The FDA found Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes were not substantially equivalent to brands on the market longer, or since Feb. 15, 2007.
Since 2009, the FDA has had the authority to require new cigarette brands to prove they pose no more risks to smokers than cigarettes already on the market before Feb. 15, 2007.
The FDA found R.J. Reynolds failed to show the new products do not raise different questions of public health or expose smokers to greater levels of menthol, new ingredients compared to predicate products, or greater levels of harmful or potentially harmful chemicals.
Those four brands are now considered adulterated and misbranded. As a result, it is illegal to sell or distribute the product in interstate commerce, or sell or distribute the product received from interstate commerce. The FDA does not intend to take enforcement action for 30 days on previously purchased products that a retailer has in its inventory.
“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, JD, 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.”
