TUESDAY, Sept. 15, 2015The U.S. Food and Drug Administration has ordered the R.J. Reynolds Tobacco Co. to stop selling four new cigarette brands because they violate provisions in the 2009 tobacco control law.
The agency determined that the cigarettes are substantially different from existing Reynolds tobacco products on the market and need a full agency review before they can be marketed. The cigarettes are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.
These new cigarettes contain higher levels of some ingredients and ingredients that were not in the comparison products, the agency said Tuesday. Camel Crush Bold, for example, contains a menthol capsule in its filter that the agency believes would make it more attractive to younger smokers.
“These products had been provisionally marketed while our scientific review has taken place,” Mitch Zeller, director of FDA’s Center for Tobacco Products, said during a morning news conference.
Going forward, these products can no longer “be sold, distributed, imported or marketed in interstate commerce,” Zeller said. Selling or distributing these brands could result in FDA enforcement action, including seizure, the agency said.
Retail stores, however, have 30 days to dispose of any inventory on hand.
These cigarettes were put on the market during a “grace period” granted under the 2009 Tobacco Control Act, which gave the FDA oversight authority for tobacco products. This grace period covered products that entered the market after February 2007 and before March 2011, Zeller explained.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA order is precedent-setting.
“For the first time since being granted regulatory authority over tobacco products by a 2009 law, the FDA today ordered a tobacco company to pull a major cigarette brand off the market,” Myers said in a statement.
He said tobacco manufacturers have a long history of modifying their products to make them more attractive and more addictive. They also target new brands and styles to specific segments of the market, including children, he said.
“Today’s decision sets an important precedent that almost certainly will apply to other brands,” he said.
For the products to be marketed, R.J. Reynolds has to reapply to the FDA, Zeller said.
Zeller said that all four cigarette products have different characteristics than the comparison cigarettes that preceded them.
“The company did not adequately show that those differences did not cause these products to raise different questions of public health,” he said.
Speaking at the news briefing, David Ashley, director of the Office of Science at FDA’s Center for Tobacco Products, said that harmful ingredients in the new products included increased amounts of the chemicals formaldehyde and toluene, and dyes. There were also high levels of menthol and new ingredients that could affect toxicity, Ashley said.
Efforts by HealthDay to reach R.J. Reynolds for comment were unsuccessful.
For more on the FDA and tobacco, visit the U.S. Food and Drug Administration.
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