WASHINGTON -- The U.S. Food & Drug Administration on Thursday issued additional tobacco product review decisions, allowing the sale and marketing of four new tobacco products through the substantial equivalence (SE) pathway.
The FDA issued orders for two HBI International roll-your-own tobacco papers and tips, including Elements Aficionado 1 ¼ and Elements Aficionado KS Slim.
In addition, FDA issued orders for two Republic Tobacco roll-your-own filtered cigarette tubes, including Top Regular 100MM and Top Gold 100MM.
The FDA determined these products to be "substantially equivalent" to the predicate products to which they were compared. FDA concluded that, the differences between the new and predicate tobacco products are such that the new products do not raise different questions of public health.
In late June, Greensboro, N.C.-based Lorillard Tobacco Co.'s Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box were the first new tobacco products that the FDA approved since the Family Smoking Prevention & Tobacco Control Act of 2009 gave it the authority to regulate tobacco products.
Click here for the FDA's web page on tobacco product market orders and substantial equivalence.
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