh health questions.
In a statement issued on Tuesday, R.J. Reynolds Tobacco Co, which happens to be a division of Reynolds American, said that it strongly disagrees with this new ruling by the FDA. According to R.J. Reynolds, the four cigarettes targeted by the FDA are not substantial equivalents of older cigarettes.
Every single product launched after February 15, 2007 was allowed to stay on the market on a temporary basis under the above-mentioned law of 2009 providing the manufacturing company submitted its marketing application within March 22, 2011.
Here, it must be mentioned that hundreds of such applications seeking authorization for selling new products have been submitted to the FDA by manufacturers. Reports suggest that the agency has denied a total of 113 such applications and authorized 257 of them.
These recently announced FDA recalls is surely the most high-profile one so far. The ruling comes just three weeks after the FDA notified Reynolds and a couple of its rival firms that they don’t have the right to claim that products marketed by them are “addictive free” or “natural”. For those who don’t know: the Natural American Spirit cigarettes are basically Reynolds creations; the company sells them via a subsidiary called Santa Fe Natural Tobacco Co.
According to the FDA, Reynolds products contain high levels of potentially harmful or harmful constituents, menthol and a series of new ingredients. The agency also said that the company has failed to show that changes made to its products don’t raise fresh health questions.