FDA OKs Three RYO Products via Substantial Equivalence Pathway

SILVER SPRING, Md. -- The Food and Drug Administration (FDA) approved three more products that have been waiting in its substantial equivalence (SE) pipeline.

On Wednesday, the agency revealed it is authorizing the sale and marketing of three roll-your-own (RYO) tobacco paper products through the SE pathway. The products manufactured by Republic Tobacco Co. are OCB Organic Hemp King Size Slim, OCB Organic Hemp 1¼ Size and OCB Organic Hemp Single Wide.

The agency determined these products to be "substantially equivalent" to a marketed predicate tobacco product. The FDA concluded that, while the new products have different characteristics than the predicate product, the new products do not raise different questions of public health.

According to the agency, 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.

The issuance of the three substantial equivalence orders for Republic Tobacco products is an activity that is funded under FDA's user fee program in the Center for Tobacco Products. Some FDA activities that do not rely on annual appropriations are continuing during the government shutdown, the agency explained.