Tobacco

How Should Retailers React to FDA Ruling on RJR Brands?

Inventory now considered "adulterated and misbranded”

WASHINGTON -- The U.S. Food & Drug Administration (FDA) issued orders on September 15 to stop the sale and distribution of four R.J. Reynolds cigarette brands—Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes—because they are "not substantially equivalent" (NSE) to their respective previously marketed products.

R.J. Reynolds Camel Crush Bold FDA

Click here for complete coverage, including R.J. Reynolds’ response.

Consequently, the FDA said, these products can no longer be sold, distributed, imported or marketed in interstate commerce, including by convenience stores and other tobacco retail outlets.

When the FDA issues an NSE order, the tobacco product in inventory, including at a retail location, becomes "adulterated and misbranded," the agency said. As a result, it is illegal to sell or distribute the product in interstate commerce or to sell or distribute the product received from interstate commerce. Doing so may result in the FDA initiating enforcement action, including seizure, without further notice.

Recognizing that retailers may have limited options for disposing of products in their current inventories, the FDA said it does not intend to take enforcement action for 30 days on previously purchased products that a retailer has in its inventory. Retailers can sell their remaining inventory of the four brands through Oct. 15, 2015. This policy does not apply to inventory purchased by retailers after the date of the order.

The FDA is encouraging retailers to contact their supplier or manufacturer to discuss options for existing inventories at specific retailer locations, it said.

R.J. Reynolds Tobacco, an indirect subsidiary of Reynolds American Inc., Winston-Salem-N.C., is the second-largest tobacco company in the United States. Its brands include Newport, Camel and Pall Mall. These brands, and its other brands, including Doral, Misty and Capri, are manufactured in a variety of styles and marketed in the United States.

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