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SILVER SPRING, Md. -- It may have taken a couple of years to get started, but the Food and Drug Administration (FDA) is working its way through the backlog of substantial equivalence (SE) applications.
On Thursday, the FDA issued tobacco product review decisions, allowing the sale and marketing of four new tobacco products through the substantial equivalence pathway. The agency issued orders for two HBI International roll-your-own tobacco papers and tips, including Elements Aficionado 1¼, and Elements Aficionado KS Slim.
In addition, the FDA issued orders for two Republic Tobacco roll-your-own filtered cigarette tubes, including Top Regular 100MM and Top Gold 100MM.
The agency determined these products to be "substantially equivalent" to the predicate products to which they were compared. The differences between the new and predicate tobacco products are such that the new products do not raise different questions of public health, according to the FDA.
The SE pathway allows tobacco manufacturers to legally sell a new product by establishing that it is substantially equivalent to a valid predicate product already on the market and does not present more harm to public health than the product to which it is compared.
In June, Lorillard Tobacco Co. became the first to receive the FDA marketing authorization for two new products: Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, as CSNews Online previously reported. Lorillard Tobacco Co. is a subsidiary of Greensboro, N.C.-based Lorillard Inc.