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FDA Orders Stop to Imports, Sales and Distribution of Four Cigarette Products

Thursday, September 17, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration issued Sept. 15 orders that will stop the further sale and distribution of four currently marketed cigarette products. The FDA concluded that these products have different characteristics than their predicate products (i.e., that they were “not substantially equivalent”) and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to the predicates. Consequently, these products can no longer be imported, sold, distributed or marketed in interstate commerce.

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

However, because retailers may have limited options for disposing of products in their current inventories, the FDA does not intend to take enforcement action for 30 days on previously purchased products that a retailer has in its inventory. This policy does not apply to inventory purchased by retailers after the date of the order.

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