FDA Approves Additional Products Under Its Substantial Equivalence Program

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

Today, the U.S. Food and Drug Administration (FDA) announced that the Agency is authorizing the sale and marketing of three additional tobacco products through the substantial equivalence pathway. As directed by the Family Smoking Prevention and Tobacco Control Act, FDA has a responsibility to protect public health by not allowing new tobacco products under FDA’s authority to come to market without FDA review.

FDA issued orders for three roll-your-own tobacco paper products, manufactured by Republic Tobacco: OCB Organic Hemp King Size Slim, OCB Organic Hemp 1 ¼ Size, and OCB Organic Hemp Single Wide.
The Agency determined these products to be “substantially equivalent” to a marketed predicate tobacco product. 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. 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.

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