Tobacco industry regulators ordered RJ Reynolds Tobacco (RJRT) to stop distribution and sales of four variants of the Camel, Pall Mall and Vantage cigarette brands, the Food and Drug Administration said.

FDA rejected RJRT’s argument that the four products are substantially equivalent to ones marketed prior to 15 Feb, 2007, which is a cut-off date under federal legislation requiring an FDA marketing order for all new tobacco products sold across state borders. RJRT’s four variants fell under a transition rule that allowed them to stay on the US market pending an FDA ruling on Substantial Equivalent (SE) applications filed by a second cut-off date; 22 March, 2011.
Federal regulators on 15 Sept said Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Filter Menthol and Vantage Tech 13 were not substantially equivalent to predicate products.
“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” said FDA Center for Tobacco Products Director Mitch Zeller. “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.”
Several market approval routes are available, however most manufacturers have opted for Substantial Equivalency. More than 3,000 SE applications were filed by the 2011 cut-off date. To date, records show FDA approved 257 SE requests. About half that total, 125 authorizations, were handed down this past June. The agency has rejected 116 applications and nearly 890 requests have been withdrawn.