Premarket Tobacco Applications
Exemption from Substantial Equivalence
FDA issued approval orders under the substantial equivalence pathway for Swedish Match's 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.
Finally, we have some good news to report about the FDA Tobacco Products Division!
Enjoy your Snus!
Swedish Snus Ambassador to the United States
Reporting for SnusCENTRAL.org