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U.S. Department of Health and Human Services

Tobacco Products

This Week in CTP – November 15, 2013


Announcing New Tobacco Product Review Decisions

Today, the U.S. Food and Drug Administration (FDA) announced that the Agency is authorizing the sale and marketing of eight additional tobacco products through the substantial equivalence pathway. FDA issued orders for eight smokeless tobacco products, manufactured by Swedish Match North America, Inc.: Timber Wolf Long Cut Wintergreen, Renegade Long Cut Straight, Renegade Long Cut Wintergreen, Timber Wolf Long Cut Apple, Timber Wolf Long Cut Peach, Timber Wolf Long Cut Straight, Timber Wolf Long Cut Cool Wintergreen, and Timber Wolf Fine Cut Wintergreen.
The Agency determined these products to be “substantially equivalent” to predicate tobacco products. FDA concluded that, while the new products have different characteristics than the predicate products, the new products do not raise different questions of public health. An SE Marketing Order is not a finding that the product is safe or safer than its predicate product, or less harmful in general. In addition, the law makes clear that companies cannot say their products are FDA approved.

For more information, visit our Tobacco Product Marketing Order webpage.