The Food and Drug Administration stopped the sale of four cigarette brands these days, declaring that merchants will have to remove them off the shelves and informing the manufacturer, R.J. Reynolds that they are not allowed to sell them any further.
The agency made use of its new, restricted authority over tobacco products to declare the four new brands do not meet up with what is called significant equivalence. FDA does not want to be seen “granting” a tobacco product, but can reject an application to advertise something new.
The four cigarette brands are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes – are new formulations.
“Today’s steps reveal the FDA’s power to utilize its legal capacity under scientific evaluation,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said.
The FDA stated the Camel Crush product possesses a little capsule of menthol in the filter that is completely new. After “substantial back and forth», R.J. Reynolds was incapable to demonstrate that the menthol capsule didn’t alter the product’s risk and didn’t modify how consumer might consider the brand. Regarding the Pall Mall products, the company would not provide FDA sufficient information about sweeteners and other flavors included in the cigarettes, Zeller mentioned.
Retailers will have 30 days to eliminate the products, after which FDA claims it can seize them.
“These four tobacco products are currently viewed as misbranded,” the FDA’s Ann Simoneau mentioned.
“R.J. Reynolds Tobacco Company firmly disagrees,” the company explained. It stated it evidently demonstrated the cigarettes were similar to older products already available on the market. “We have furnished the agency with considerable information on every product, and replied to all of the agency’s questions,” it claimed.
Therefore, companies will have to either modify an existing product so it’s “significantly equivalent”, or opt for a new authorization of a new tobacco product.
