FDA Approves Eight Swedish Match Smokeless Tobacco Products

Today, FDA announced it was authorizing the sale and marketing of eight Swedish Match smokeless tobacco products in the US.

These first eight are not in the snus category but their approval would seem to indicate that all Swedish Match snus falling within the qualifying date range should easily win approval.

Swedish Match as of last month had 195 product applications on file with FDA.

FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco. Instead, FDA regulates tobacco products based on a public health standard intended to reduce the toll that tobacco use causes.

To legally market a new tobacco product in the United States, a manufacturer must receive a written order from FDA permitting the marketing of the new tobacco product under one of three pathways. These three pathways are:

Premarket Tobacco Applications
Substantial Equivalence
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!