US regulators bar sales of four kinds of cigarettes

US regulators today ordered tobacco giant RJ Reynolds to stop selling and distributing four kinds of cigarettes because they are too different from previously approved cigarettes.
The four products are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes, the US Food and Drug Administration said in a statement.
"The company's submissions for these products did not meet requirements" that the products be "substantially equivalent" to products already on the market as of February 15, 2007, the FDA said.
"More specifically, the agency concluded the products have different characteristics than the predicate products and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to them," said the FDA statement.

A key issue in the case of Camel Crush Bold appears to be the addition of a menthol capsule in the filter, which the FDA said may "affect consumer perception."
The order means that the four products can no longer be sold, distributed, imported or marketed in interstate commerce in the United States.

They were allowed on the market during a grace period established by the Family Smoking Prevention and Tobacco Control Act of 2009, which permitted companies to submit an application stating that any new products were substantially equivalent to those already for sale, which would then be reviewed by the FDA.

"These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use," said Mitch Zeller, director of the FDA's Center for Tobacco Products.
"The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law.