WASHINGTON -- On Wednesday, Oct. 9, the U.S. Food & Drug Administration (FDA) announced that it is authorizing the sale and marketing of three additional tobacco products through the substantial equivalence pathway.
The FDA issued orders for three roll-your-own tobacco paper products, manufactured by Republic Tobacco Co.: OCB Organic Hemp King Size Slim, OCB Organic Hemp 1 ¼ Size and OCB Organic Hemp Single Wide.
As directed by the Family Smoking Prevention & Tobacco Control Act, the 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, it said.
The FDA has determined these products to be "substantially equivalent" (SE) to a marketed predicate tobacco product. It 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.
For more information, visit the Tobacco Product Marketing Order webpage.
In June, 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. In September, 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. It also issued orders for two Republic Tobacco roll-your-own filtered cigarette tubes, including Top Regular 100MM and Top Gold 100MM.
The issuance of three SE orders for Republic Tobacco 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, the FDA said.
Glenview, Ill.-based Republic Tobacco is owned by DRL Enterprises, a holding company founded in 1969 by Chicago entrepreneur Donald Levin. DRL has businesses in aircraft, medical equipment, machinery leasing, film making and licensed sports product manufacturing.
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