FDA orders Reynolds to stop selling four brands

The Food and Drug Administration has targeted four cigarette products, including Camel and Pall Mall brands, for not meeting regulations, the latest companies to get ensnared in a burgeoning agency dragnet.

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 now marketed products – when compared to the predicate products – do not raise different questions of public health.

The FDA said the Camel Crush product has a little capsule of menthol in the filter that’s new. The FDA said that because some retailers might have difficulty disposing of products already on their shelves, the agency doesn’t intend to take enforcement actions for 30 days.

In 2009 the FDA gained authority to manage some points of cigarettes and different tobacco merchandise.

The FDA has ordered other cigarettes off the market before, but those actions involved much smaller companies selling much less popular cigarettes.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA order is precedent-setting.

“Today’s decision sets an important precedent that nearly certainly will apply to other brands”.

The products receiving NSE orders entered the market during a provisional period established by the Family Smoking Prevention and Tobacco Control Act of 2009. The FDA said four brands from R.J. Reynolds failed to show that they don’t raise new safety concerns.

The agency concluded that the products have “different characteristics than the predicate products”, or that the four products have changed in composition from their previous versions, the FDA said in a press release. “We stay away from that word [approve]”. Reynolds sells Natural American Spirit cigarettes through its subsidiary, Santa Fe Natural Tobacco Co. That was the first time the FDA acted under the 2009 law.

So companies will have to either tweak an existing product so it’s “substantially equivalent”, or go for a new approval of a new product. The company said the affected brands account for a very small portion – 0.4 percent – of its overall market presence.