(Story updated at 6:15 p.m. ET.)
The Food and Drug Administration on Tuesday banned sales of four cigarette brands from R.J. Reynolds because they did not meet the agency's safety review requirements.
Under FDA rules, companies that launch new cigarettes must show that the products are essentially the same as older products in terms of health risks. The FDA said four brands from R.J. Reynolds failed to show that they don't raise new safety concerns.
Agency officials said they participated in a "considerable back and forth" with North Carolina-based R.J. Reynolds before ordering the cigarettes off the market. The FDA's action doesn't explicitly mean that the products are 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 are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.
Tuesday's action means it is illegal for retailers to sell or distribute the four cigarette brands. However, the agency said it will not take action for 30 days to give stores and distributors time to dispose of the products.
R.J. Reynolds Tobacco Co. did not immediately return calls and emails seeking comment.
The FDA has previously banned a number of new tobacco products, including a dozen in 2015. However, anti-tobacco activists said Tuesday's action was the first to target a major cigarette brand: Camel Crush Bold.
Camel is one of the three most popular cigarette brands among youth smokers, with 15 percent preferring Camel, according to the Campaign for Tobacco Free Kids.
"The FDA's action is a critical step in preventing the introduction of tobacco products that may be more appealing to youth, more addictive or more harmful," the group said in a statement.
Camel Crush features a menthol capsule in the filter that releases the flavor when crushed. The FDA determined that this and other new features and ingredients raised new health concerns.
In 2009 the FDA gained authority to regulate some aspects of cigarettes and other tobacco products. The agency can evaluate new tobacco products for their health risks and ban those that pose new or uncertain health risks.
FDA officials said Tuesday they have cleared 257 new tobacco products for marketing since the regulations took effect. The agency has also rejected 113 applications for new products.
R.J. Reynolds released a statement noting its strong disagreement with the FDA's ruling (PDF). It added that its applications “fully satisfied the guidance the agency provided” and it responded to all of the FDA's questions. “Our submissions to the agency on these brands were comprehensive and we believe we effectively demonstrated substantial equivalence,” Jeffery Gentry, R.J. Reynolds executive vice president of operation and chief science officer, said in the statement. “We're examining all of our options at this time.”
The company added that the four brands in question are only a small part of its business and, together, have less than 0.4% share of the market.
--Andis Robeznieks contributed to this story.
