The U.S. Food and Drug Administration has ordered the R.J. Reynolds tobacco company to stop selling four new brands of cigarettes.
The FDA said the four brands: Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Recessed Deep Filter Menthol and Vantage Tech 13, cannot be sold and retailers must remove them from their shelves.
The brands violate provisions of a 2009 tobacco control law, the FDA says, because they don't meet what's called substantial equivalence — in other words, R.J. Reynolds hadn't proved the products were substantially the same as previous products the company cited as equivalents for comparison.
Instead, the brands contain ingredients that were not in the comparison products, and those that were contained higher levels, the agency said in a release.
That "raised questions for us," said Mitch Zeller, director of FDA's Center for Tobacco Products.
"The company did not adequately show that those differences did not cause these products to raise different questions of public health," he explained.
Sale of the brands must be halted even though they have already been introduced in the marketplace, he said, adding that, for the brands to be reintroduced, R.J. Reynolds would have to reapply to the FDA.
"These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use," Zeller said.
The FDA ruling means the four brands can no longer be distributed, sold, imported or marketed in interstate commerce.
"These four tobacco products are now considered misbranded and adulterated," said the FDA's Ann Simoneau.
Enforcement of the ruling would be delayed for 30 days to allow retailers to dispose of their existing stocks of the four brands, the agency said.
Anti-smoking activists lauded the FDA decision, calling it precedent-setting.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said tobacco companies have long engaged in the practice of modifying their cigarettes to make them more attractive and more addictive while using new brands and style to target specific market segments, including children.
"Today's decision sets an important precedent that almost certainly will apply to other brands," he says.
"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."
